Repertoire Immune Medicines to Present at Oppenheimer 31st Annual Healthcare Conference

On March 16, 2021 Repertoire Immune Medicines, a clinical-stage biotech company creating a new category of immune therapies for cancer, autoimmunity and infectious disease, reported that John Cox, Chief Executive Officer, will present at the Oppenheimer 31st Annual Healthcare Conference on Thursday, March 18, 2021, at 10:00 a.m. ET (Press release, Repertoire, MAR 16, 2021, View Source [SID1234576743]).

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GRAIL, AccessHope Collaborate to Optimize Patient and Healthcare Provider Experience for Galleri, First-of-Kind Multi-Cancer Early Detection Blood Test

On March 16, 2021 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, reported it is joining forces with AccessHope to offer a world-class service experience to people who use Galleri, GRAIL’s first-of-kind multi-cancer early detection blood test (Press release, Grail Bio, MAR 16, 2021, View Source [SID1234576742]). This collaboration is part of GRAIL’s effort to help patients and their healthcare providers achieve favorable outcomes by making the test experience, from blood draw to cancer care, as seamless as possible.

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AccessHope, a company that provides cancer expertise to employers and their healthcare partners, will offer Galleri users coordination services during the test experience, including access to a support team for guidance and information. AccessHope also will provide support to physicians as they determine next steps to evaluate a positive Galleri test result.

"Most cancers are diagnosed too late, when outcomes are poor," said Dr. Joshua Ofman, chief medical officer and head of external affairs at GRAIL. "The introduction of Galleri as a complement to recommended cancer screening tests provides an opportunity to fundamentally change the way that we detect cancer. Best-in-class expert services like those offered by AccessHope will be an essential part of GRAIL supporting providers and their patients from test to diagnosis to treatment."

GRAIL previously announced it will introduce Galleri in the second quarter of 2021. An earlier version of Galleri demonstrated the ability to detect more than 50 types of cancers — over 45 of which lack recommended screening tests today — with a low false positive rate of less than 1%. When a cancer signal is detected, Galleri can determine where in the body the cancer is located with high accuracy, all from a single blood draw. This is critical to help guide diagnostic follow-up and care.

"The rising cost of cancer care — coupled with the extraordinary rate of innovation and changes in best practices — make early detection even more vital when it comes to improving a patient’s healthcare experience, outcomes, value, and care," said Mark Stadler, CEO of AccessHope. "Our mission at AccessHope is to deploy the latest cancer care knowledge to the places and people who need it most when it is most valuable. Providing support services for Galleri offers another way we can touch more lives and extend our mission."

Galleri, which will require a prescription, will be available initially through partner health systems, medical practices, and self-insured employers.

Cancer is projected to become the world’s leading cause of death in 2021. In the U.S., more than 600,000 people died from cancer last year. This is in large part because the majority of cancers are found too late when outcomes are often fatal. Recommended screening tests in the U.S. save lives, but they only cover five cancers and screen for a single cancer at a time. In fact, cancers responsible for 71% of cancer deaths have no recommended early detection screening at all.

Be Bio Announces Appointment of Cell and Gene Therapy Veterans Joanne Smith-Farrell, Ph.D., as Chief Executive Officer and Rick Morgan, Ph.D., as Chief Scientific Officer

On March 16, 2021 Be Biopharma ("Be Bio"), whose mission is to pioneer the emerging new category of engineered B cells as medicines, reported that Joanne Smith-Farrell, Ph.D., has been appointed Chief Executive Officer and Director (Press release, Be Biopharma, MAR 16, 2021, View Source [SID1234576741]). Dr. Smith-Farrell will be joined by Chief Scientific Officer, Richard Morgan, Ph.D., a leading expert in cell and gene therapies.

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Be Bio’s rapidly growing team of scientists, drug developers, manufacturing experts, and business builders is leading the creation of a new category of cellular therapies, engineered B cell medicines. B cells are exquisitely designed by nature to embody a unique mix of functionalities, including prolific protein production, tissue targeting, and durable engraftment in cellular niches. Be Bio was founded by Longwood Fund in October 2020 with a $52 million Series A investment led by Atlas Ventures and RA Capital, and joined by Alta Partners and Takeda Ventures to unlock this rich biology by precisely engineering B cells as therapies to develop a broad pipeline of potent and potentially curative cellular medicines.

Prior to joining Be Bio as Chief Executive Officer, Dr. Smith-Farrell was Chief Operating Officer and Business Unit Head, Oncology, at bluebird bio, where she led the growth of bluebird Oncology from an early single-candidate effort into a leading oncology cell therapy business. Prior to this, she held executive leadership roles as Chief Business Officer of bluebird bio, Vice President of Transactions at Merck, and Vice President of Business Development at Pfizer, as well as executive positions in public and private biotechs. Prior to entering the biopharmaceutical industry, she worked in the healthcare practice at The Boston Consulting Group. Dr. Smith-Farrell did her postdoctoral research in Biomedical Engineering in Bob Langer’s lab at the Harvard-MIT Division for Health Science and Technology and holds a Ph.D. in Physics from The Catholic University of America and a B.S. in Physics and Mathematics from Vanderbilt University.

"Be Bio’s mission – to unleash the power of B cells, nature’s protein factories, on many of humanity’s most challenging diseases – is an inspiring and humbling journey to be joining," said Dr. Smith-Farrell. "It has been a great privilege to participate in the birth of the first generation of cell therapies to come to market, and to witness, first-hand, cell therapy’s power to transform the lives of patients with devastating diseases. Be Bio’s aspiration, fueled by the broad utility of engineered B cell medicines to offer previously impossible solutions across a wide array of therapeutic areas, takes the potential of cell therapy to an entirely new level."

Rick Morgan, Ph.D., joins Be Bio as Chief Scientific Officer, and brings decades of experience as one of the pioneers of cell and gene therapy. Most recently, Dr. Morgan was Senior Vice President of Immunogenetics at Editas Medicine, where he focused on genome engineering to produce off-the-shelf cell medicines for cancer. Prior to that, he was Vice President of Immunotherapy at bluebird bio in 2013, where he led pre-clinical activities for bluebird’s first oncology medicine, the anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy idecabtagene vicleucel (ide-cel)—the first CAR-T for the treatment of multiple myeloma filed in the U.S. and Europe. He started his career at the National Institutes of Health, where he conducted groundbreaking research in the development of gene therapy for genetic diseases such as hemophilia, HIV/AIDS, and cancer immunotherapy. He was a member of the team that published the first approved human gene transfer experiment in 1990, and was also the first to report the successful use of T-cell receptor gene therapy for the treatment of cancer in 2006.

"By exploiting the intrinsic drug-like properties of B cells, we can make redosable medicines with superior pharmacokinetic profiles that can be administered without toxic conditioning regimens," said Dr. Morgan. "Be Bio’s ability to engineer B cells is a true paradigm shift in gene therapy that creates major opportunities to treat diseases such as cancer, autoimmune conditions, infectious disease, and protein deficiencies. As CSO, I am excited to have the rare opportunity to shape the development of a new class of medicine from the very start."

"Extraordinary science attracts extraordinary leaders," said David Steinberg, Longwood General Partner, Director and and outgoing Chief Executive Officer, Be Bio. "For over 25 years, Dr. Smith-Farrell has been leading teams that are committed to conquering cancer and rare diseases, most recently at bluebird bio where she built a 400 person oncology cell therapy business unit. We are very fortunate to have her joining alongside Dr. Morgan, an internationally recognized trailblazer in cell and gene therapy and a member of an elite group of scientists who have successfully developed these groundbreaking medicines. Together, Joanne and Rick will be invaluable to Be Bio as they lead our efforts to unlock the potential of B cell medicines, bringing transformational therapies to patients in need."

aTyr Pharma to Webcast Conference Call Reporting Fourth Quarter and Full Year End 2020 Financial Results

On March 16, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that it will report fourth quarter and full year 2020 financial results and provide a corporate update after the market close on Tuesday, March 23, 2021 (Press release, aTyr Pharma, MAR 16, 2021, https://investors.atyrpharma.com/news-releases/news-release-details/atyr-pharma-webcast-conference-call-reporting-fourth-quarter-and [SID1234576740]). Management will host a conference call and webcast to review the results and provide an operational update.

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Spectrum Pharmaceuticals Provides Update on ROLONTIS® (eflapegrastim) Pre-Approval Inspection

On March 16, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the U.S. Food and Drug Administration (FDA) has scheduled the pre-approval inspection at the ROLONTIS (eflapegrastim) manufacturing site in May 2021 (Press release, Spectrum Pharmaceuticals, MAR 16, 2021, View Source [SID1234576739]). In October 2020, the company received notification from the agency that it would defer its decision on the BLA because an inspection of the Hanmi Bioplant in South Korea could not be conducted during the review cycle due to restrictions on travel related to the COVID-19 pandemic.

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"I am thrilled that the FDA informed us that they will be conducting a pre-approval inspection of the ROLONTIS manufacturing facility in May," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We believe the pre-approval inspection marks the final step in the ROLONTIS review process."

About ROLONTIS

ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.