On September 19, 2022 Moffitt Cancer Center, one of the nation’s leading cancer care and research institutions, and Deerfield Management, a health care investment firm, reported a major translational research alliance to accelerate the development of new therapeutics to treat cancer (Press release, Moffitt Cancer Ctr, SEP 19, 2022, View Source [SID1234619669]). Through a newly launched company called Bayfield Therapeutics LLC, Deerfield has committed up to $130 million over the next 10 years to this new collaboration.

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"This partnership is a strong representation of what we aim to achieve at Deerfield to help shape the future of health care," said James E. Flynn, managing partner at Deerfield Management. "Alongside the impressive team at Moffitt, we’ll have the opportunity to combine our financial, operational and development expertise with their existing pipeline, offering a flexible approach and access to additional resources that will ideally bring several new and improved therapeutic solutions to patients battling cancer."

"This new research collaboration will help build upon Moffitt’s stellar reputation of translating our research from the bench to the bedside. Through Bayfield Therapeutics we aim to accelerate the rate at which we are translating these discoveries, into potentially lifesaving therapies for cancer patients," said John Cleveland, Ph.D., executive vice president and center director of Moffitt. "Together, we hope to make a lasting impact on cancer care, improving outcomes for patients in our community and beyond."

Bayfield Therapeutics, LLC is a private company wholly owned by affiliates of Deerfield Management. Its goal is to fund projects that have uncovered novel therapeutics that have the potential to cure life-altering diseases. This collaboration will build upon the robust drug pipeline already established by scientists at Moffitt.

"We are very excited to partner with Deerfield in this effort to advance novel cancer drugs toward the clinic. Moffitt has a strong and innovative basic and pre-clinical drug discovery pipeline with deep expertise in state-of-the-art technologies," said Derek Duckett, Ph.D., chair of the Drug Discovery Department at Moffitt. "With the operational support from Deerfield, we are confident that this new collaboration will accelerate the development of our unique and promising molecules to achieve Investigational New Drug readiness."

As part of the alliance, Deerfield will provide development expertise to help shepherd potential cutting-edge treatments to cancer patients.

Starting this fall, researchers at Moffitt will have the opportunity to submit proposals to Deerfield for review. Each selected project will receive resources and expertise to support the progression from the discovery research phase to clinical testing. Selected proposals will also have eligibility for additional capital investments to create spinoff companies.

On September 19, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company that is developing and commercializing oncology medicines, reported that England’s health technology assessment institute, the National Institute for Health and Care Excellence (NICE), has issued a final appraisal document (FAD) recommending BRUKINSA (zanubrutinib) for the treatment of Waldenström’s Macroglobulinemia (WM) in adults who have had at least one treatment, only if bendamustine plus rituximab is also suitable (Press release, BeiGene, SEP 19, 2022, View Source [SID1234619668]).

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This decision from NICE marks BRUKINSA as the first and only treatment for WM to be recommended for routine use in England and Wales. The NICE Committee acknowledged the high unmet need for an effective and well tolerated treatment for WM "where current chemoimmunotherapy options can cause severe adverse reactions and the need for frequent hospital visits".i

WM is a rare form of B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin lymphomas. There are around 4,000 people living with WM in the UK. ii

"BRUKINSA is a highly selective BTK inhibitor," said Dr Shirley D’Sa, consultant hematologist and clinical lead at the University College London Hospitals Centre for WM and Associated Disorders. "NICE’s positive recommendation for zanubrutinib allows eligible patients in England and Wales to access an important new treatment option that may offer improved outcomes compared to the current standard of care."

In its appraisal, NICE concluded that zanubrutinib could be considered "a step-change" in managing the disease as clinical evidence suggests that people with WM may live longer and have a better quality of life with zanubrutinib compared to standard of care. The NICE recommendation states that BRUKINSA is considered cost-effective at a threshold of £20,000-30,000 per quality-adjusted life year (QALY).i

"I am very pleased that NICE have agreed that BRUKINSA is a valuable treatment option for eligible WM patients in England and Wales, enabling those patients to be among the first patients in Europe to have access to BRUKINSA," commented Dr. Robert Mulrooney, BeiGene General Manager, UK and Ireland. "BeiGene’s mission is to achieve affordable access to our innovative medicines and we look forward to working with NICE and the National Health Service in the UK to create further treatment options for UK patients with blood cancers."

About Waldenström’s Macroglobulinemia

WM is a rare B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin lymphomas.iii The disease usually affects older adults and is primarily found in bone marrow, although lymph nodes and the spleen may be involved.iv Typically, patients present between the ages of 60 and 70 years. For reasons that are unclear, WM is almost twice as common in men as in women and is more common in Caucasians than other ethnic groups.v Waldenström’s macroglobulinemia is a rare cancer seen only in approximately three to five per million people per year.iv

About BRUKINSA

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other licensed BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 3,300 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 16,000 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three licensed medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under U.S. Food and Drug Administration (FDA) review, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

On September 19, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the global leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, reported that Abigail "Abbey" L. Jenkins, MS, has joined as President & CEO (Press release, Gamida Cell, SEP 19, 2022, View Source [SID1234619667]). Ms. Jenkins has also been appointed to Gamida Cell’s Board of Directors. Ms. Jenkins succeeds Julian Adams, Ph.D., who is retiring in accordance with planned succession and will continue to serve on the company’s Board of Directors.

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"Abbey is an inspiring leader who brings to Gamida Cell an expertise in building and scaling organizations as they mature through commercialization alongside continued advancement of innovations in R&D. In addition, she is skilled in corporate strategy and is highly respected by her colleagues for her commitments to build strong company cultures focused on patient centric missions," said Robert Blum, Chairman of Gamida Cell’s Board of Directors. "On behalf of Gamida Cell’s Board, we welcome Abbey and thank Julian for his longstanding commitment to the company’s science and values during a pivotal time during which the company achieved major milestones including the submission of the BLA for omidubicel and the initiation of the clinical development of GDA-201. We look forward to his continued service and scientific counsel to the Board."

Ms. Jenkins brings over 20 years of leadership experience in the biopharmaceutical industry delivering life-enhancing therapies from research to commercialization for patients in need. She served as the Chief Commercial and Business Officer at Lyndra Therapeutics, where she established and led global commercial, business development, corporate strategy and portfolio management across multiple therapeutic areas. Prior to Lyndra, she served as Senior Vice President and Business Unit Head of Vaccines at Emergent BioSolutions, where she oversaw the company’s largest therapeutic division from discovery through commercialization. Ms. Jenkins also served as Chief Commercial Officer and U.S. Business Head at Aquinox Pharmaceuticals. Additionally, she has held senior commercial and business development positions at Relypsa, Actavis, Pfizer and Medimmune/AZ.

Ms. Jenkins holds a Master of Science in biotechnology and biotech business enterprise from The Johns Hopkins University, a Bachelor of Arts in psychology and biology from Indiana University, and a certificate of achievement in General Management as a Kellogg Executive Scholar. In September, she was recognized by PharmaVoice as one of the top 100 Most Inspiring Leaders, Disrupter category, for change-agents who are defining excellence in leadership in the biopharma industry.

"I am excited to lead Gamida Cell as we work to fulfill our mission of creating cures for blood cancers and serious hematologic diseases. Under Julian’s leadership, the team has built a strong pipeline of next-generation cell therapies that hold the potential to meaningfully change the future of cancer care for patients and healthcare providers," said Ms. Jenkins. "Our next goal will be to successfully deliver the first-ever allogeneic hematopoietic stem cell therapy, omidubicel, to market if approved and which we believe can expand access and eligibility for cancer patients in need of a stem cell transplant as well as reduce the overall burden on healthcare resources."

"It has been a distinct honor and a privilege to discover and develop novel medicines over the course of my 40-year career and to serve this company as its CEO these past five years," said Dr. Adams. "I wish to thank all my Gamida Cell colleagues for their unwavering support as well as their extraordinary efforts to bring our science of NAM-enabled cell therapies closer to benefiting patients with hematologic malignancies. Today, Gamida Cell is in a position of strength, with excellent prospects for the future."

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.

About Omidubicel
Omidubicel is a NAM-enabled 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.

The BLA for omidubicel has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. If approved, omidubicel will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers in need of a stem cell transplant.

On September 19, 2022 Naveris, Inc., a commercial-stage life sciences company dedicated to improving patient care through earlier detection of viral-driven cancers, reported a $33.4 million expansion of its Series A financing, bringing the total investment in Naveris to $51 million (Press release, Naveris, SEP 19, 2022, View Source [SID1234619666]). The financing was led by Gurnet Point Capital, joined by TechU Ventures and BrightEdge, the impact and venture capital arm of the American Cancer Society.

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Naveris’ blood tests for earlier cancer detection use proprietary patented DNA fragmentomics technology to distinguish between viral DNA arising from cancers versus infection. Proceeds from this financing will be used to advance commercialization of NavDx, Naveris’ flagship blood test for the early detection of cancers caused by the human papillomavirus (HPV), and to generate the clinical data needed to expand into other cancer types and indications.

"We are delighted to have the continued support of Gurnet Point Capital and TechU Ventures, and to welcome Alice Pomponio and the rest of the BrightEdge team, who collectively bring a deep understanding of both the oncology space and commercial-stage businesses," said Piyush B. Gupta, Ph.D., Naveris founder and Chief Executive Officer. "We founded Naveris on the belief that advances in molecular diagnostics will play a vital role in improving cancer outcomes. This new investment underscores NavDx’s commercial success and potential, and our experienced team’s ability to transform this vision into a reality for patients and oncologists."

"Since our initial investment in 2020, we have been impressed by the Naveris team’s vision and their ability to commercially execute on a differentiated strategy in the rapidly developing field of blood-based cancer detection," said Travis Wilson, Partner at Gurnet Point Capital. "We are pleased to be providing additional capital to ensure that their transformative technology for early cancer detection will benefit as many patients as possible."

"We could not be more excited to back Piyush and his team as Naveris works to increase access to diagnose, detect, and monitor viral cancers" said Alice Pomponio, BrightEdge Managing Director. "We understand the burden of HPV related cancers on patients. And we seek to build on the years of research and advocacy of the American Cancer Society to support the next generation of mission aligned companies reducing patient burden."

Along with Naveris’ commercial activities, more than 25 medical institutions have partnered with the company to conduct clinical studies and trials utilizing its technology. The company has also partnered with biotechnology companies developing immunotherapies for HPV-related cancers.

On September 19, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it will host a virtual key opinion leader (KOL) webinar on Sept. 22, 2022 at 12:00 p.m. ET (Press release, Lantern Pharma, SEP 19, 2022, View Source [SID1234619665]). The webinar will focus on challenges in drug development for pediatric cancers and the potential of Lantern’s drug candidates LP-184 and LP-284 for several rare pediatric cancers.

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The webcast will feature a leading expert in pediatric cancer research, Peter Houghton, Ph.D., Professor & Principal Investigator at Greehey Children’s Cancer Research Institute (Greehey CCRI) at UT Health Science Center-San Antonio. During the webcast, Dr. Houghton will discuss the disparities and hurdles that currently exist in pediatric cancer research, drug development, and clinical trial design compared to adults. He will also provide details on exciting new preclinical results for LP-284 and its preclinical efficacy in vivo for several pediatric cancer models including Ewing’s sarcoma, malignant rhabdoid tumors, and alveolar rhabdomyosarcomas. Details on the webinar and how to register can be found below:

Virtual KOL Webinar Details:

When: Thursday, September 22, 2022 at 12:00 p.m. ET
Webinar Length: 20 minutes
Registration, please use the link below:
View Source
A replay of the webinar will be available on Lantern’s website beginning on September 23, 2022:
www.lanternpharma.com
In early 2022, Lantern entered a research collaboration with Dr. Houghton to evaluate Lantern’s drug candidates LP-184 and LP-284 in several pediatric cancer models. Preliminary results from the initial phase of the LP-284 experiments have been obtained, with additional experiments planned for both LP-184 and LP-284 in the second half of 2022.

About Dr. Peter Houghton:

Dr. Houghton is an internationally recognized researcher in pediatric oncology and drug development. He received his Ph.D. in 1976 from the Institute of Cancer Research at the University of London, after which he spent over 30 years with St. Jude Children’s Research Hospital where he was the chair of Molecular Pharmacology and co-leader of the Solid Malignancies Research Program. Most recently, he served as the Director of the Greehey CCRI at UT Health Science Center-San Antonio from 2014 to 2021. At the Greehey CCRI, Dr. Houghton’s laboratory focuses on the development of novel approaches for the treatment of pediatric cancers, which has included creating of one of the most comprehensive patient-derived xenograft (PDX) model libraries for pediatric cancers. These PDX models are a critical resource to evaluate novel therapeutics in clinically relevant pediatric cancer models.

About the Greehey CCRI:

Since 2004, UT Health San Antonio, Greehey CCRI’s mission has been to advance scientific knowledge relevant to childhood cancer, contribute to understanding its causes, and accelerate the translation of knowledge into novel therapies. Greehey CCRI strives to have a national and global impact on childhood cancer by discovering, developing, and disseminating new scientific knowledge. More information on the Greehey CCRI can be found on their Website, Facebook, Twitter, LinkedIn, and Instagram.