On February 1, 2021 OncoNano Medicine, Inc. reported the appointment of Martin Driscoll as Chief Executive Officer and a member of the company’s Board of Directors (Press release, OncoNano Medicine, FEB 1, 2021, View Source [SID1234574472]). An accomplished industry veteran with multiple decades of biopharmaceutical development and commercialization experience, Mr. Driscoll most recently served as President and Chief Executive Officer of Spring Bank Pharmaceuticals. Mr. Driscoll succeeds co-founder and CEO Ravi Srinivasan, Ph.D., who has stepped down in a planned transition to pursue other interests.

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"We are thrilled to welcome Marty to our team. Marty’s extensive experience and proven track record at the helm of several successful biopharmaceutical development companies will undoubtedly provide OncoNano with the leadership to advance our business and translate our novel discoveries into important new interventions and treatments for cancer patients," said Al Guillem, Ph.D., Chairman of OncoNano. "Marty joins OncoNano at an important time as we progress our lead program into the pivotal trial stage and advance our first oncology therapeutic, ONM-501, towards the first human studies for this novel immuno-modulator." Dr. Guillem continued, "On behalf of the OncoNano board of directors, I want to thank Ravi for his many contributions to the growth of our company and wish him great success in his future endeavors."

"I’m joining OncoNano at an exciting point in the evolution of the company and I look forward to building on the strong foundation established by Ravi and the OncoNano team as we advance the clinical development of our impressive portfolio of differentiated programs," said Mr. Driscoll. "I was attracted to this opportunity to lead OncoNano by the exciting potential for the company’s innovative core technology that exploits the universal pH biomarker of solid tumors to enhance real-time surgical imaging and enable more efficient and effective delivery of cancer treatments."

Mr. Driscoll brings a proven record in leading privately-held and publicly-traded biopharmaceutical development and commercial-stage companies. He has been involved with or led the commercialization of several important therapies, the direct negotiation of numerous licensing and M&A transactions, multiple private and public capital fundraising efforts and the successful submission of major global product regulatory filings. Mr. Driscoll has also served as a director on the boards of eight biopharmaceutical and diagnostic companies during his career.

On February 1, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported that Gilead Sciences is increasing its ownership in Arcus to 19.5%, from approximately 13%, by purchasing 5,650,000 additional shares of Arcus’s common stock at a per share purchase price of $39.00 (Press release, Arcus Biosciences, FEB 1, 2021, View Source [SID1234574471]).

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"Gilead’s additional investment in Arcus demonstrates the strength of our relationship, a recognition of the depth of our pipeline and our shared commitment to bringing innovative, transformative therapies to cancer patients as quickly as possible," said Terry Rosen, Ph.D., Chief Executive Officer of Arcus. "The proceeds from this financing will support and enable the acceleration of our development plans for our four clinical-stage molecules, including AB680, our small molecule CD73 inhibitor, for which we recently presented encouraging data in first-line metastatic pancreatic cancer. We appreciate Gilead’s continued confidence in Arcus and our ability to execute. We look forward to providing a multitude of data readouts across our entire portfolio of clinical molecules, including the ARC-7 study interim analysis for domvanalimab expected in the second quarter, throughout what we expect will be a transformational year for the company."

The Arcus-Gilead partnership, which closed in July 2020, includes an Option, License and Collaboration Agreement, a Common Stock Purchase Agreement, and an Investor Rights Agreement. Collectively, this transaction established a 10-year partnership to co-develop and co-commercialize next-generation cancer immunotherapies, provided for an initial equity investment and upfront payment to Arcus totaling $375 million, and gave Gilead the right, but not the obligation, to make additional equity investments in Arcus by purchasing additional shares of Arcus’s common stock. Arcus and Gilead entered into an amended and restated Common Stock Purchase Agreement to provide for this purchase of 5,650,000 additional shares of Arcus’s common stock. No other agreements or terms were amended. Following this investment, Arcus expects its cash and investments to fund its operations through at least 2023.

On February 1, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) will perform an accelerated assessment of the Marketing Authorisation Application (MAA) for the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel) (Press release, Janssen Pharmaceuticals, FEB 1, 2021, View Source [SID1234574470]). Accelerated assessment is granted by the CHMP when a medicinal product is expected to be of major public health interest and therapeutic innovation and can significantly reduce the review timelines to evaluate an MAA.1

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Cilta-cel is an investigational BCMA-directed CAR-T therapy in development for the treatment of adults with relapsed and/or refractory multiple myeloma.2 CAR‑T therapy is a highly personalised technology where a patient’s own T-cells are re-programmed to target and eradicate cancer.3

"Multiple myeloma is a rare, incurable cancer, and has long been an area of focus for Janssen," said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research Development, Janssen Research & Development, LLC. "We are deeply committed to improving outcomes for patients with multiple myeloma, with a goal of delivering innovations that have the potential to expand current remission periods and improve quality of life."

The cilta-cel MAA, which is targeted for submission in the first half of 2021, is supported by the positive results from the Phase 1b/2 CARTITUDE-1 study.2 The latest results from the CARTITUDE-1 study were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Annual Meeting.2

"We are excited that the potential clinical benefit of cilta-cel is being recognised and now look forward to working with the EMA to bring this highly innovative treatment to patients in need," said Saskia De Haes, Vice President, EMEA Regulatory Affairs, Janssen R&D BE.

This accelerated approval milestone in Europe follows the December 2020 announcement of a rolling submission of the Biologics License Application (BLA) for cilta-cel to the U.S. Food and Drug Administration (FDA).4

About CARTITUDE-1
CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multicentre study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma, 99 percent of whom were refractory to the last line of treatment; 88 percent of whom were triple-class refractory, meaning their cancer did not, or no longer responds to an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody.2,5

The primary objective of the CARTITUDE-1 study is to characterise the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2) and to evaluate the efficacy of cilta-cel with overall response as the primary endpoint.2,5

About Ciltacabtagene Autoleucel (cilta-cel)
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy for the treatment of patients with multiple myeloma. The design comprises a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies.2 CAR-T cells are an innovative approach to eradicating cancer cells by harnessing the power of a patient’s own immune system.6 BCMA is a protein that is highly expressed on myeloma cells.7

In December 2017, Janssen Biotech, Inc. (Janssen) entered into an exclusive worldwide license and collaboration agreement with Legend Biotech to develop and commercialise cilta-cel.8 In May 2018, Janssen initiated a Phase 1b/2 CARTITUDE-1 trial (NCT03548207) to evaluate the efficacy and safety of cilta-cel in adults with relapsed and/or refractory multiple myeloma, informed by the LEGEND-2 study results.2,9

In April 2019, cilta-cel was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA).10 PRIME offers enhanced interaction and early dialogue with developers of promising medicines, to optimise drug development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.11 In February 2020, the European Commission granted orphan designation for cilta-cel.12

About Multiple Myeloma
Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.13 In Europe, more than 48,200 people were diagnosed with MM in 2018, and more than 30,800 patients died.14 Around 50 percent of newly diagnosed patients do not reach five-year survival,15,16 and almost 29 percent of patients with multiple myeloma will die within one year of diagnosis.17

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.18 Refractory MM is when a patient’s disease progresses within 60 days of their last therapy.19 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.15 While some patients with MM have no symptoms at all, others are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.20 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and require new therapies for continued disease control.21

On February 1, 2021 MOMA Therapeutics, a biopharmaceutical company discovering the next generation of precision medicines by targeting molecular machines that underlie human disease, reported that Asit Parikh, M.D., Ph.D., has been appointed as the company’s president and chief executive officer, effective April 5, 2021 (Press release, MOMA Therapeutics, FEB 1, 2021, View Source [SID1234574469]). Dr. Parikh brings more than 20 years of academic and industry experience to MOMA. He will succeed interim founding CEO, Reid Huber, Ph.D., a partner at Third Rock Ventures, who will remain on MOMA’s Board of Directors.

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"Asit shares MOMA’s singular focus on patients and brings to our team a deep and diverse R&D, strategy and business background. His experience leading successful interdisciplinary teams and building innovation-rich product portfolios will be highly synergistic with MOMA’s team of passionate drug hunters," said Dr. Huber. "Asit’s appointment as MOMA’s CEO marks an important milestone toward our goal of transforming the lives of patients. We are thrilled to welcome him to our team."

Prior to MOMA, Dr. Parikh served as senior vice president and head of Takeda’s gastroenterology unit since 2012. Under his leadership, Takeda has achieved global approvals for Entyvio for ulcerative colitis and Crohn’s disease, European adult and U.S. pediatric approvals for Gattex/Revestive for short bowel syndrome, Japan and China approvals for Takecab/Vocinti for acid related disorders, a European approval for Alofisel for perianal fistulizing Crohn’s disease, and a U.S. approval for Motegrity for chronic constipation. Prior to Takeda, he worked in the clinical research division at Millennium Pharmaceuticals, where he held leadership roles in inflammation and oncology drug development. Dr. Parikh remains actively engaged in the practice of medicine as a consulting gastroenterologist at Newton-Wellesley Hospital in Newton, Mass., and serves as a board member of Ambys Medicines, Phathom Pharmaceuticals and Vanderbilt University School of Medicine, Basic Sciences. Dr. Parikh earned his Ph.D. in biochemistry and M.D. from Vanderbilt University, completed his internal medicine residency at the University of Pennsylvania and subspecialty training in gastroenterology at Massachusetts General Hospital. He performed postdoctoral research in cancer biology at the Massachusetts Institute of Technology.

"I joined MOMA in large part because of its unique and compelling vision – the possibility that systematically drugging molecular machines can deliver an entirely new class of medicines to patients who need them," said Dr. Parikh. "MOMA’s approach, coupled with its world-class team and scientific founders, represented an unprecedented opportunity to join a disruptive young biotech poised to make a true difference in medicine."

On February 1, 2021 Legend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted a request for an accelerated assessment of the Marketing Authorisation Application (MAA) for the investigational B-cell maturation antigen (BCMA) targeted chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel) (Press release, Legend Biotech, FEB 1, 2021, View Source [SID1234574468]).

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The request was made by Legend’s collaborator, Janssen Biotech, Inc. (Janssen). An accelerated assessment of the MAA is granted by the CHMP when a medicinal product is expected to be of major public health interest and therapeutic innovation.1

The MAA, which is targeted for submission in the first half of 2021, is based on results from the pivotal Phase 1b/2 CARTITUDE-1 study which evaluated the efficacy and safety of cilta-cel in the treatment of patients with relapsed and/or refractory multiple myeloma. Results from the study were presented (Abstract #177) at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting last month.2

"The acceptance of the request for an accelerated assessment is an important testament for the potential use of cilta-cel in treating patients with multiple myeloma," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "Together with our collaborator Janssen, we look forward to working with the EMA as we advance this treatment option toward market and provide new hope for patients."

The accelerated assessment milestone in Europe follows the December 2020 announcement of initiation of a rolling submission of the Biologics License Application for cilta-cel to the U.S. Food and Drug Administration (FDA). Cilta-cel previously received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019.

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma, 99 percent of whom were refractory to the last line of treatment; 88 percent of whom were triple-class refractory (to at least 1 immunomodulatory drug [IMiD], 1 proteasome inhibitor [PI] and 1 anti-CD38 antibody).3

The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint. 3

About Ciltacabtagene autoleucel (cilta-cel)

Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 outside of China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.4 Although treatment may result in remission, unfortunately, patients will most likely relapse. 5 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.6 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.7,8 While some patients with multiple myeloma have no symptoms until later stages of the disease, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.9 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options.10