PALM BEACH, Florida, June 6, 2018 /PRNewswire/ --
MarketNewsUpdates.com News Commentary
Overthe past month of May, the iShares Nasdaq Biotechnology ETF has risen by more than 7% as it was a big week to start June for the biotech industry with the kick-off of the much-anticipated American Society of Clinical Oncology (ASCO) annual meeting in
Moleculin Biotech, Inc. (NASDAQ: MBRX) BREAKING NEWS: Moleculin Biotech, 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, today announced that has entered into an agreement with The University of Iowa Pharmaceuticals for the development of a formulation for WP1732. "WP1732, which we believe, based on preclinical testing, is a breakthrough discovery, is now advancing to the stage of formulation development," commented Walter Klemp, Moleculin's Chairman and CEO. "With the demand for clinical testing of WP1066 continuing to grow, it is easy to forget that we believe WP1732 represents a major expansion of our STAT3 inhibition capability by providing a highly soluble alternative that is ideally suited for IV administration. This agreement marks the beginning of our creating a preclinical package to submit to the FDA in order to request Investigational New Drug status." Read this and more news for Moleculin Biotech at: http://www.marketnewsupdates.com/news/mbrx.html In other pharma and biotech developments in the markets:
Abeona Therapeutics Inc. (NASDAQ: ABEO) recently announced the opening of The Elisa Linton Center for Rare Disease Therapies, the commercial GMP manufacturing facility for gene and cell therapies in Cleveland, Ohio. The GMP facility will have the capability to manufacture clinical and commercial grade products over Abeona's multiple programs, including recessive dystrophic epidermolysis bullosa (RDEB) and Sanfilippo syndrome. The ribbon-cutting ceremony and first facility walk-through will be held today, May 31, 2018. "The opening of The Elisa Linton Center for Rare Disease Therapies is a momentous occasion and underscores Abeona's ongoing commitment to transforming patients' lives," said Carsten Thiel, Ph.D., Abeona's Chief Executive Officer. "Our development of internal manufacturing capabilities bolsters our position for commercial readiness as we continue to execute on our vision to bring these therapies to the patient communities that need them."
Jounce Therapeutics Inc. (NASDAQ: JNCE) recently announced preliminary data from its ongoing Phase 1/2 ICONIC trial, an adaptive design, open-label trial evaluating JTX-2011 alone and in combination with nivolumab in patients with advanced solid tumors. Safety and preliminary clinical activity data from all evaluable patients across multiple tumor types will be presented in an oral presentation today, Saturday, June 2, 2018 at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. "We are encouraged by the early signal of clinical activity in heavily pre-treated patients, accompanied by an ICOS pharmacodynamic biomarker. We believe that this biomarker may help guide further development of JTX-2011," said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. "Importantly, JTX-2011 continues to be safe and well-tolerated both as a single agent and in combination with nivolumab. We look forward to continuing clinical evaluation of JTX-2011, including initiation of new combination dose escalation cohorts within the ICONIC trial of JTX-2011."
Nektar Therapeutics Inc. (NASDAQ: NKTR) and Bristol-Myers Squibb (NYSE:BMY) recently announced presentation of preliminary data from the ongoing PIVOT Phase 1/2 Study, which is evaluating the combination of Bristol-Myers Squibb's Opdivo (nivolumab) with Nektar's investigational medicine, NKTR-214. The preliminary results presented at the 2018 American Society of Clinical Oncology (ASCO) reported safety, efficacy and biomarker data for patients enrolled in the Phase 1 dose-escalation stage of the study and for the first patients consecutively enrolled in select dose expansion cohorts in Phase 2. Enrollment is ongoing in the Phase 2 stage of the PIVOT study in over 400 patients with melanoma, renal cell, urothelial, non-small cell lung and triple negative breast cancers. Preliminary results from the ongoing PIVOT study presented today showed that pre-specified efficacy criteria were achieved in three tumor types: first-line melanoma, first-line renal cell carcinoma and first-line urothelial cancer. As a result, Nektar and Bristol-Myers Squibb will initiate a Phase 3 registrational trial in first-line advanced melanoma patients in Q3 2018, and pivotal studies are also being designed in renal cell carcinoma and urothelial cancer.
Sangamo Therapeutics Inc. (NASDAQ: SGMO) recently announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom has granted the Clinical Trial Authorisation (CTA) for enrollment of subjects into ongoing Phase 1/2 clinical trials evaluating SB-318 and SB-913, zinc finger nuclease (ZFN) in vivo genome editing treatments for Mucopolysaccharidosis Type I (MPS I) and MPS II, respectively. "Patients with MPS I and MPS II have very few treatment options, and we are excited to expand access to our clinical trials to the U.K.," said Dr. Edward Conner, Chief Medical Officer at Sangamo. "We are pleased with the MHRA's rapid action on our CTA applications and to be working closely with them to advance our evaluation of zinc finger nuclease genome editing treatments into younger patient populations for whom we believe the need and potential benefits are greatest."
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