Gamida Cell Appoints Abigail L. Jenkins as President and Chief Executive Officer, Bringing Broad Leadership Experience in Commercializing Innovative Therapies

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.

Naveris, Inc. Raises $51 Million to Advance Commercialization of NavDx

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.

Lantern Pharma to Host Virtual KOL Webinar on the Treatment of Pediatric Cancers During Childhood Cancer Awareness Month, featuring Peter Houghton, Ph.D.

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.

165,797 Orion Corporation A shares converted into B shares

On September 19, 2022 Orion Corporation reported that , 165,797 A shares have been converted into 165,797 B shares (Press release, Orion Biotechnology, SEP 19, 2022, View Source,Register%20on%2019%20September%202022. [SID1234619664]). The conversion has been entered into the Trade Register on 19 September 2022.

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The total number of shares in Orion Corporation is 141,134,278 which, after the conversion, consists of 34,310,524 A shares and 106,823,754 B shares. The number of votes of the company’s shares is after the conversion 793,034,234.

OGTR grants DIR licence allowing VAXINIA Phase 1 trial expansion to Australia

On September 19, 2022 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that the Australian Government’s Office of the Gene Technology Regulator (OGTR) has granted Imugene the DIR licence required to expand its VAXINIA Phase 1 clinical trial within Australia (Press release, Imugene, SEP 19, 2022, https://mcusercontent.com/e38c43331936a9627acb6427c/files/62a3b420-798b-d7c4-4a34-5ff2a546823c/IMU.pdf [SID1234619663]).

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The licence, numbered DIR 192 and titled ‘Clinical trial of a genetically modified (GM) chimeric Orthopoxvirus (CF33-hNIS) as a cancer treatment’, is required as part of the Australian regulatory framework for dealings involving the intentional release of genetically modified organisms into the environment.

Imugene’s multicenter Phase 1 VAXINIA trial commenced in May 2022 at US sites, delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹.

The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." Overall the study aims to recruit 100 patients across approximately 10 clinical trial sites in the United States and Australia.

The trial is anticipated to run for approximately 24 months and is funded from existing budgets and resources.

Imugene MD & CEO, Ms Leslie Chong said: "We’re pleased to see this regulatory hurdle cleared on schedule which will allow the smooth progression of our VAXINIA Phase 1 trial as planned."