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Janssen Announces Initiation of Phase 1b/2 Clinical Development Program Evaluating JNJ-68284528 CAR-T Cells for the Treatment of Multiple Myeloma

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

Sierra Oncology to Present at the Jefferies Global Healthcare Conference in New York

On May 30, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported that Dr. Nick Glover, President and Chief Executive Officer, will present an overview of the company at the Jefferies Global Healthcare Conference being held in New York on June 5-8 (Press release, Sierra Oncology, MAY 30, 2018, View Source [SID1234526943]). The presentation is scheduled for 8:30 a.m. ET on Thursday, June 7. A live audio webcast and archive of the presentation will be accessible through the Sierra Oncology website at www.sierraoncology.com.

Rocket Pharmaceuticals to Present at the Jefferies 2018 Healthcare Conference

On May 30, 2018 Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT) ("Rocket"), a leading U.S.-based multi-platform gene therapy company, reported that Gaurav Shah, M.D., Chief Executive Officer and President of Rocket, will present at the Jefferies 2018 Healthcare Conference on Thursday, June 7, 2018, at 2:00 p.m. Eastern Time (ET) (Press release, Rocket Pharmaceuticals, MAY 30, 2018, View Source;p=RssLanding&cat=news&id=2351191 [SID1234526942]).

Mustang Bio Announces Preclinical Data on Potency of its CAR T Cells in Glioblastoma Published in JCI Insight

On May 30, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ:MBIO), a Fortress Biotech (NASDAQ:FBIO) Company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology, reported the publication of preclinical data demonstrating that glioblastoma (GBM)-targeted CD4+ CAR T cells mediate superior antitumor activity over CD8+ CAR T cells (Press release, Mustang Bio, MAY 30, 2018, View Source [SID1234526941]). The results were published in the May 17, 2018, edition of JCI Insight, a peer-reviewed journal of the American Society for Clinical Investigation. Mustang licensed the IL13Rα2‐specific CAR (MB-101) technology used in this preclinical study from the City of Hope National Medical Center ("City of Hope").

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "Optimizing T cell potency has the potential to enhance the antitumor efficacy of CAR T therapies in challenging solid tumors, which includes engineering the appropriate composition of CD4+ and CD8+ subsets. This important study conducted by our research partner City of Hope demonstrated the superior antitumor effect of CD4+ over CD8+ T cells in glioblastoma models. Optimizing T cell potency is one of many avenues Mustang is exploring to improve CAR T efficacy, and we look forward to the application of this research in the ongoing Phase 1 trial of our MB-101 IL13Rα2‐specific CAR T therapy in patients with glioblastoma."

Dr. Christine Brown, Heritage Provider Network Professor in Immunotherapy and Associate Director of the T Cell Therapeutics Research Laboratory at City of Hope, said, "This study provides important insight into the differences between CD4+ and CD8+ CAR T cells for maintaining killing potency and resisting exhaustion under conditions of high disease burden. These findings are part of our larger efforts to develop more powerful CAR therapies for the treatment of brain tumors."

In the study, City of Hope investigated the antitumor effect of CD4+ and CD8+ CAR T cells targeting the GBM-associated antigen IL-13 receptor α2 (IL13Rα2) in mouse models. Upon stimulation with IL13Rα2+ GBM cells, the CD8+ CAR T cells exhibited robust short-term effector function but became rapidly exhausted. In comparison, CD4+ CAR T cells persisted after tumor challenge and sustained effector potency.

Mixing with CD4+ CAR T cells failed to improve the effector dysfunction of CD8+ CAR T cells, and CD4+ CAR T cell effector potency was weakened when applied with CD8+ CAR T cells. In orthotopic GBM models, CD4+ outperformed CD8+ CAR T cells, specifically with respect to long-term antitumor response. Maintenance of the CD4+ subset was positively correlated with the recursive killing ability of CAR T cell products derived from GBM patients.

Humanigen CEO to Present at 8th Annual LD Micro Invitational

On May 30, 2018 Humanigen, Inc. (OTCQB:HGEN), a biopharmaceutical company developing cutting-edge T-cell optimization and oncology treatments, reported that Cameron Durrant, M.D., chairman and CEO, will present a company overview at the 8th Annual LD Micro Invitational on Monday, June 4, 2018, at 4 p.m. PDT (7 p.m. EDT) (Press release, Humanigen, MAY 30, 2018, View Source [SID1234526940]).

Dr. Durrant will discuss Humanigen’s focus to enhance T-cell therapies in oncology with its proprietary Humaneered monoclonal antibodies, including lead asset lenzilumab as a potential prophylactic therapy to optimize treatment and minimize or prevent neurotoxicity associated with chimeric antigen receptor T-cell (CAR-T) therapy. Lenzilumab is a first-in-class recombinant monoclonal antibody that targets and is an antagonist of soluble granulocyte-macrophage colony-stimulating factor (GM-CSF), an upstream druggable target for inflammatory cascade side effects caused by CAR-T treatments.

A live webcast of the presentation will be available at View Source Following the conference, an archived version of the webcast will be available 120 days for replay on the Humanigen website at View Source