On October 10, 2017 GT Biopharma Inc. (OTCQB: GTBP) (Euronext Paris: GTBP.PA) reported that the first four patients have completed treatment in their Food and Drug Administration-approved (FDA) Phase 2 clinical trial of its promising cancer therapy, OXS-1550 (Press release, GT Biopharma , OCT 10, 2017, View Source [SID1234539538]). Additional patient enrollment is ongoing.

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GT Biopharma owns the worldwide rights to commercialize OXS-1550. The targeted immuno-oncology company is focused on novel antibody constructs that provide alternative treatments to cancer patients for whom existing therapies have failed.

The Phase 2 clinical trial is being conducted with GT Biopharma’s partner, the University of Minnesota’s Masonic Cancer Center. Earlier this year, researchers at the University of Minnesota completed a Phase 1 trial of OXS-1550 to determine the safe highest tolerated dose of the drug. A seamless Phase 2 trial followed and began in April. Topline results of the Phase 2 trial are expected to be released in the first quarter of 2018.

Anthony Cataldo, Executive Chairman of GT Biopharma said, "We are pleased with the progress of our four patients in the Phase 2 trial as we continue to move forward with this promising technology."

Dr. Kathleen Clarence-Smith said, "The product performed well in Phase 1 studies of blood cancers, enrollment in the Phase II study is advancing rapidly, and we look forward to providing a targeted immunotherapy product that has the capability of treating a number of different liquid tumors."

OXS-1550 is an ADC (Antibody Drug Conjugate) drug. ADCs, such as ADCETRIS (brentuximab vedotin) from Seattle Genetics (SGEN), a first-in-class FDA approved antibody-drug conjugate, have paved the way for this type of next-generation platform drug.

OXS-1550 uses a proprietary immunoconjugate platform technology as a treatment for leukemia and other blood-born cancers. What sets OXS-1550 (DT2219ARL) apart from other treatments, such as chemotherapy, is that it is designed to specifically target and kill cancer cells while minimizing damage to normal tissues.

Dr. Daniel Vallera, director of the section on Molecular Cancer Therapeutics at the University of Minnesota Masonic Cancer Center, helped develop OXS-1550.

"The initiation of Phase 2 patient treatment is a key opportunity to demonstrate the effectiveness of this promising cancer therapy," Dr. Vallera said.

The clinical progress for OXS-1550 brings the company closer to an important alternative to toxic and poorly tolerated chemotherapies and to costly cell therapies, such as those from Kite Pharma, Inc. (KITE), and from Juno Therapeutics (JUNO), for cancer patients.

The news about OXS-1550 follows another major corporate development about GT Biopharma, Inc. with the announcement that it had completed its merger with GTP (Georgetown Translational Pharmaceuticals, Inc.), a move that brought in new management and a class of close-to-market Central Nervous Systems (CNS) products to GT Biopharma.

The inclusion of products and new management can be accessed thru the company’s website (gtbiopharma.com) which highlights several benefits of the acquisition for its shareholders.

On October 10, 2017 Quadriga Biosciences, a privately held, pharmaceutical company focused on developing novel, proprietary amino acid mimics for the treatment of cancer, reported that the Company has been awarded a Phase II Small Business Innovation Research Grant (SBIR) of $2 million from the National Institutes of Health (NIH) to support the development of its compounds for the treatment of glioblastoma multiforme (GBM), an extremely deadly form of brain cancer for which no long term effective treatment options are available (Press release, Quadriga BioSciences, OCT 10, 2017, View Source [SID1234527723]).

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"We appreciate the NIH’s continued recognition of our science and the importance of the development of our lead molecules for the treatment of GBM," said Dr. Gordon Ringold, Chief Executive Office of Quadriga Biosciences. "GBM is the most malignant form of brain cancer and new therapeutic approaches will be required to significantly impact the progression of this disease. Given the high unmet medical need, we are excited about the opportunity to advance our lead compound through preclinical development over the ensuing months and be in a position to initiate clinical trials by late next year."

On October 10, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") and Seattle Genetics Inc., Inc., (NASDAQ: SGEN) reported dosing of the first patient in EV-201, a registrational phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with checkpoint inhibitor (CPI) therapy (Press release, Astellas, OCT 10, 2017, View Source [SID1234520836]). The EV-201 study will assess the antitumor activity and safety of enfortumab vedotin to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations.

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"Locally advanced or metastatic urothelial cancers are often aggressive and treatment-resistant. Treatment options are limited for those many patients who do not respond to chemotherapy and checkpoint inhibitors, or CPIs. In addition, there are no FDA-approved therapies for patients who progress following CPI treatment," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "Initiation of this pivotal phase 2 trial of enfortumab vedotin is a significant advance toward our goal of providing a new treatment option for patients with locally advanced or metastatic urothelial cancer."

The primary endpoint of the single-arm, open-label trial is confirmed objective response rate (ORR), per independent review. Secondary endpoints include assessments of overall survival, progression free-survival, safety and tolerability. The study will enroll approximately 120 patients at multiple centers globally, and enfortumab vedotin will be administered three of every four weeks for the duration of treatment.

"The initiation of the EV-201 clinical trial demonstrates our continued commitment to patients living with locally advanced or metastatic urothelial cancer," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. "Our decision to move forward with this registrational trial is based on the results of our ongoing Phase 1 study, and we look forward to future clinical development milestones for enfortumab vedotin."

The companies also plan to initiate a combination trial of enfortumab vedotin with CPI therapy in late 2017.

For more information about the phase 2 pivotal trial, including enrolling centers, please visit www.clinicaltrials.gov.

About Urothelial Cancer

Urothelial cancer is most commonly found in the bladder (90 percent). According to the American Cancer Society, approximately 79,000 people in the U.S. will be diagnosed with bladder cancer during 2017 and almost 17,000 will die from the disease. Outcomes are poor for patients diagnosed with metastatic disease, with a five-year survival rate of five percent.

About Enfortumab Vedotin

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary, industry-leading linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Agensys (an affiliate of Astellas), which is expressed on many solid tumors. Nectin-4 is highly expressed in urothelial cancers, particularly in bladder cancer. Preclinical data demonstrate that enfortumab vedotin binds to Nectin-4 on cancer cells and releases the cell-killing agent into these target cells upon internalization.

On October 9, 2017 ARMO BioSciences, Inc., a late-stage immuno-oncology company, reported the appointment of Joseph Leveque, M.D. as Chief Medical Officer. An accomplished industry veteran, Dr. Leveque has significant experience in immuno-oncology drug development, with a focus on bringing novel therapies to patients living with cancer (Press release, ARMO BioSciences, OCT 9, 2017, View Source [SID1234520853]).

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Dr. Leveque will lead the ongoing and planned pivotal Phase 3 clinical trials of ARMO’s lead investigational immuno-oncology drug AM0010 (pegilodecakin, PEGylated Interleukin-10) as well as the plans to advance the Company’s pipeline, which includes an anti-PD-1 monoclonal antibody.

"Joe has been on the forefront of innovation in the immuno-oncology field and has successfully brought multiple drugs to patients," said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences. "After being involved in developing some of the most important breakthrough immuno-oncology drugs, Joe brings valuable experience to the company as we advance AM0010, which we believe may offer the next important breakthrough in this field. We are confident that Joe will help drive the full potential of this novel cancer therapy as well as our broader pipeline."

"Over the past decade, I was involved in the development and commercialization of the first generation of immuno-oncology (IO) therapeutics, including a CTLA-4 inhibitor, a PD-1 inhibitor, and a PD-L1 inhibitor," said Dr. Leveque. "I believe next-generation IO therapeutics like AM0010, used alone or in combination with other IO therapies or other novel approaches, have the promise to significantly advance the oncology field and provide renewed hope to cancer patients who have difficult-to-treat tumors."

Dr. Leveque has more than 20 years of experience in the biopharmaceutical industry leading teams in the successful development and commercialization of oncology therapeutics. Dr. Leveque was the Chief Medical Officer of EMD Serono, the North America subsidiary of Merck KGaA and the Vice President and Head of U.S. Medical Oncology at Bristol-Myers Squibb (BMS) where he was involved in the development and commercialization of the first generation of immuno-oncology (IO) therapeutics, including Bavencio, Opdivo and Yervoy. Prior to BMS, Dr. Leveque was the Vice President of Medical and Scientific Affairs at Onyx Pharmaceuticals, where he was involved in the development of Kyprolis and was recognized by the Multiple Myeloma Research Foundation as one of the top 15 innovators in multiple myeloma over the last 15 years. Earlier in his career, he served as Vice President of Medical and Scientific Affairs at Cephalon Oncology and a Medical Director at Amgen, where he worked on several therapeutic programs for solid tumor and hematological malignancies.

Dr. Leveque received a Bachelor of Arts and Sciences with an emphasis in biology from the Santa Clara University. He earned a Medical Doctorate from University of Texas School of Medicine in Houston and completed his post-graduate medical training in internal medicine at the Cedars-Sinai Medical Center, a teaching affiliate of UCLA. In addition, Dr. Leveque holds a Master in Business Administration from the Wharton School of the University of Pennsylvania.

On October 09, 2017 ImCheck Therapeutics, an emerging biopharmaceutical company developing a new generation of immunomodulatory antibodies against cancer and auto-immune diseases, reported a funding award of €930,000 from Bpifrance to contribute to the advancement of one of its novel immunotherapy program in cancer (Press release, ImCheck Therapeutics, OCT 9, 2017, View Source [SID1234522234]).

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The funding will be dedicated to conducting translational studies and launching the production of a novel therapeutic antibody active on both adaptive and innate immune cells and whose target remains confidential at this stage. These studies will be performed in partnership with several renowned international expert academic institutions and will aim at validating the clinical benefit of predictive biomarkers for future treatments as well as study the mechanism of action of the antibody in various hematological cancers (e.g. acute myeloid leukemia, lymphoma) and solid tumors (e.g. colorectal, pancreas, lung, gynecological cancers).

«We are delighted to benefit from the support of the French State as we are preparing for the entry of our antibody in its clinical development phases. ImCheck has a very ambitious development plan building on the discovery work of Daniel Olive’s team, notably on the control mechanisms of gamma-delta T-cells, an immune cell population drawing increasing attention» said Benjamin Charles, Chief Business Officer of ImCheck Therapeutics.

« Bpifrance supports several companies in the highly-innovative and highly-competitive field of immuno-oncology. ImCheck’s projects are highly-differentiated and very well-positioned. We are pleased to support them with this funding. » added Françoise Marchand, Project Innovation Officer at Bpifrance.

The Company plans to take this first antibody candidate into Phase 1 in 2019 and will apply for further additional non-dilutive funding, notably through the FUI program from Bpifrance.

«We hope to rapidly deliver this new generation of immunomodulators with the potential to overcome resistance to existing cancer immunotherapies. In parallel, we intend to develop the proper personalization tools to precisely identify & select responders to this new therapeutic agents» concluded Pierre d’Epenoux, CEO of ImCheck Therapeutics.