On June 9, 2020 Oasmia Pharmaceutical reported that it will publish its Year End Report for the financial year 2019/2020 on June 18, 2020, at 08.00 am CET (Press release, Oasmia, JUN 9, 2020, View Source [SID1234560932]).

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The company will hold a conference call and an online presentation on the same day at 10.00 am (CEST). The call will be hosted by Francois Martelet, CEO, and Michael af Winklerfelt, CFO. The presentation will be in English.

On June 9, 2020 Lyvgen, a biopharmaceutical company focused on developing innovative immuno-oncology therapeutics, reported that it has entered into a clinical trial collaboration agreement with a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, U.S.A., known as MSD outside of the U.S. and Canada (Press release, Lyvgen Biopharma, JUN 9, 2020, View Source [SID1234560948]). The collaboration will evaluate Lyvgen’s LVGN6051, a second generation 4-1BB (CD137) agonist antibody, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in a Phase 1 study in adult patients with advanced malignancy including lung cancer, melanoma, gastrointestinal cancer with MSI-high or DMMR, and lymphoma.

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"We are very excited about this clinical collaboration with MSD to evaluate the combination of KEYTRUDA with LVGN6051, our innovative 4-1BB (CD137) agonist antibody," said Jieyi Wang, Ph.D., Chief Executive Officer of Lyvgen. "CD137 signaling provides critical support for CD8+ effector T cells in a manner complementary to the effect of PD-1 blockade. We believe that the combination of LVGN6051 and KEYTRUDA has the potential to improve treatment outcomes for patients with advanced cancer and may broaden the applications of cancer immunotherapy."

Lyvgen has initiated a Phase I clinical trial (NCT04130542) in October of 2019.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About LVGN6051
Lyvgen uses its xLinkAb platform that leverages IgG and FcγRIIB interaction to generate agonist antibodies targeting co-stimulatory receptors with selectivity for tumor microenvironment to enhance efficacy and therapeutic index. LVGN6051 specifically binds human CD137 (4-1BB) and activates its signaling only when the engineered Fc of LVGN6051 engages FcγRIIB. In contrast to the first generation CD137 agonist antibodies that entered clinic, LVGN6051 has bi-specificity for CD137 and FcγRIIB.

About Lyvgen’s xLinkAb Platform
xLinkAb platform creates agonist IgG antibodies by leveraging both Fab and Fc binding specificity to achieve target activation selectively in the tumor microenvironment. To increase selectivity for tumors, Lyvgen discovers antibodies that agonize their targets only in the presence of FcγRIIB (FCGR2B; CD32B), which is expressed on immune cells enriched in the tumor microenvironment, including B cells, monocytes and NK cells.

On June 9, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported its submission of a De Novo classification request to the U.S. Food & Drug Administration (FDA) for the nCounter Dx LymphMark Assay, a novel, genomic lymphoma subtyping test (Press release, Veracyte, JUN 9, 2020, View Source [SID1234560933]). The in vitro diagnostic test is used on the nCounter Flex Analysis System, Veracyte’s diagnostics platform, and is intended to add to Veracyte’s portfolio of tests that address complex clinical problems, helping to inform diagnoses and better treatment decisions.

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Veracyte has proposed the LymphMark test as an aid in disease characterization and prognosis to support disease management for patients newly diagnosed with diffuse large B-cell lymphoma (DLBCL). The LymphMark test utilizes gene-expression profiling of RNA extracted from formalin-fixed paraffin-embedded tissue to classify the "cell of origin" subtype of DLBCL tumors. The World Health Organization recommends gene-expression profiling for patients with DLBCL, given that certain subtypes are associated with poorer clinical outcomes, which may potentially be mitigated by more-specific treatments that are under development.1

"This submission marks an important milestone for Veracyte in our efforts to expand the menu of advanced genomic tests we provide on the nCounter system. Ultimately, our goal is to make our broader menu of tests accessible to patients worldwide through hospitals and laboratories that can perform them locally," said Bonnie Anderson, Veracyte’s chairman and chief executive officer.

Veracyte acquired the LymphMark test in December 2019 as part of its acquisition from NanoString of the exclusive global diagnostic rights to the nCounter system.

"DLBCL is an aggressive form of lymphoma with heterogeneous clinical behavior – outcomes significantly depend upon the distinct molecular subtype of each patient’s tumor," said Dr. David Scott, associate professor in the Department of Medicine at the University of British Columbia and a scientist in the Department of Lymphoid Cancer Research at BC Cancer, a program of the Provincial Health Services Authority. "The ability to determine this information from gene-expression profiling of tissue samples collected routinely in a clinical setting has the potential to transform patient care, making personalized treatment options more accessible."

Non-Hodgkin lymphoma ranks among the top-10 common cancers worldwide, with over 500,000 new cases estimated in 2018.2 DLBCL accounts for approximately 30 percent of lymphomas.3

On June 9, 2020 Rafael Holdings, Inc., (NYSE: RFL), reported revenue of $1.2 million and a loss per share of $0.14 for the fiscal quarter ended April 30, 2020 (Press release, Rafael Holdings, JUN 9, 2020, View Source [SID1234560950]).

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Q3 FY 2020 Consolidated Highlights

Revenue of $1.2 million in Q3 FY2020, generated by Rafael Holdings’ real estate portfolio, decreased from $1.4 million in the year-ago quarter. The loss per share of $0.14 increased from $0.07 in the year ago quarter largely on increased R&D expense incurred by the Barer Institute.
Rafael Pharmaceuticals

On May 26, 2020, Rafael Pharma announced positive results of a single-arm, open-label, Phase 1 study of CPI-613 (devimistat) with gemcitabine and nab-paclitaxel in patients with locally advanced or metastatic pancreatic cancer. The data was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program.
On April 28, 2020, Rafael Pharma announced the expansion of its Phase 2 clinical trial of CPI-613 (devimistat) for patients with relapsed or refractory Burkitt’s lymphoma/leukemia. The clinical trial began enrolling patients at MD Anderson Cancer Center, where Dr. Raphael Steiner serves as principal investigator.
On March 24, 2020, Rafael Pharma announced that it had enrolled more than 75% of the 500 patients needed for its pivotal Phase 3 clinical trial for metastatic pancreatic cancer (AVENGER 500). The trial is evaluating the efficacy and safety of Rafael’s lead compound CPI-613️ (devimistat) in combination with modified FOLFIRINOX (mFFX) as first-line therapy.
LipoMedix

At April 30, 2020, Rafael Holdings held 57.9% of the issued and outstanding ordinary shares of LipoMedix, a development-stage Israeli company focused on the development of an innovative, safe and effective cancer therapy based on liposome delivery.

Lipomedix was awarded a Seal of Excellence for its Promitil project by European Innovation Council of the European Union.
LipoMedix’s Phase IB study of Promitil in Israel continued to enroll patients with advanced cancer requiring palliative radiotherapy for inoperable tumors or metastatic disease.
Barer Institute

Rafael Holdings increased its investment in pharmaceutical development through its Barer Institute subsidiary. The Barer Institute is currently testing indications for lead compounds targeting cancer metabolism and has initiated a preclinical in-licensing effort on selected compounds that target the unique mechanisms of cancer.

Remarks by Howard Jonas, Chairman and CEO of Rafael Holdings

"Rafael Holdings’ key pharmaceutical investments, Rafael Pharma and LipoMedix and our wholly owned Barer Institute, continue to execute on their development and clinical programs despite the challenges posed by the worldwide Covid-19 pandemic. I am especially gratified that Rafael Pharma has surpassed the 80% enrollment milestone in its pivotal Phase 3 Avenger 500 study of patients with pancreatic cancer. The Barer Institute is evaluating promising candidates for potential clinical development programs. And finally, we continue to work to monetize our New Jersey real estate assets, while our asset in Israel is now fully leased."

On June 8, 2020 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that it has commenced an underwritten public offering of its common stock (Press release, Fate Therapeutics, JUN 8, 2020, View Source [SID1234560898]). Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, including the construction, commissioning and qualification of its new facility, the conduct of preclinical research and development, and for general corporate purposes. In connection with the offering, Fate Therapeutics expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All shares of common stock to be sold in the offering will be offered by Fate Therapeutics. 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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Subject to the completion of the offering and the expiration or early termination of applicable waiting periods relating to certain antitrust filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, the Company also expects to sell to Johnson & Johnson Innovation-JJDC, Inc. in a private placement, a number of shares of common stock in an aggregate purchase price of up to $50.0 million, at a price per share equal to the price to the public in the underwritten public offering.

Jefferies, SVB Leerink and Barclays are acting as joint book-running managers for the offering.

The securities described above are being offered by Fate Therapeutics pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-228513) that was previously filed by Fate Therapeutics with the Securities and Exchange Commission (the "SEC") and automatically became effective upon filing on November 21, 2018.

A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source A copy of the preliminary prospectus supplement and accompanying prospectus can be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 547-6340; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6218 or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847 or by email at [email protected].

This press release does 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.