On April 13, 2023 Affini-T Therapeutics, Inc., a precision immunotherapy company unlocking the power of T cells against oncogenic driver mutations, reported a licensing agreement with MSK (Press release, Affini-T Therapeutics, APR 13, 2023, View Source [SID1234630067]). As a result of the collaboration, which includes a sponsored research agreement with MSK’s Klebanoff lab, Christopher A. Klebanoff, M.D., Associate Member and Attending Physician, Laboratory Head, Human Oncology and Pathogenesis Program, and Member Investigator, Center for Cell Engineering at MSK, will join Affini-T as a Scientific Co-founder and Advisor.

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"We are committed to pushing forward a first-in-class pipeline of treatments targeting oncogene driver mutations for patients with solid tumor malignancies," said Jak Knowles, M.D., Co-founder, President and Chief Executive Officer, Affini-T Therapeutics. "In addition to his role as a leading cancer researcher and medical oncologist at MSK, Dr. Klebanoff and his lab team bring valuable insights into tumor biology, oncogene-specific targeting, T cell fitness within solid tumors, translational medicine and more to our company. We’re pleased to have him as part of our outstanding scientific team and look forward to working together to advance meaningful therapies for patients in need."

Dr. Klebanoff is deeply involved in translational research, which fuels the discovery cycle at MSK across multiple domain areas. "The Klebanoff/Affini-T collaboration embodies MSK’s longstanding commitment to innovation with impact, using bench-to-bedside research to transform cancer care for patients around the globe," said Gregory Raskin, MD, Senior Vice President, Technology Development at MSK.

"Core to the PICI mission is the need to overcome hurdles and forge collaborations. I am thrilled that Chris Klebanoff of MSK and Affini-T Scientific Co-founder Phil Greenberg of the Fred Hutchinson Cancer Center, two exceptional PICI affiliated researchers, have joined forces to form a powerful partnership," said Sean Parker, Executive Chairman of the Parker Institute for Cancer Immunotherapy and Board Observer, Affini-T Therapeutics. "Chris Klebanoff is an esteemed scientist with significant experience in KRAS targeting and T cell receptor development, and I am delighted to welcome him in this critical role at Affini-T."

Prior to joining MSK, Dr. Klebanoff was a Howard Hughes Medical Institute Research Scholar and Assistant Clinical Investigator at the National Cancer Institute (NCI) in Bethesda, Maryland. Dr. Klebanoff has contributed to the successful early phase development of numerous T cell-based therapies, notably Yescarta (axicabtagene ciloleucel) at NCI. He is an elected member of the American Society for Clinical Investigation (ASCI) and has received prestigious awards including the Damon Runyon Clinical Investigator Award, a National Institutes of Health (NIH) MERIT Award and NIH Fellows Award for Research Excellence.

"As a practicing medical oncologist, my singular professional focus and that of my lab is to address the urgent needs of patients with cancer. While continuing in my work as a physician-scientist at MSK, I am proud to be joining a team passionately working towards a shared mission of engineering transformative therapies for patients with solid tumors," said Dr. Klebanoff. "Affini-T is rapidly advancing its ground-breaking research toward the clinic, and I am honored to join its distinguished group of scientific co-founders and advisors whose pioneering research complements our work in the Klebanoff laboratory.

On April 13, 2023 -Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib, a potential first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported upcoming presentations including data on eganelisib by Infinity’s collaborator, Professor Judith A. Varner of the UCSD Moores Cancer Center, La Jolla, California, at the 2023 Annual Meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) to be held April 14 – 19, 2023 in Orlando, Florida (Press release, Infinity Pharmaceuticals, APR 13, 2023, View Source [SID1234630066]).

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Highlights of the presentations include preclinical and translational data further reinforcing the mechanism of action of PI3K-γ inhibition:

Single cell transcriptomics data showing PI3K-γ knockout switches tumor associated macrophages in head and neck squamous cell carcinoma (HNSCC) and non small cell lung cancer (NSCLC) tumor models to activated, antigen-presenting, T cell-stimulating macrophages.
Preclinical data supporting tumor growth delay of HNSCC tumor models in PI3K-γ knockout mice is mediated by intra-tumoral interleukin-12, interferon gamma and CD8+ T cells, key drivers of immune response to cancer.
Translational data from the MARIO-275 clinical trial showing increased systemic immune activation in patients treated with nivolumab in combination with eganelisib over nivolumab alone, with enrichment of genes from interferon signaling, antigen presentation, and T cell receptor pathways.
Translational data from the MARIO-3 clinical trial, showing immune activation within the tumor microenvironment in patients treated with eganelisib, nab-paclitaxel and atezolizumab, with up-regulation of interferon signaling, antigen presentation, and T cell receptor pathways.
Following translational data from MARIO-1 indicating increased expression of the TGF-β activating integrin αVβ8 in HNSCC patients treated with combination of eganelisib and nivolumab, initial preclinical studies showing anti-αVβ8 monoclonal antibody treatment prevents growth of HNSCC tumor model in PI3K-γ knock-out mice.
"Our presentations describe exciting aspects of the role of PI3K-γ as a fundamental molecular switch controlling immune response by myeloid cells in the tumor microenvironment," said Professor Varner. "Our preclinical data suggest key roles for antigen-presenting activated macrophages, intra-tumoral IL-12, IFN-γ release and activated CD8+ T cells in mediating the effect of PI3K-γ knockout or PI3K-γ inhibition in tumor models. In line with our preclinical studies, emerging translational data from the MARIO-275 and MARIO-3 clinical trials support the mechanism of action of eganelisib through reprogramming and activation of tumor associated macrophages to reshape the tumor microenvironment and favor anti-tumor activity. Altogether, these data continue to underscore the potential of eganelisib as a next generation macrophage reprogramming immunotherapeutic, in combination with checkpoint inhibitors or potentially new immuno-oncology agents like anti-αVβ8 monoclonal antibodies."

Details of the presentations are as follows:

Presentation time: Saturday, April 15, 2023, 8:30am-8:50am EDT
Title: Macrophages rule in cancer
Session: ED034 – Antigen Presentation: The Macrophage-Dendritic Cell Debate
Presenter: Judith A. Varner

Presentation time: Tuesday, April 18, 2023, 10:20am-10:40am EDT
Title: Basic and clinical impacts of targeting myeloid cells in tumors
Session: Session SY14 – Next Generation of Myeloid Checkpoints in Cancer
Presenter: Judith A. Varner

On April 13, 2023 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported that management will participate in a fireside chat at the Canaccord Genuity 2023 Horizons in Oncology Virtual Conference on Thursday, April 20, 2023, at 1:00 p.m. ET (Press release, Arcellx, APR 13, 2023, View Source [SID1234630065]).

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A live webcast of this discussion will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.

On April 13, 2023 TORL BioTherapeutics LLC (TORL), a biopharmaceutical company focused on developing new biologics for cancer treatment, reported its public launch and the closing of a $158 million Series B financing (Press release, TORL Biotherapeutics, APR 13, 2023, View Source [SID1234630063]). TORL’s pipeline of antibody-drug conjugates (ADCs) and monoclonal antibodies (mAbs) were discovered in the laboratory of scientific co-founder Dennis Slamon, M.D., Ph.D., Professor of Medicine, and Chief of the Division of Hematology/Oncology at UCLA’s David Geffen School of Medicine (DGSOM). He is an accomplished physician and scientist whose research was pivotal in identifying HER2 as a target in breast cancer and the development and initial approval of trastuzumab (Herceptin). Dr. Slamon’s lab went on to discover CDK4/6 as an important target in hormone receptor (HR+) positive breast cancer. Subsequently, his group led the clinical development of CDK4/6 inhibitors, resulting in breakthrough status therapies palbociclib (Ibrance) and ribociclib (Kisqali), in HR+ breast cancer.

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TORL is built on a strategic partnership with the Slamon Research Lab at UCLA, whereby the Company has exclusive development and commercial rights to biologics-based drug candidates focused on promising cancer targets. TORL’s lead drug programs target Claudin 6 (CLDN 6) and Claudin 18.2 (CLDN 18.2), both of which are currently in clinical trials. The Company also expects to put 2-3 additional compounds into clinical trials over the next 12 months, with plans to advance 1-2 new compounds each year.

"It has been very rewarding to use 30 years of experience, lessons learned, and preclinical models developed in our lab for this new company for," said Dennis Slamon, M.D., Ph.D., Co-Founder of TORL. "This unique academic/corporate partnership allows us to quickly identify novel targets, validate them preclinically, then proceed to bring these new biologic treatments into clinical testing and development in an exceptionally rapid and efficient manner. Our goal is to develop compounds that address critical or as yet unmet medical needs while simultaneously providing new and effective treatment options for cancer patients that can be life and practice changing. There are more of these to come, and we are thrilled we have this partnership to expand cancer therapy."

Leveraging the Slamon research lab’s unique discovery engine and validation platforms, TORL was founded to promote its novel oncology biologics with industry leading speed and capital efficiency. Since its inception in 2018, TORL has moved forward three, internally developed drug programs into the clinic and advanced two more through IND-enabling studies with less than $50 million.

"It has been tremendously gratifying to pioneer TORL’s innovative approach to drug discovery and development, culminating in the launch of multiple clinical trials with our drugs over the past year", said David Licata, TORL’s CEO. "We created and demonstrated an original, capital efficient structure which, despite the challenging market conditions, attracted a distinguished group of biotech investors with a shared vision for rapid cancer drug development. With the close of this Series B financing, we can advance our new programs into the clinic and existing clinical-stage programs into the next phase."

"Despite meaningful advances in the diagnosis and treatment of cancer, most patients worldwide continue to face serious morbidity and significant mortality," said Mark Alles, TORL’s Executive Chairman. "With strong support from our highly accomplished investors, we are building a preeminent biopharmaceutical company dedicated to the discovery, development and commercialization of first and best-in-class antibody-based immunotherapies to improve and extend the lives of people living with this terrible disease."

"TORL represents a unique model for company formation. Through their holistic relationship with the Slamon research lab and UCLA, the Company can leverage decades of scientific expertise and deep research capabilities while avoiding the significant costs and risks associated with early-stage discovery," said Amit Sinha, Head of Life Sciences Investing within Goldman Sachs Asset Management. "We believe TORL-1-23 and TORL-2-307 represent promising potential therapies for ovarian and gastric cancers, two indications with significant unmet patient need. We look forward to partnering with the TORL team to rapidly advance the lead programs toward late-stage clinical trials while progressing the broader portfolio of novel programs."

TORL builds on a 30-year history of scientific collaboration amongst a team of clinical pioneers and laboratory researchers. In addition to Dr. Dennis Slamon, the scientific founding team includes:

John Glaspy, M.D., MPH, Professor of Medicine, DGSOM, UCLA
Neil O’Brien, Ph.D., Associate Professor of Medicine, DGSOM, UCLA
Martina McDermott, Ph.D., Adjunct Assistant Professor of Medicine, DGSOM, UCLA
Ben Hoffstrom, Ph.D., Adjunct Assistant Professor, Medicine, DGSOM, UCLA
Sarah Larson, M.D., Assistant Professor, Medicine DGSOM, UCLA
Mike Press, M.D., Ph.D, Professor of Pathology, Keck School of Medicine of USC
With scientific advisors including Tom Boone, Ph.D., Brian Lawliss, Ph.D., and Leonard Presta, Ph.D.

TORL Board of Directors

Mark Alles – Executive Chairman
Mark Attanasio – Co-Founder and Managing Partner, Crescent Capital Group LP
David Licata – Co-Founder and CEO
Neil O’Brien, Ph.D. – Co-Founder
Amit Sinha – Partner, Goldman Sachs
Lynn Seely, M.D. – President and CEO of Lyell Immunopharma
Dennis Slamon, M.D., Ph.D. – Co-Founder
TD Cowen acted as exclusive placement agent for the Series B financing.
Crandon Law LLC served as counsel to TORL BioTherapeutics LLC.
Latham & Watkins LLP. served as counsel to Goldman, Sachs & Co. LLC.

On April 13, 2023 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, and Flare Therapeutics, a biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, reported a multi-year strategic collaboration to accelerate precision medicine approaches across five of Flare’s therapeutic programs into clinical trials through advanced molecular profiling approaches that guide patient selection and participation (Press release, Caris Life Sciences, APR 13, 2023, View Source [SID1234630062]).

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The partnership reinforces Flare’s commitment to longitudinal testing, leveraging Caris’ comprehensive molecular tissue and liquid profiling services including whole exome sequencing and whole transcriptome sequencing for patients enrolled in Flare’s clinical trials, while also applying Caris’ data and analytics tools to bolster future clinical trial enrollment programs and companion diagnostics capabilities.

"We understand the importance of shaping translational insights early on as a major area of focus to help ensure efficient drug development at scale and clinical trial preparedness," said Michaela Bowden, Ph.D., Chief Development Officer at Flare. "With access to Caris’ robust clinico-genomic real-world data, comprehensive molecular profiling and extensive precision oncology alliance network, we are well positioned to unlock the full potential of drugging transcription factors by further unraveling the molecular complexities of cancer at the patient level and successfully enter the next phase of our growth as a clinical stage company."

Through comprehensive molecular profiling and the application of advanced artificial intelligence and machine learning, Caris has created the largest clinico-genomic database coupled with cognitive computing to unravel the molecular complexity of disease. Under the terms of the agreement, Flare will leverage Caris’ industry-leading next generation sequencing technology for the molecular testing of patients treated with Flare’s assets. In addition, Flare will receive access to Caris’ data insights and analytics capabilities to accelerate oncology drug discovery, identify novel biomarkers and optimize clinical positioning strategies for their pipeline. Flare will also leverage Caris’ biomarker-driven patient selection for clinical trials, allowing Caris the first option to develop a companion diagnostic for any drug candidate developed as part of the collaboration.

"This broad partnership with Flare will leverage Caris’ leading molecular science and technology solutions to support Flare’s novel approach to decipher the biology of transcription factors to develop small molecule medicines," said Milan Radovich, Ph.D., Senior Vice President and Chief Scientific Officer of Caris Life Sciences. "The data accessibility and continuum across real world and clinical trial populations will provide Flare the necessary insights for successful molecule discovery and development.