BeyondSpring to Host R&D Day to Discuss Novel Immune Agent Plinabulin’s Development Program in Anti-cancer Indications

On June 17, 2021 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, reported it will host a Research and Development (R&D) Day to discuss the development program for its novel immune agent, Plinabulin, in anti-cancer indications on Friday, June 25th, at 8:00 a.m. ET (Press release, BeyondSpring Pharmaceuticals, JUN 17, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-to-host-rd-day-to-discuss-novel-immune-agent-plinabulins-development-program-in-anti-cancer-indications [SID1234585698]).

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The webinar will feature presentations by Key Opinion Leaders (KOLs) Steven Lin, M.D. (MD Anderson Cancer Center), and Trevor M. Feinstein, M.D. (Piedmont Cancer Institute), who will discuss the current treatment landscape and unmet medical need in treating patients with non-small cell lung cancer (NSCLC) and patients who failed checkpoint inhibitors. Drs. Lin and Feinstein will be available to answer questions following the formal presentations.

Also featured will be a management discussion of BeyondSpring’s pipeline, including lead asset plinabulin, a selective immunomodulating microtubule-binding agent (SIMBA), being developed as a "pipeline in a drug." Topics management will cover include:

Plinabulin and G-CSF combination, which received priority review by the U.S. Food and Drug Administration (FDA) for its NDA for prevention of chemotherapy-induced neutropenia (CIN), which also received breakthrough designation. The Company has a PDUFA date of November 30, 2021.
Plinabulin and docetaxel combination, which is in a fully enrolled pivotal Phase 3 global study (DUBLIN-3) as a potential direct anticancer agent in patients with NSCLC. DUBLIN-3 is expected to report data in mid-2021.
Plinabulin in combination immune-oncology regimens, leveraging its MOA as a potent APC (antigen presenting cell) inducer. Plinabulin has demonstrated promising Phase 1 data in 2nd/3rd line SCLC (ASCO 2021); company has recently initiated a Phase 1 study in 7 cancers which failed checkpoint inhibitors to investigate plinabulin’s potential to reverse resistance to immunotherapy.
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Steven Lin, M.D., Ph.D.
Dr. Lin is an Associate Professor and Physician-Scientist at MD Anderson Cancer Center, with joint appointments in the Departments of Radiation Oncology and Experimental Radiation Oncology. Dr. Lin’s practice focuses on thoracic malignancies, and he oversees several clinical trials including the use of proton beam therapy for esophageal cancer and in the combination of immunotherapy with radiotherapy in lung and esophageal cancers. Dr. Lin runs a translational research team that evaluates biomarkers for treatment response and disease outcomes after chemoradiation therapy and immunotherapy. On the basic science side, Dr. Lin’s main interests lie in identifying novel approaches that could enhance radiotherapy and immunotherapy combinations in lung cancer that could be translated to innovative clinical trials for patients.

Trevor M. Feinstein, M.D.
Dr. Feinstein is board certified in medical oncology and hematology by the American Board of Internal Medicine and is director of research at Piedmont Fayette Hospital. He joined Piedmont Cancer Institute in 2011 from private practice in West Palm Beach, Florida where he cared for cancer patients. Dr. Feinstein is actively involved in clinical trials focused on improved therapies for various cancers and is a certified member of MD Anderson Cancer Network. He is a co-investigator on several peer-reviewed research projects and has authored numerous publications and abstracts in Hematology and Oncology. Dr. Feinstein graduated from University of Illinois medical school and completed his residence and fellowships at the University of Pittsburgh.

Multimeric Biotherapeutics to Present at Keystone Symposium on Innovative Vaccine Approaches

On June 17, 2021 Multimeric Biotherapeutics, Inc., a biotechnology company developing vaccines against cancer and infectious diseases, reported that it has been accepted to present at the Keystone Symposium on Innovative Vaccine Approaches (Press release, Multimeric Biotherapeutics, JUN 17, 2021, View Source [SID1234585488]). The meeting will be held as a virtual web conference scheduled June 28-30, 2021.

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Cannabics Pharmaceuticals to launch Drug Development Programs for Prostate Cancer and Neurodegenerative & Mental Health Diseases

On June 17, 2021 Cannabics Pharmaceuticals Inc. (CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported the expansion of its research program with new drug development projects targeting Prostate Cancer, Neurodegenerative & Mental Health diseases (Press release, Cannabics Pharmaceuticals, JUN 17, 2021, View Source [SID1234584202]). The announcement of the new research projects follows promising initial preclinical results obtained in the company’s in-house drug discovery facility in Rehovot, Israel.

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Study results indicate the potential efficacy of a variety of specific analytes for the indications tested. The experiments performed were conducted on cell lines and human biopsies obtained under Helsinki Committee approval. The company plans to continue development of these drug candidates and continue testing with animal models while entering a drug regulatory development route for each indication.

This announcement also comes following the company’s promising animal model study results for company’s proprietary Colorectal Cancer treatment drug candidate RCC-33. The company has also recently announced a decision to enter the Melanoma and Breast Cancer markets with new drug development projects.

Gabriel Yariv, company President and COO said: "We have invested a great deal of effort over the past 18 months in expanding our drug development projects. In doing so, we have established a drug development pipeline addressing an estimated $78.1B market size. This market is also expected to grow in the coming years. For example, the Breast Cancer market alone is estimated to grow from $21.58B in 2019 to $55.27B in 2027, according to Fortune Business Insights. We now have four cancer treatment drug development projects for Colorectal Cancer (CRC), Melanoma, Breast Cancer and Prostate Cancer; one pre-cancer antitumor drug development project for the treatment of Adenomatous Polyps in collaboration with Digestix Bioscience Inc.; one palliative drug development project for the treatment of Cancer related Anorexia Cachexia Syndrome (CACS); and two early-stage drug discovery projects targeting Neurodegenerative and Mental Health diseases".

Eyal Barad, Cannabics Pharmaceuticals’ Co-founder and CEO commented: "During the past year and a half, we have made announcements of several important milestones that we have achieved, all as part of our strategy focused on creating a portfolio of valuable intellectual property to support our methodology and expanding product pipeline development. Today, we see the outcome of this ongoing effort in looking at our core growth initiatives ultimately aimed at developing products to help large groups of patients around the world and cater to their medical needs, including several of their unmet needs. We continue to put together a robust package for scheduling our Pre IND meeting with the FDA and before heading into human trials. We have doctors and hospitals already looking to collaborate with us on such clinical studies and hope to be able to do so during 2022. In parallel, we continue the development of our new drug candidates and plan to enter animal model studies later this year."

Orion Biotechnology Secures $11.5M Series A Financing

On June 17, 2021 Orion Biotechnology Canada Ltd., a clinical-stage biotechnology company, reported that it has raised $11.5M USD in a Series A financing (Press release, Orion Biotechnology, JUN 17, 2021, View Source [SID1234584176]).

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The oversubscribed round was led by Keiretsu Forum, a global group of investors and included corporate/institutional investors, venture capitalists and existing shareholders. Howard Lubert, President Keiretsu Forum Mid-Atlantic, commented "As early investors in disruptive life sciences companies, we have seen how cutting-edge technologies like Orion’s can bring significant value to the industry and lead to the delivery of innovative new treatments for patients. We believe that Orion has developed a truly innovative technology for effectively targeting G Protein-Coupled Receptors (GPCRs)." The investment includes conversion of a Simple Agreement for Future Equity (SAFE) as well as closing the first tranche of a Series A investment.

"It’s rewarding to see a Canadian biotech company receive support for their novel technology from across the Keiretsu Forum ecosystem following our cross border due diligence process. Our investors are excited to be a part of their growth and innovation" said Kevin Sterling, President Keiretsu Forum Toronto.

Proceeds from the financing will be used to advance Orion’s pipeline of novel precision-engineered therapeutics, including its lead oncology candidate, which is a first-in-class Chemokine Analog with best-in-class potency. The investment will also enable the company to extend its proprietary discovery platform for effectively targeting complex GPCRs that have proven difficult to target using traditional drug classes.

"We are pleased to have the support and confidence of a large network of seasoned life science investors" said Mark Groper, President and CEO of Orion Biotechnology. "With the completion of this funding round, we are positioned to build on the momentum we have created, advance our multi-asset portfolio, and further leverage our proprietary discovery platform to deliver new precision engineered therapies in collaboration with industry partners".

Anji to Advance MCL1 Inhibitor Program from Broad Institute into Clinical Trials

On June 17, 2021 Anji Pharma ("Anji"), a global pharmaceutical company focused on tackling high-value drug targets validated by human genetics, reported that an Anji subsidiary has acquired worldwide development and commercialization rights to an MCL1 inhibitor program through a license from the Broad Institute of MIT and Harvard and will work to advance the program’s MCL1 inhibitors through clinical development (Press release, Anji Pharmaceuticals, JUN 17, 2021, View Source [SID1234584173]).

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MCL1 is a member of the Bcl-2 family, normally acting as a "brake" on the apoptosis pathway. In many human cancers, the Mcl-1 gene is highly amplified, shifting the balance from pro- to anti-apoptotic signals and promoting cancer cell survival and tumor formation. Molecules which selectively block MCL1 function induce rapid and specific killing of cancer cells in preclinical models when administered as single agent or in combination with other targeted therapy.

"MCL1 has always been at the top of our list for oncology mechanisms, given its pronounced amplification across tumor types and central role in orchestrating chemotherapy resistance," noted Dan Meyers, M.D., Chief Medical Officer of Anji. "We believe this specific class of MCL1 inhibitors has a unique profile that could offer a wider safety window and better outcomes for cancer patients."

"Our interest in this MCL1 program reaffirms our commitment to pursue compelling mechanisms – regardless of disease indication – and develop therapies that can help patients across the globe," added Brian Hubbard, Ph.D., Chief Executive Officer of Anji. "What matters to us most is whether it will work, and then we commit our clinical and regulatory experience to bring treatments to patients as safely and quickly as possible."

The MCL1 program is one of several programs pursued by the Center for Development of Therapeutics (CDoT) at the Broad Institute. CDoT is a highly collaborative team of professional scientists who work closely with Broad’s principal investigators to advance deep biological insights into therapeutics.