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.

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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]).

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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.​

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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.

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"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.

Novartis-backed ImmPACT Bio snags $111M and new CEO as cancer CAR-T yields phase 1 results

On January 20, 2022 ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate based chimeric antigen receptor (CAR) T-cell therapies for treating cancer, reported that it has closed $111 million in Series B financing, led by venBio Partners along with co-leads Foresite Capital and Decheng Capital (Press release, ImmPACT-Bio, JAN 19, 2022, View Source [SID1234605608]). Surveyor Capital (a Citadel company) also joined this financing round. Additional investors include the company’s existing investors OrbiMed, Novartis Venture Fund, RM Global Partners (RMGP), and Bukwang Pharmaceutical. The company also announced the appointment of Sheila Gujrathi, M.D., as chair of its board of directors, and Sumant Ramachandra, M.D., Ph.D., M.B.A., as president and chief executive officer (CEO), who will also join ImmPACT Bio’s board.

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In addition, ImmPACT Bio provided an update to the Phase 1 clinical study evaluating its CD19-CD20 bi-specific CAR T in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (R/R B-cell NHL) at University of California, Los Angeles (UCLA). In a total of eight patients treated to date with 12 months median followup, seven patients achieved and remain in complete remission (CR). A favorable tolerability profile was noted with no treatment-related neurotoxicity and no cytokine release syndrome above grade 1. Data will be presented in a future scientific forum.

The company’s logic-gate based CAR T platforms address key biological challenges in treating cancer. ImmPACT Bio’s technologies are specifically designed to address antigen escape, ‘on-target – off-tumor’ toxicities, and the immunosuppressive tumor microenvironment. The company’s technologies are based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA, and Gideon Gross, Ph.D., from the MIGAL-Galilee Research Institute. Proceeds from the financing will be used to further the company’s development of logic-gate-based CAR T-cell platforms.

"ImmPACT Bio is thrilled to receive such strong support from this outstanding group of investors," said newly appointed ImmPACT Bio CEO Dr. Ramachandra. "We are encouraged by these initial results of our Phase 1 clinical study and look forward to advancing our pipeline of transformative next-generation CAR T-cell therapies that harness the immune system and address key challenges for current cell therapies in cancer."

"We believe ImmPACT Bio’s technology platforms will help to expand the curative potential of cell therapies in certain cancers and to address challenges that have limited the efficacy of cell therapies in hard-to-treat tumor types," said Richard Gaster, M.D., Ph.D., managing partner at venBio Partners. "We are excited to work with the scientists and clinicians at ImmPACT Bio to translate their engineering innovations into novel cell therapy products for multiple malignancies."

"We’re honored to work with ImmPACT Bio as they develop novel strategies to address unmet oncology needs," said Jim Tananbaum, founder and CEO of Foresite Capital. "With Drs. Gujrathi and Ramachandra at the helm, this is an incredibly exciting time for ImmPACT Bio and the patients who are waiting for next-generation cancer therapies."

"ImmPACT Bio’s logic-gate-based CAR T platform holds tremendous potential to usher in a step-change in the treatment of solid tumors and blood cancers. We are pleased to join this distinguished group of healthcare investors supporting this world-class team to advance what we believe could become a new paradigm in cancer treatment," said Min Cui, Ph.D., founder and managing director of Decheng Capital.

As part of the financing, Yvonne Yamanaka, Ph.D., of venBio Partners, Cindy Xiong, Ph.D., of Foresite Capital, and Min Cui, Ph.D., of Decheng Capital will join the company’s board.

Sheila Gujrathi Named New Chair of Board of Directors

ImmPACT Bio also announced the appointment of Dr. Gujrathi as board chair. Erez Chimovits, partner at OrbiMed and ImmPACT Bio’s chairman, will remain on the company’s board.

"It is my pleasure to welcome Sheila to the board of ImmPACT Bio," said Mr. Chimovits. "This is a transformational period in ImmPACT Bio’s evolution, and Sheila is an exceptional fit for the company’s next stage of growth, given her deep experience leading biotech companies."

"ImmPACT Bio possesses an innovative and proprietary CAR T-cell platform, compelling clinical and early-stage assets, and a dynamic leadership team. Today’s announcement of the company’s Series B financing bolsters the potential to transform the oncology therapeutic landscape," said Dr. Gujrathi. "I’m thrilled to join as board chair and help ImmPACT Bio achieve its vision of developing transformative oncology medicines for cancer patients who have exhausted their treatment options."

Dr. Gujrathi is currently a venture advisor at OrbiMed and serves as executive chair of Ventyx Biosciences, chair of ADARx Pharmaceuticals, and director of Janux Therapeutics. She previously served as chair of Turning Point Therapeutics and is the co-founder and former CEO of Gossamer Bio. Prior to Gossamer, Dr. Gujrathi served as chief medical officer of Receptos, which was acquired by Celgene. Previously, she held development leadership positions at Bristol-Myers Squibb and Genentech where she led development and numerous global regulatory filings and approvals for immunology and oncology programs. Earlier in her career, she was a management consultant in McKinsey & Company’s healthcare practice. Dr. Gujrathi received both her M.D. in the accelerated Honors Program in Medical Education and her B.S. in biomedical engineering with highest distinction from Northwestern University. She completed her internal medicine internship and residency at Brigham and Women’s Hospital and Harvard Medical School and additional fellowship training in allergy/immunology at University of California, San Francisco (UCSF) and Stanford University Medical Center.

Industry Veteran Sumant Ramachandra Named President and CEO

Dr. Ramachandra brings more than 30 years’ experience in healthcare, including more than two decades in the pharmaceutical and medical device industry across multiple roles. CEO Rick Kendall, Ph.D., will continue as chief scientific officer (CSO) of ImmPACT Bio.

"I am confident ImmPACT has selected in Sumant the right leader to build on our success to date and to drive value for the company as he has done for several companies in the healthcare industry," said Dr. Gujrathi. "I want to thank Rick for his leadership in bringing ImmPACT Bio forward to a clinical-stage company and I look forward to working closely with this ‘dream team’ and contributing to our continued growth."

"I am excited to join ImmPACT Bio at such a crucial time in our development. I am impressed with the strong scientific foundation that the co-founders, management team, and board have built across its programs and platforms that aim to bring curative therapies to patients living with cancer," said Dr. Ramachandra.

Prior to joining ImmPACT Bio, Dr. Ramachandra was chief science, technology, and medical officer at Baxter International, which he joined in June 2017. In addition to these responsibilities, he was appointed president of Baxter Global Pharmaceuticals in mid-2019 and was appointed as chair of Baxter’s Global Inclusion Council focused on inclusion and diversity. Previously, he was at Pfizer, most recently as senior vice president, head of research and development, Pfizer Essential Health. He served as CSO at Hospira from 2008 to 2015 prior to Pfizer’s acquisition of Hospira in 2015. Earlier in his career, Dr. Ramachandra worked with Pfizer and Merck & Co. in various senior-level oncology global product development, medical affairs, and business development and licensing roles, and as a clinical pharmacologist. Before entering the industry in 2000, he was an intern and resident physician at Massachusetts General Hospital and Harvard Medical School.

Dr. Ramachandra earned a Ph.D. in experimental pathology in the study of chronic lymphocytic leukemia (CLL), an M.D., and a B.A. in biochemistry at Rutgers University. In addition, he holds an M.B.A. from the Wharton School of the University of Pennsylvania.

Leading the Next Generation of CAR T

For hematological malignancies, the company’s lead program is a CD19-CD20 bispecific ‘OR-gate’ CAR T designed to address antigen escape, which is a key challenge for current approved CD19 therapies. Early results indicate the potentially best-in-class bispecific CAR T-cell candidate is safe and effective in patients with R/R B-cell NHL.

Treating solid tumors is even more challenging, partially due to off-target safety considerations and the immunosuppressive tumor microenvironment. ImmPACT Bio is developing novel strategies for addressing this unmet need, designing next-generation CAR T to assure tumor specificity and efficacy in the hostile tumor environment, while protecting the normal tissue.

ImmPACT Bio’s second platform features engineered T cells with an activator/inhibitor ‘NOT-gate’ CAR combination that uniquely differentiates between tumor and normal cells. The activator CAR kills the tumor cells while the inhibitory CAR protects normal cells. The activator/inhibitor platform technology has the potential to deliver multiple products across solid tumors by pairing different activator/inhibitor combinations, providing diverse opportunities in an emerging and promising area of cancer therapy.

The company’s third platform, a TGF-β CAR that can be modularly equipped with tumor-targeting binding domains to generate bispecific ‘OR-gate’ CARs, rewires the T-cell response to TGF-β to convert this potent immunosuppressive cytokine into a T-cell stimulant. Single-chain bispecific CARs that simultaneously convert TGF-β signaling while directly targeting surface-bound tumor antigens enable T cells to robustly eliminate tumor cells in otherwise highly immunosuppressive microenvironments.