On March 7, 2023 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, reported a strategic research partnership with Incyte Corporation (NASDAQ:INCY) to augment precision medicine approaches for Incyte’s oncology pipeline (Press release, Caris Life Sciences, MAR 7, 2023, View Source [SID1234628282]).

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Caris’ unique platform combines data from whole exome sequencing, whole transcriptome sequencing, protein analysis, and proprietary AI models and signatures to improve patient outcomes through advancement of personalized medicine. The partnership will apply Caris’ data and analytics tools, comprehensive molecular tissue and liquid profiling services, and clinical trial enrollment program capabilities across two therapeutic programs initially, with the option for Incyte to expand to four total programs.

"This partnership with Incyte will leverage Caris’ leading molecular science and technology solutions to support Incyte’s oncology research and development efforts," said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris Life Sciences. "The aggregate strength of our platform, which provides patient level DNA and RNA data both in tissue and blood, may help to better identify and predict patient response to therapy, which in turn may accelerate clinical trial enrollment, optimize clinical positioning and potentially enhance technical and regulatory success."

Under the terms of the agreement, Incyte will leverage Caris’ data insights and analytics capabilities to discover novel biomarkers and optimize clinical positioning strategies for its oncology programs. For drug candidates developed under the collaboration, patients enrolled in Incyte-led clinical trials will undergo longitudinal testing with Caris’ comprehensive tissue and liquid molecular profiling assays. Incyte will also leverage Caris’ biomarker-driven patient selection for clinical trials including options to partner on developing companion diagnostics for programs in the partnership.

"Incyte is committed to identifying new treatments for cancer patients using approaches exploring both single agents and combinations of targeted therapies and immunotherapies in areas of high unmet medical need," said Jeff Jackson, Ph.D., Vice President, Translational Sciences at Incyte. "Our partnership with Caris will bring a comprehensive suite of precision medicine capabilities to augment Incyte’s success in developing key programs in our robust oncology portfolio."

On March 7, 2023 Danaher Corporation (NYSE: DHR), a global science and technology innovator, reported a strategic partnership with the University of Pennsylvania (Penn) focusing on cell therapy innovation (Press release, Danaher, MAR 7, 2023, View Source [SID1234628281]). The multi-year partnership aims to develop new technologies that will improve the consistency of clinical outcomes for patients and overcome manufacturing bottlenecks in the delivery of next generation engineered cell products.

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There are currently six CAR T cell therapies approved by the U.S. Food and Drug Administration, and at least 560 programs in ongoing clinical trials. This scale of clinical development indicates the potential the biopharma industry sees for these therapies to improve the treatment landscape for patients with limited options today. However, the impact of cell therapies on human health is being limited by an inability to scale manufacturing in a cost- and time-effective way.

Vanessa Almendro, VP, Science and Technology Innovation, Danaher, said: "Our understanding of science is evolving faster than ever, but to efficiently translate these discoveries into potentially life-changing therapies we need an equivalent acceleration in manufacturing innovation. We are delighted to be partnering with the CAR T pioneers at Penn and believe that combining our expertise in science and technology will help bring the next generation of cell therapies to patients faster."

Carl H. June, MD, Richard W. Vague Professor of Immunotherapy, University of Pennsylvania, said: "We look forward to working together to address some of the current challenges of the complex manufacturing process for CAR T cell therapy and to maximize the impact of these cellular immunotherapies for more patients in need."

The Beacon for Cell Therapy Innovation with Penn is a part of the Danaher Beacons program, which funds pioneering scientific research carried out in academic settings. The ultimate objective of this program is to develop innovative technologies and applications that can improve human health. The program’s focus areas include genomic medicines, precision diagnostics, next generation biomanufacturing, human systems, and data sciences.

The focus of this Beacon will be on product solutions that address bottlenecks impacting cell therapy manufacturing yield and quality. Penn’s work will be led by Joseph Fraietta, PhD, assistant professor of Microbiology; Saar Gill, MD, PhD, associate professor of Hematology-Oncology; Friederike Herbst-Nowrouzi, PhD, director of the Human Genome Editing Laboratory; and Megan Suhoski, PhD, director, Product Development Laboratory. All of the principal investigators involved are part of the Center for Cellular Immunotherapies, led by Carl June.

On March 7, 2023 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported that the SPLASH clinical trial for the PSMA-targeted PNT2002 program is not experiencing any manufacturing or drug supply issues or delays (Press release, Point Biopharma, MAR 7, 2023, View Source [SID1234628279]).

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"POINT’s first investments were into supply chain and a commercial scale manufacturing facility," said Joe McCann, Ph.D., CEO of POINT Biopharma. "We believe our focus on supply chain and manufacturing will drive broad access for patients and healthcare practitioners. The use of radioligand therapy in precision oncology is an untapped and underutilized area in the treatment of cancer, and POINT’s platform has been built to enable these drugs to reach their full potential."

In-house production of no-carrier-added 177Lu at POINT’s Indianapolis facility is expected to commence by the end of 2023. In addition to its manufacturing facility in Indianapolis, Indiana, POINT also maintains active relationships with radiopharmaceutical contract manufacturers and isotope suppliers across multiple geographies. Establishing redundancy across every key business area is a pillar of POINT’s value proposition to physicians and patients, and to ensure resiliency to radiopharmaceutical supply chain disruptions.

On March 7, 2023 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, reported that the company has taken steps to focus its clinical strategy on the planned future FDA trials for TCB-008 in AML as a monotherapy and other oncology indications in combination with additional assets (Press release, TC Biopharm, MAR 7, 2023, View Source [SID1234628278]).

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The pending protocol submission will be a Phase 1b safety trial, with a relatively small patient population and a short timeline to completion. In conjunction with refocusing the clinical team’s efforts on the USA, the Company intends to file the first IND in the third quarter of 2023 with an expected additional IND to be filed in the fourth quarter or early 2024. At this juncture, the Company is anticipating a dose escalating study of approximately 9 patients with an expansion cohort at the optimal dose.

"Our business development efforts over the last 12 months have generated multiple research collaborations and strategic relationships, the majority of which are US based and beginning to come to fruition," said Bryan Kobel, Chief Executive Officer. "Prioritizing US trials realigns us with our long term goal of becoming a leading commercial stage company, with a myriad of oncological treatment applications for TCB-008 (Omnimmune) as both a monotherapy and as a combination therapeutic. We firmly believe in the potential of our asset and the best way to position the Company for success is to commence with this proposed US trial protocol and to pursue future trials through the FDA pathways. Our partnership with MD Anderson will be valuable, both for this study and future FDA trials, and I anticipate that we’re now better positioned for near term success and sustainability, including potentially multiple data readouts in 2024."

TC BioPharm expects this US clinical trial enrollment to be relatively rapid due to the the fact that America offers a significantly greater pool of patients with more than 20,000 AML diagnoses each year. This transition will allow TC BioPharm to become more economically efficient by simplifying its strategy and reducing manufacturing and production efforts.

On March 7, 2023 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a precision oncology company, reported a corporate update and reported financial results for the fourth quarter and year-end of 2022 (Press release, Corbus Pharmaceuticals, MAR 7, 2023, View Source [SID1234628277]).

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"The fourth quarter and recent weeks have been a productive period for Corbus as we continue to evolve into a precision oncology company," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "With the execution of our exclusive licensing agreement for CRB-701, a next generation Nectin-4 ADC, we are excited to have a compelling, differentiated asset in the clinic. Concurrently, we continue on-track to the clinic with CRB-601 supported by our latest pre-clinical data presented at SITC (Free SITC Whitepaper) 2022".

Key Corporate and Program Updates:

CRB-701 next generation Nectin-4 ADC

Acquired CRB-701 through licensing agreement with CSPC Pharmaceutical Group granting exclusive development and commercialization rights in the United States, Canada, the European Union (including the European Free Trade Area), the United Kingdom, and Australia.

CRB-701 is designed to achieve an improved therapeutic index and patient convenience and could act on a broad range of Nectin-4 expressing tumors.

Clinical development is underway and will focus on urothelial cancer and other Nectin-4-positive solid tumors potentially including lung, breast and prostate cancer.

CRB-601 blocking the activation of TGFβ

CRB-601 is a potent and selective anti-αvβ8 integrin monoclonal antibody designed to block the activation of latent TGFβ within the tumor microenvironment.

CRB-601 significantly inhibits tumor growth as a single agent and enhances the efficacy of anti-PD-1 immunotherapy in checkpoint inhibitor (CPI) sensitive and CPI-resistant tumor models.

Pre-clinical data presented at SITC (Free SITC Whitepaper) 2022 indicate that anti-tumor activity of CRB-601 as a monotherapy correlates with protein expression of αvβ8. CRB-601 is scheduled for IND submission in the second half of 2023 in solid tumor cancer patients with the first patient treated by the end of 2023.

Additions to the Board and Management Changes

Dr. Yong Ben joined the Corbus Board of Directors on March 1, 2023. Dr Ben is a distinguished oncology researcher and pharma industry executive, with multiple drug approvals to his credit. This appointment augments our Board with his extensive oncology experience both in the United States and China.

Craig Millian, the Company’s Chief Operating Officer, will be departing Corbus on April 14, 2023 to pursue other opportunities. "We are very grateful for Craig’s contributions over the past four years. We thank him for his efforts and leadership and wish him well in his future endeavors", stated Yuval Cohen Ph.D., Chief Executive Officer of Corbus.
Financial Results for Fourth Quarter Ended December 31, 2022:

The Company reported a net loss of approximately $10.9 million, or a net loss per diluted share of $2.61, for the three months ended December 31, 2022, compared to a net loss of approximately $10.3 million, or a net loss per diluted share of $2.46, for the same period in 2021. For the year ended December 31, 2022, the Company reported a net loss of approximately $42.3 million, or a net loss per diluted share of $10.15, compared to a net loss of approximately $45.6 million, or a net loss per diluted share of $11.15 for the same period in 2021.

Operating expenses for Q4 2022 increased by $0.8 million to approximately $10.8 million for the three months ended December 31, 2022, compared to $10.0 million in the comparable period in the prior year. The increase was primarily attributable to pre-clinical costs to support IND filing for CRB-601 offset by decreased clinical trial and drug manufacturing costs, as well as an overall reduction in compensation expense. A reverse stock split of 1-for-30 was effected on February 14, 2023 and all per share amounts except the authorized shares have been retroactively adjusted to reflect the reverse split.

As of December 31, 2022, the Company has $59.2 million of cash and investments on hand which is expected to fund operations through the second quarter of 2024, based on the current planned expenditures.