Regen BioPharma, Inc. to Present at the Emerging Growth Conference on March 3, 2023

On March 7, 2023 Regen BioPharma, Inc. (OTC PINK: RGBPD) (OTC PINK: RGBAD) (a biotechnology company advancing a diverse pre-clinical pipeline spanning cell therapies, RNA vaccines, RNA and DNA therapeutics and small molecule drugs) reported taht it will be presenting at the Emerging Growth Conference on March 8, 2023 (View Source) (Press release, Regen BioPharma, MAR 7, 2023, View Source [SID1234628283]).

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This live interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company’s CEO, Dr. David Koos, in real time. Please ask your questions during the event and Dr. Koos and his team will do their best to address as many of your questions as possible.

"We plan to use this time to update our stakeholders on our recent reverse stock split, our future financing and programmatic plans and also to answer shareholder questions," says Dr. David Koos, CEO and Chairman of the Company.

Regen BioPharma, Inc. will be presenting 1:10 – 1:20 Eastern time on Wednesday March 8, 2023. Please register here to ensure you are able to attend the conference and receive any updates that are released View Source;tp_key=9ac5970e97&sti=rgbp.

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com.

About the Emerging Growth Conference

The Emerging Growth conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in a time efficient manner.

The Conference focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of individual and institutional investors, as well as investment advisors and analysts.

Caris Life Sciences and Incyte Enter Into Broad Precision Medicine Partnership to Advance Incyte’s Oncology Pipeline

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."

Danaher Partners with the University of Pennsylvania’s Center for Cellular Immunotherapies to Address Manufacturing Challenges Impacting the Uptake of Cell Therapies

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.

POINT Biopharma Confirms No Disruptions to the Manufacturing and Clinical Supply for the 177Lu-PNT2002 SPLASH Trial, a Phase 3 Study in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

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.

TC BioPharm Shifts Focus to FDA Clinical Trials

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.