On September 29, 2015 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing novel therapies for treatment of cancer, reported its plans for the further advancement of its lead investigational drug, CA4P (combretastatin A4 phosphate, or fosbretabulin) (Press release, OXiGENE, SEP 29, 2015, View Source [SID:1234507610]). This follows a thorough evaluation of the company’s pipeline opportunities. Schedule your 30 min Free 1stOncology Demo! OXiGENE’s advancement plans include two phase 2/3 clinical trials evaluating whether CA4P improves the current standard-of-care in patients who have failed to respond to initial treatment. Both trials planned by the company are designed as two stage, phase 2/3 studies. The first stage of each trial would be a randomized, investigator-blinded, placebo-controlled study with up to 80 patients. The second stage of each trial would be a large, double-blind, placebo-controlled, confirmatory phase 3 study, the start of which would be triggered by a demonstration of efficacy in the first stage. Each trial is designed so that a particularly robust efficacy signal in the first stage would accelerate the timing of the transition into the larger second stage phase 3 portion.
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Ovarian cancer
The first clinical trial OXiGENE plans to initiate will be in platinum-resistant ovarian cancer, with the goal of determining whether the addition of CA4P to the standard-of-care (chemotherapy plus Avastin (bevacizumab)) improves patient outcomes. Patients would be randomized on a 1:1 basis to receive either the current standard-of-care or the current standard-of-care plus CA4P. The primary endpoint will be progression-free survival (PFS). The company expects to initiate the trial in the first half of 2016.
The proposed phase 2/3 trial is based on the results of the recent GOG186I study in which the anti-vascular combination of CA4P and Avastin showed statistically significant improvements in PFS compared to Avastin alone. The benefits appeared to be particularly robust in patients with platinum-resistant disease where a post-hoc subgroup analysis of the study showed that patients who had platinum-resistant disease had a median PFS of 6.7 months when treated with Avastin and CA4P compared to 3.4 months for those receiving Avastin alone.
"In analyzing the various clinical trials that OXiGENE has conducted over the years, CA4P, also known as fosbretabulin, has repeatedly shown a positive effect in the treatment of solid tumors," stated William D. Schwieterman, M.D., OXiGENE’s President and CEO. "However, the effect of CA4P has been markedly stronger when it is given in combination with an anti-VEGF agent such as Avastin, since the two drugs attack a tumor’s blood-flow in a complementary manner. The most striking example of this that we have seen was in platinum-resistant patients in the most recent ovarian cancer trial, and we aim to build upon these positive results in our planned trial by including the chemotherapy that most patients receive."
Given the greater potential commercial value of the currently proposed study, OXiGENE no longer plans to study or submit a Special Protocol Assessment for the combination of CA4P and Avastin without chemotherapy.
In the U.S., approximately 22,000 women are diagnosed with ovarian cancer each year, of which 4,300 are resistant to platinum-based therapies.
Glioblastoma multiforme
The second phase 2/3 clinical trial OXiGENE plans to initiate will be in glioblastoma multiforme (GBM) patients who have failed first-line chemotherapy treatment, with the goal of determining whether CA4P improves upon the current standard of care, which is treatment with Avastin alone. Patients will be randomized on a 1:1 basis to receive either Avastin or Avastin plus CA4P. The primary endpoint will be PFS. The company expects to initiate the trial in the second half of 2016.
"The combination of CA4P and Avastin, without any chemotherapy, is the same treatment regimen that ovarian cancer patients recently received in the GOG study. Based on the highly vascular nature of tumors in GBM, similar to ovarian cancer tumors, we believe that CA4P can have a potentially meaningful effect in this indication," continued Dr. Schwieterman. "The medical need is unquestionable, and I believe that this unmet need combined with the dearth of other GBM treatment options and competing clinical trials will provide us the shortest potential path towards approval."
In the U.S., approximately 11,000 patients are diagnosed with glioblastoma multiforme each year, of which 6,000 are considered recurrent.
Other programs continue on track
The company also announced that it will continue to evaluate CA4P in two ongoing studies, which are:
A phase 1b/2 clinical trial in combination with VOTRIENT (pazopanib) in advanced recurrent ovarian cancer. Initial data from the dose escalation portion is expected to be presented at the European Society of Gynaecological Oncology conference being held October 24-27, 2015.
A phase 2 clinical trial as a single agent in patients with gastrointestinal and pancreatic neuroendocrine tumors, with interim data expected to be available approximately year-end 2015.
OXiGENE’s other investigational drug, OXi4503, is being studied in a phase 1 clinical trial in patients with Acute Myeloid Leukemia (AML), and the company is in the process of expanding the trial to include additional investigator sites.
Conference Call
Members of OXiGENE’s management team will host a webcast and conference call tomorrow, September 30, 2015, at 9:00 a.m. EDT (6:00 a.m. PDT) to discuss OXiGENE’s CA4P development plans.
To listen to a live or an archived version of the audio webcast, please log on to the Company’s website, www.oxigene.com. Under the "Investors & Media" tab, select the link to "Events and Presentations." OXiGENE’s conference call can also be heard live by dialing (888) 841-3431 in the United States and Canada, or +1 (678) 809-1060 for international callers, five minutes prior to the beginning of the call. The conference ID is 51228074.
Author: [email protected]
GTx Announces Enrollment of First Patient in Phase 2 Clinical Trial of Enobosarm in ER+/AR+ Breast Cancer
On September 29, 2015 GTx, Inc. (Nasdaq: GTXI) reported the enrollment of the first patient into its Phase 2 clinical trial of enobosarm (GTx-024) to treat women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer (Press release, GTx, SEP 29, 2015, View Source [SID:1234507609]). Enobosarm, a selective androgen receptor modulator (SARM), is the Company’s lead product candidate. Schedule your 30 min Free 1stOncology Demo! "Additional endocrine directed therapies are needed for the treatment of estrogen receptor positive breast cancer as many women who respond to hormonally directed therapy will continue to demonstrate response with subsequent hormonal manipulation," said Robert J. Wills, Ph.D., Executive Chairman of GTx. "We believe that enobosarm may provide a new hormonal approach for the treatment of estrogen receptor positive breast cancer and may delay the need for chemotherapy in these women."
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The open-label, multi-center, multinational Phase 2 clinical trial (NCT02463032) will assess the efficacy and safety of orally administered enobosarm in up to 88 evaluable patients with metastatic or locally advanced, ER+/AR+ breast cancer. Patients will receive either enobosarm 9 mg or 18 mg given daily for up to 24 months. The initial stage of evaluation will be assessed among the first 18 evaluable patients for each dosing arm. If at least 3 of 18 patients achieve clinical benefit at week 24, then the trial will proceed to the second stage of enrollment for that dosing arm to assess clinical benefit in a total of 44 evaluable patients per arm. Clinical benefit is defined as a complete response, partial response, or stable disease, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks. The lead investigator for the trial is Dr. Beth Overmoyer from the Dana Farber Cancer Institute and the Harvard Medical School.
About enobosarm
Enobosarm, a selective androgen receptor modulator (SARM), has been evaluated in 23 completed or ongoing clinical trials enrolling over 1,500 subjects at doses ranging from 0.1 mg to 100 mg. At all evaluated dose levels, enobosarm was observed to be generally safe and well tolerated.
Most recently, enobosarm 9 mg has been tested in a Phase 2, proof of concept clinical trial of 22 postmenopausal women with ER+ metastatic breast cancer who have previously responded to endocrine therapy. Seventeen of the 22 patients were confirmed to be AR+. Six of these 17 patients demonstrated clinical benefit at six months. Seven patients in total (one patient with indeterminate AR status) achieved clinical benefit at six months. The results also demonstrated that, after a median duration on study of 81 days, 41 percent of all patients (9/22) achieved clinical benefit as best response and also had increased PSA which appears to be an indicator of AR activity. Enobosarm was well tolerated. The most common adverse events reported were pain, fatigue, nausea, hot flash/night sweats, and arthralgia.
About ER+/AR+ Breast Cancer
Breast cancer is the most commonly diagnosed cancer in women, and one in eight women will develop invasive breast cancer in their lifetime. In 2012, 1.7 million women were diagnosed with breast cancer, and there were 6.3 million women alive who had been diagnosed with breast cancer in the previous five years. Clinical assessment of breast cancer provides for routine characterization of receptor status including the presence or absence of estrogen receptor (ER), progesterone receptor, and human epidermal growth factor receptor 2 (HER2) in the tumor tissue. Receptor status is used to assess metastatic potential as well as to guide treatment decisions. The majority of breast cancers are considered hormone receptor positive (expressing ER or progesterone receptor). Approximately 70 percent of women in the U.S. with breast cancer have ER+ tumors, and 75 to 90 percent of these cancers are also AR+.
Estrogen promotes the growth of breast cancers that are hormone receptor positive. Therefore, treatment is directed at blocking the effects of estrogen on the breast cancer either through blocking the estrogen receptor or minimizing the production of estrogen. This endocrine therapy is the cornerstone of treatment for the majority of women with hormone receptor positive advanced breast cancer and is the preferred initial treatment over alternative approaches such as chemotherapy, due to its efficacy and favorable safety profile. Patients who respond to one endocrine therapy are likely to respond to subsequent hormonal therapies. Therefore, the standard of care for women with hormone receptor positive breast cancer typically involves the sequencing of endocrine agents until intolerance or development of resistance occurs, or metastatic progression necessitates a transition to chemotherapy.
Enobosarm may offer an alternate hormonal approach for the treatment of endocrine sensitive advanced breast cancer prior to the introduction of chemotherapy.
U.S. FDA GRANTS PRIORITY REVIEW STATUS TO sNDA FOR ANTICANCER AGENT HALAVEN(R) AS TREATMENT FOR SOFT TISSUE SARCOMA
On September 29, 2015 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Eisai’s in-house developed anticancer agent Halaven (eribulin mesylate) as a treatment for soft tissue sarcoma, and granted the sNDA Priority Review status (Press release, Eisai, SEP 29, 2015, View Source [SID:1234507599]). Schedule your 30 min Free 1stOncology Demo! The FDA’s Priority Review designation is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of January 29, 2016, six months after the sNDA was submitted.
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Eisai submitted applications seeking approval for the additional indication of soft tissue sarcoma in the United States and Europe (EU) respectively on July 29, 2015, and in Japan on July 30, 2015.
Soft tissue sarcoma is a collective term for a diverse group of malignant tumors that occur throughout the soft tissue (fat, muscle, nerves, fibrous tissues and blood vessels) in the body. Approximately 12,000 patients in the United States and 29,000 patients in Europe are diagnosed with soft tissue sarcoma each year. According to a patient survey conducted by the MHLW, there are approximately 4,000 patients with soft tissue sarcoma in Japan. Meanwhile, Halaven has been designated as an orphan drug for the treatment of soft tissue sarcoma in the United States and Japan.
Halaven is a halichondrin class microtubule dynamics inhibitor with a novel mechanism of action. It was first approved for the treatment of metastatic breast cancer in the United States in November 2010, and is currently approved in approximately 60 countries including Japan and countries in Europe, the Americas and Asia.
Eisai remains committed to providing further clinical evidence for Halaven aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.
CBMG Announces Positive Results from CAR-T EGFR Immunotherapy in Advanced Relapsed/Refractory Patients with Solid Tumors
On September 28, 2015 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, reported results from an expanded Phase I/II clinical trial evaluating the safety, feasibility and anti-tumor activity of its Chimeric Antigen Receptor-Modified T-Cells (CAR-T) immunotherapy (CBM-EGFR.1) targeting wild type EGFR (Epidermal Growth Factor Receptor) for the treatment of patients with EGFR expressing advanced relapsed/refractory solid tumors. Based on the results from 24 patients treated with CBM-EGFR (Press release, Cellular Biomedicine Group, SEP 28, 2015, View Source [SID:1234507606]).1 (17 patients with non-small cell lung cancer (NSCLC), 5 patients with cholangiocarcinoma, 1 patient with pancreatic cancer and 1 patient with renal cell carcinoma (RCC)), the early results showed that CBM-EGFR.1 immunotherapy was safe, well tolerated, and had positive signal of clinical activity in several indications. The data was selected for a late-breaking oral presentation entitled EGFR-Targeted Chimeric Antigen Receptor-Modified T Cells Immunotherapy for Patients With EGFR-Expressing Advanced or Relapsed/Refractory Solid Tumors at the 5th World Congress on Cancer Therapy in Atlanta, Georgia on September 28, 2015. The abstract can be viewed online here. The results from the first 11 NSCLC patients in the trial outlined in the abstract, entitled Chimeric Antigen Receptor-Modified T-Cells for the Immunotherapy of Patients with HER-1 Expressing Advanced Relapsed/Refractory Non-Small Cell Lung Cancer was presented at the 2015 European Cancer Congress’ (ECCO) annual meeting held in Vienna, Austria from September 25-29, 2015. The abstract can be viewed online here.
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About the Trial
The CBM-EGFR.1 phase I/II trial was designed and conducted by Chinese PLA General Hospital ("PLAGH", Beijing, also known as "301 Hospital"), led by Principal Investigator Wei Dong Han, M.D., Ph.D., head of the cancer immunotherapy department and director of molecular immunology department of the life science institute of PLAGH. The trial enrolled 24 EGFR positive (defined as at least 50% membrane staining of EGFR based on immunohistochemistry), advanced, relapsed/refractory patients with NSCLC, cholangiocarcinoma, RCC or pancreatic cancer. Most of the NSCLC patients failed EGFR-TKI therapy prior to CBM-EGFR.1 treatment. All patients provided written informed consent before enrollment, and received dose escalating infusions of CBM-EGFR.1 cells with or without conditioning chemotherapy. Autologous CBM-EGFR.1 cells were generated from 50 to 80 ml peripheral blood after a 10 to 12-day in vitro expansion, and the total CAR-expressing T cell number of 1×106/kg was set as an output control. The presence of EGFR positive cells in tumor tissues was evaluated by means of immunohistochemistry (IHC). Serum cytokines such as IL-6, IL-2, TNF-a, copy numbers of CAR-EGFR.1 transgene in peripheral blood and biopsied tissues, were monitored periodically according to assigned protocol. Clinical responses were evaluated using RECIST 1.1 and adverse events were graded by CTCAE 4.0. This study is registered with the U.S. National Institute of Health (NIH) here.
Highlight of Phase I/II clinical trial for CBMG CAR-T products in multiple advanced, refractory/relapsing solid tumors
First known report of positive safety and signal of clinical activity of EGFR CAR-T in multiple solid tumor indications
Most NSCLC patients treated with CBM-EGFR.1 failed EGFR-TKI therapy prior to CBM-EGFR.1 treatment
Overall disease control rate (DCR) is 79% (19 of 24). 100% DCR in cholangiocarcinoma (5/5), 71% DCR in NSCLC (12/17)
Objective response rate (ORR) of 25% in combined indications: 2 complete response (CR) and 1 partial response (PR) in cholangiocarcinoma, 2 PR in NSCLC and 1 PR in pancreatic cancer
The clinical responses were evaluated with RECIST1.1 and immune-related response criteria by a team of experts, and adverse events were graded with CTCAE 4.0. Of the 24 patients with evaluable clinical outcome, the overall DCR was 79% (19 of 24). Under standard protocol, an independent review of the clinical data by a separate team of experts will commence at the end of the trial. Of the 5 cholangiocarcinoma patients reported here, 2 achieved CR, 1 achieved PR, and 2 had stable disease (SD). The single pancreatic cancer patient had a PR and a single RCC patient achieved SD. Of the 17 NSCLC patients treated, 2 had PR, 10 had SD, and 5 had progressive disease. Of the 26 adverse events experienced by patients, only 1 was grade 3-4 where the patient experienced serum lipase increase. No patients experienced drug related deaths. Grade 1-2 pruritus was the most frequent adverse event experienced by patients (9/26; 35%). Desquamation and constipation are the other two frequently observed adverse events in the trial (4/26 each; 15%). Only 3 out of 24 patients exhibited Grade 2 cytokine release syndrome within one week post infusions. The median dose of transfused CBM-EGFR.1 cells was 1.18×107 cells/kg (IQR, 0.76 to 1.43×107 cells/kg). The transgene copies measured by PCR in both blood and biopsy tissues post CBM-EGFR.1 infusions indicated the trafficking of CART cells into the tumor tissues. Pathological eradication of EGFR positive tumor cells after CBM-EGFR.1 treatment was observed in tumor biopsies, along with clear evidence of the CBM-EGFR.1 cells detected in tumor-infiltrating T cells in all patients with available tumor biopsies post treatment.
Yihong Yao, Ph.D., Chief Scientific Officer of the Company commented, "The early signal of clinical activity, especially those observed in patients with late stage cholangiocarcinoma, and those with late stage NSCLC that failed prior EGFR-TKI therapy, are very encouraging. To our knowledge this is the first report of positive safety and tolerability data of EGFR CAR-T in multiple solid tumor indications. We are moving forward to confirm the safety and tolerability profile of CBM-EGFR.1 in cholangiocarcinoma and NSCLC, and will actively explore the opportunities in other solid tumor indications by implementing state-of-the-art translational medicine strategy in the clinical development. We are determined to look for early possibilities of conducting multi-center Phase IIb trials to validate the clinical activity from early observations. We have also begun to evaluate potential partners to develop an immunohistochemistry based diagnostic assay to aid in the patient selection whenever needed. We are optimistic that CBM-EGFR.1 will be able to provide late stage cancer patients with another option to extend their lives."
The Company also previously announced positive clinical data results for its Phase I clinical trials for CBM-CD19.1, CBM-CD20.1 and CBM-CD30.1 CAR-T assets targeting late-stage hematological cancer. Clinical trial data for all three constructs can be found registered with the U.S. National Institute of Health (NIH) here: NCT01864889, NCT01735604, NCT02259556.
"We are extremely excited by the recent developments resulting from the collaboration between CBMG and PLA General Hospital. These two reports on CBM-EGFR.1 therapy for late stage solid tumors have clearly demonstrated our ability to innovate, advance boundaries between basic research and translational medicine and streamline the manufacture of CAR-T and clinical treatment. We are confident and determined to be at the forefront of clinical development of these breakthrough CAR-T therapies for late stage cancer patients with solid tumors," concluded Dr. William (Wei) Cao, Chief Executive Officer of Cellular Biomedicine Group.
CBMG Responds to Inquiries from Investors and the Scientific Community About Its Immuno-Oncology Cell Therapy Platform
On September 28, 2015 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, reported that it responded to inquiries from investors and the scientific community about its Immuno-Oncology cell therapy platform as it relates to information surrounding CD19, CD20 and CD30 (Press release, Cellular Biomedicine Group, SEP 28, 2015, View Source [SID:1234507605]).
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Dr. William (Wei) Cao, Chief Executive Officer of Cellular Biomedicine Group commented, "We are taking a proactive approach to addressing inquiries from the investment and scientific community on the Company’s Immuno-Oncology cell therapy platform on a more real-time basis. This area has been well followed and we would like to take this opportunity to expand on frequently asked questions and dispel misinformation in the marketplace. We will continue to keep our stakeholders apprised of ongoing business and pipeline developments."
Can CBMG clarify what constructs were a part of the acquisition from PLA General Hospital’s ("PLAGH") Chimeric Antigen Receptor T cell (CAR-T) therapy and was CART-33 a part of this acquisition?
As the Company had previously announced on February 9, 2015, the recombinant expression vectors CD-19, CD-20, CD-30 and Human Epidermal Growth Factor Receptor’s (EGFR or HER1) were the only constructs acquired in addition to its respective patent applications and Phase I clinical data. At no time has CBMG acquired CART-33, which is a classification of which the Company is unaware. Details related to the acquisition and the respective constructs can be found in the Company’s Form 8-Ks filed February 9, 2015, March 25, 2015, May 26, 2015; the Form 10-K filed March 31, 2015; and the Form 10-Qs filed on May 15 and August 13, 2015. Any statement made otherwise is simply false.
In order for the community to better benchmark CBMG’s data relative to its competitors, can the Company clarify CBMG’s lead drug as it relates to patients enrolled with chemotherapy refractory advanced diffuse large B cell lymphomas (DLBCL) and the respective indications of each construct?
Different from other clinical trials that have been published, CBMG’s lead drug candidate is CD-20 CART and not CD-19 CART for DLBCL. At this time we would like to reiterate that the clinical trial data presented for CD-19 CART was for B-cell Lineage Acute Lymphoblastic Leukemia (B-cell ALL); CD20 CART was for Advanced Diffuse Large B Cell Lymphoma (DLBCL) and CD30 CART was for Hodgkin’s lymphoma. It is important to note here that comparing clinical outcomes from two different drugs that target two different tumor antigens could be misleading if the detailed background of the trials are not provided. Clinical trial data for all three constructs can be found registered with the U.S. National Institute of Health (NIH) at the following links: NCT01864889, NCT01735604, NCT02259556.
What is the accurate overall response rate (ORR) for CD-19 CART?
As we had previously announced on March 25, 2015, nine adult patients with relapsed or chemotherapy-refractory B-cell lineage acute lymphoblastic leukemia (B-ALL) were enrolled in this CAR-CD19 T cell therapy trial. Different from other competitive trials, pediatric patients were not enrolled as part of this trial. Results showed a complete response (CR) rate of 22.2% (two out of nine patients) and a partial response (PR) rate of 44.4% (four out of nine patients) for an overall response rate (ORR) of 66.7% (six out of nine patients). Further subgroup analysis showed an overall response rate (ORR) of 71.4% (five out of seven patients) in the six CD-19 patients with extramedullary involvement and one patient with no extramedullary lesions and treated with autologous CAR-CD19 T cell therapy. In the six CD19 patients with extramedullary leukemia involvement or bulky adenopathy, an overall response rate (ORR) of 66.7% (four out of six patients) was achieved. It should be noted that 2 out of the 9 patients were infused with allogeneic CD-19 CART. When comparing clinical trial results that were carried out with autologous CART only, the patients infused with allogeneic CART should be excluded to allow meaningful comparison.
Can the Company clarify the overall response rate (ORR) for its CD-20 CART and CD-30 CART?
As the Company had previously reported on March 25, 2015, the results for CAR-CD20 T cell therapy trial showed an overall response rate (ORR) of 83% with five of six patients with evaluable clinical efficacy achieving complete response (CR) or partial response (PR). The Company had also previously reported on May 22, 2015, the results for CAR-CD30 T cell therapy trial showed overall response rate (ORR) of 71% with five of seven patients achieving CR or partial response PR.
Can the Company explain which vector was used in the genetic modification of patients’ T cells with anti-CD19 CAR and anti-CD20 CAR?
The transduction method utilized in the genetic modification of patients’ T cells is in fact the lentiviral vector transduction method. The Company made an error in the filing with clinicaltrials.gov and will rectify the situation immediately.
What is the next major clinical milestone for CBMG?
The Company will present CAR-T Phase I/II clinical trial data for Non Small Cell Lung Cancer (NSCLC) and Cholangiocarcinoma (CC or CCA) at the 5th World Congress on Cancer Therapy on September 28 in Atlanta, Georgia.