On April 5, 2017 APAC Biotech, reported that it was granted with a commercial license by Indian FDA (CDSCO – Central Drugs Standard Control Organization) to market product, APCEDEN, a Dendritic cell-based autologous Immuno-oncology product for four cancer indication namely Prostate, Ovarian, Colo-rectal and Non Small Cell Lung carcinoma (Press release, APAC Biotech, APR 5, 2017, View Source [SID1234562370]).

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The Indian Food and Drug Administration authorities, after their stringent review of the application, have issued the commercial license (Form 46) to conduct a post marketing surveillance on statistically significant number of patients for each indication.

Other products namely STEMPEUCEL, an allogeneic-cultured mesenchymal cells from Stempeutics and OSSORON, an autologous-cultured adult osteoblast and CHONDRON, an autologous-cultured adult chondrocyte from Regenerative Medical Services, Mumbai, also received the marketing license at the same time.

"The past decades have seen revolutionary progress in the development and application of cell and genetic engineering in an effort to personalize the treatment of cancer. We are now confident that it is possible to treat cancer patients using this approach as observed during clinical trials across India. The results are encouraging and mark a potential new paradigm in treating these solid tumors that do not respond to standard therapies," said a leading oncologist, Dr. Ashok Vaid.

APCEDEN, an autologous monocyte-derived mature Dendritic cell when loaded with tumor antigen have the ability to generate an effective immune response against the tumor. In the year 2011, an ATTEST trial was conducted where refractory solid tumor with multiple chemo failure patients were enrolled and administered with APCEDEN. The results were published in International Journal of Cytotherapy in the year 2014. ATTEST study included a stringent logistics management and was uniquely, effectively, conducted under the leadership of Principal investigator, Medical oncologist, Dr. P P Bapsy.

The trial was designed to understand the potential benefits and risk of the therapy. In the trial 28.9% of cases showed stability of disease with good quality of life. A retrospective study was also conducted on the advice of CBBTDEC (Cell Biology Based Therapeutic Drug Evaluation Committee), ICMR (Indian Council of Medical Research) where more than 200 days’ of survival benefit was observed as compared to the retrospective control group.

On April 4, 2017 Oxis International Inc. (OTCQB: OXIS and Euronext Paris OXI.PA) reported that the Food and Drug Administration has cleared the way for the Company’s wholly owned subsidiary, Oxis Biotech Inc., to begin a FDA Phase 2 clinical trial for its promising cancer treatment OXS-1550 in the treatment of lymphoma and leukemia (Press release, OXIS International, APR 4, 2017, View Source [SID1234539558]).

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Oxis Biotech, a targeted immuno-oncology company focused on novel antibody constructs, owns the worldwide rights to commercialize OXS-1550.

The FDA Phase 2 clinical trial will be conducted with Oxis’ partner, the University of Minnesota’s Masonic Cancer Center. Researchers at the University of Minnesota recently completed a FDA Phase 1 trial of OXS-1550. The Phase 1 portion of the trial completed a safety review to determine the safe and effective dose of the 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 minimizing damage to normal tissues.

"This milestone represents a major step forward for our technology. The product has performed well in its phase 1 studies in blood cancers and we look forward to positive results in Phase 2," said Anthony Cataldo, Chairman and Chief Executive Officer of Oxis. "This next generation drug has the possibility of treating a number of different liquid tumors and, if successful, will drastically change the paradigm now being developed that relies on highly expensive autologous cell therapies such as presented by Kite Pharma, Inc. (KITE), Juno Therapeutics, Inc. (JUNO) and other autologous or semi-autologous and adoptive therapy approaches currently under development."

Dr. Daniel Vallera, director of the section on Molecular Cancer Therapeutics at the University of Minnesota Cancer Center, lead developer of OXS-1550 said, "The FDA’s clearance for Phase 2 is an important step forward for this cancer treatment."

Dr. Vallera has spent 35 years with the University of Minnesota’s cancer center, where he oversees a laboratory specializing in the development of biological recombinant drugs focusing on bispecific antibody therapies that directly deliver toxic signals to cancer cells.

"We are excited to see this new therapy proceed to Phase 2," Dr. Vallera said. "So many of these patients presenting with chemotherapy refractory cancer have few, if any, alternative choices for cancer treatment."

On April 4, 2017 OncoResponse, an immuno-oncology antibody discovery company, reported that Chief Executive Officer Clifford J. Stocks will present an update on the Company and the status of its discovery and development pipeline at the 24th annual Future Leaders in the Biotech Industry conference hosted by BioCentury (Press release, OncoResponse, APR 4, 2017, View Source [SID1234522896]). The presentation will take place at 11:00am ET on April 7, 2017 at the Millennium Broadway hotel in New York City, NY.

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OncoResponse utilizes a clinically validated platform technology to rapidly screen antibodies made by the human immune system and identify those antibodies with exceptional activity to cancer from elite responders following immunotherapy. The Company has a strategic alliance with the MD Anderson Cancer Center, which provides broad access to patient samples across multiple cancer indications and to oncology and translational medicine expertise including clinical and regulatory advice.

OncoResponse recently closed a $22.5 million Series A financing with a syndicate of blue chip venture capital and strategic investors including MD Anderson Cancer Center, ARCH Venture Partners, GreatPoint Ventures, Helsinn Investment Fund, Shire, Canaan Partners, HT Family Office (of China), Alexandria Real Estate Equities and William Marsh Rice University.

(Filing, Annual, Celyad, 2016, APR 4, 2017, View Source [SID1234518464])

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On April 3, 2017 SignalRx Pharmaceuticals Inc., focused on developing novel small-molecule cancer therapeutics targeting key orthogonal and synergistic oncotargets, reported the upcoming presentation of scientific data on the company’s triple PI3K/CDK4-6/BRD4 inhibitor program and first-in-class triple inhibitor SRX3177 (Press release, SignalRx, APR 3, 2017, http://www.ireachcontent.com/news-releases/signalrx-to-present-at-the-aacr-annual-meeting-on-its-first-in-class-triple-pi3kcdk4-6brd4-inhibitor-srx3177-for-treating-cancer-617971313.html [SID1234527324]). The poster presentation by Dr. Donald L. Durden, MD, PhD, senior scientific advisor for SignalRx, will be poster #LB-298 at the April 5th late breaking poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Washington, DC.

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SRX3177 is developed on the rationale that concurrent PI3K inhibition can prevent resistance to CDK4/6 inhibition, and combined CDK4/6 and PI3K inhibition leads to synthetic lethality reported in a number of cancer types, including breast cancer and mantle cell lymphoma, and blocking the chromatin reader protein BRD4 downregulates MYC and cyclin D1 transcription, further promoting cell cycle arrest in G1.

The presentation will describe the discovery and early development of the molecularly designed small-molecule triple inhibitor SRX3177. Key highlights to be presented include:

SRX3177’s potent in vitro enzymatic inhibition profile (IC50: CDK4 = 2.54 nM, CDK6 = 3.26 nM; PI3Kα = 79.3 nM, PI3Kδ = 83.4 nM; BRD4-BD1 = 32.9 nM, BRD4-BD2 = 88.8 nM).
SRX3177 rational design based on thieno-pyranone scaffold and target modeling.
Up to 82-fold more potent than palbociclib in a panel of mantle cell lymphoma, neuroblastoma, and hepatocellular carcinoma cell lines.
5-Fold more potent in cancer cells than combination of BKM120 (PI3K inhibitor) + palbociclib (CDK4/6 inhibitor) + JQ1 (BRD4 inhibitor).
40-Fold less toxic to normal epithelial cells than combination of BKM120 + palbociclib + JQ1.
Cell cycle arrest and apoptosis induction with proven mode of action (p-AKT, p-Rb, chromatin release).
SignalRx is also announcing that it is seeking partnering opportunities to accelerate the development of this program and its PI3K-BRD4 program to advance novel small molecules into first-in-man clinical trials based on the promising profile of its inhibitors shown so far. Since these are single molecules with a single PK/PD and toxicity profile, there is a great opportunity to develop them as single therapeutics and streamline their development in combination therapies focused on companion diagnostics built around synthetic lethality discoveries in human cancers.