On May 30, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the initiation of a Phase 1b/2 clinical development program studying JNJ-68284528 (developed based on Legend’s LCAR-B38M), a chimeric antigen receptor T cell (CAR-T) therapy directed against B cell maturation antigen (BCMA), in patients with relapsed or refractory multiple myeloma (Press release, Janssen Pharmaceuticals, MAY 30, 2018, View Source [SID1234526946]). The planned start of the Phase 1b/2 study (68284528MMY2001), scheduled to begin enrollment in the second half of 2018, follows the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application submitted by Janssen.

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As announced in December 2017, Janssen entered into a worldwide collaboration and license agreement with Legend Biotech USA Inc. and Legend Biotech Ireland Limited ("Legend"), subsidiaries of GenScript Biotech Corporation. Under the terms of the agreement, Legend granted Janssen Biotech, Inc. a worldwide license to jointly develop and commercialize JNJ-68284528 in multiple myeloma.

"We are committed to rapidly advancing JNJ-68284528, and we are pleased to initiate a global clinical development program to further evaluate this cell-based therapy," said Peter F. Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "As we strive to eliminate multiple myeloma, we are hopeful that this BCMA targeted CAR-T therapy will play an important role in the treatment of this disease."

The Phase 1b/2, open-label, multicenter study will evaluate the safety and efficacy of JNJ-68284528 in adults with relapsed or refractory multiple myeloma. The primary objective of the Phase 1b portion of the study is to characterize the safety and establish the dose of JNJ-68284528, which was informed by the first-in-human study with LCAR-B38M CAR-T cells (Legend-2). The primary objective for the Phase 2 portion of the study is to evaluate the efficacy of JNJ-68284528 (primary endpoint: overall response rate [partial response or better] as defined by the International Myeloma Working Group response criteria).

About CAR-T and BCMA
CAR-T cells are an innovative approach to eradicating cancer cells by harnessing the power of a patient’s own immune system. BCMA is a protein that is highly expressed on myeloma cells. By targeting BCMA via a CAR-T approach, CAR-T therapies may have the potential to redefine the treatment paradigm for multiple myeloma and potentially advance towards cures for patients with the disease.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.1,2 Refractory cancer occurs when a patient’s disease is resistant to treatment or in the case of multiple myeloma, patients progress within 60 days of their last therapy.3,4 Relapsed cancer means the disease has returned after a period of initial, partial or complete remission.5 In 2018, it is estimated that 30,700 people will be diagnosed and 12,770 will die from the disease in the United States.6 Most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood counts, fatigue, calcium elevation, kidney problems or infections.7

On May 30, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX),reported a clinical stage targeted oncology company, will present at the Jefferies Annual Global Healthcare Conference in New York on Friday, June 8th at 8:30 a.m. ET/ 5:30 a.m. PT (Press release, Mirati, MAY 30, 2018, View Source [SID1234526965]). Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer will present a corporate overview at the conference.

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The presentation will be webcast and made available through the "Investors" section of www.mirati.com, and replays will be made available for 90 days following the events.

On May 30, 2018 Perrigo Company plc (NYSE; TASE: PRGO) reported that Ron Winowiecki, Perrigo Chief Financial Officer, will present at the Jefferies 2018 Healthcare Conference at 8:30 AM EST on Tuesday, June 5, 2018 (Press release, Perrigo Company, MAY 30, 2018, View Source [SID1234527002]). Interested parties can access the presentation webcast at View Source

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On May 30, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported that the company will present at the Jefferies 2018 Global Healthcare Conference in New York (Press release, Corvus Pharmaceuticals, MAY 30, 2018, View Source;p=RssLanding&cat=news&id=2351343 [SID1234526947]). The presentation is scheduled for Wednesday, June 6, at 10:00 a.m. Eastern Time.

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A webcast of the presentation will be available live and for 30 days following the event. The webcast may be accessed via the conference website and from the investor relations section of the Corvus website.

On May 30, 2018 Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, and Nektar Therapeutics (Nasdaq: NKTR) reported a non-exclusive, clinical collaboration to evaluate the safety and efficacy of Nektar’s NKTR-214, a CD122-biased agonist, in combination with entinostat, Syndax’s oral, small molecule Class 1 specific HDAC inhibitor, in patients with metastatic melanoma who have previously progressed on treatment with an anti-PD-1 (programmed death receptor-1) agent (Press release, Syndax, MAY 30, 2018, View Source [SID1234526966]).

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Under the terms of the agreement, Syndax and Nektar will collaborate on a study to evaluate the combination. The Phase 1b portion of the trial aims to establish safety and a recommended dose for the combination regimen and will be followed by a Phase 2 portion designed to assess efficacy, as defined by objective response rate and durability of response. Progression free survival and overall survival will also be evaluated. Correlative biomarker analyses that aim to identify patients with enhanced responses to the combination, including analyses exploring the potential of elevated levels of classical peripheral blood monocytes, will be incorporated. Syndax will be responsible for conducting the Phase 1b/2 trial and the agreement includes a provision where the parties may extend the collaboration to include a pivotal trial based on mutual interest.

"We are excited to be working with Nektar as we build upon our strategy of establishing clinical collaborations to test novel combinations of entinostat with leading edge immune therapies," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Previous Phase 2 data with entinostat and high dose IL-2 in renal cell cancer1 and our promising preclinical data generated with NKTR-214, laid the scientific and clinical foundation for this collaboration. Working with Nektar allows us to increase the potential impact entinostat may have in the treatment of PD-1 refractory metastatic melanoma patients, and complements the exciting data we have seen when combining entinostat with KEYTRUDA in a similar population."

In preclinical testing, the results of which were recently presented at the 2018 American Association of Cancer Research Annual Meeting2, the combination of entinostat and NKTR-214 significantly inhibited tumor growth in tumor models of kidney and colon cancer. The anti-tumor activity of the combination was accompanied by a dramatic increase in the activation and cytotoxic activity of CD8+ T cells in the tumor, along with modulation of immune suppressor cells found in the tumor microenvironment.

"The combination of NKTR-214 and entinostat demonstrated a unique synergy in our preclinical models which warrants further study in the clinic," said Jonathan Zalevsky, Ph.D, Senior Vice President and Chief Scientific Officer of Nektar. "Importantly, we observed elevated levels of cytokine-positive tumor-infiltrating cytotoxic T cells following treatment with the combination. We believe this important preclinical finding could translate to improved tumor responses in patients who have become refractory to checkpoint inhibitors. We look forward to working with Syndax as this combination advances into the clinic."

Additional financial details and other terms of the agreement were not disclosed.

About Entinostat

Entinostat is a once-weekly, oral, small molecule, class I HDAC inhibitor currently being evaluated in a Phase 3 clinical trial in combination with exemestane for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer, an indication for which it has been granted Breakthrough Therapy Designation by the FDA. Entinostat has been shown to block the function of immune suppressive cells in the tumor microenvironment, and is being evaluated in combination with several approved PD-1/PD-L1 antagonists, including in ongoing Phase 1b/2 clinical trials combining entinostat with KEYTRUDA from Merck & Co., Inc. for non-small cell lung cancer, melanoma and colorectal cancer; with TECENTRIQ from Genentech, Inc. for triple negative breast cancer as well as advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer; and with BAVENCIO from Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer.

About NKTR-214

NKTR-214 is an experimental therapy designed to stimulate cancer-killing immune cells in the body by targeting CD122 specific receptors found on the surface of these immune cells, known as CD8+ effector T cells and Natural Killer (NK) cells. Growing these tumor-infiltrating lymphocytes (TILs) in vivo and replenishing the immune system is critically important as many patients battling cancer lack sufficient TIL populations to benefit from approved checkpoint inhibitor therapies. In preclinical studies, treatment with NKTR-214 resulted in a rapid expansion of these cells and mobilization into the tumor micro-environment.1,2 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.