On October 3, 2019 Ryvu Therapeutics, a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, reported that two abstracts have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting (SITC 2019) in National Harbor, MD from November 6 – 10, 2019 (Press release, Ryvu Therapeutics, OCT 3, 2019, View Source [SID1234540052]).

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The abstracts, which will be presented in a poster session, include leading immuno-oncology and immunometabolism programs developed by the company: novel, dual A2A/A2B antagonist and small molecule, direct STING agonists.

Details of the posters are as follows:

Poster 797: Novel dual A2A/A2B receptor antagonist reverses adenosine-mediated immune suppression – in vitro and in vivo characterization.
Category: Novel Single-Agent Immunotherapies

Poster 661: Development and characterization of next generation small molecule STING agonists
Category: Immune-stimulants and immune modulators

To view these abstracts, please visit the SITC (Free SITC Whitepaper) 2019 website located at View Source

Last week, Ryvu Therapeutics (formerly Selvita) published a poster on its leading A2A/A2B program at the CICON 2019 – Translating science into survival – Conference, which took place in Paris, France, September 25-28. Poster entitled "Characterization of novel potent dual A2A/A2B adenosine receptor antagonists for cancer immunotherapy" is now available at Ryvu corporate website: View Source

On October 3, 2019 Heron Therapeutics, Inc. ("Heron") (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that it intends to offer and sell shares of its common stock in an underwritten registered public offering (Press release, Heron Therapeutics, OCT 3, 2019, View Source [SID1234540035]). Heron intends to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the shares sold in the public offering. All of the shares of common stock in the offering are to be sold by Heron. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Heron intends to use the proceeds from the proposed sale of its shares of common stock for the commercial launch of HTX-011, if approved by the U.S. Food and Drug Administration, the continued commercialization and marketing of SUSTOL and CINVANTI, Heron’s ongoing and future clinical trials, including further clinical studies for HTX-011, preclinical development work, other product development activities and general corporate purposes.

Jefferies, Cowen and Evercore ISI are acting as joint book-running managers for the offering. Cantor is acting as lead manager for the offering, and JMP Securities, Needham & Company and Northland Capital Markets are acting as co-managers for the offering.

The offering is being made pursuant to a registration statement that was filed with the U.S. Securities and Exchange Commission (the "SEC") and became automatically effective on July 6, 2017. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Copies of the preliminary prospectus supplement and accompanying prospectus relating to these securities may also be obtained by sending a request to Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388, or by email at [email protected], Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or Evercore Group L.L.C. at Attention Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected].

On October 3, 2019 Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, reported it has entered into an exclusive distribution agreement for its non-opioid metastatic cancer pallion drug, Strontium-89 Chloride Injection USP (Strontium-89)/Metastron, with Jubilant Radiopharma for the United States market (Press release, Q BioMed, OCT 3, 2019, View Source [SID1234540053]). Jubilant Radiopharma is an industry leading pharmaceutical company specializing in nuclear medicine focused on developing, manufacturing, commercializing and distributing high quality and sustainable diagnostic and therapeutic agents on a global scale.

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Strontium-89 is an FDA-approved non-opioid radiopharmaceutical indicated for the treatment of painful skeletal metastases caused by cancer. The product is administered intravenously once every three months as an alternative to opioid analgesics and plays a critical role in the treatment of metastatic bone pain.

The partnership between Q BioMed and Jubilant Radiopharma means that once the FDA approves the Q BioMed contract manufacturer, the large population of potential Strontium-89 patients in the United States will again have the opportunity to access the drug. Denis Corin, CEO of Q BioMed, said of the deal, "Our partnership with Jubilant Radiopharma is an essential component of our upcoming commercial launch and means that we’ll be able to reach providers and patients across the country through a scalable, highly-efficient program, thereby re-establishing supply of this life-changing therapy to those suffering from this debilitating pain."

Jubilant Radiopharma operates the second largest commercial radiopharmacy network in the United States. Pramod Yadav, CEO, Jubilant Pharma Limited stated, "Jubilant Radiopharma is committed to improving lives through Nuclear Medicine by providing healthcare professionals access to high quality, FDA approved products that enable better patient outcomes. We are pleased to partner with Q BioMed to bring this important cancer pain therapy to healthcare providers and patients who so desperately need choices in cancer pain treatment."

Q BioMed and Jubilant Radiopharma intend to announce further details regarding availability of Strontium-89 later this year.

On October 3, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that pre-clinical data on AUTO6NG, the company’s next generation GD2-targeting CAR T cell therapy, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting (Press release, Autolus, OCT 3, 2019, View Source [SID1234550685]). The meeting will be held from November 6 to November 10, 2019, at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

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Poster Presentation

Abstract #: P146
Abstract Title: "AUTO6NG: Next generation GD2-targeting CAR T-cell therapy with improved persistence and insensitivity to TGFb and checkpoint inhibition for relapsed/refractory neuroblastoma", Achkova, D., et al.
Session Date: Saturday, November 9
Session Time: 7:00 am – 8:30 pm Eastern Time

About AUTO6NG

AUTO6NG is a next generation programmed T cell product candidate in pre-clinical development. AUTO6NG builds on preliminary proof of concept data from AUTO6, a CAR in clinical development for the treatment of neuroblastoma, which has the ability to target GD2-expressing cancers with a chimeric antigen receptor (CAR). AUTO6NG uses the clinically-derisked CAR of AUTO6 and incorporates additional programming modules designed to enhance the efficacy, safety and persistence of the CAR T therapy. With the enhanced properties of AUTO6NG, it may be suitable for the treatment of GD2-expressing solid tumors, including neuroblastoma, osteosarcoma, melanoma, small cell lung cancer, and soft tissue sarcoma.

AUTO6 is currently in a Phase 1 clinical trial for pediatric neuroblastoma conducted by Cancer Research UK in collaboration with University College London. Autolus has worldwide commercial rights to the GD2-targeting programmed T cell product candidate.

On October 3, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, reported updated data from the ongoing Phase 1b study of investigational ME-401, a selective oral inhibitor of PI3K delta (Press release, MEI Pharma, OCT 3, 2019, View Source2019-10-03-MEI-Pharma-Announces-Updated-Clinical-Data-from-ME-401-Phase-1b-Study-in-Patients-with-Indolent-B-cell-Malignancies" target="_blank" title="View Source2019-10-03-MEI-Pharma-Announces-Updated-Clinical-Data-from-ME-401-Phase-1b-Study-in-Patients-with-Indolent-B-cell-Malignancies" rel="nofollow">View Source [SID1234540036]). These new data will be presented at MEI’s Investor and Analyst Event being held tomorrow, October 4, 2019, at 8:00 am ET.

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Highlights of the ME-401 updated data include:

Overall response rates of 78% in relapsed or refractory (r/r) follicular lymphoma (FL) and 89% in r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
Rates of Grade 3 adverse events of special interest related to ME-401 exposure were observed in <10% of patients dosed on an intermittent schedule (IS).
Median duration of response not yet reached in patients with FL or CLL/SLL on the IS regimen. Median follow-up for FL and CLL/SLL patients is 9.2 months (range 3.4-20.7 months) and 7.4 months (range 2.6-14.7 months), respectively.
At the Investor and Analyst event MEI will also review progress across the pipeline of its four clinical-stage oncology candidates with a focus on voruciclib, a cyclin-dependent kinase (CDK) inhibitor with potent CDK9 inhibition. Voruciclib is in a Phase 1b study in patients with r/r B-cell malignancies or Acute Myeloid Leukemia (AML) after failure of prior standard therapies. In addition, we plan to evaluate voruciclib in combination with venetoclax (marketed as Venclexta), a B-cell lymphoma (Bcl) 2 inhibitor, in patients with r/r AML.

"ME-401 continues to exceed expectations in the Phase 1b study; the overall response rate remains high at 81% with 73 evaluable FL and CLL/SLL patients being followed for treatment," Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Currently, our primary focus is the ME-401 Phase 2 TIDAL study evaluating patients with relapsed or refractory follicular lymphoma, which may support an accelerated approval of a marketing application with FDA, as well as the continuing exploration of various combination regimens with ME-401."

Dr. Gold continued: "More broadly, MEI has a strong foundation to build value through advancing our pipeline, evaluating drug combination opportunities across the B-cell malignancy landscape, and continuing to create and explore strategic opportunities to most effectively leverage the potential of the pipeline. Each of our four clinical-stage oncology candidates is well positioned for continued clinical development."

Investor and Analyst Event Information

Date: Friday, October 4, 2019
Time: 8 am -11 am ET

The investor event will feature presentations from the following MEI Pharma executives:

Dan Gold, Ph.D., President and Chief Executive Officer, MEI Pharma.

Robert Mass, M.D., Chief Medical Officer, MEI Pharma.

Richard Ghalie, M.D., Senior Vice President, Clinical Development, MEI Pharma.
The event will also feature presentations by the following guest speakers:

Lewis C. Cantley, Ph.D., Meyer Director of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medical College, Professor of Cancer Biology in Medicine.

Nishitha M. Reddy, M.D., M.B.B.S., Associate Professor of Medicine at Vanderbilt University Medical Center.

Matthew J. Matasar, M.D., Medical Director, Memorial Sloan Kettering Bergen.
You can access the live webcast under the investor relations section of MEI’s website on the "Events and Presentation" page at: www.meipharma.com. A replay of the webcast will be archived for at least 30 days after the conclusion of the live event.

The full Investor and Analyst Event presentation will be available on the home page of the Investor Relations section of MEI Pharma’s website at: View Source

About MEI’s Clinical-Stage Oncology Pipeline

About ME-401
ME-401 is an oral, once-daily, selective phosphatidylinositol 3-kinase (PI3K) delta inhibitor in clinical development for the treatment of B-cell malignancies. MEI owns worldwide rights in all geographies except Japan, which we licensed to Kyowa Kirin Company (formerly "Kyowa Hakko Kirin Co., Ltd.") in 2018.

MEI is conducting two ongoing studies evaluating ME-401. The first is a Phase 2 clinical trial evaluating ME-401 as a monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma ("FL") after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. Subject to the results, upon completion of the Phase 2 clinical trial, we are planning a submission with the FDA to support an accelerated approval of a marketing application under 21 CFR Part 314.500, Subpart H. The second is a multi-arm, open-label, Phase 1b dose escalation and expansion trial evaluating ME-401 as a monotherapy and in combination with other therapies or investigational agents in patients with relapsed or refractory B-cell malignancies.

About Voruciclib
Voruciclib is an orally administered cyclin-dependent kinase (CDK) inhibitor differentiated by its potent in vitro inhibition of CDK9, in addition to CDK6, 4 and 1. Voruciclib is currently being evaluated in a Phase 1b dose ranging trial in patients with relapsed and/or refractory B-cell malignancies or acute myeloid leukemia (AML) after failure of prior standard therapies.

About ME-344
ME-344 is our novel and tumor selective, isoflavone-derived mitochondrial inhibitor drug candidate. It directly targets the OXPHOS complex 1, a pathway involved in ATP production in the mitochondria. ME-344 was recently studied in an investigator-initiated, multi-center, randomized clinical trial in combination with the vascular endothelial growth factor (VEGF) inhibitor bevacizumab (marketed as Avastin ) in a total of 42 patients with HER2 negative breast cancer. The data established significant biologic activity in the ME-344 treatment group as measured by Ki67 reductions (a measure of cell proliferation that is highly correlated with tumor response).

About Pracinostat
Pracinostat is an oral histone deacetylase (HDAC) inhibitor being evaluated in a pivotal Phase 3 global registration clinical trial for the treatment of adults with newly diagnosed AML who are unfit to receive intensive chemotherapy. Pracinostat is also being evaluated in a Phase 2 trial in patients with high or very high-risk myelodysplastic syndrome (MDS). In August 2016, we entered into an exclusive worldwide license, development, manufacturing and commercialization agreement with Helsinn Healthcare SA, a Swiss pharmaceutical corporation for pracinostat in AML, MDS and other potential indications.