On July 28, 2017 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that it has entered into a global strategic license with NantCell, Inc., for the exclusive rights to develop and commercialize aldoxorubicin for all indications (Press release, CytRx, JUL 28, 2017, View Source [SID1234519933]). NantCell, a private subsidiary of NantWorks, LLC, is a clinical stage immuno-oncology company focused on developing novel molecularly targeted therapeutics including antibody, T-cell and NK cell based treatments for patients with cancer.

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"We are excited to forge this new relationship with NantCell. They are committed not just to bringing aldoxorubicin to the market for patients with soft tissue sarcomas, but to expand aldoxorubicin’s potential use in combination with both immuno-oncology and cell based therapies to better serve patients suffering from cancer," said Steven A. Kriegsman, CytRx’s Chairman and Chief Executive Officer. "This license and strategic investment will put aldoxorubicin in the hands of a committed partner who pioneered the development of albumin based chemotherapeutics, and will allow CytRx to continue to create new ultra-high potency drug candidates based on our LADR technology platform. Aldoxorubicin will clearly benefit from the first-hand experience of the NantCell management team led by Dr. Patrick Soon-Shiong, who developed and gained regulatory approval under a 505(b)(2) pathway and commercialized Abraxane, an albumin-mediated cytotoxic agent which currently grosses approximately $1 billion in annual sales."

"Aldoxorubicin’s distinct profile makes it the first anthracycline to allow for continuous dosing without increasing cardiac toxicity which would be beneficial for the 17 indications for which doxorubicin is currently approved and other indications where it could provide benefit," stated Dr. Soon-Shiong, NantCell’s Chairman and Chief Executive Officer. "We aim to rapidly incorporate aldoxorubicin into multiple treatment protocols for major tumor types like breast and brain cancers as well as sarcomas."

Under the terms of the license agreement, NantCell made a strategic investment by purchasing $13 million of CytRx common stock at $1.10 per share, representing approximately a 92% premium to CytRx’s most recent market price. CytRx is entitled to receive up to an additional $343 million in milestone payments related to regulatory approvals and commercial milestones for aldoxorubicin. In addition, CytRx will receive increasing double-digit royalties for sales of aldoxorubicin for soft tissue sarcomas and mid to high single digit royalties for all other indications. NantCell will be responsible for all future development, manufacturing and commercialization expenses. CytRx also issued NantCell a warrant to purchase up to 3 million shares of common stock at $1.10 over the next 18 months.

Aldoxorubicin is a rationally-engineered cytotoxic which combines doxorubicin, a widely used chemotherapeutic agent, with a novel linker molecule that binds directly and specifically to circulating albumin, the most abundant protein in the bloodstream. Protein-hungry tumors concentrate albumin, which facilitates 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. Typically, 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. Using this acid-sensitive linker technology, aldoxorubicin delivers greater doses of doxorubicin (3 ½ to 4 times). To date, there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 6,500 mg/m2 of doxorubicin equivalents. Aldoxorubicin is the first-ever single agent to show superiority over doxorubicin in a randomized clinical trial in first-line soft tissue sarcomas.

In addition, CytRx has amended its long-term loan facility and will make a payment of $5 million to the lender upon the closing of the exclusive global license and strategic investment for aldoxorubicin.

CytRx was represented by Skadden, Arps, Slate, Meagher & Flom LLP on the global license and strategic investment.

On July 28, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported consolidated financial results for the second quarter of 2017 and provided updates on its clinical development program for indoximod, NewLink Genetics’ small molecule targeting the IDO pathway with a distinct mechanism of action (Press release, NewLink Genetics, JUL 28, 2017, View Source [SID1234519925]).

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"We continue to focus on indoximod, our leading drug candidate, as it advances into late-stage clinical development," said Charles J. Link, Jr., M.D., Chairman, Chief Executive Officer, and Chief Scientific Officer. "We have made great progress since the end of the first quarter. We have strengthened the IP around this program with the USPTO Notice of Allowances for indoximod salts and prodrug formulations, and NLG802 entered the clinic."

Recent Highlights:

NewLink Genetics recently completed a successful face-to-face meeting with the FDA to review the proposed design for the pivotal trial with indoximod for patients with advanced melanoma.

First patient dosed in the Phase 1 study of NLG802, a novel prodrug of indoximod. NLG802 is a distinct investigational agent targeting the IDO pathway and represents an important step in the Company’s product life-cycle planning.

A Notice of Allowance (NOA) by the US Patent and Trade Office (USPTO) was received in early July for our patent application covering indoximod salts and prodrugs. When issued, this patent will provide exclusivity until 2036 and cover both the formulation of indoximod to be used in the pivotal trial and NLG802.

Phase 2 data from a randomized trial of indoximod in combination with the cancer vaccine, PROVENGE (sipuleucel-T), for patients with metastatic castration resistant prostate cancer (mCRPC) were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 5th. These data showed a statistically significant improvement in radiographic progression-free survival (rPFS) of 10.3 months compared to 4.1 months in the placebo arm, with no difference in adverse events between the two arms.

Phase 1b data from a trial of indoximod in combination with standard of care chemotherapy for patients with newly diagnosed Acute Myeloid Leukemia (AML) were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress on June 23rd. These early data showed that after one cycle of induction therapy, 7/7 patients who achieved complete response (CR) were seen to have no evidence of minimal residual disease (MRD-neg), suggesting that the addition of indoximod has the potential to reduce the proportion of patients with evidence of leukemia after initial therapy.
Guidance for remainder of 2017:

First patients dosed with novel salt formulation of indoximod.

Updated data from Phase 2 trial of indoximod plus gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer to be presented at an oncology meeting in late 2017 or early 2018.

Initiation of a pivotal trial of indoximod in combination with PD-1 checkpoint blockade for patients with advanced melanoma, with the goal of full enrollment by end of 2018.
Financial Results for the Three-Month Period Ended June 30, 2017

Cash Position: NewLink Genetics ended the second quarter with cash and cash equivalents totaling $107.8 million compared to $131.5 million for the year ending December 31, 2016.

R&D Expenses: Research and development expenses were $18.2 million in the second quarter of 2017 compared to $27.4 million in the second quarter of 2016. The decrease was due primarily to a $1.8 million decline in clinical trial spend, a decrease in supplies and other expense of $6.8 million, a decrease in personnel-related spend of $2.2 million, offset by an increase in manufacturing-related spend of $1.3 million, and an increase in licensing and consulting fees of $300,000.

G&A Expenses: General and administrative expenses in the second quarter of 2017 were $8.9 million compared to $9.1 million in the second quarter of 2016. The decrease was due to a decline of $1.0 million in personnel-related spend, offset by an increase of $261,000 in consulting and legal fees, an increase in stock compensation expense of $64,000, and an increase in supplies and other expense of $387,000.

Net Loss: NewLink Genetics reported a net loss of $16.7 million or ($0.57) per diluted share for the second quarter of 2017 compared to a net loss of $32.4 million or ($1.12) per diluted share for the second quarter of 2016.

NewLink Genetics ended the quarter with 29,281,301 shares outstanding.

Financial Guidance and Upcoming Investor Meetings

We expect to end 2017 with approximately $75 million in cash and equivalents, which excludes any cash that may be received from financing.

We look forward to presenting at the Baird Healthcare Conference and the Cantor Fitzgerald Healthcare Conference in September in New York City.

On July 28, 2017 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported recent highlights and reported financial results for the quarter ended June 30, 2017 (Press release, ImmunoGen, JUL 28, 2017, View Source [SID1234519924]).

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"We made substantial progress during the second quarter towards our strategic priorities, generating compelling data with our lead program, advancing our novel pipeline, and strengthening our balance sheet," said Mark Enyedy, ImmunoGen’s president and chief executive officer. "We reported single-agent and combination therapy data with mirvetuximab soravtansine in over 150 patients at ASCO (Free ASCO Whitepaper), which strengthen our confidence in the potential of mirvetuximab in the FORWARD I patient population and as we move into earlier lines of treatment for ovarian cancer. In addition, we presented encouraging initial clinical results for IMGN779 in AML, demonstrating dose-dependent biological and anti-leukemia activity, and the ability to retreat patients. Lastly, we significantly improved our cash position through transactions with Sanofi and Debiopharm, enabling us to increase our focus on the development of mirvetuximab and our IGN programs. We look forward to continued execution on these programs over the back half of the year, including filing the IND for IMGN632, our novel CD123-targeting ADC for hematological malignancies."

Recent Highlights

Proprietary Portfolio

Presented pooled analyses of three Phase 1 expansion cohorts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrating the safety and efficacy profile of mirvetuximab soravtansine in the patient population being enrolled in FORWARD I, the ongoing Phase 3 registration trial in women with folate receptor alpha (FRα)-positive ovarian cancer;
Presented encouraging data from the Phase 1b/2 FORWARD II study at ASCO (Free ASCO Whitepaper), evaluating mirvetuximab soravtansine in combination with Avastin (bevacizumab), carboplatin, Doxil (pegylated liposomal doxorubicin), or Keytruda (pembrolizumab), demonstrating its potential to complement currently available therapies for FRα-positive ovarian cancer in a range of treatment settings, including earlier lines of therapy; and
Presented first-in-human data at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) on IMGN779 in patients with relapsed or refractory adult acute myeloid leukemia (AML), whose tumors express CD33, demonstrating safety and tolerability across seven dose levels, with no dose limiting toxicities, as well as evidence of dose-dependent biological and anti-leukemia activity.
Partner Programs

In exchange for a $30 million payment, ImmunoGen granted sanofi-aventis U.S. LLC (Sanofi) a fully-paid, exclusive license to develop, manufacture, and commercialize the following experimental agents in development: isatuximab (SAR650984), an unconjugated anti-CD38 antibody in Phase 3 development for relapsed and refractory multiple myeloma; SAR566658, an ADC targeting CA6; SAR408701, an anti-CEACAM5 ADC; an additional ADC directed to an undisclosed target; and SAR428926, an ADC targeting LAMP1;
In exchange for a $25 million upfront payment, Debiopharm International, S.A. (Debiopharm) acquired the Company’s IMGN529/DEBIO 1562, a clinical-stage anti-CD37 ADC for the treatment of patients with B-cell malignancies, such as non-Hodgkin lymphoma. ImmunoGen will receive a $5 million milestone payment upon completion of the transfer of technologies related to the asset, which is expected before year end, and is also eligible for a second success-based milestone payment of $25 million upon IMGN529/DEBIO 1562 entering a Phase 3 clinical trial;
CytomX announced the treatment of the first patient in a Phase 1/2 clinical trial evaluating CX-2009, a ProbodyTM drug conjugate, as monotherapy in select advanced solid tumors, resulting in a $1 million milestone payment to ImmunoGen; and
Bayer announced that the Phase 2 trial assessing anetumab ravtansine in patients with recurrent malignant pleural mesothelioma did not meet its primary endpoint of progression-free survival. The safety and tolerability of anetumab ravtansine were consistent with earlier clinical findings and Bayer is continuing development in additional studies, including a Phase 1b multi-indication study in six different types of advanced solid tumors, and a Phase 1b combination-study in patients with recurrent platinum-resistant ovarian cancer.
Additional Upcoming Events

ImmunoGen anticipates filing an investigational new drug (IND) application in the third quarter of 2017 to support clinical testing with IMGN632, a CD123-targeting ADC integrating a more potent DNA-alkylating payload intended to treat a range of hematological malignancies.
The Company expects to present updated clinical data for IMGN779 in patients with relapsed or refractory adult AML at an upcoming medical meeting.
ImmunoGen plans to publish results from the 40 patient Phase 1 mirvetuximab soravtansine expansion cohort evaluating the use of prophylactic steroid eye drops. The findings support the use of eye drops in the Phase 3 FORWARD I trial.
Financial Results

Revenues for the quarter ended June 30, 2017 were $39.0 million, compared to $7.4 million for the quarter ended June 30, 2016. License and milestone fees for the second quarter of 2017 included a $30 million paid-up license fee related to an amendment to the Company’s collaboration and license agreement with Sanofi and a $1 million Phase 1 milestone payment pursuant to the Company’s license agreement with CytomX. Revenues in the second quarter of 2017 included $6.4 million in non-cash royalty revenues, compared with $5.9 million in non-cash royalty revenues for the same quarter in 2016. Revenues for the second quarter of 2017 also included $0.9 million of research and development (R&D) support fees and $0.6 million of clinical materials revenue, compared with $1.3 million and $0.1 million, respectively, for the same quarter in 2016.

Operating expenses for the second quarter of 2017 were $44.2 million, compared to $48.0 million for the same quarter in 2016. Operating expenses in the second quarter of 2017 include R&D expenses of $35.3 million, compared to $38.7 million for the same quarter in 2016. This change is primarily due to a workforce reduction resulting from the strategic review in September 2016, decreased clinical trial costs driven by the Phase 1 mirvetuximab soravtansine and IMGN529 studies winding down, and lower third party costs. These decreases were partially offset by increased costs related to the FORWARD I Phase 3 clinical trial, as well as an increase in antibody expense driven by mirvetuximab soravtansine commercial-readiness activities. Operating expenses include general and administrative expenses of $8.8 million in the second quarter of 2017 compared to $9.3 million in the same quarter in 2016. This decrease is primarily due to decreased personnel expenses.

ImmunoGen reported a net loss of $8.9 million, or $0.10 per basic and diluted share, for the second quarter of 2017 compared to a net loss of $45.9 million, or $0.53 per basic and diluted share, for the same quarter last year.

ImmunoGen had approximately $150.3 million in cash and cash equivalents as of June 30, 2017, compared with $160.0 million as of December 31, 2016, and had $100.0 million of convertible debt outstanding in each period. Cash used in operations was $8.9 million for the first six months of 2017, compared with $59.0 million for the same period in 2016. The current period benefited from a $30 million paid-up license fee received from Sanofi, which is included in revenue in the current period, and a $25 million upfront payment received from Debiopharm that is included in deferred revenue as of June 30, 2017. Capital expenditures were $0.8 million and $5.2 million for the six months ended June 30, 2017 and 2016, respectively.

Financial Guidance

ImmunoGen has updated its guidance for 2017. Expected revenues are now projected to be between $115 million and $120 million, compared with previous guidance of between $70 million and $75 million; and cash and cash equivalents at December 31, 2017 are expected to be between $90 million and $95 million, compared to previous guidance of $35 million to $40 million. These changes are a result of the Debiopharm and Sanofi agreements executed in the second quarter of 2017. Operating expenses remain unchanged and are expected to be between $175 million and $180 million.

ImmunoGen expects that its current cash plus expected cash revenues from partners and collaborators will enable the Company to fund operations into the second half of 2018.

On July 28, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Venclexta (venetoclax) in combination with low dose cytarabine (LDAC) for elderly patients with previously untreated AML who are ineligible for intensive chemotherapy (Press release, Hoffmann-La Roche, JUL 28, 2017, View Source [SID1234519919]). FDA breakthrough therapy designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious or life-threatening diseases and to help ensure that patients receive access to medicines as soon as possible. This is the seventeenth breakthrough therapy designation for Roche’s portfolio of medicines, and the fourth for Venclexta.

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Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.
Breakthrough therapy designation was granted based on data from an ongoing open-label phase Ib study of Venclexta in combination with LDAC in previously untreated elderly patients (over 65 years) with AML, an aggressive form of leukaemia, who are ineligible for intensive chemotherapy. Preliminary data from this study (M14-387) presented at the 22nd European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, 22-25 June, in Madrid 2017 (Abstract E911) showed durable efficacy with an acceptable safety profile for Venclexta in combination with LDAC in this patient group.

About AML
AML is an aggressive form of leukaemia that starts in immature forms of blood-forming cells, known as myeloid cells, found in the bone marrow.2 AML is the most common type of aggressive leukaemia in adults.1 It has one of the lowest survival rates of all types of leukaemia3. Even with the best available therapies, older patients aged 65 and over have survival rates comparable to patients with advanced lung cancer, with a five year overall survival rate of <5%.4,5 Approximately 20,000 people in the United States and 18,000 in Europe are diagnosed with AML each year.6,7

About Venclexta
Venclexta is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). It is believed that blocking BCL-2 may restore the signalling system that tells cells, including cancer cells, to self-destruct.

Venclexta is being co-developed by AbbVie and Roche. Together, the companies are committed to research with Venclexta, which is currently being evaluated in phase III clinical trials for the treatment of relapsed, refractory and previously untreated chronic lymphocytic leukaemia, along with studies in several other cancers including AML. Venclexta is commercialised jointly by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.