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GT BIOPHARMA, INC, ANNOUNCES CLOSING OF OXIS INTERNATIONAL – GEORGETOWN TRANSLATIONAL PHARMACEUTICALS MERGER

On September 5, 2017 GT Biopharma Inc. reported the closing of the merger of GT Biopharma, Inc. (formerly Oxis International Inc.) (OTCQB: OXISD) and Georgetown Translational Pharmaceuticals Inc (Press release, GT Biopharma, SEP 5, 2017, View Source [SID1234539564]). The merger brings GT Biopharma, Inc a new Chief Executive Officer, a robust intellectual property portfolio, and a multi-million dollar financing that leaves the Company well-positioned to continue pursuing its pipeline of oncology and Central Nervous System (CNS) drugs.

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As part of the transaction, GTP shareholders were issued 16,927,878 of GT Biopharma (OTCQB: OXISD) common stock. Also, as a requirement of Closing, GT Biopharma completed a financing of over $4.5 million and retired 100% of the company’s debt. The new funding provides capital for GT Biopharma to continue to pursue regulatory approval of the drugs in its oncology pipeline and newly acquired CNS pipeline. Completion of the merger and elimination of all debt is a key milestone accomplishment which positions GT Biopharma to pursue its strategy for acceptance to the Nasdaq Exchange.

The merger closed just days after Gilead Sciences announced it would pay $11.9 billion to acquire Kite Pharma (symbol: KITE) and its CAR-T cancer treatment, shining a spotlight on companies pursuing immunotherapy cancer treatment – including GT Biopharma’s platform targeted immunotherapy BiKE and TriKE technologies.

Anthony J. Cataldo, GT Biopharma’s Executive Chairman said, "This is a major accomplishment for our shareholders. We have now positioned the company to be a significant player in the expanding fight against cancer. In this calendar year we corrected our balance sheet, advanced our product pipeline (OXS-1550 phase 2 FDA trial), signed a partnership agreement with Altor Biosciences, Inc., chaired by Dr. Patrick Soon-Shiong, and advanced our highly valued TriKE platform, which is anticipated to initiate clinical trials in the US in the first half of 2018. GT Biopharma research partners at the University of Minnesota were awarded the NIH REACH award in 2016 to further pursue TriKE technology. This is given by the NIH for technologies judged likely to achieve commercial success. We also brought in an accomplished CEO (Kathleen Clarence-Smith, MD, PhD). She has already demonstrated at several major pharmaceutical companies and at VC-backed start-up companies (most recently Chase Pharmaceuticals) her ability to efficiently and rapidly develop drugs through the FDA process. Additionally, she brings to GT Biopharma a team of highly experienced, seasoned professionals in drug development, and a suite of products which are close to filing an application with the FDA to obtain approval (NDA) to market the products."

"I am pleased to be part of GT Biopharma. Our pipelines in oncology and CNS are bulging and our knowledge and expertise are in place. We are fully prepared to execute on our development plans to shepherd our drugs to commercialization and meet the urgent and expanding needs of patients with oncological and neurological disorders," said Dr. Kathleen Clarence-Smith.

Prior to founding GTP, Dr. Clarence-Smith co-founded Chase Pharmaceuticals Corporation in Washington D.C. and served as Chairman of the company’s Board from 2008 to 2014. Chase Pharmaceuticals was acquired by Allergan, PLC (AGN) in 2016 in a deal that, with significant up-front payment and milestones could reach $1 billion.

Dr. Clarence-Smith also held executive management positions with Sanofi, Roche, Otsuka Pharmaceutical and Prestwick Pharmaceuticals. She is co-founder and a managing member of KM Pharmaceutical Consulting in Washington, D. C.

GT Biopharma shares will trade under the symbol OXISD for before shifting to GTBP later this month.

Georgetown’s CNS pipeline includes Pain Brake for the treatment of chronic neuropathic pain and a drug candidate GTP-004 for the treatment of myasthenia gravis, a rare muscular disease. The only approved drug for this disease (pyridostigmine) carries significant GI side effects, limiting its achievable efficacy. GTP-004 combines pyridostigmine with another approved treatment. The goal is to reduce side effects, providing greater safety, and to improve efficacy over existing protocols involving treatment with pyridostigmine.

A third drug candidate, GTP-011, is a treatment for motion sickness. This is a repurposed version of an existing drug. It was designed to be as effective as the scopolamine patch, but to have fewer side effects, especially fewer memory problems. Reducing or even eliminating memory disturbances is particularly important in elderly patients.

About GT Biopharma, Inc.: GT Biopharma, Inc (formerly known as Oxis International, Inc.) is an immuno-oncology focused company developing innovative drugs focused on the treatment of cancer and other unmet medical needs. Oxis’ lead drug candidate, OXS-1550 (DT2219ARL) is a novel bispecific scFv recombinant fusion protein-drug conjugate composed of the variable regions of the heavy and light chains of anti-CD19 and anti-CD22 antibodies and a diphtheria toxin as its cytotoxic drug payload. OXS-1550 targets and binds to cancer cells expressing the CD19 receptor or CD22 receptor or both receptors. When OXS-1550 binds to cancer cells they internalize the drug and are killed due to the cytotoxic payload. OXS-1550 has demonstrated encouraging results in early human clinical trials in patients with relapsed/refractory B-cell lymphoma or leukemia. OXS-3550 TriKE technology was developed by researchers at the University of Minnesota Masonic Cancer Center. As demonstrated in non-clinical models, this targeted immunotherapy directs NK cells to kill cancer cells while diminishing drug-related toxicity, and is anticipated to be to NK cells what CAR-T is to T-cells.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

(Filing, 10-K, MEI Pharma, SEP 5, 2017, View Source [SID1234520389])

MEI Pharma Announces Exclusive License Agreement with Presage Biosciences
for Voruciclib, An Oral, Selective CDK Inhib

September 5, 2017 — MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported that it has entered into a license agreement with Presage Biosciences, Inc. for voruciclib, a clinical-stage, oral and selective cyclin-dependent kinase (CDK) inhibitor. Under the terms of the agreement, MEI Pharma receives exclusive worldwide rights to develop, manufacture and commercialize voruciclib. In exchange, Presage will receive near-term payments of $2.9 million and additional potential payments of up to $181 million upon the achievement of certain development, regulatory and commercial milestones. Presage will also receive mid-single-digit tiered royalties on the net sales of any product successfully developed.
"We are very excited by this opportunity to add voruciclib to our growing pipeline of clinical-stage oncology drug candidates," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "Voruciclib is a selective CDK inhibitor, a class of drugs that has recently demonstrated significant clinical and commercial value, and is differentiated by its potent inhibition of CDK9. This is an attractive asset that comes with an established clinical safety profile, along with compelling pre-clinical data showing suppression of MCL1, a known mechanism of resistance to BCL2 inhibitors, and synergy with the FDA-approved BCL2 inhibitor venetoclax. We believe this provides a clear and efficient clinical development path forward in combination with venetoclax. We appreciate that Presage put their trust in us to execute this plan and we are eager to get started."
Voruciclib (formerly P1446A) has been tested in more than 70 patients in multiple Phase 1 studies and has been associated with manageable side effects consistent with other drugs in its class, including nausea, vomiting and diarrhea. In pre-clinical studies, voruciclib alone induces cell death in multiple patient-derived chronic lymphocytic leukemia (CLL) samples . In addition, voruciclib shows dose-dependent suppression of MCL1 at concentrations achievable with doses that appeared to be generally well tolerated in the Phase 1 studies. Studies have shown that MCL1 is an established resistance mechanism to the B-cell lymphoma 2 (BCL2) inhibitor venetoclax (marketed as Venclexta) .
"Voruciclib is a promising drug candidate with the potential to overcome mechanisms of drug resistance and significantly improve patient outcomes," said David Johnson, Chairman of Presage. "The management team at MEI Pharma has a proven track record in oncology therapeutic development and we believe they have the clinical, regulatory and CMC expertise to maximize the value of this asset. This transaction also enables us to focus our attention on identifying and advancing additional drug candidates and combinations using our powerful CIVO intratumoral microdosing platform.
There are currently two CDK inhibitors approved by the U.S. Food and Drug Administration, palbociclib (marketed as Ibrance) and ribociclib (marketed as Kisqali), both oral, selective CDK 4/6 inhibitors approved for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in combination with hormonal therapy. A third, abemaciclib, was recently granted priority review by the FDA.

MEI Pharma Announces Exclusive License Agreement with Presage Biosciences
for Voruciclib, An Oral, Selective CDK Inhibitor

On September 5, 2017 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported that it has entered into a license agreement with Presage Biosciences, Inc. for voruciclib, a clinical-stage, oral and selective cyclin-dependent kinase (CDK) inhibitor (Press release, MEI Pharma, SEP 5, 2017, View Source [SID1234520396]). Under the terms of the agreement, MEI Pharma receives exclusive worldwide rights to develop, manufacture and commercialize voruciclib. In exchange, Presage will receive near-term payments of $2.9 million and additional potential payments of up to $181 million upon the achievement of certain development, regulatory and commercial milestones. Presage will also receive mid-single-digit tiered royalties on the net sales of any product successfully developed.

"We are very excited by this opportunity to add voruciclib to our growing pipeline of clinical-stage oncology drug candidates," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "Voruciclib is a selective CDK inhibitor, a class of drugs that has recently demonstrated significant clinical and commercial value, and is differentiated by its potent inhibition of CDK9. This is an attractive asset that comes with an established clinical safety profile, along with compelling pre-clinical data showing suppression of MCL1, a known mechanism of resistance to BCL2 inhibitors, and synergy with the FDA-approved BCL2 inhibitor venetoclax. We believe this provides a clear and efficient clinical development path forward in combination with venetoclax. We appreciate that Presage put their trust in us to execute this plan and we are eager to get started."

Voruciclib (formerly P1446A) has been tested in more than 70 patients in multiple Phase 1 studies and has been associated with manageable side effects consistent with other drugs in its class, including nausea, vomiting and diarrhea. In pre-clinical studies, voruciclib alone induces cell death in multiple patient-derived chronic lymphocytic leukemia (CLL) samples . In addition, voruciclib shows dose-dependent suppression of MCL1 at concentrations achievable with doses that appeared to be generally well tolerated in the Phase 1 studies. Studies have shown that MCL1 is an established resistance mechanism to the B-cell lymphoma 2 (BCL2) inhibitor venetoclax (marketed as Venclexta) .

"Voruciclib is a promising drug candidate with the potential to overcome mechanisms of drug resistance and significantly improve patient outcomes," said David Johnson, Chairman of Presage. "The management team at MEI Pharma has a proven track record in oncology therapeutic development and we believe they have the clinical, regulatory and CMC expertise to maximize the value of this asset. This transaction also enables us to focus our attention on identifying and advancing additional drug candidates and combinations using our powerful CIVO intratumoral microdosing platform.

There are currently two CDK inhibitors approved by the U.S. Food and Drug Administration, palbociclib (marketed as Ibrance) and ribociclib (marketed as Kisqali), both oral, selective CDK 4/6 inhibitors approved for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in combination with hormonal therapy. A third, abemaciclib, was recently granted priority review by the FDA.

TG Therapeutics Announces Completion of Target Enrollment in the UNITY-CLL Phase 3 Trial

On September 5, 2017 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that target enrollment for the UNITY-CLL Phase 3 trial has been achieved (Press release, Manhattan Pharmaceuticals, SEP 5, 2017, View Source [SID1234520379]). The UNITY-CLL Phase 3 trial is a randomized study of TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in combination with TGR-1202 (umbralisib), the Company’s PI3K delta inhibitor (together referred to as the U2 regimen), compared to an active control arm of obinutuzumab plus chlorambucil, in patients with both treatment naïve and relapsed or refractory Chronic Lymphocytic Leukemia (CLL). Per the protocol, the target enrollment was 175 patients in each the U2 arm and the active control arm. While target enrollment has been reached, in order to provide an opportunity for all patients already identified to participate, enrollment is expected to continue until mid-October. The UNITY-CLL Phase 3 trial is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration (FDA).

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We are extremely pleased to announce the completion of target enrollment in the UNITY-CLL clinical trial, nearly 9 months earlier than our original projections. From the beginning, enrollment in this study has exceeded our expectations, putting us in position to deliver top-line data on the ORR endpoint earlier than anticipated, now expected in the second quarter of 2018. If positive, pursuant to our SPA, the ORR data may be used to support a filing for accelerated approval." Mr. Weiss continued, "We want to thank the UNITY-CLL Investigators, research staff, and their patients, for their participation in this important clinical research. Without their commitment and trust, advancing novel medicines would not be possible."

John Gribben, MD, DSc, of the Barts Cancer Institute in London, UK, and Global Study Chair for the UNITY-CLL study stated, "The design of the UNITY-CLL trial is a paradigm shift in the way we approach oncology research, allowing two novel drugs to be evaluated together in a single four-arm study for potential approval. The speed in which target enrollment has completed is even more impressive, considering the size and scope of this innovative study, which also underscores the need for new treatment options despite recent advances. I am eagerly looking forward to presenting results from this study next year."

Ian Flinn, MD, PhD, Director of the Blood Cancer Research Program, Sarah Cannon Research Institute, and a lead US enroller in the UNITY-CLL study stated, "We were pleased at Tennessee Oncology to not only lead enrollment in the first-in-human study of umbralisib, but to now be one of the leading enrollers to the Phase 3 UNITY-CLL trial. The rapid rate of enrollment for both the first-in-human study of umbralisib and the Phase 3 study UNITY study is a testament to the continued need for better, patient-friendly, easy to use, treatment options for both treatment naïve CLL patients and those relapsed or refractory to prior therapy. BTK intolerance and difficulties in delivering anti-bcl2 therapy are challenges for delivering effective chemo-free treatment options for many patients. Approval of the ublituximab + umbralisib regimen would provide new hope to many of those patients.

ABOUT UNITY-CLL PHASE 3 TRIAL

UNITY-CLL is a global Phase 3 randomized controlled clinical trial in patients with Chronic Lymphocytic Leukemia (CLL) that includes two key objectives: first, was to demonstrate contribution of each agent in the TG-1101 (ublituximab) + TGR-1202 (umbralisib) or U2 regimen, and second, to demonstrate superiority in Progression Free Survival (PFS) over the standard of care to support the submission for full approval of the combination. In addition, upon completion of enrollment, this trial will evaluate Overall Response Rate (ORR) for accelerated approval. The study initially randomized patients into four treatment arms: TG-1101 plus TGR-1202, TG-1101 single agent, TGR-1202 agent, and an active control arm of obinutuzumab plus chlorambucil. Pursuant to the Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), an early interim analysis was conducted to assess contribution of each single agent which allowed for early termination of both single agent arms.