On May 30, 2018 F-star, a clinical-stage biopharmaceutical company developing novel bispecific antibodies, reported that its partner Denali Therapeutics (NASDAQ: DNLI) (Denali) has chosen to exercise early its option to acquire the asset-centric vehicle F-star Gamma Ltd (F-star Gamma) (Press release, f-star, MAY 30, 2018, View Source [SID1234526962]).

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In the ongoing collaboration between F-star and Denali announced in August 2016, the partners are developing Fcabs (Fc-domains with antigen-binding) against up to three different transporters in the blood-brain barrier (BBB). These Fcabs enable delivery of biologic therapies into the central nervous system (CNS). In addition to the early acquisition of F-star Gamma, Denali has exercised its right to nominate the two remaining Fcab targets under the terms of the original agreement.

The acquisition of F-star Gamma provides Denali with exclusive rights to the Fcabs developed under the collaboration. The total consideration for the option exercise and expanded collaboration amounts to $24M, plus any net cash held by F-star Gamma at closing of the transaction. Further payments of up to $447M are contingent on achievement of future milestones.

John Haurum, CEO of F-star said "Denali’s early exercise of its option to acquire F-star Gamma is testimony to the progress of our collaboration. We are delighted that our Modular Antibody Technology is being applied to address significant unmet needs beyond F-star’s therapeutic focus in immuno-oncology."

Ryan Watts, CEO of Denali Therapeutics said "Our decision to exercise the option to buy F-star Gamma reflects the progress in our collaboration with F-star and the generation of data showing that our proprietary transport vehicle (TV) platform technology will enable us to deliver biologics across the BBB and into the brain. Furthermore, the expanded collaboration allows us to deepen and broaden our research efforts supporting our BBB platform technology."

F-star will invest its proceeds from the transaction in progressing its proprietary pipeline of first-in-class immuno-oncology bispecific antibodies through clinical development.

On May 30, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 11:00 a.m. EDT on Thursday, June 7, at the Jefferies 2018 Healthcare Conference (Press release, Puma Biotechnology, MAY 30, 2018, View Source [SID1234526963]).

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com . The presentation will be archived on the website and available for 30 days.

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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