On January 9, 2023 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, and Natera, Inc., a global leader in cell-free DNA testing, reported an early access program for clinical use of FoundationOne Tracker, a personalized circulating tumor DNA (ctDNA) monitoring assay (Press release, Foundation Medicine, JAN 9, 2023, View Source [SID1234626135]). In addition, the investigational use only version of the test is now available for use in clinical trials.

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FoundationOne Tracker combines genomic information derived from FoundationOneCDx, Foundation Medicine’s tissue-based comprehensive genomic profiling test, with personalized assay design and ctDNA analysis from Natera. The test offers physicians the ability to serially monitor their patients’ response to treatment, especially immunotherapies, using a simple blood draw, and to use those insights to make informed decisions for future care. FoundationOne Tracker is now available through an early access program to a limited number of clinical customers, with plans to expand for broad availability in the United States later in 2023.

The current imaging-based standard of care for cancer monitoring is not precise or applicable to all cancer types and treatments, which has an impact on patient outcomes.1-4 For example, immunotherapy is used broadly across patients with advanced cancer, yet there remains an unmet need when assessing response to therapy and disease progression. FoundationOne Tracker offers physicians a tissue-informed, efficient and precise tool for treatment response monitoring (TRM) to inform personalized treatment strategies. It can be used as a complementary tool to imaging in order to more accurately assess response to treatment and inform next steps in patient care, particularly in cases when imaging is ambiguous or conflicting.

"We developed FoundationOne Tracker to help physicians identify patients who are resistant to their current treatment and may need additional therapy, or those who are responding well to therapy and may benefit from skipping unnecessary doses," says Foundation Medicine Chief Executive Officer Brian Alexander, M.D., M.P.H. "With this new tool that leverages the molecular fingerprint of the cancer, we hope to maximize the impact of genomic profiling to support a higher degree of personalized cancer care for patients."

The version of FoundationOne Tracker for research use was launched in June 2021 for retrospective analysis of archived specimens, providing a cost-effective and efficient path to bring personalized monitoring tools to Foundation Medicine’s biopharma and academic partners. The investigational use version of the test, which may be used for real-time processing of fresh specimens in ongoing prospective studies, is now available to gain earlier insights on treatment response in clinical studies.

"We are pleased to collaborate with Foundation Medicine and support broader access to cutting-edge tools that enable precision medicine," says Natera’s Chief Executive Officer, Steve Chapman. "This aligns with Natera’s mission to make our personalized monitoring assay technology available to all patients and improve outcomes."

This launch closely follows two publications demonstrating the clinical validity of FoundationOne Tracker’s value in the TRM and molecular residual disease (MRD) settings, respectively. Research published in Molecular Oncology features results from the OMICO-MoST study, the first advanced pan-cancer solid tumor study to demonstrate FoundationOne Tracker’s ctDNA dynamics for treatment response monitoring for two forms of immunotherapy. In another study recently published in the International Journal of Molecular Sciences, researchers established the feasibility of ctDNA-based MRD detection in metastatic colorectal cancer patients undergoing surgical resection. These studies are part of the extensive body of evidence both Foundation Medicine and Natera are generating to support the value of integrating tissue-informed ctDNA monitoring in clinical practice.

In February 2022, FoundationOne Tracker was granted a Breakthrough Device designation from the FDA for the assay’s use in the detection of MRD in early-stage cancer after curative therapy. The commercial launch of FoundationOne Tracker expands Foundation Medicine’s portfolio of molecular tests, which includes FDA-approved blood- and tissue-based CGP testing options and offers physicians a toolkit of options for detecting genomic alterations and tracking treatment response to help guide personalized cancer care.

On January 9, 2023 Minerva Biotechnologies, a private company developing 1st-in-human therapies for the treatment of solid tumor cancers, reported that the FDA has approved their IND (Investigational New Drug) application to conduct clinical trials with huMNC2-CAR22, aka MUC1*-CAR-1XX, for the treatment of metastatic breast cancers (Abstracts, Minerva Biotechnologies, JAN 9, 2023, View Source [SID1234626134]). huMNC2-CAR22 targets MUC1* (muk 1 star), the growth factor receptor that drives the growth and metastasis of most solid tumor cancers.

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Minerva’s first CAR T that targets MUC1*, huMNC2-CAR44, is already in a clinical trial for metastatic breast cancers. Initial results show CAR T cell expansion, patients going from Progressive Disease to Stable Disease and Partial Response. However, for a durable response, we needed to overcome CAR T cell exhaustion, which is common to CAR T cell treatment of solid tumor cancers. This second MUC1* CAR T, huMNC2-CAR22, bears the "1XX" mutations in the T cell’s CD3-z signaling domain. These four Tyrosine to Phenylalanine mutations block tyrosine phosphorylation in two of the three signaling domains of CD3-z, which slow signaling and dramatically increase persistence. Unexpectedly, the 1XX mutations give the CAR T cells the added benefit of being able to recognize and kill the low antigen expressing cancer cells that lead to cancer recurrence.

"These 1XX mutations solve the two hurdles that have thus far stood in the way of an effective CAR T treatment for solid tumor cancers: 1) CAR T cell exhaustion; and 2) failure to kill the low antigen expressing cells," said Minerva’s CEO Dr. Cynthia Bamdad, "Together with our MUC1* antibodies that recognize an epitope only available on cancer cells, huMNC2-CAR22 promises to be a big leap ahead in our fight against cancers."

We thank our scientists, collaborators, and the patients and their families for their courage.

Minerva holds a license from Memorial Sloan Kettering for use of the 1XX technology.

About the trial

NCT04020575 is a first-in-human trial of huMNC2-CAR22 and huMNC2-CAR44, autologous CAR T cells targeting MUC1* in metastatic breast cancer in patients with MUC1* positive tumors.

On January 9, 2023 Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP), a biotechnology company advancing a diverse pre-clinical pipeline spanning cell therapies, RNA vaccines, RNA and DNA therapeutics and small molecule drugs reported that it will be presenting at the Emerging Growth Conference on January 11, 2023 (View Source) (Press release, Regen BioPharma, JAN 9, 2023, View Source [SID1234626133]).

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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 them as possible.

"We plan to use this time to update our shareholders on our goals for 2023 and answer shareholder questions," says Dr. David Koos, CEO and Chairman of the Company.

Regen BioPharma, Inc. will be presenting from 2:55 – 3:05 Eastern time zone on Wednesday, January 11, 2023. Please register here to ensure you are able to attend the conference and receive any updates that are released View Source;tp_key=4acb9c592c&sti=rgbp.

If attendees are not able to join the event live on the day of the conference, a link will be shared on Regen’s twitter account (View Source) of the archived webcast from the Emerging Growth Conference.

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.

On January 9, 2023 OncoPep, Inc. reported that it is proud to be a presenter at this year’s Biotech Showcase January 9-11 in San Francisco (Press release, OncoPep, JAN 9, 2023, View Source [SID1234626132]). The company will be sending members of its executive team including Chief Operating Officer Michael Krepps and Chief Strategy Officer Jaehan Park. The Showcase, hosted by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development.

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"We’re excited about presenting an overview of our clinical progress to-date and our future development plans for our pipeline to investors as well as to potential pharma/biotech collaborators," said CSO Jaehan Park. "Being together with industry professionals at this well-established, highly respected conference will foster and create funding opportunities for us and give us the chance to set up partnerships to accelerate our development timelines. The timing of this conference is key as it will set the tone for the year."

OncoPep’s presentation is scheduled to be given at 3 pm on January 10. Along with the presentation to the conference, the OncoPep team will also be participating in both in-person and virtual one-on-one partnering meetings.

"OncoPep strives to continually build our investor network to ensure we have the funding necessary to allow our scientists and staff to focus on bringing our immunotherapeutics to the patients who desperately need them," said COO Michael Krepps. "With this year’s Biotech Showcase, we get an excellent start on 2023’s efforts to generate investor interest in OncoPep’s pipeline so that we may continue the development of novel, life-saving therapeutics."

On January 9, 2023 Boehringer Ingelheim and 3T Biosciences, reported that they have entered into a strategic collaboration and licensing agreement to discover and develop next-generation cancer therapies to address high unmet patient needs. The partnership will bring together 3T Biosciences’ best-in-class 3T-TRACE (T-Cell Receptor Antigen and Cross-Reactivity Engine) discovery platform with Boehringer Ingelheim’s two-pronged research strategy combining cancer cell-directed and immune cell-targeting compounds, further strengthening the company’s pipeline (Press release, Boehringer Ingelheim, JAN 9, 2023, View Source [SID1234626131]).

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Cancer immunotherapies have brought dramatic breakthroughs, but only for a minority of cancer patients. 3T’s platform aims to address this challenge by identifying novel shared T-cell receptor (TCR) targets of productive immune responses and comprehensively screening TCRs and TCR mimetics for specificity and off-target cross-reactivities. The platform identifies the most prevalent and immunogenic targets in solid tumors by uniquely combining high-diversity target libraries with active machine learning. This may lead to tumor-specific, safer therapies that can be delivered at higher doses.

"At Boehringer Ingelheim, we are committed to transforming patients’ lives. Through our new partnership with 3T Biosciences, we aim at accelerating and expanding our pipeline of first-in-class T-cell based therapies for patients affected by cancer," said Lamine Mbow, Ph.D., Global Head of Cancer Immunology + Immune Modulation, Boehringer Ingelheim.

"On behalf of the entire team at 3T Biosciences, we are extremely pleased to partner with Boehringer Ingelheim, a company advancing transformative cancer treatments," said Stefan J. Scherer, M.D., Ph.D., president and CEO of 3T Biosciences. "3T’s 3T-TRACE discovery platform has the potential to transform the treatment of cancers and beyond. By using data from patients for patients we aim to discover the best immunogenic targets for multiple tumor indications and across patient populations."

Under the agreement, Boehringer Ingelheim will provide patient-derived TCR data to fuel 3T’s target discovery efforts to identify antigens using its 3T TRACE discovery platform. 3T will receive an upfront payment and research and development support, and is eligible for discovery, preclinical, clinical, regulatory, and commercial milestones totaling $268 million in addition to royalties on future Boehringer Ingelheim product sales. Boehringer Ingelheim is eligible to receive royalties on future product sales by 3T Biosciences arising from the agreement.