On August 3, 2015 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the three months ended June 30, 2015, and also provided an overview of recent accomplishments and upcoming milestones for its clinical development programs (Filing, 8-K, CytRx, AUG 3, 2015, View Source [SID:1234506975]).

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"The second quarter of 2015 has been very productive for CytRx. Enrollment in our ongoing pivotal global Phase 3 clinical trial of aldoxorubicin in soft tissue sarcoma (STS) continues on track to be completed in the first quarter of 2016. On the financial front, we successfully closed a public equity offering raising an additional $28.8 million in gross proceeds, which significantly strengthens our balance sheet and allows us to further advance the aldoxorubicin program, provide for pre-commercialization launch expenses, and introduce our next generation of therapies into the clinic in 2016," said Steven A. Kriegsman, Chairman and CEO of CytRx. "The second quarter also included the announcement of promising updated data from our Phase 2 programs evaluating aldoxorubicin in Kaposi’s Sarcoma (KS) and glioblastoma (GBM), in addition to compelling data in our two combination trials."

Mr. Kriegsman continued: "We were also pleased to recently unveil our proprietary LADR (Linker Activated Drug Release) technology platform which will be used for the development of our next-generation therapeutic drug conjugates which we may employ as treatments for liver, pancreatic, and non-small cell lung cancers, among others. These conjugates, developed at our laboratory facilities in Freiburg, Germany, will be designed to control release in tumors of high-potency chemotherapeutics that are attached to either albumin or anti-cancer antibodies. We believe this proprietary platform is highly complementary to and builds upon our ongoing global Phase 3 aldoxorubicin program."

Second Quarter 2015 and Recent Highlights

Strengthened the Corporate Balance Sheet. In July 2015, CytRx successfully completed a public offering of common stock securing gross proceeds of approximately $28.8 million. CytRx intends to use the net proceeds of the offering to fund clinical trials of its drug candidate aldoxorubicin and its drug discovery activities and for general corporate purposes, which will include pre-commercialization activities relating to aldoxorubicin, working capital and capital expenditures.

Unveiled proprietary LADR (Linker Activated Drug Release) Technology Platform. In June 2015, CytRx announced its proprietary LADR technology platform, a discovery engine designed to leverage the Company’s expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies. CytRx expects the LADR platform to rapidly expand its pipeline of oncology drug candidates, providing an avenue for the development of propriety therapies that complement its global Phase 3 aldoxorubicin program. Among the cancers being pursued are liver, pancreatic, and non-small cell lung cancer.

Reported Interim Phase 2 Data for Aldoxorubicin for HIV-Related Kaposi’s Sarcoma. In June 2015, at the 18th International Workshop on Kaposi’s Sarcoma Herpesvirus (KSHV) and Related Agents in Hollywood, Florida, CytRx reported interim results from its ongoing open-label Phase 2 pilot study evaluating the efficacy and safety of aldoxorubicin for the treatment of Kaposi’s Sarcoma (KS) in HIV-infected patients. The preliminary analysis from nine patients who received at least six cycles of aldoxorubicin (mean = 6.3 cycles), four of whom had received prior Doxil chemotherapy, showed six (67%) demonstrated a partial response (PR) to aldoxorubicin at the end of study visit (EOS), and 7 (78%) demonstrated PR within 4 months of EOS. Most importantly, doxorubicin could be detected in all tumor biopsies and higher doxorubicin concentrations were demonstrated within KS lesions relative to skin next to the lesions for 3/4 (75%) patients for whom adequate tissue was available for analysis. Five of 6 (83%) patients receiving aldoxorubicin and for whom data are available exhibited reduced intratumoral viral loads during therapy. A subset of patients also exhibited improvements in quality of life during treatment, and all patients exhibited either improvement or stability in immunologic and virologic HIV treatment parameters.

Strengthened the Leadership Team. In June 2015, CytRx appointed Cheryl Cohen to its Board of Directors. Ms. Cohen served as the Chief Commercial Officer of Medivation, Inc., from September 2011 to July 2014, where she built the company’s commercial framework and led its successful launch of Xtandi in the United States. Her experience will be highly valuable as the Company prepares for the commercialization of aldoxorubicin.

Reported Aldoxorubicin Cardiotoxicity Data in a Poster Presentation at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In May 2015, in a poster presentation at ASCO (Free ASCO Whitepaper), CytRx reported cardiotoxicity data from 200 patients across 7 clinical trials (1 Phase 3, 3 Phase 2 and 3 Phase 1) evaluating aldoxorubicin. The results showed that none of the patients exhibited a decrease in left ventricular ejection fraction (LVEF) that was below 50% of their institution’s normal value. 14% of patients demonstrated a ≥ 10% drop in LVEF and 21% had a ≥ 10% increase in LVEF. Other side effects observed were consistent with effects seen in other anthracycline treatments. Patients in these trials have received up to 5,439 mg/m2 of doxorubicin equivalents, or 12 times the peak cumulative dose of standard doxorubicin, without any evidence of cardiotoxicity. These results suggest that aldoxorubicin can be safely administered at cumulative doses of over 2 g/m2 without evidence of cardiotoxicity.

Reported Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer). In May 2015, CytRx reported positive updated data from its open-label, multisite trial in evaluating the preliminary efficacy and safety of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation and temozolomide. The updated trial results in 18 patients showed three pathological complete responses, as well as tumor shrinkage and prolonged stable disease. Aldoxorubicin was also well tolerated.

Reported Positive Interim Results from two Phase 1b Aldoxorubicin Trials in Chemotherapy Resistant Cancers. In May 2015, the Company announced positive interim results from its two ongoing Phase 1b clinical trials evaluating aldoxorubicin in chemotherapy resistant cancers. Interim results from seven patients in the first study, evaluating the preliminary safety and activity of ascending doses of aldoxorubicin plus ifosfamide/mesna for the first-line treatment of patients with locally advanced, unresectable, and/or metastatic sarcomas, show that the combination of aldoxorubicin plus ifosfamide/mesna was well tolerated, with one bone cancer patient achieving a complete tumor response (as assessed by PET/CT scan) following five treatment cycles. Interim results from seven patients in the second study, evaluating the preliminary safety and activity of ascending doses of aldoxorubicin plus gemcitabine in patients with advanced, unresectable, metastatic solid tumors that have either relapsed or were refractory to treatment following at least one prior chemotherapy or immunotherapy regimen, show that the combination of aldoxorubicin plus gemcitabine was well tolerated, with tumor shrinkage observed in three of seven patients following two treatment cycles. One patient with a history of chronic severe pain and inability to function normally demonstrated meaningful quality of life improvements, including stopping prescription narcotic pain medications and returning to work full-time. These results suggest that aldoxorubicin in combination with other chemotherapeutic agents has the potential to bolster anti-cancer activity.

Announced the Publication of a Clinical Case Study of Aldoxorubicin in Glioblastoma. In April 2015, the Company announced the publication of a case study, titled "Albumin-Linked Doxorubicin (Aldoxorubicin) as Treatment for Relapsed Glioblastoma: A Case Report," in the Journal of Nuclear Medicine & Radiation Therapy. In a 54 year old male patient with recurrent left parietal lobe glioblastoma multiforme (GBM) who was administered a single cycle of intravenous aldoxorubicin 350 mg/m2 (260 mg/m2 doxorubicin equivalents), histopathological assessment of tissue following a subsequent tumor debulking procedure showed no evidence of recurrent glioblastoma throughout the entire surgical specimen. These findings suggest that aldoxorubicin allows doxorubicin to cross the tumor’s blood-brain barrier in humans and induce tumor necrosis (tumor cell death). The full publication can be accessed here.

Upcoming Milestones

· Complete enrollment in the first quarter of 2016 in the ongoing pivotal global Phase 3 clinical trial of aldoxorubicin as a second-line treatment for STS under a Special Protocol Assessment, or SPA, granted by the FDA, with PFS data announced in the second half of 2016

· Report further results from its ongoing Phase 2 clinical trial of aldoxorubicin in patients with unresectable GBM by year-end 2015

· Report further results from its ongoing Phase 2 clinical trial of aldoxorubicin for the treatment of KS in HIV-infected patients by year-end 2015

· Complete enrollment in the ongoing Phase 1b clinical trial with a combination of aldoxorubicin and ifosfamide/mesna as first-line treatment for advanced sarcomas in the second half of 2015

· Complete enrollment in the ongoing Phase 1b clinical trial with a combination of aldoxorubicin and gemcitabine in metastatic solid tumors in the second half of 2015

· Complete enrollment in the ongoing Phase 2b clinical trial of aldoxorubicin in relapsed/refractory small cell lung cancer in the first quarter of 2016, with PFS data expected by the second half of 2016

· Announce a new oncology pipeline drug candidate, which utilizes novel linker technologies that couple chemotherapeutic agents and proteins either inside the body or externally, and then concentrate drug in tumors, in 2015

Second Quarter 2015 Financial Results

CytRx reported cash, cash equivalents and short-term investments of $53.8 million as of June 30, 2015.

Net loss for the three months ended June 30, 2015 was $11.7 million, or $0.21 per share, compared with a net loss of $15.7 million, or $0.28 per share, for the three months ended June 30, 2014. The decrease of $4.0 million in net loss during the current three-month period resulted primarily from a gain of $2.4 million on warrant derivative liability in the current quarter, as compared to a loss on warrant derivative liability of $2.5 million in the comparative 2014 period, for a difference of $4.9 million.

Research and development (R&D) expenses were $10.0 million for the second quarter of 2015, and included development expenses of $8.2 million for aldoxorubicin. The remaining $1.8 million of R&D expenses were primarily related to research and development support costs. R&D costs were $10.4 million for the second quarter of 2014.

General and administrative (G&A) expenses were $4.2 million for the second quarter of 2015, compared with $2.9 million for the second quarter of 2014. G&A expenses for the second quarter of 2015 included non-cash employee stock-compensation expense of $1.7 million, compared to $0.3 million for the same period in 2014.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About SCLC

An estimated 1.6 million new cases of lung cancer are diagnosed worldwide each year. In the Western world, approximately 13-15% of cases are SCLC, a deadly form of lung cancer associated with tobacco use. The five year survival rate is less than 7%, in part because an estimated 70% of patients have extensive disease at diagnosis. According to the National Cancer Institute, more than 30,000 new cases will be diagnosed in the USA in 2014. The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.

About Glioblastoma Multiforme

Glioblastoma is the most common and most malignant primary brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. The median survival after diagnosis is approximately 14 months, despite patients subsequently receiving surgical resection, radiotherapy and chemotherapy. Limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood:brain barrier.

About Kaposi’s Sarcoma

Kaposi sarcoma is a cancer that causes lesions (abnormal tissue) to grow in the skin; the mucous membranes lining the mouth, nose, and throat; lymph nodes; or other organs. The lesions are usually purple and are made of cancer cells, new blood vessels, red blood cells, and white blood cells. Kaposi sarcoma is different from other cancers in that lesions may begin in more than one place in the body at the same time. KS remains the most common HIV-associated tumor worldwide. The condition is also endemic in certain parts of Central Africa and Central and Eastern Europe.

About Bone Cancers (Osteosarcoma, Chondrosarcoma)

Bone cancer is a highly aggressive type of cancer that develops in bone. It starts in immature bone cells (osteoblasts) that normally form new bone tissue. According to the National Cancer Institute, there are approximately 3400 new cases of bone and joint cancer diagnosed each year in the United States, with approximately half of these occurring in children and teens. In addition, the estimated deaths in the U.S. were 1,460 in 2014. Although they can arise in any bone in the body, the most frequent sites are at the ends of the long bones of the legs and arms. In most cases, treatment consists of both chemotherapy and surgery, but patients with metastatic bone cancer continue to have a poor 5-year survival rate (15-30%).

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx is also seeking to expand its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx’s expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies.

On August 3, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that in July it has enrolled 33 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, AUG 3, 2015, View Source [SID:1234506982]). This marks a new monthly record. Total study enrollment now stands at 521 patients as of July 31, 2015 in the world’s largest Phase 3 study in head and neck cancer.

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"We continue to deliver record monthly enrollment numbers, which are in line with our expectations and bring us to over 500 patients enrolled in our Phase 3 study as of the end of July," stated CEL-SCI Chief Executive Officer Geert Kersten.

A total of 880 patients are expected to be enrolled, through approximately 100 clinical centers in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling just diagnosed, not yet treated patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only. Standard of care for these patients consists of the surgical removal of the tumor and any locally involved lymph nodes, followed by radiotherapy or concurrent radiochemotherapy.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

On August 3, 2015 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the three months ended June 30, 2015, and also provided an overview of recent accomplishments and upcoming milestones for its clinical development programs (Press release, CytRx, AUG 3, 2015, View Source [SID:1234506983]).

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"The second quarter of 2015 has been very productive for CytRx. Enrollment in our ongoing pivotal global Phase 3 clinical trial of aldoxorubicin in soft tissue sarcoma (STS) continues on track to be completed in the first quarter of 2016. On the financial front, we successfully closed a public equity offering raising an additional $28.8 million in gross proceeds, which significantly strengthens our balance sheet and allows us to further advance the aldoxorubicin program, provide for pre-commercialization launch expenses, and introduce our next generation of therapies into the clinic in 2016," said Steven A. Kriegsman, Chairman and CEO of CytRx. "The second quarter also included the announcement of promising updated data from our Phase 2 programs evaluating aldoxorubicin in Kaposi’s Sarcoma (KS) and glioblastoma (GBM), in addition to compelling data in our two combination trials."

Mr. Kriegsman continued: "We were also pleased to recently unveil our proprietary LADR (Linker Activated Drug Release) technology platform which will be used for the development of our next-generation therapeutic drug conjugates which we may employ as treatments for liver, pancreatic, and non-small cell lung cancers, among others. These conjugates, developed at our laboratory facilities in Freiburg, Germany, will be designed to control release in tumors of high-potency chemotherapeutics that are attached to either albumin or anti-cancer antibodies. We believe this proprietary platform is highly complementary to and builds upon our ongoing global Phase 3 aldoxorubicin program."

Second Quarter 2015 and Recent Highlights

Strengthened the Corporate Balance Sheet. In July 2015, CytRx successfully completed a public offering of common stock securing gross proceeds of approximately $28.8 million. CytRx intends to use the net proceeds of the offering to fund clinical trials of its drug candidate aldoxorubicin and its drug discovery activities and for general corporate purposes, which will include pre-commercialization activities relating to aldoxorubicin, working capital and capital expenditures.

Unveiled proprietary LADR (Linker Activated Drug Release) Technology Platform. In June 2015, CytRx announced its proprietary LADR technology platform, a discovery engine designed to leverage the Company’s expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies. CytRx expects the LADR platform to rapidly expand its pipeline of oncology drug candidates, providing an avenue for the development of propriety therapies that complement its global Phase 3 aldoxorubicin program. Among the cancers being pursued are liver, pancreatic, and non-small cell lung cancer.

Reported Interim Phase 2 Data for Aldoxorubicin for HIV-Related Kaposi’s Sarcoma. In June 2015, at the 18th International Workshop on Kaposi’s Sarcoma Herpesvirus (KSHV) and Related Agents in Hollywood, Florida, CytRx reported interim results from its ongoing open-label Phase 2 pilot study evaluating the efficacy and safety of aldoxorubicin for the treatment of Kaposi’s Sarcoma (KS) in HIV-infected patients. The preliminary analysis from nine patients who received at least six cycles of aldoxorubicin (mean = 6.3 cycles), four of whom had received prior Doxil chemotherapy, showed six (67%) demonstrated a partial response (PR) to aldoxorubicin at the end of study visit (EOS), and 7 (78%) demonstrated PR within 4 months of EOS. Most importantly, doxorubicin could be detected in all tumor biopsies and higher doxorubicin concentrations were demonstrated within KS lesions relative to skin next to the lesions for 3/4 (75%) patients for whom adequate tissue was available for analysis. Five of 6 (83%) patients receiving aldoxorubicin and for whom data are available exhibited reduced intratumoral viral loads during therapy. A subset of patients also exhibited improvements in quality of life during treatment, and all patients exhibited either improvement or stability in immunologic and virologic HIV treatment parameters.

Strengthened the Leadership Team. In June 2015, CytRx appointed Cheryl Cohen to its Board of Directors. Ms. Cohen served as the Chief Commercial Officer of Medivation, Inc., from September 2011 to July 2014, where she built the company’s commercial framework and led its successful launch of Xtandi in the United States. Her experience will be highly valuable as the Company prepares for the commercialization of aldoxorubicin.

Reported Aldoxorubicin Cardiotoxicity Data in a Poster Presentation at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In May 2015, in a poster presentation at ASCO (Free ASCO Whitepaper), CytRx reported cardiotoxicity data from 200 patients across 7 clinical trials (1 Phase 3, 3 Phase 2 and 3 Phase 1) evaluating aldoxorubicin. The results showed that none of the patients exhibited a decrease in left ventricular ejection fraction (LVEF) that was below 50% of their institution’s normal value. 14% of patients demonstrated a ≥ 10% drop in LVEF and 21% had a ≥ 10% increase in LVEF. Other side effects observed were consistent with effects seen in other anthracycline treatments. Patients in these trials have received up to 5,439 mg/m2 of doxorubicin equivalents, or 12 times the peak cumulative dose of standard doxorubicin, without any evidence of cardiotoxicity. These results suggest that aldoxorubicin can be safely administered at cumulative doses of over 2 g/m2 without evidence of cardiotoxicity.

Reported Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer). In May 2015, CytRx reported positive updated data from its open-label, multisite trial in evaluating the preliminary efficacy and safety of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation and temozolomide. The updated trial results in 18 patients showed three pathological complete responses, as well as tumor shrinkage and prolonged stable disease. Aldoxorubicin was also well tolerated.

Reported Positive Interim Results from two Phase 1b Aldoxorubicin Trials in Chemotherapy Resistant Cancers. In May 2015, the Company announced positive interim results from its two ongoing Phase 1b clinical trials evaluating aldoxorubicin in chemotherapy resistant cancers. Interim results from seven patients in the first study, evaluating the preliminary safety and activity of ascending doses of aldoxorubicin plus ifosfamide/mesna for the first-line treatment of patients with locally advanced, unresectable, and/or metastatic sarcomas, show that the combination of aldoxorubicin plus ifosfamide/mesna was well tolerated, with one bone cancer patient achieving a complete tumor response (as assessed by PET/CT scan) following five treatment cycles. Interim results from seven patients in the second study, evaluating the preliminary safety and activity of ascending doses of aldoxorubicin plus gemcitabine in patients with advanced, unresectable, metastatic solid tumors that have either relapsed or were refractory to treatment following at least one prior chemotherapy or immunotherapy regimen, show that the combination of aldoxorubicin plus gemcitabine was well tolerated, with tumor shrinkage observed in three of seven patients following two treatment cycles. One patient with a history of chronic severe pain and inability to function normally demonstrated meaningful quality of life improvements, including stopping prescription narcotic pain medications and returning to work full-time. These results suggest that aldoxorubicin in combination with other chemotherapeutic agents has the potential to bolster anti-cancer activity.

Announced the Publication of a Clinical Case Study of Aldoxorubicin in Glioblastoma. In April 2015, the Company announced the publication of a case study, titled "Albumin-Linked Doxorubicin (Aldoxorubicin) as Treatment for Relapsed Glioblastoma: A Case Report," in the Journal of Nuclear Medicine & Radiation Therapy. In a 54 year old male patient with recurrent left parietal lobe glioblastoma multiforme (GBM) who was administered a single cycle of intravenous aldoxorubicin 350 mg/m2 (260 mg/m2 doxorubicin equivalents), histopathological assessment of tissue following a subsequent tumor debulking procedure showed no evidence of recurrent glioblastoma throughout the entire surgical specimen. These findings suggest that aldoxorubicin allows doxorubicin to cross the tumor’s blood-brain barrier in humans and induce tumor necrosis (tumor cell death). The full publication can be accessed here.

Upcoming Milestones

Complete enrollment in the first quarter of 2016 in the ongoing pivotal global Phase 3 clinical trial of aldoxorubicin as a second-line treatment for STS under a Special Protocol Assessment, or SPA, granted by the FDA, with PFS data announced in the second half of 2016

Report further results from its ongoing Phase 2 clinical trial of aldoxorubicin in patients with unresectable GBM by year-end 2015
Report further results from its ongoing Phase 2 clinical trial of aldoxorubicin for the treatment of KS in HIV-infected patients by year-end 2015

Complete enrollment in the ongoing Phase 1b clinical trial with a combination of aldoxorubicin and ifosfamide/mesna as first-line treatment for advanced sarcomas in the second half of 2015

Complete enrollment in the ongoing Phase 1b clinical trial with a combination of aldoxorubicin and gemcitabine in metastatic solid tumors in the second half of 2015

Complete enrollment in the ongoing Phase 2b clinical trial of aldoxorubicin in relapsed/refractory small cell lung cancer in the first quarter of 2016, with PFS data expected by the second half of 2016

Announce a new oncology pipeline drug candidate, which utilizes novel linker technologies that couple chemotherapeutic agents and proteins either inside the body or externally, and then concentrate drug in tumors, in 2015

Second Quarter 2015 Financial Results

CytRx reported cash, cash equivalents and short-term investments of $53.8 million as of June 30, 2015.

Net loss for the three months ended June 30, 2015 was $11.7 million, or $0.21 per share, compared with a net loss of $15.7 million, or $0.28 per share, for the three months ended June 30, 2014. The decrease of $4.0 million in net loss during the current three-month period resulted primarily from a gain of $2.4 million on warrant derivative liability in the current quarter, as compared to a loss on warrant derivative liability of $2.5 million in the comparative 2014 period, for a difference of $4.9 million.

Research and development (R&D) expenses were $10.0 million for the second quarter of 2015, and included development expenses of $8.2 million for aldoxorubicin. The remaining $1.8 million of R&D expenses were primarily related to research and development support costs. R&D costs were $10.4 million for the second quarter of 2014.

General and administrative (G&A) expenses were $4.2 million for the second quarter of 2015, compared with $2.9 million for the second quarter of 2014. G&A expenses for the second quarter of 2015 included non-cash employee stock-compensation expense of $1.7 million, compared to $0.3 million for the same period in 2014.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About SCLC

An estimated 1.6 million new cases of lung cancer are diagnosed worldwide each year. In the Western world, approximately 13-15% of cases are SCLC, a deadly form of lung cancer associated with tobacco use. The five year survival rate is less than 7%, in part because an estimated 70% of patients have extensive disease at diagnosis. According to the National Cancer Institute, more than 30,000 new cases will be diagnosed in the USA in 2014. The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.

About Glioblastoma Multiforme

Glioblastoma is the most common and most malignant primary brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. The median survival after diagnosis is approximately 14 months, despite patients subsequently receiving surgical resection, radiotherapy and chemotherapy. Limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood:brain barrier.

About Kaposi’s Sarcoma

Kaposi sarcoma is a cancer that causes lesions (abnormal tissue) to grow in the skin; the mucous membranes lining the mouth, nose, and throat; lymph nodes; or other organs. The lesions are usually purple and are made of cancer cells, new blood vessels, red blood cells, and white blood cells. Kaposi sarcoma is different from other cancers in that lesions may begin in more than one place in the body at the same time. KS remains the most common HIV-associated tumor worldwide. The condition is also endemic in certain parts of Central Africa and Central and Eastern Europe.

About Bone Cancers (Osteosarcoma, Chondrosarcoma)

Bone cancer is a highly aggressive type of cancer that develops in bone. It starts in immature bone cells (osteoblasts) that normally form new bone tissue. According to the National Cancer Institute, there are approximately 3400 new cases of bone and joint cancer diagnosed each year in the United States, with approximately half of these occurring in children and teens. In addition, the estimated deaths in the U.S. were 1,460 in 2014. Although they can arise in any bone in the body, the most frequent sites are at the ends of the long bones of the legs and arms. In most cases, treatment consists of both chemotherapy and surgery, but patients with metastatic bone cancer continue to have a poor 5-year survival rate (15-30%).

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

On July 31, 2015 ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops novel anticancer therapeutics using its antibody-drug conjugate (ADC) technology, reported financial results for the Company’s 2015 fiscal year ended June 30, 2015 (Press release, ImmunoGen, JUL 31, 2015, View Source [SID:1234506779]). ImmunoGen also provided an update on product programs and guidance for its 2016 fiscal year.

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"This is clearly a transformational year for ImmunoGen," commented Daniel Junius, President and CEO. "Our lead product candidate, mirvetuximab soravtansine, has demonstrated impressive single-agent activity against platinum-resistant ovarian cancer in early clinical testing, and we are on track to initiate a trial later this year that could potentially support an accelerated registration pathway. We are also preparing to start a separate trial by year end to assess mirvetuximab soravtansine used in combination with other anticancer agents to potentially help more patients benefit from this promising agent, including women with earlier-stage disease. We plan to start the clinical assessment of our IMGN529 ADC in combination with rituximab shortly, with combination assessment of our other promising ADC for B-cell malignancies, coltuximab ravtansine, expected to start in 2016. And we are on track to submit an IND this fall for our next novel anticancer agent, IMGN779, which utilizes one of our potent new IGN payload agents."

Mr. Junius continued, "In the coming months, we also expect the progress being made by ImmunoGen partners to become more visible, with several programs on track to advance into potential registration trials in 2016, and other programs moving toward IND filing and the start of clinical testing. We believe our product pipeline will look markedly different – in stage and breadth – a year from now."

Updates on Product Programs

Mirvetuximab soravtansine (IMGN853), a potential new therapy for many cases of ovarian cancer as well as for other solid tumors that highly express folate receptor α (FRα); wholly owned by ImmunoGen.

Data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in May showed that treatment with mirvetuximab soravtansine monotherapy achieved marked tumor shrinkage in 53% of patients with FRα-positive platinum-resistant ovarian cancer in the expansion cohort of a Phase I trial. The enrollment of patients into this expansion cohort is expected to complete by year end, with presentation of the findings for the full 40-patient cohort anticipated in mid-2016.

ImmunoGen plans to initiate a Phase 2 trial assessing mirvetuximab soravtansine as a single agent for FRα-positive pre-treated ovarian cancer in late 2015; this trial potentially could support an accelerated registration pathway.

The Company also is preparing to start by year end a Phase 1b/2 trial assessing this ADC in combination regimens for FRα-positive ovarian cancer.

FRα is highly expressed on cases of many different types of solid tumors, including endometrial, breast, and lung cancers. Mirvetuximab soravtansine currently is being evaluated in a Phase 1 expansion cohort for the treatment of relapsed/refractory endometrial cancer, with other potential uses being assessed preclinically.

The Company recently established a collaboration with the National Comprehensive Cancer Network’s Oncology Research Program to facilitate assessment of mirvetuximab soravtansine in a variety of preclinical and clinical settings.

IMGN529 and coltuximab ravtansine (SAR3419), CD37- and CD19-targeting ADCs, respectively, are potential treatments for diffuse large B-cell lymphoma (DLBCL) and other B-cell malignancies; both are wholly owned by ImmunoGen.

The Company plans to begin assessment of IMGN529 for DLBCL in combination with rituximab later this year. Preclinical findings with this combination were presented in June, with additional data planned for submission to a medical conference in December. ImmunoGen also expects to begin assessment of IMGN529, used as a single agent, for the treatment of chronic lymphocytic leukemia in 2H2015.

For coltuximab ravtansine, ImmunoGen is assessing alternative combination strategies and expects to initiate combination clinical testing in 2016.

IMGN779, a CD33-targeting ADC utilizing one of ImmunoGen’s DNA-acting payload agents; a potential treatment for acute myeloid leukemia and myelodysplastic syndrome; wholly owned by ImmunoGen.

Remains on track for IND submission in 2H2015.
Anticipated events for partner product programs include:

Kadcyla (ado-trastuzumab emtansine) – Roche expects to apply for marketing approval in 2016 for second-line treatment of HER2-positive advanced gastric cancer using the results from its GATSBY trial, if positive;
ImmunoGen expects up to three partner compounds to advance into potentially pivotal Phase 2 or Phase 3 testing in 2016;
The Company anticipates several of its partners will have clinical data presentations in the next 12 months; and
ImmunoGen expects 2 to 4 additional partner compounds to advance into clinical testing by mid-2016.

Fiscal Year 2015 Financial Results

For the Company’s fiscal year ended June 30, 2015 (FY2015), ImmunoGen reported a net loss of $60.7 million, or $0.71 per basic and diluted share, compared to a net loss of $71.4 million, or $0.83 per basic and diluted share, for its fiscal year ended June 30, 2014 (FY2014). For the quarter ending June 30, 2015, ImmunoGen reported a net loss of $30.5 million, or $0.35 per basic and diluted share, compared to a net loss of $26.5 million, or $0.31 per basic and diluted share, for the same quarter in FY2014.

Revenues in FY2015 were $85.5 million, compared to $59.9 million in FY2014. FY2015 revenues include $57.8 million of license and milestone fees compared to $39.5 million in FY2014, with the increase primarily due to more development and commercialization licenses being taken by Novartis and Lilly in FY2015 and the associated amortization of upfront license fees, as well as increased revenue from milestone payments. FY2015 revenues also include $2.8 million of research and development support fees, compared to $7.2 million in such fees for FY2014, and $5.5 million of clinical materials revenue, compared to $2.9 million for FY2014. The level of research support and the number of batches of clinical materials produced and released to partners varies on a year-to-year basis.

FY2015 revenues also include $13.9 million of cash royalty revenues and $5.5 million of non-cash royalty revenues on Roche sales of Kadcyla for the nine-months ended December 31, 2014 and three months ended March 31, 2015, respectively. The latter reflects that royalties on Kadcyla sales occurring after January 1, 2015 are covered by the royalty purchase agreement announced in March 2015, and thus the associated cash is remitted to Immunity Royalty Holdings L.P. In FY2014, royalty payments received on sales of Kadcyla during the twelve months ended March 31, 2014 totaled $10.3 million.

Operating expenses in FY2015 were $140.0 million, compared to $131.4 million in FY2014. FY2015 operating expenses include research and development expenses of $111.8 million, compared to $107.0 million in FY2014 (inclusive of a $12.8 million non-cash charge related to a collaboration established with CytomX). The increase in FY2015 is primarily due to greater third-party costs related to the advancement of ImmunoGen product candidates, increased costs associated with the manufacturing of clinical materials on behalf of our partners, and higher personnel expenses, principally due to recent hiring. Operating expenses also include general and administrative expenses of $28.2 million in FY2015, compared to $24.5 million in FY2014. This increase is primarily due to greater personnel expenses, patent expenses and third-party service fees.

FY2015 expenses also include $5.4 million in imputed non-cash interest expense related to the sale of future Kadcyla royalties, which is treated as a liability for accounting purposes. ImmunoGen will be recording non-cash interest expense related to this transaction on an on-going basis.

ImmunoGen had approximately $278.1 million in cash and cash equivalents as of June 30, 2015, compared with $142.3 million as of June 30, 2014 and had no debt outstanding in either period. Cash used in operations was $55.3 million in FY2015, compared with $53.7 million in FY2014. Capital expenditures were $7.4 million and $8.2 million for FY2015 and FY2014, respectively.

Financial Guidance for 2016 Fiscal Year

For its fiscal year ending June 30, 2016, ImmunoGen expects: its revenues to be between $70 million and $80 million; its operating expenses to be between $175 million and $180 million; its net loss to be between $120 million and $125 million; its cash used in operations to be between $100 million and $105 million; and its capital expenditures to be between $13 million and $15 million. Cash and marketable securities at June 30, 2016 are anticipated to be between $165 million and $170 million.

Conference Call Information

ImmunoGen is holding a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 913-312-0951; the conference ID is 2265897. The call also may be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through August 14, 2015.

On July 31, 2015 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer, reported consolidated financial results for the second quarter of 2015 and progress in its clinical and business development programs (Press release, NewLink Genetics, JUL 31, 2015, View Source [SID:1234506780]).

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"NewLink Genetics continues to drive forward, and to execute on, its strategy of developing treatment options for patients with cancer using targeted immune response and disruptive checkpoint blockade," said Dr. Charles Link, Chairman and Chief Executive Officer. "We have seven product candidates across multiple cancer types in clinical development from Phase 1 to Phase 3. Our combined platform of product candidates positions us well to execute on our vision of combining cancer vaccines and checkpoint blockade inhibitors through our HyperAcute Immunotherapy and indoleamine 2,3-dioxygenase (IDO) pathway inhibitor platforms."

"During the second quarter, we continued our planned hiring and pre-commercial activities relating to our HyperAcute Immunotherapy algenpantucel-L, which is being studied for adjuvant treatment of patients with surgically resected pancreatic cancer," said Dr. Nicholas Vahanian, President and Chief Medical Officer.

The Company continued to build its presence with key opinion leaders by having a booth and poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The poster (#2070) highlighted encouraging results of the Phase 1b portion of a study showing that the combination of indoximod and temozolomide in temozolomide-refractory patients with progressive or refractory glioblastoma was well tolerated, with preliminary evidence of efficacy. Enrollment of the Phase 2 portion of the study is underway.

In addition, the Company hosted its first-ever analyst day on July 14, outlining its vision and execution plans surrounding its clinical programs. A webcast of the Company’s presentations can be found at View Source

Program Updates:

HyperAcute Immunotherapy Cancer Programs
NewLink Genetics’ proprietary HyperAcute Immunotherapy programs may prove to have broad potential for patients across a spectrum of cancer indications, including use in combination with checkpoint inhibitors. NewLink Genetics has multiple HyperAcute Immunotherapy programs in various stages of clinical development, including for pancreatic cancer, lung cancer, melanoma, renal cell cancer and prostate cancer.

Algenpantucel-L is NewLink Genetics’ HyperAcute Immunotherapy pancreatic cancer candidate in a Phase 3 clinical trial called IMPRESS, or IMmunotherapy for Pancreatic RESsectable Cancer Study. During the second quarter, following the second interim analysis of the study, the Company announced the recommendation of the data safety monitoring committee to proceed without modification to final analysis. The Company has announced that at the time of the second interim analysis, the estimated blended median overall survival in the trial from the time of randomization was 28.5 months for all patients. Median time from surgery to randomization was approximately 1.5 months. Therefore median survival from surgery was estimated to be approximately 30 months for all patients in our study. We believe that the median months of overall survival from randomization in the control arm is in the low twenties. The study is powered to show an improvement in overall survival after 442 events.

PILLAR, or Pancreatic Immunotherapy with Algenpantucel-L for Locally Advanced Non-Resectable Disease, is our Phase 3 clinical trial studying the efficacy of algenpantucel-L in patients with borderline resectable or locally advanced pancreatic cancer. We expect to complete enrollment in this study during 2015.

NewLink Genetics’ HyperAcute Immunotherapy product candidate tergenpumatucel-L is being tested versus docetaxel in a randomized Phase 2b study in patients with advanced lung cancer. We are currently enrolling patients in this study.

HyperAcute Immunotherapy product candidate dorgenmeltucel-L for patients with melanoma is being evaluated in a randomized Phase 2 study in combination with the checkpoint inhibitors ipilimumab, nivolumab, and pembrolizumab versus these checkpoint inhibitors alone.

IDO Pathway Inhibitor Programs

NewLink Genetics’ proprietary IDO pathway inhibitor, indoximod, is in multiple Phase 1 and Phase 2 clinical trials for the treatment of patients with breast, prostate, pancreatic and brain cancers as well as melanoma. We expect to complete enrollment of the following studies with indoximod within the next 12-15 months.

NLG2101, a global randomized Phase 2 trial testing indoximod in combination with docetaxel or paclitaxel in patients with metastatic breast cancer, is expected to fully enroll by the end of 2015. NewLink Genetics intends to present preliminary data from this study at an upcoming medical meeting in 2015.

NLG2102 is a Phase 2 trial of the combination of indoximod and temozolomide in refractory or relapsed glioblastoma multiforme patients.

NLG2103 is a Phase 2 trial testing indoximod in combination with the checkpoint inhibitors ipilimumab, nivolumab or pembrolizumab in patients with advanced melanoma. We expect to report top-line Phase 1b results at the Immunotherapy in Cancer Poster Session of the ESMO (Free ESMO Whitepaper)/ECC meeting in Vienna on Saturday, September 26 (#248, abstract 514).

NLG2104 is in a Phase 1b/2 trial testing indoximod in combination with gemcitabine plus nab-paclitaxel in patients with metastatic pancreatic cancer. Top-line Phase 1b results are expected in 2016.

NewLink Genetics has also entered into an exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development of the IDO inhibitor GDC-0919. Based on pre-clinical data presented at ASCO (Free ASCO Whitepaper) by our partner, GDC-0919 demonstrated decreases in plasma kynurenine levels and regulatory T-cells as well as an anti-tumor efficacy when combined with anti-PD-L1 and anti-CTLA4. This product candidate is currently in Phase 1 clinical development in patients with advanced solid tumors, and Phase 1 data on GDC-0919 is expected to be presented in a poster presentation at the ESMO (Free ESMO Whitepaper)/ECC meeting in Vienna on Sunday, September 27 (#157, abstract 346). In addition, a Phase 1 clinical trial, with a planned enrollment target of 224 patients, will study GDC-0919 in combination with Genentech’s PD-L1 inhibitor MPDL3280A for patients with locally advanced or metastatic solid tumors. An additional study is planned for GDC-0919 in combination with an OX40 inhibitor.

Financial Results for the Three-Month Period Ended June 30, 2015

Cash Position: NewLink Genetics ended the quarter on June 30, 2015, with cash and equivalents totaling $207.6 million, compared to $202.8 million for the year ending December 31, 2014.

R&D Expenses: Research and development expenses in the second quarter of 2015 were $16.1 million, compared to $6.5 million during the comparable period in 2014. The increase is primarily due to clinical trial expenses related to NewLink Genetics’ broad pipeline of product candidates, as well as expenses for manufacturing and research related to the Ebola vaccine candidate. Most of the Ebola-related expenses are subject to reimbursement under government contracts.

Net Income/Loss: NewLink Genetics reported a net loss of $14.1 million, or ($0.49) per diluted share, for the second quarter of 2015, compared to a net loss of $9.2 million, or ($0.33) per diluted share, for the comparable period in 2014.

NewLink Genetics ended the quarter with 28,661,588 shares outstanding.

Financial Guidance

NewLink Genetics expects to have more than $160 million in cash and equivalents on December 31, 2015.

"Our research and development expenses and capital expenditures continue to reflect our commitment to developing a broad pipeline of drug candidates and to ensure that we have the infrastructure in place to support the commercialization and manufacturing of algenpantucel-L," said Jack Henneman, Executive Vice President and Chief Financial Officer. "We will continue to make significant investments for the remainder of 2015 to support these efforts."