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.

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.

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

On June 5, 2018 Polaris Group, a biopharmaceutical company focused on developing novel drugs for cancer, reported results from a phase 1 clinical study that features Polaris lead therapeutic candidate ADI‑PEG 20 in combination with pemetrexed and cisplatin (ADIPEMCIS) in first-line treatment for argininosuccinate synthetase (ASS1) deficient metastatic uveal melanomas (Press release, Polaris Pharmaceuticals, JUN 5, 2018, View Source [SID1234527207]). The results were presented by Dr. Peter Szlosarek from Barts Cancer Center in the UK (abstract No.2589) at the American Society Clinical Oncology’s 2018 annual meeting.

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ADIPEMCIS was well tolerated in a cohort of 10 patients. The best response was stable disease; which was observed in 7 of 10 patients and hence a disease control rate of 70%. The 12-month survival rate was 50% and the median overall survival is 11.5 months, with 1 patient still alive at 27.1 months.

Metastatic uveal melanoma has been resistant to systemic therapies, with low response rates and low overall survival. There is clearly an unmet medical need that requires the development of an effective and safe treatment for these patients. It has been observed previously that ADI‑PEG 20 had efficacy as a monotherapy in several earlier melanoma studies and now the combination with PEM/CIS has further enhanced the activity.

"ADIPEMCIS showed activity in these metastatic uveal melanoma patients," said John Bomalaski, M.D., Executive Vice President, Medical Affairs, of Polaris. "We believe that ADI‑PEG 20 would benefit these patients, for whom there is no established treatment regimen. Based on this encouraging data as well as for ADI‑PEG 20 monotherapy in uveal melanoma, a trial of ADI‑PEG 20 in combination with checkpoint inhibitors, including programmed death and CTLA-4 antibodies is planned for uveal melanoma patients."

About ADI-PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.

On June 5, 2018 Nimbus Therapeutics, a privately held biotechnology company applying deep computational expertise throughout drug discovery and development, reported that it has raised $65 million in new capital to accelerate the company’s pipeline progress and fuel its expansion into new high-value targets aimed at overlapping biological mechanisms in immunology, oncology and metabolic disease (Press release, Nimbus Therapeutics, JUN 5, 2018, View Source [SID1234527171]). Each of the company’s current investors participated in the financing, including Atlas Venture, SR One, Lilly Ventures, Bill Gates, Pfizer Venture Investments, Lightstone Ventures, and Schrödinger. Bruce Booth, Partner of Atlas Venture, Board Chair and co-founder of Nimbus noted, "this round of investment reflects the existing syndicate’s strong and enthusiastic support for Nimbus’ proven management team and exciting new programs."

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"The continued support from our world-class investor base is testament to our team’s repeated success in designing and developing promising candidates through our unique combination of massive computational-chemistry horsepower with founding partner, Schrödinger, coupled with additional cutting-edge technologies in structural biology, cryo-EM, and machine learning-augmented ADMET prediction to rapidly advance our pipeline to the clinic," said Don Nicholson, Ph.D., Chief Executive Officer. "We have made substantial progress across our entire portfolio, including inhibitors of Tyk2 (tyrosine kinase 2) and antagonists of STING (stimulator of interferon genes), both under our immunology alliance with Celgene. Additionally, our wholly owned STING agonist program has generated novel, highly potent, bona fide small molecules with compelling preclinical data."

"This most recent infusion of capital from our investors, together with proceeds from business development activity, enables Nimbus to remain a privately held LLC organization, which has allowed us to transact multiple deals with world leading partners such as Gilead, Celgene, and Genentech," said Jeb Keiper, Chief Financial Officer and Chief Business Officer. "Nimbus’ success has built a nine-figure balance sheet of resources for the rapid advancement and expansion of our pipeline and technology, which will allow us to develop several other undisclosed target programs forward to the clinic in the next few years."

About Tyk2 (tyrosine kinase 2)

Tyk2 is an important signal-transduction kinase for key pro-inflammatory cytokine receptors, including IL-23, IL-12 and interferons α and β. As a result, Tyk2 is a key target for the treatment of several challenging auto-immune disorders, including SLE (lupus), Crohn’s disease, psoriasis, multiple sclerosis, rheumatoid arthritis and others. In addition, some cancers, like T-ALL, appear to be driven by Tyk2 hyper-activation and are responsive to Tyk2 inhibition. Nimbus’ Tyk2 program is partnered under the immunology alliance with Celgene.

About STING (STimulator of INterferon Genes)

STING agonism (turning STING "on") plays a key role in anti-tumor immunity by activation of the innate immune system and induction of the Type-I interferon response, leading to recruitment and activation of cytotoxic T lymphocytes that attack tumor cells. STING agonism provokes anti-tumor responses alone, and in combination with checkpoint inhibitors and cell therapy. Further, STING agonists have been shown to provide benefit in areas of virology, such as efforts to achieve HIV cure. STING antagonists (turning STING "off") may have therapeutic potential in Type-I interferonopathies, such as SLE (lupus), where STING drives an exaggerated interferon response. Nimbus’ STING antagonist program is partnered under the immunology alliance with Celgene, while the STING agonist program remains wholly owned by Nimbus.