TESARO Announces Collaboration to Evaluate ZEJULA® in Combination With Anti-PD-L1 Cancer Immunotherapy and MEK Inhibitor in Platinum-Sensitive Ovarian Cancer

On June 5, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported that it has entered into a clinical collaboration with Genentech, a member of the Roche Group, to evaluate the combination of the PD-L1 antibody atezolizumab (TECENTRIQ), the MEK inhibitor cobimetinib (COTELLIC) and TESARO’s PARP inhibitor ZEJULA (niraparib) in patients with platinum-sensitive ovarian cancer (Press release, TESARO, JUN 5, 2018, View Source [SID1234527187]).

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"This partnership enables us to further expand the clinical assessment of niraparib-based combinations as we work to advance therapies for women living with ovarian cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Preclinical data has demonstrated potential synergy between MEK and PARP inhibitors, and there is emerging evidence to support an immunomodulatory role for PARP inhibitors. Data suggest the addition of atezolizumab may potentially further enhance the anti-cancer immune response. We look forward to evaluating the potential for this combination to further prolong responses to chemotherapy."

TESARO and Genentech are also working together to evaluate the combination of ZEJULA and atezolizumab in patients with metastatic bladder cancer as a part of MORPHEUS, Roche’s novel cancer immunotherapy development platform. MORPHEUS is a Phase 1b/2 adaptive platform to develop combinations of cancer immunotherapies more rapidly and efficiently. The planned trial will be conducted by Genentech and is expected to begin by the end of 2018.

TECENTRIQ (atezolizumab) and COTELLIC (cobimetinib) are registered trademarks of Genentech, a member of the Roche Group.

About ZEJULA (Niraparib)
ZEJULA (niraparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.

Foundation Medicine to Present at Upcoming Investor Conferences

On June 5, 2018 Foundation Medicine, Inc. (NASDAQ:FMI) reported that members of the company’s management team will present at the following upcoming investor conferences (Press release, Foundation Medicine, JUN 5, 2018, View Source [SID1234527172]):

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Goldman Sachs Annual Healthcare Conference on Tuesday, June 12, 2018 at 1:20 p.m. P.T. in Rancho Palos Verdes, California.

William Blair Growth Stock Conference on Thursday, June 14, 2018 at 8:40 a.m. C.T. in Chicago.

A live, listen-only webcast of the presentation may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of each presentation and will be archived on the company’s website for 90 days.

(CORRECTION) Immune Therapeutics Acquires 10% Stake in Cytocom; Obtains Exclusive Rights to Lodonal™ for Pets in United States

On June 5, 2018 Immune Therapeutics, Inc. (OTCQB:IMUN) ("Immune," "IMUN" or the "Company"), a clinical late stage biopharmaceutical company focused on the development of two immunomodulating therapies for the treatment of autoimmune diseases, inflammatory diseases, cancer and HIV/AIDS reported a modification of the Company’s 2014 exclusive licensing agreement with Cytocom, Inc., a late stage biotechnology company that specializes in T-Cell activation immunotherapies (Press release, Immune Therapeutics, JUN 5, 2018, https://www.immunetherapeutics.com/2022/08/correction-immune-therapeutics-acquires-10-stake-in-cytocom-obtains-exclusive-rights-to-lodonal-for-pets-in-united-states/ [SID1234618215]).

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In addition to the rights granted in the 2014 agreement to make products containing Lodonal and Met-Enkelphline in Africa, Central America, South American and the Caribbean and to market and distribute the same for human use in certain emerging markets, the newly amended and restated license agreement also grants the Company the exclusive marketing and distribution rights for products containing Lodonal and Met-Enkelphline for treatment of animals in the United States.

According to Global Industry Analysts, Inc., the global market for animal medication is projected to reach US $44.4 billion by 2022, driven by increasing investments in animal drug development in response to unmet animal health needs and developments in veterinary diagnostics and services. The Company is developing its strategy to capture a portion of this market.

The Company’s CEO, Noreen Griffin, stated that: "We are confident in our ability to fast track our development program for companion animals in several qualified OMUMS (The Office of Minor Use and Minor Species) indications. Once approved, the company will receive seven years of exclusive marketing rights, which means we should face no competition from another sponsor marketing the same drug in the same dosage form for the same intended use for that time frame."

The amended and restated license agreement was entered in conjunction with a stock purchase agreement where the Company agreed to acquire 10% of Cytocom’s issued and outstanding common stock in exchange for cancelation of approximately $4,100,000 of debt owed by Cytocom to the Company. Under the original spin-out of Cytocom from the Company, IMUN was required to return all Cytocom shares to Treasury upon the funding of Cytocom, leaving them with no ownership in Cytocom. The Company’s Board, after due discussions and review of Cytocom’s potential, decided to make the investment. The acquisition solidifies the new direction of the strategic alliance between the Company and Cytocom.

Corporate Update

The Company has retained the services of a Ruderfer & Associates, Inc. Verona, NJ 07044 to assist with the search for a new CEO so that Noreen Griffin can be released to serve Cytocom and help grow the value of the Company’s investment in Cytocom.

The Company has filed two new patents in the last 30 days. At this time, the Company has now filed six patents pending applications in the last 18 months. The newest two patents include the use of Lodonal as a combination therapy for inflammation, autoimmune disease and cancer in both humans and animals, as well as use of Met-Enkelphline as a combination immunotherapy in the treatment of cancer.

The Company continues to work with the Pharmacy and Poison Board in Kenya and will update shareholders as soon as the Company receives additional information.

The Company is moving forward in Nigeria with implementing the launch of a marketing program with its partner Fidson Healthcare Plc and is hopeful that the initiative will result in sales in the coming months following the initiative.

BeiGene to Present at the William Blair 2018 Growth Stock Conference

On June 5, 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, reported that the company will present at the William Blair 2018 Growth Stock Conference in Chicago (Press release, BeiGene, JUN 5, 2018, View Source;p=RssLanding&cat=news&id=2353190 [SID1234527170]). The presentation is scheduled for 10:50 AM CT on Tuesday, June 12, 2018.

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A live webcast can be accessed from the investors section of BeiGene’s website at View Source An archived replay will be available for 90 days following the event.

VBL Therapeutics Presents Positive Data on its MOSPD2 Platform Technology in Oncology and Inflammation at BIO 2018

On June 5, 2018 VBL Therapeutics (NASDAQ:VBLT) reported data on its novel MOSPD2 program in oncology and inflammation at the 2018 BIO International Convention in Boston, Massachusetts (Press release, VBL Therapeutics, JUN 5, 2018, View Source [SID1234527188]).

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"Our research has shown that MOSPD2 plays a key role in the regulation of cell motility," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We have generated data indicating that MOSPD2 is required for directional movement, or chemotaxis, of tumor cells and certain immune cells, and therefore appears to play a central role in both oncology and inflammation. We continue to advance our exciting VB-600 series of antibodies as drug candidates for oncology and inflammatory indications."

MOSPD2 can be found in many types of solid tumors, and is highly expressed on tumor cells when they start invading tissues or creating metastatic lesions. VBL’s data indicate that knock-out of MOSPD2 in tumor cells may reduce metastasis by up to 95%. At the AACR (Free AACR Whitepaper) conference in April this year, VBL presented a late-breaking proof-of-concept study demonstrating antibody-mediated killing of MOSPD2-expressing cancer cells.

VBL research has also shown that knocking-out the MOSPD2 gene in mice could protect the animals from developing some inflammatory diseases. The Company has generated antibodies that block immune cell migration and show efficacy in a model of multiple sclerosis.

VBL is developing the VB-600 platform of biologic drug candidates for oncology and inflammatory indications. The Company plans to file an IND in this program by year-end 2019. For a webcast of VBL’s presentation at BIO see: LINK