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RedHill Biopharma Extends Option Agreement for Phase II-Stage Pancreatic Cancer Drug RP101

On July 15, 2015 RedHill Biopharma reported that it has elected to extend its August 2014 exclusive option agreement with RESprotect GmbH, a privately-held German-based biotech company for the acquisition of the oncology drug candidate RP101 (Press release, RedHill Biopharma, JUL 15, 2015, View Source [SID:1234506339]).

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RP101 is a proprietary, first-in-class, orally-administered, heat shock protein 27 (Hsp27) inhibitor intended to prevent the induction of resistance to chemotherapy (chemoresistance), thus maintaining sensitivity of the tumor to chemotherapy and potentially enhancing patient survival. RP101 has completed several clinical studies, including a Phase II study in pancreatic cancer and has been granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Under the terms of the binding exclusive option agreement with RESprotect GmbH, RedHill has the option to acquire the worldwide exclusive rights to RP101 for all indications, other than for the pancreatic cancer indication in South Korea. If RedHill elects to exercise this option, it will acquire the exclusive rights to RP101 for a total payment of $100,000, for both the exercise option and the acquisition of the rights, as well as potential milestone payments and tiered royalties on net revenues, ranging from single digits to mid-teens. RedHill has agreed to pay $25,000 for a one-year extension of the option agreement.

RedHill recently commenced a preclinical development program for RP101 to examine the efficacy of the drug candidate in various tumor models. The preclinical program is intended to support the existing clinical data and to assess a potential clinical development path for RP101.

About RP101:

RP101 is a nucleoside analogue found by Prof. Rudolf Fahrig at the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) in Hannover, Germany, to inhibit development of chemoresistance in various cancer models. It is an orally-administered, patent-protected small molecule which binds to heat shock protein 27 (Hsp27) and inhibits its multidrug-resistance gene amplification activity. Hsp27 is a chaperone protein which is found in abnormally high levels in cancer cells. The overexpression of Hsp27, which results in the amplification of a multidrug-resistance (MDR) gene, has been linked to tumor resistance to cytotoxic drugs and the development of metastasis. By inhibiting Hsp27, RP101 may prevent the induction of resistance to chemotherapy (chemoresistance) and maintain sensitivity of tumors to chemotherapy, thus potentially enhancing patient survival. RP101 has been studied in several Phase I and Phase II clinical studies with a total of 249 subjects treated, including a Phase II study in pancreatic cancer. RP101 has been granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Mersana Therapeutics and Recepta Biopharma S.A. Enter License Agreement for Novel Antibody

On July 14, 2015 Mersana Therapeutics, Inc. and Recepta Biopharma S.A. reported that they have entered into an exclusive license agreement in which Mersana will use its proprietary Fleximer technology to develop and commercialize an immunoconjugate with the undisclosed cancer antibody licensed from Recepta (Press release, Mersana Therapeutics, JUL 14, 2015, View Source [SID1234609623]).

Under the terms of the agreement, Recepta will provide Mersana exclusive rights to its novel monoclonal antibody to an undisclosed target, and Mersana will leverage Fleximer to develop an immunoconjugate against the target. Financial terms of the agreement include an upfront payment and subsequent payments to Recepta, which together could total $86 million plus royalties if certain development, regulatory and commercial milestones are achieved. Mersana will conduct and fund clinical development and regulatory activities. Recepta will have rights to commercialize in Brazil, while Mersana will have rights to commercialize in the rest of the world. Mersana will be eligible to receive royalties from Recepta on sales in Brazil.

"This licensing deal with Mersana follows pioneering R&D conducted by Recepta with this antibody, which was discovered by Ludwig Cancer Research, our partner and a global nonprofit research organization. It will enable the development of a novel immunoconjugate that has the potential to improve patient outcomes in oncology," said José Fernando Perez, PhD, Chief Executive Officer of Recepta.

"We are excited to develop a Fleximer-based immunoconjugate with this antibody to address unmet needs in cancer," said Anna Protopapas, President and Chief Executive Officer of Mersana. "This will expand our pipeline of oncology therapies that address the limitations of currently available antibody-drug conjugates and complement our objective to pursue one IND each year, starting with XMT-1522 later this year."

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

(Filing, 10-K, Peregrine Pharmaceuticals, JUL 14, 2015, View Source [SID:1234506333])

Fate Therapeutics and Regents of the University of Minnesota Enter Into Research Collaboration for Translation of Natural Killer Cell Cancer Immunotherapies

On July 14, 2015 Fate Therapeutics, Inc. reported that it has entered into a research collaboration with Regents of the University of Minnesota for the development of natural killer (NK) cell-based cancer immunotherapeutics (Press release, Fate Therapeutics, JUL 14, 2015, View Source [SID1234516709]). The collaboration will foster the advancement of two distinct therapeutic programs, both of which aim to leverage the inherent ability of NK cells to rapidly detect and effectively destroy malignant cells without prior antigen exposure or administration of a patient’s own immune cells. While adoptive transfer of NK cells has demonstrated anti-tumor activity, the isolation and generation of clinically-relevant quantities of homogeneous populations of highly-persistent NK cells has been challenging. Fate Therapeutics will utilize its cell programming approach and proprietary induced pluripotent stem cell technology under the collaboration to pursue the development of optimized "off-the-shelf" NK cell-based cancer therapeutics.

"Cell-based immunotherapies are rapidly emerging as one of the most promising treatment paradigms for many oncology indications, and NK cell-based therapeutics in particular may offer a compelling off-the-shelf therapeutic approach to adoptive cancer immunotherapy," said Christian Weyer, M.D., M.A.S., President and Chief Executive Officer of Fate Therapeutics. "The University of Minnesota has pioneered the basic research and clinical investigation of NK cell-based therapeutics, and we look forward to collaborating with their expert team in the development of NK cell-based immunotherapies that may provide distinct advantages in transforming the treatment of cancer."

The antibody-dependent cellular cytotoxicity program will be led by renowned NK cell biologist Jeffrey S. Miller, M.D., Deputy Director of the Masonic Cancer Center and the Deputy Director of the Clinical and Translational Science Institute at the University of Minnesota. Dr. Miller and his team have recently identified an "adaptive" NK cell phenotype that exhibits a unique metabolic program shown in preclinical studies to promote long-term persistence in vivo, and that has an epigenetic profile similar to that of cytotoxic T lymphocytes, which may induce potent anti-tumor activity against a variety of tumors. Under the collaboration, Dr. Miller and Fate Therapeutics will apply the Company’s cell programming approach with the intent to optimize NK cell persistence and cytotoxicity and accelerate the development of a programmed "adaptive" NK cellular therapeutic for use in combination with tumor-specific monoclonal antibodies.

"We are excited about the prospects of utilizing cell programming to optimize the anti-tumor properties of the phenotype, and look forward to collaborating with Fate Therapeutics in the development of programmed adaptive NK cell-based immunotherapeutics to treat cancer," said Dr. Miller. "Our data demonstrate that the adaptive phenotype is functionally distinct from conventional NK cells upon triggering through the CD16 receptor, which may make these cells ideal effectors to elicit an enhanced antibody-mediated cytotoxic effect."

The second program, focusing on induced pluripotent stem cell (iPSC)-derived targeted cancer immunotherapy, will be led by Dan Kaufman, M.D., Ph.D., Professor of Medicine and a member of the Masonic Cancer Center at the University of Minnesota. Dr. Kaufman has pioneered the derivation of NK cells from pluripotent stem cells (iNK cells), including the establishment of a clinically-compatible culture system and differentiation protocol that enable the efficient generation of large quantities of cytotoxic NK cells. Leveraging the Company’s proprietary iPSC technology, Dr. Kaufman and Fate Therapeutics will genetically-modify iPSCs to express tumor cell-targeting modalities, creating an immune-engineered pluripotent cell source for use in the derivation of "off-the-shelf" NK cell-based targeted immunotherapies.

"The introduction of antigen-specificity by genetically engineering induced pluripotent stem cells, combined with the unlimited proliferative potential and differentiation capacity of such cells, may prove to be the cornerstone of off-the-shelf targeted cancer immunotherapy," said Dr. Kaufman. "We look forward to developing engineered iNK cell-based cancer therapeutics in collaboration with Fate Therapeutics that may overcome key limitations of adaptive autologous cell therapy including the requirement to isolate and engineer cells for each individual patient."

In consideration for funding the collaboration activities, Fate Therapeutics has the option to secure exclusive patent rights to all intellectual property arising under the collaboration. Additionally, Fate Therapeutics has secured an exclusive option to certain background intellectual property of the University of Minnesota. Drs. Miller and Kaufman will serve as advisors to the Company in the development of hematopoietic cell-based immunotherapies, including those derived from induced pluripotent stem cells.

ProMIS Neurosciences Inc. announces name change – shares will begin trading under the new name July 14, 2015

On July 14, 2015 ProMIS Neurosciences Inc. ("ProMIS Neurosciences" or, the "Company") (formerly, Amorfix Life Sciences Ltd.), reported that it has effected its name change to ProMIS Neurosciences Inc. on July 8, 2015 and shares will begin trading under the new name on July 14, 2015 (Press release, ProMIS Neurosciences, JUL 14, 2015, View Source [SID:1234510740]).
TORONTO, Ontario – July 14, 2015 – the common shares of the Company will commence trading on the Toronto Stock Exchange under the new name "ProMIS Neurosciences Inc." and the new stock symbol "PMN" at the opening of trading on July 14 2015. The new CUSIP number is 74346M109 and the new ISIN number is CA 74346M1095.