On August 1, 2022 Gracell Biotechnologies Inc. ("Gracell" or the "Company",NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported the appointment of Wendy Li, M.D., as its Chief Medical Officer (CMO) (Press release, Gracell Biotechnologies, AUG 1, 2022, View Source [SID1234617227]). In this role, Dr. Li will oversee Gracell’s clinical development activities, including the advancement of its pipeline of autologous and allogeneic product candidates across the Company’s multiple proprietary technology platforms.

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Dr. Li brings to Gracell over 20 years of experience leading all critical aspects of clinical and medical operations at early-stage and large pharmaceutical organizations in the U.S. and China. Her expertise spans both clinical development and medical affairs, including leading early- and late-stage clinical trials for several therapeutic candidates for the treatment of hematological malignancies and solid tumors, and overseeing over 30 successful Investigational New Drug applications (INDs), New Drug Applications (NDAs) and Biologics License Applications (BLAs) that led to several multi-billion-dollar blockbuster drugs.

"Dr. Li is a distinguished and enthusiastic clinical leader and shares our commitment to discovering and developing breakthrough cell therapies. We are excited to add her experience to Gracell’s global leadership team," said Dr. William (Wei) Cao, Founder, Chairman and CEO of Gracell. "Dr. Li’s decades of experience in leading clinical development and strategy across many types of cancers and treatment modalities, as well as expertise in working with regulatory agencies, will be invaluable as we continue to advance our pipeline of breakthrough cell therapies and approach the filing of our U.S. IND application for GC012F later this year."

Prior to joining Gracell, Dr. Li served as CMO of EXUMA Biotech, where she provided strategic medical and clinical leadership for the advancement of its cell therapy pipeline in the U.S. and Asia. She has also held clinical development and medical affairs leadership positions at Pfizer, Sanofi, Genentech, and Sihuan Pharmaceutical. Dr. Li holds an M.D. from Sun Yat-Sen University of Medical Sciences.

"With years of experience in CAR-T, I recognize this therapy’s potential to fulfill patients’ unmet needs and am eager to join a company with a pipeline as promising as Gracell’s," Dr. Li said. "I believe the company’s FasTCAR and TruUCAR platforms have vast potential to solve some of the greatest challenges facing CAR-T therapy. The lead candidate, GC012F, is a highly differentiated CAR-T therapy that potentially affords competitive efficacy, combined with a favorable safety profile and faster delivery to patients. I look forward to joining Gracell’s leadership team and bringing the company to its next stage of growth."

On August 1, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company will participate in two upcoming virtual investor conferences in August 2022 (Press release, G1 Therapeutics, AUG 1, 2022, View Source [SID1234617163]).

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On Tuesday August 9, 2022, G1’s Chief Executive Officer Jack Bailey and other members of the executive team will participate in the virtual 2022 BTIG Biotechnology Conference. BTIG-hosted events are intended for prospective and existing BTIG clients only. To listen to the live event, please contact your BTIG representative with interest.

On Wednesday August 10, 2022, Jack Bailey and other members of the executive team will participate in the virtual 2022 Wedbush Pacgrow Healthcare Conference. Mr. Bailey will participate in a "Commercial Oncology" panel at 8:35AM ET. The webcast and replay of this event will be accessible on the Events & Presentations page of View Source

On August 1, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that after a successful call for proposals, University of Dundee has been awarded its first funding within the beLAB1407 BRIDGE initiative (Press release, Evotec, AUG 1, 2022, View Source [SID1234617180]). beLAB1407 is a translational BRIDGE collaboration between Evotec and Bristol Myers Squibb, aiming to accelerate translational research from the UK’s academic life science ecosystem.

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Building on unique insights into cytokine biology originating from the lab of Dr Ignacio Moraga at the University of Dundee, the selected project will focus on the development of novel biologics for the treatment of inflammatory disorders including inflammatory bowel disease ("IBD"). By promoting the regenerative properties of cytokines while negating the often detrimental inflammatory properties, this method offers a unique approach to treat a variety of conditions. The lab of Dr Mairi McLean at Dundee will provide complimentary expertise in gastrointestinal human tissue organoid cultures.

Using Evotec’s integrated discovery and development platform, beLAB1407 will validate the concept of the approach. beLAB1407 was launched in May 2021 as a translational collaboration between Evotec and Bristol Myers Squibb.

Dr Thomas Hanke, EVP & Head of Academic Partnerships at Evotec, commented: "We are delighted to award and fund a Dundee project within the beLAB1407 BRIDGE. After being initiated in 2021, beLAB1407 makes good progress in supporting a portfolio of competitive drug discovery projects and we are pleased to work on the project aiming to resolve chronic autoimmune processes proposed by Dr Ignacio Moraga and his team."

Anne Muir, Head of IP and Commercialisation at University of Dundee commented: "I am delighted that this first award for Dundee involves the Schools of Life Sciences and Medicine working together. We look forward to more awards from this exciting initiative and to successfully supporting the spinout opportunities that it will enable."

On August 1, 2022 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative therapeutic products for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, and Chief Financial Officer, Steven Binder will participate in the BTIG Biotechnology Conference taking place on Monday, August 8 – Tuesday, August 9, 2022 (Press release, Mannkind, AUG 1, 2022, View Source [SID1234617196]).

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This conference is being hosted by BTIG, a global financial services firm specializing in institutional trading, investment banking, research, and related brokerage services. BTIG’s Corporate Access program hosts client events across the consumer, digital assets, energy and infrastructure, financials, healthcare, real estate, and technology sectors.

Management will be participating in one-on-one meetings throughout the event. To join the conference and arrange a meeting with management, please email [email protected].

On August 1, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) for omidubicel for the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant (Press release, Gamida Cell, AUG 1, 2022, View Source [SID1234617212]). Omidubicel is a first-in-class, advanced NAM-enabled stem cell therapy candidate with breakthrough and orphan drug designations.

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The FDA granted Priority Review for the BLA and has set a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. The FDA grants Priority Review to product applications that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. At this time, the FDA has indicated that it is not planning an advisory committee meeting as part of the BLA review.

"The FDA’s acceptance of our BLA with Priority Review signifies a critical milestone in our mission to deliver a new stem cell therapy option for patients in need of a donor for an allogeneic stem cell transplant," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We are encouraged by the positive and sustained follow-up results from patients participating in the Phase 3 trial of omidubicel, including a positive overall survival trend one-year out from treatment. These results provide promising rationale that, if approved, omidubicel could become a treatment of choice for patients in need of an allo-HSCT transplant. We look forward to working with the FDA throughout the review process to bring omidubicel to patients as quickly as possible."

Upon FDA approval, omidubicel will be manufactured at the Gamida Cell owned manufacturing facility in Israel. This is a newly constructed, state-of-the-art, modular facility which allows for additional capacity to be added to address growing demand. Batches from this facility were used to support the BLA for omidubicel and the facility is currently manufacturing clinical batches.

The omidubicel BLA is supported by the statistically significant results from Gamida Cell’s pivotal Phase 3 study, the results of which were published in Blood, the official journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). Results for the study’s primary endpoint, the median time to neutrophil engraftment in patients with hematologic malignancies undergoing allogeneic bone marrow transplant with omidubicel compared to standard umbilical cord blood (UCB), demonstrated a median time to neutrophil engraftment of 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p < 0.001). The secondary endpoints of this Phase 3 study were all achieved and were statistically significant. These secondary endpoints were platelet engraftment, the rate of infection, and days alive and out of hospital. Omidubicel was generally well tolerated in the Phase 3 study.

The full Blood manuscript is available here: View Source

In 2019, approximately 8,000 patients who were 12 years old and up with hematologic malignancies underwent an allogeneic stem cell transplant in the United States.1 Unfortunately, it is estimated that another 1,200 patients were eligible for transplant but could not find a donor source.2 If approved, omidubicel has the potential to improve outcomes for patients based on transplanter feedback and to potentially increase access for patients to get to transplant. If approved, omidubicel has the potential to treat approximately 2,000 – 2,500 patients each year in the U.S.

Conference Call Information

Gamida Cell will host a conference call today, August 1, 2022, at 8:00 a.m. ET to discuss this update. To access the conference call, please register here and please be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Omidubicel

Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.

Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit View Source

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.