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Gamida Cell Provides Update on Omidubicel BLA Submission

On January 19, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported that following receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration (FDA) yesterday, the company plans to initiate a rolling Biologics License Application (BLA) submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant (Press release, Gamida Cell, 19 19, 2022, View Source [SID1234605659]). As previously disclosed, in late 2021 the FDA requested a revised analysis of the manufacturing data generated at Gamida Cell’s wholly owned commercial manufacturing facility to demonstrate the analytical comparability to the Lonza clinical manufacturing site that produced omidubicel for the Phase 3 study. Gamida Cell and the FDA have now reached alignment that analytical comparability has been established between the commercial manufacturing facility and the product that was manufactured for the Phase 3 study. Based on this demonstration of comparability, along with the positive clinical results of the Phase 3 study, the FDA has agreed that the initiation of a rolling BLA submission is appropriate. Additional clinical data will not be required to initiate the BLA submission.

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"We are very pleased that our productive interactions with the FDA have resulted in alignment on the omidubicel manufacturing comparability analysis and agreement to initiate a rolling submission of our BLA application," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the FDA and has the potential to be the first FDA-approved advanced cell therapy for allogeneic bone marrow transplant. Initiating the BLA submission will move us one step closer toward bringing potentially curative therapies to patients. We plan to complete the full BLA submission in the first half of this year, which will be an important achievement for Gamida Cell and the bone marrow transplant community."

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with blood cancers. Omidubicel is the first bone marrow transplant graft to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. For more information about omidubicel, please visit View Source

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

Alterome Therapeutics Launches With $64M Series A Financing

On January 19, 2022 Alterome Therapeutics, Inc., a biopharmaceutical company developing alteration-specific targeted therapies for the treatment of cancer, reported the closing of a $64M Series A financing (Press release, Alterome Therapeutics, JAN 19, 2022, View Source [SID1234605658]). The financing was led by OrbiMed, with participation from Nextech Invest, Vida Ventures, Boxer Capital, and others. Alterome Therapeutics was co-founded by Eric Murphy, Ph.D., and Ryan Corcoran, M.D., Ph.D.

Dr. Murphy, an industry veteran with 20 years in oncology research and drug discovery, will serve as the Company’s chief executive and chief scientific officer. He most recently served as co-founder and chief scientific officer of Kinnate Biopharma. Dr. Corcoran, Scientific Director of the Termeer Center for Targeted Therapy and Director of the Gastrointestinal Cancer Center Program at the Massachusetts General Hospital Cancer Center, will serve on the board of directors and scientific advisory board.

"The Alterome team is grateful for the dedication and support provided by this world class investor syndicate that enables a tabula rasa to advance the precision oncology field by creating alteration-specific medicines," commented Dr. Murphy of Alterome Therapeutics, Inc.

In conjunction with the financing, Carl Gordon, Ph.D., CFA, Managing Partner at OrbiMed, Thilo Schroeder, Ph.D., Partner at Nextech, and Arjun Goyal, M.D., M.Phil, Co-Founder and Managing Director at Vida Ventures, will join the board of directors.

"We are pleased to work with this experienced management team and investor syndicate to raise the bar in targeted oncology," commented Dr. Gordon of OrbiMed.

"Founded on compelling science, Alterome’s novel approach has the potential to transform the treatment paradigm for cancer patients globally," commented Dr. Goyal of Vida Ventures.

Biogen to Report Fourth Quarter and Full Year 2021 Financial Results February 3, 2022

On January 20, 2022 Biogen Inc. (Nasdaq:BIIB) reported that it will report fourth quarter and full year 2021 financial results Thursday, February 3, 2022, before the financial markets open (Press release, Biogen, JAN 19, 2022, View Source [SID1234605653]).

Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at investors.biogen.com. Following the live webcast, an archived version of the call will be available on the website.

TriSalus Life Sciences Announces Collaboration with the University of Colorado Anschutz Medical Campus to Advance Research on Innovative Immuno-oncology Treatments for Patients With Liver and Pancreatic Tumors

On January 20, 2022 TriSalus Life Sciences, an immunotherapy company on a mission to extend and improve the lives of patients living with liver and pancreatic tumors, reported a strategic research collaboration with the University of Colorado Anschutz Medical Campus to advance research of immuno-oncology treatments for patients with liver and pancreatic tumors (Press release, TriSalus Life Sciences, JAN 19, 2022, View Source [SID1234605649]). This collaboration will leverage TriSalus’ immunotherapy platform, which integrates immunotherapeutics and innovative drug delivery technology to address the unique challenges of treating tumors in the liver and pancreas and improve outcomes for patients.

Over the next three years, TriSalus will collaborate with the University of Colorado Anschutz Medical Campus on studies using TriSalus’ proprietary Pressure-Enabled Drug Delivery (PEDD) method for the administration of an investigational toll-like receptor 9 (TLR9) agonist, SD-101. Pre-clinical and clinical studies involving this platform aim to build upon the scientific knowledge around treatments available for cancers of the liver and pancreas and enable more patients to benefit from immunotherapy. In collaborating with TriSalus, CU Innovations has led the establishment of the business relationship while the CU Anschutz research team will focus on creating clinical research to advance TriSalus’ approach.

"This collaboration bolsters the instructional and research objectives of the University of Colorado Anschutz Medical Campus while fostering the development of scientific knowledge that can improve patient care," said Gordon McLennan, MD, vice chairman for clinical research and section chief of interventional radiology at the University of Colorado School of Medicine. "As a world-class medical institution at the forefront of transformative science, education and healthcare, we look forward to collaborating with TriSalus Life Sciences to help bring potentially transformative treatments to patients living with liver and pancreatic cancers."

Despite progress in cancer treatment, patients with liver and pancreatic tumors still experience poor outcomes, as these tumors remain stubbornly difficult to treat. Two of the most significant barriers that prevent optimal delivery and performance of therapeutics for these tumors include immune response suppression and ineffective drug delivery due to high intratumoral pressure. Together, these barriers prevent therapeutics from getting inside tumors and limit the effectiveness of immunotherapy for patients.

"Supporting pre-clinical and clinical research that pushes the boundaries of current knowledge will help us to advance promising therapies for patients with liver and pancreatic tumors, who are in desperate need of more effective treatments," said Christopher Lieu, MD, associate director of clinical research at the University of Colorado Cancer Center.

TriSalus’ platform consists of an investigational immunotherapy, SD-101, that aims to reactivate the immune system within these organs for targeted tumor killing, and the Pressure-Enabled Drug Delivery method, that modulates pressure and flow within blood vessels to improve therapy uptake and tumor response.

"Collaborating with the University of Colorado Anschutz Medical Campus exemplifies our commitment to overcome current limitations of immunotherapy treatment for liver and pancreatic tumors," said Steven C. Katz, MD, FACS, chief medical officer at TriSalus. "By combining our collective expertise in cancer research, together we can help realize the potential for the TriSalus platform to bring meaningful benefit to patients."

The collaboration with University of Colorado Anschutz Medical Campus extends TriSalus’ ongoing partnerships with the country’s leading cancer centers. To learn more about clinical trials underway, visit trisaluslifesci.com.

Marker Therapeutics Receives FDA Orphan Drug Designation for its Multi-Antigen Targeted T Cell Therapy for Pancreatic Cancer

On January 19, 2022 Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that the United States Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug designation to MT-601, a multi-tumor-associated antigen (MultiTAA)-specific T cell product optimized for the treatment of patients with pancreatic cancer.

"The FDA’s orphan drug designation underscores MT-601’s potential as a treatment for pancreatic cancer, a cancer typically diagnosed at an incurable advanced stage with a total overall 5-year survival rate of 10%," said Peter L. Hoang, President & CEO of Marker Therapeutics. "Our novel therapy has shown encouraging results in an ongoing Phase 1 trial sponsored by Marker’s partners at the Baylor College of Medicine. In results reported at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting, our therapy has demonstrated the potential to safely produce durable responses in combination with chemotherapy as a first-line treatment option for patients with advanced or metastatic pancreatic adenocarcinoma. The results also revealed that epitope spreading was consistent in responders to Multi-TAA-specific T cells. Following MT-401 for the treatment of post-transplant acute myeloid leukemia (AML), MT-601 is Marker’s second novel MultiTAA-specific T cell product to receive orphan drug designation and the first in a solid tumor indication, underscoring the potential of Marker’s multi-antigen targeting T cell therapy approach in both solid tumors and blood cancers."

Marker developed MT-601, a new product targeting six tumor-associated antigens (PRAME, NY-ESO-1, Survivin, MAGE-A4, SSX2, WT1) highly expressed in pancreatic cancer. The Company intends to initiate a Phase 1 multicenter study of MT-601 administered in combination with front-line chemotherapy to patients with locally advanced unresectable or metastatic pancreatic cancer. Marker designed the study to include an initial antigen escalation period followed by a dose escalation period and will enroll 20 – 25 patients for the study.

The Company plans to file an Investigational New Drug Application (IND) for MT-601 for the treatment of pancreatic cancer in 2022.

Orphan designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax credits, FDA user-fee benefits, and seven years of market exclusivity in the United States following marketing approval by the FDA. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. For more information about orphan designation, please visit the FDA website at www.fda.gov.