On October 10, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported that the Company will be presenting at the BIO Investor Forum, October 17-18, 2018, at the Westin St. Francis Hotel in San Francisco (Press release, Onconova, OCT 10, 2018, View Source [SID1234529839]). Ramesh Kumar, CEO, will present at the conference and meet with investors.

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Presentation details
Date/Time: Thursday, October 18th at 11:00 AM
Venue: The Westin St. Francis, San Francisco
Presenter: Ramesh Kumar, CEO

On October 10, 2018 Hemispherx Biopharma, Inc. (NYSE American: HEB) reported the signing of a clinical trial agreement with Roswell Park Comprehensive Cancer Center to evaluate Ampligen in combination with checkpoint inhibitors (CPIs) (Press release, Hemispherx Biopharma, OCT 10, 2018, View Source [SID1234530604]). The Phase IIa clinical trial will evaluate the immune-mediated effects of cytokine modulation in combination with CPIs in patients with primary resistance to CPI therapy. The protocol will seek to evaluate the combination of Ampligen and CPIs in patients with advanced urothelial carcinoma, renal cell carcinoma and melanoma. Ampligen is the Company’s investigational immune-enhancing TLR3 agonist that has demonstrated a robust anti-cancer effect in preclinical models when combined with CPIs. This new agreement expands the extensive prior clinical and preclinical work into the clinical checkpoint blockade arena and offers the opportunity to begin evaluation of this combination therapy in patients with a variety of solid tumors where large numbers of patients do not respond or progress following treatment with standard CPI-based therapy.

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The Phase IIa study will be led by Pawel Kalinski, MD, PhD, Vice Chair for Translational Research and Professor of Oncology in the Department of Medicine and Co-Leader of the Tumor Immunology and Immunotherapy Program at Roswell Park, in collaboration with Mateusz Opyrchal, MD, PhD, of the Roswell Park Department of Medicine. Additional details about trial design, implementation and timing will be disclosed upon approval by Roswell Park’s institutional review board.

"This event marks an important milestone for Hemispherx as we evaluate Ampligen in combination with CPIs in difficult-to-treat solid tumors and among a patient population that is largely relapsed and/or refractory to treatment," said Thomas K. Equels, Chief Executive Officer of Hemispherx. "Our expanded collaboration with Roswell Park offers an ideal setting for these early stage trials. We have developed a productive working relationship with this world-class team and look forward to beginning these important clinical trials."

On October 10, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that new data relating to its molecule WP1122 will be presented at the upcoming Society for Neuro-Oncology Annual Scientific Meeting (Press release, Moleculin, OCT 10, 2018, View Source [SID1234529841]).

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"We continue to make progress in the development of our inhibitor of glycolysis, WP1122," commented Dr. Donald Picker, Moleculin’s Chief Science Officer. "We believe that we have discovered new data during our IND-enabling research with animals that confirms a highly beneficial metabolism of WP1122 and significant organ accumulation of the inhibitor of glycolysis in the brain and also in the pancreas. This is especially significant because both brain and pancreatic tumors are highly dependent upon glucose for survival and WP1122 appears to have the ability to inhibit glycolysis, the process by which these tumors convert glucose into energy."

Walter Klemp, Moleculin’s Chairman and CEO added, "Metabolic inhibition of tumors is conceptually a very important approach, and we believe we have a clear translational focus. We have been pushing hard to prepare WP1122 for Investigational New Drug (IND) status. It is encouraging to have discoveries during this process that appear to confirm the initial premise and give us more hope that WP1122 could become an important new way to deal with difficult cancers like glioblastoma and pancreatic cancer."

The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education. Now in its twenty fourth year, the Society continues to grow and mature as the premier North American organization for clinicians, basic scientists, nurses and other health care professionals whose focus is central nervous system tumors in children and adults. This year’s Annual Scientific Meeting will be held November 15 – 18, 2018 at the Marriott Hotel in New Orleans, Louisiana.

On October 10, 2018 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) reported the submission of a clinical trial application to initiate a Phase 2 clinical trial of Tedopi in advanced or metastatic pancreatic cancer (Press release, OSE Immunotherapeutics, OCT 10, 2018, View Source [SID1234529889]). The trial will compare Tedopi, 10 neoepitopes associated to activate cytotoxic T-lymphocytes, in combination with nivolumab, an immune checkpoint inhibitor releaving the brakes that prevent optimal T lymphocyte activation versus maintenance standard of care treatment with Folfiri.

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The clinical trial application has been submitted in France to the ANSM (the French National Agency for Medicines and Health Products Safety) and to the central Ethics Committee by the oncology cooperative group GERCOR, who is sponsoring the clinical trial as part of PRODIGE intergroup. The Company expects activation of the trial and opening of clinical centers in early 2019.

The Phase 2 clinical trial, named TEDOPaM, aims to evaluate Tedopi as a maintenance therapy, alone or in combination with immune checkpoint inhibitor nivolumab, and evaluated versus Folfiri, a combination chemotherapy with folinic acid, fluorouracil and irinotecan and the standard of care. The study will be completed in HLA-A2 positive patients with stable disease who have received four months of first line standard-of-care chemotherapy Folforinox, a combination chemotherapy with folinic acid, fluorouracil, irinotecan and oxaliplatin.

"This new step marks the expansion of the development of Tedopi, already under evaluation in a Phase 3 study in advanced lung cancer, to an additional oncology indication, a particularly aggressive cancer for which new therapeutic options are strongly needed. With this new clinical development program evaluating Tedopi in combination with the PD-1 inhibitor nivolumab, a checkpoint inhibitor, in advanced pancreatic cancer, we are broadening our exploration of new pathwaysin immuno-oncology," commented Alexis Peyroles, chief executive officer of OSE Immunotherapeutics.

"The study’s rationale is based on the interest of a combination of immunotherapies that stimulate cytotoxic T-cells with Tedopi, whose antigens are overexpressed in pancreatic tumor, and a PD-1 checkpoint inhibitor nivolumab, whose preclinical data available to date in this cancer plead in favor of a combination with a neoepitope-type immunotherapy, likely to potentiate its activity. Our network of clinicians is now mobilizing to start this Phase 2 trial," concluded Professor Christophe Louvet, president of GERCOR.

Tedopi is a combination of 10 neoepitopes selected and optimized from five tumor associated antigens able to generate a specific response against cytotoxic T-cells expressing at least one of these tumor associated antigens and an associated helper T-cell response.

ABOUT GERCOR
GERCOR is an association of physicians whose purpose is to improve the care of patients affected by cancer by developing clinical research in the scope of an independent, multidisciplinary and multi-focused group. GERCOR
concentrates its efforts on only one mission: clinical research. Thanks to its network, GERCOR offers patients easy
access to its up-to-date treatments. To achieve this goal, GERCOR stimulates the inclusion into its network of the
greatest number of physicians involved in the treatments it is conducting, offers vital logistical assistance to research
physicians whose job is to direct and monitor the application of the treatments to patients.

On October 10, 2018 Gotham Therapeutics, a biotechnology company developing a novel drug class targeting RNA-modifying proteins, reported with a $54 million Series A financing co-led by founding investor Versant Ventures, Forbion and S.R. One (Press release, Gotham Therapeutics, OCT 10, 2018, View Source [SID1234550889]). The syndicate also included Celgene Corporation and Alexandria Venture Investments. Gotham is part of New York’s rapidly growing biopharma community with a subsidiary at one of Europe’s leading life science clusters near Munich, Germany.

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Versant created and seeded Gotham based upon the seminal discoveries of co-founder Samie Jaffrey, M.D. Ph.D., a pioneer in an exciting new field within RNA metabolism called epitranscriptomics. Dr. Jaffrey is a professor of pharmacology at Weill Cornell Medicine and a member of the Scientific Advisory Board for Gotham Therapeutics. His work has shed light on the role of post-transcriptional mRNA modifications in health and disease. These modifications and their biological effects are driven by protein complexes commonly described and categorized as writers, erasers and readers of the epitranscriptomic code.

With its seed funding, Gotham built a platform to assess the impact of RNA-modifying proteins on disease biology and developed small molecules against priority targets. The Series A proceeds will allow Gotham to establish clinical proof of concept and to invest broadly in a pipeline of preclinical candidates that have potential to treat diseases intractable to classical approaches.

"As we pursue several important targets, the information we glean will help us further validate and build our platform for increasingly broad applications. Our goal is to become the leader in drugging key proteins that modulate mRNA functionality, thereby impacting disease onset and progression," said Lee Babiss, Ph.D., CEO of Gotham.

"While academic research and the pharmaceutical industry focused initially on modifications of DNA, a growing body of evidence indicates that mRNA modifications help determine to which degree genes are translated into proteins. RNA modifications and their associated protein complexes therefore represent an untapped frontier that could yield new therapeutic approaches," added Dr. Jaffrey.

Gotham has assembled an experienced founding team led by Dr. Babiss, former President of Pharma Research at Roche. Dr. Babiss is an early adopter of RNA drug discovery approaches who has a track record of translating discoveries into therapeutic candidates. He also has served as CSO of PPD, and as Head of Human Genetics and Personalized Healthcare at Glaxo Wellcome.

"After following the developments in the RNA drug discovery field for a number of years, we felt this was the right time to build a company that could capitalize on translating the scientific discoveries into a whole new class of drug candidates," said Carlo Rizzuto, Ph.D., Partner at Versant. "With our initial investment, the Gotham team constructed a platform able to validate critical links between specific types of RNA modifications and disease biology. We look forward to advancing a number of drug candidates with this new round of financing."

"We are excited to invest in Gotham, one of the pioneers in the fast-emerging field of RNA metabolism, which could create a paradigm shift in both cancer therapy and other major diseases," commented Holger Reithinger, Ph.D., General Partner at Forbion. "Gotham represents the first investment by our recently announced Forbion IV fund. Our new fund aims to help build leading companies around exciting new science, proven teams or in-licensed assets."

Dr. Reithinger will join Dr. Babiss, Dr. Rizzuto and Jill Carroll, Principal, SR One, on Gotham’s Board of Directors. Jorge DiMartino M.D., Ph.D., Vice President, Translational Development Oncology at Celgene and Head of Celgene’s Epigenetics Thematic Center of Excellence, has joined the board in an observer role.