Dr. Reddy’s Laboratories Limited to present at the 36th Annual J.P. Morgan Healthcare Conference

On January 6, 2018 Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that the Company will be presenting at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Dr Reddy’s, JAN 8, 2018, View Source [SID1234522935]).

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Alok Sonig, Executive Vice President and Head, North America will present on Tuesday, January
9, 2018 at 2 p.m. (PST) [3:30 a.m. IST on January 10, 2018].

Presentation material will be available on the Company’s website www.drreddys.com

H3 Biomedicine To Present 2018 Outlook at the 36th Annual J.P. Morgan Healthcare Conference

On January 9, 2018 H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of next generation cancer medicines using its data science and precision chemistry product engine, reported that it will outline its key 2018 strategies and goals that build upon its success in advancing three differentiated, internally generated cancer therapies into clinical trials (Press release, H3 Biomedicine, JAN 8, 2018, View Source [SID1234522971]). Markus Warmuth, M.D., President and CEO of H3 Biomedicine, will provide an overview of the company and further details on its 2018 goals during its presentation at the 36th Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2017, at 9:00 a.m. PST in the Elizabethan D conference room at the Westin St. Francis Hotel in San Francisco.

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"Over the past six years, we built a leading oncology product engine at the interface of data science and precision chemistry with the goal of discovering cancer therapies that address molecular traits driving cancer in select patient segments. Last year, we continued to see the successful translation of this innovation as we advanced our third internally generated therapy into clinical trials and garnered significant interest from the scientific and medical community as evidenced by a large number of key publications, papers and presentations on our product engine and clinical pipeline," said Dr. Warmuth. "With initial clinical data expected from at least two of our three therapies and our product engine continuing to drive forward new programs to achieve additional investigational new drug (IND) filings in the future, 2018 will be a pivotal year for H3 as we continue to advance toward our vision — as embodied in our name — of improving Health and providing Hope for Humans."

2017 Accomplishments

Received FDA acceptance for our IND application and dosed first patients with H3B-6545, an oral, first-in-class ESR1 covalent antagonist targeting wild-type and mutant estrogen receptor α in endocrine-therapy resistant metastatic breast cancer patients. H3 has two additional therapies in Phase I clinical trials including:
– H3B-6527, an oral, potent and highly selective small molecule covalent inhibitor of FGFR4 for treatment of hepatocellular carcinoma (HCC) patients with overexpression of FGF19; and
– H3B-8800, an oral, first-in-class, selective SF3b modulator treating hematological malignancies with spliceosome mutations;
Achieved orphan drug designation in the U.S. from the Food and Drug Administration for H3B-8800
in acute myelogenous leukemia and chronic myelomonocytic leukemia and H3B-6527 in HCC;
Garnered significant interest from the medical and scientific community with numerous publications
accepted in leading scientific and medical journals, with highlights as follows:
– Publication in Cancer Research highlighting an oral dosing of H3B-6527 in mice led to dose-dependent pharmacodynamic modulation of FGFR4 signaling and tumor regression in FGF19 altered HCC xenograft models;
– Publication in Nature Communications highlighting preclinical data describing a novel immune evasion mechanism in bladder cancer;
– Publication in Nature Communications reporting preclinical data from novel discovery research around RNA splicing modulators;
– Oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s (AACR) (Free AACR Whitepaper) New Drugs on the Horizon session on data from H3B-6545;
– Four poster presentations at AACR (Free AACR Whitepaper) on preclinical programs highlighting splicing platform and lead position in drugging RNA splicing defects in cancer;
– Oral presentation at the International Liver Cancer Association (ILCA) annual meeting demonstrating FGFR4 inhibition with H3B-6527;
– Poster presentation at the San Antonio Breast Cancer Symposium (SABCS) demonstrating potent inhibition of ERα with H3B-6545;

Extended multi-year collaboration with Foundation Medicine to continue strengthening leadership position in discovering previously unknown molecular traits driving cancers to select cancer patient populations.

Key 2018 Strategies and Goals

Drive forward clinical pipeline of differentiated cancer therapies to achieve proof of concept rapidly

Achieve Phase 2 dose for all three clinical stage programs and initiate expansion cohorts to critical decision points;
Present initial clinical data from the Phase 1/2 dose escalation and/or expansion cohorts for at least two of the three programs; and
Initiate Phase 1B combination studies for H3B-6545 and H3B-6527 as key component of strategy for these therapies.
Continue to advance our big data science and precision chemistry product engine to deliver additional INDs in the future

Advance FGFR4 mutant inhibitor program addressing hot spot mutations leading to resistance to first generation FGFR4 inhibitors to IND-enabling studies to support 2019 IND filing; Initiate lead optimization on one additional program; Achieve preclinical proof-of-concept for splice modulator-loaded antibodies, an expansion of H3’s capabilities in splice modulation and a key area of differentiation for H3; and Continue to expand data science engine to empower initiation of additional exploratory research projects.

January 2018 corporate presentation handout

On January 8, 2018 Geron presented January 2018 corporate presentation handout (Presentation, Geron, JAN 8, 2018, View Source [SID1234522987]).

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Incyte and Syros Announce Global Target Discovery and Validation Collaboration Focused on Myeloproliferative Neoplasms

On January 8, 2018 Incyte Corporation (NASDAQ:INCY) and Syros Pharmaceuticals, Inc. (NASDAQ:SYRS) reported that the companies have entered into a target discovery, research collaboration and option agreement. Under the agreement, Syros will use its proprietary gene control platform to identify novel therapeutic targets with a focus in myeloproliferative neoplasms (MPNs), and Incyte will receive options to obtain exclusive worldwide rights to intellectual property resulting from the collaboration for up to seven validated targets (Press release, Incyte, JAN 8, 2018, View Source;p=RssLanding&cat=news&id=2325356 [SID1234522990]). Incyte will have exclusive worldwide rights to develop and commercialize any therapies under the collaboration that modulate those validated targets.

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"The discovery and development of novel therapeutic approaches to treat MPNs is an important area of focus at Incyte," said Reid Huber, Ph.D., Chief Scientific Officer of Incyte. "Through this collaboration, we believe that Syros’ gene control platform will allow us to advance our understanding of the underlying biology of MPNs and potentially uncover new molecular targets for drug discovery."

"Our gene control platform has broad applicability across diseases," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "By working with Incyte, a leader in the discovery, development and commercialization of therapies for MPNs, we aim to leverage the promise of our platform to benefit patients with diseases beyond our current areas of focus. Meanwhile, we can continue advancing our own pipeline to achieve our long-term goal of building a fully integrated company with therapies that make a profound difference for patients."

Terms of the Agreement

Under the terms of the agreement, Incyte will pay Syros $10 million upfront – including $2.5 million in cash and $7.5 million in prepaid research and development (R&D) – and purchase a total of $10 million in Syros common stock at $12.61 per share.

Should Incyte exercise all of its options under the agreement, Syros could receive up to $54 million from Incyte in target selection and option exercise fees. For products resulting from the collaboration against each of the up to seven selected and validated targets, Syros could receive up to $50 million in development and regulatory milestones, as well as up to $65 million in commercial milestones. Syros would also be eligible to receive low single-digit royalties on sales of products resulting from the collaboration.

The transaction is effective immediately.

BeiGene and Mirati Therapeutics Announce Exclusive License Agreement for Sitravatinib in the Asia Pacific Region

On January 8, 2018 BeiGene, Ltd. (NASDAQ: BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, and Mirati Therapeutics (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported an exclusive license agreement for the development, manufacturing and commercialization of Mirati’s sitravatinib in Asia (excluding Japan), Australia, and New Zealand (Press release, Mirati, JAN 8, 2018, View Source [SID1234523062]). Mirati will retain exclusive rights for the development, manufacturing and commercialization of sitravatinib for the rest of world.

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Sitravatinib is an investigational tyrosine kinase inhibitor that has demonstrated potent inhibition of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET. It is being evaluated by Mirati as a single agent in a Phase 1b expansion trial in patients whose tumors harbor specific genetic alterations in non-small cell lung cancer (NSCLC) and other tumors types. Sitravatinib has shown encouraging interim results in an ongoing Phase 2 trial in combination with nivolumab in NSCLC patients who have progressed after prior treatment with a checkpoint inhibitor.

"We are delighted to enter into this exclusive clinical development and commercialization agreement for sitravantinib and look forward to working with the experienced team at Mirati. Sitravatinib is an exciting compound that has demonstrated a unique tyrosine kinase inhibition profile and promising clinical activity both as a single agent and in combination with a checkpoint inhibitor in non-small cell lung cancer. This collaboration complements our portfolio and will allow us to investigate sitravatinib in

combination with tislelizumab, our investigational anti-PD-1 antibody, in China and the rest of the licensed territory," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"We are excited to begin a partnership with BeiGene, which has built a world-class global development organization with a strong presence in Asia-Pacific, as well as an established commercial organization in China. They have demonstrated an ability to enroll patients quickly in a variety of indications which will augment our development capabilities and expand the evaluation of sitravatinib to additional tumor types for patients who are checkpoint inhibitor naïve or who have been previously treated with a checkpoint inhibitor," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati Therapeutics.

Under the agreement Mirati will receive an upfront cash payment of $10 million from BeiGene. Additionally, Mirati is eligible to receive up to $123 million of additional payments based upon the achievement of certain development, regulatory and sales milestones as well as significant royalties on future sales of sitravatinib in the licensed territory.