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.

On January 9, 2023 Caris Life Sciences(Caris), the leading molecular science, artificial intelligence (AI) and machine learning technology company actively developing and delivering innovative solutions to revolutionize healthcare, and ConcertAI, the leading oncology real-world evidence data and AI technology company, reported a unique partnership to align the two companies’ oncology capabilities (Press release, Caris Life Sciences, JAN 9, 2023, View Source [SID1234626130]). The collaboration creates one of the largest translational and clinical development research platforms aimed at supporting and accelerating biopharmaceutical drug development and novel therapeutic research.

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Unprecedented Molecular and Clinical, Multi-modal Data at Population Scale

As the pioneer in precision medicine and molecular profiling, Caris has created a molecular-rich, real-world database of hundreds of thousands of cases that include genomic, transcriptomic and proteomic data. Caris was the first in the industry to provide Whole Exome Sequencing DNA coverage and Whole Transcriptome Sequencing RNA coverage (WES / WTS) for every patient, which includes mutations, copy number variations, insertions and deletions, fusions and variant transcripts, as well as genomic signatures for gLOH, MSI, HRD, TMB, Caris FOLFIRSTai, and Caris GPSai.

ConcertAI has the largest collection of research-grade clinical data in oncology, hematology and urological cancers, representing the treatment and outcomes of almost seven million patients, partnering with healthcare providers and medical societies around the world. The company’s Patient360 specification has emerged as the reference standard for leading biopharma and other research groups. In addition, the company’s AI SaaS solutions for clinical trial design and clinical development studies have emerged as the leading solution for next generation precision oncology trials.

Two Companies, One Unified Approach

David Spetzler, MS, PhD, MBA, Caris’ President and Chief Scientific Officer, said: "As precision oncology continues to evolve, Caris’ cutting-edge work on tumor biology and molecular biomarkers combined with ConcertAI’s definitive clinical data at scale will have broad implications in the discovery and development of novel signatures and therapeutic options for patients across a range of tumor types."

Jeff Elton, PhD, MBA, ConcertAI’s Chief Executive Officer, added: "By leveraging Caris’ expansive real-world clinico-genomic database and ConcertAI’s large clinical data of multiple types (EMR, Imaging, Medical Claims), our biopharma partners are able to uncover new insights into the underpinnings of cancer biology, translate these insights with confidence into the clinic, and define clear clinical development strategies for enhancing patient clinical outcomes."

While detailed partnership terms have not been disclosed, as part of the partnership, the two organizations will also align their scientific talent and AI SaaS technologies to the research objectives of their academic and biopharma