On December 1, 2022 Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, reported a $35 million investment from Pfizer to support its rapid development of samuraciclib (CT-7001) in HR+, HER2- breast cancer, which represents more than two thirds of all new female breast cancer cases (Press release, Carrick Therapeutics, DEC 1, 2022, View Source [SID1234624661]).

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Carrick and Pfizer have also entered into an agreement under which Pfizer will provide global development capabilities and expertise to support Carrick’s Phase 2 study of samuraciclib in combination with fulvestrant for CDK4/6i-resistant HR+, HER2- advanced breast cancer. Carrick will maintain full economic ownership and control of samuraciclib and its pipeline. In conjunction with the investment, Adam Schayowitz, Ph.D., Vice President and Development Head, Breast Cancer, Colorectal Cancer and Melanoma, Pfizer Global Product Development, will join Carrick’s Scientific Advisory Board.

"Given Pfizer’s deep expertise in developing treatments for breast cancer, we are delighted to welcome them as an investor and collaborator in developing samuraciclib," said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. "We believe Pfizer’s investment further underscores the potential of samuraciclib to be a first- and best-in-class treatment for patients with advanced breast cancer, following CDK4/6i therapy."

"We believe samuraciclib has the potential to play a meaningful role in the treatment of HR+, HER2- breast cancer," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology & Rare Disease, Pfizer Global Product Development. "Our hope is that Pfizer’s development capabilities and expertise in breast cancer and next-generation cyclin dependent kinases, combined with the innovation represented by samuraciclib, will help accelerate the advancement of this potential breakthrough for patients."

About Samuraciclib (CT7001)
Samuraciclib is the most advanced oral CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer, as CDK7 regulates transcription of cancer-causing genes and promotes uncontrolled cell cycle progression and resistance to anti-hormone therapy. Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies. In addition to the above studies, it is currently being evaluated in prostate cancer with further potential in pancreatic, ovarian and colorectal cancers. Samuraciclib has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i-resistant HR+, HER2- advanced breast cancer. Carrick is also collaborating with Roche to evaluate a novel combination of samuraciclib and Roche’s oral SERD giredestrant in CDK4/6i-resistant HR+, HER2- metastatic breast cancer.

On December 1, 2022 Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, reported it has raised $25 million in a Series C financing (Press release, Carrick Therapeutics, DEC 1, 2022, View Source [SID1234624660]).
The financing round was supported by existing investors, including ARCH Venture Partners, Rosetta Capital, Lightstone Ventures, Google Ventures, Cambridge Innovation Capital, and Evotec. The Company intends to use the proceeds to fund ongoing and planned samuraciclib clinical trials, ongoing development of its CDK12/13 inhibitor / Cyclin-K glue-degrader, and for working capital and general corporate purposes.

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"This financing will enable us to accelerate development of our CDK7 and CDK12/13 inhibitors to potentially bring new treatment approaches to patients battling cancer," said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. "Separately, we announced a collaboration and $35 million investment from Pfizer, which further strengthens our conviction in the potential of samuraciclib to be a first and best-in-class treatment for patients with advanced breast cancer. We are grateful for the new investment from Pfizer and the continued support from existing investors, and we look forward to advancing clinical trials with both of these exciting assets."

"Carrick has established a talented team with extensive drug development experience and a broad and highly differentiated oncology pipeline," said Steven Gillis, Ph.D., Managing Director at ARCH Venture Partners. "We are excited to support Carrick as they work towards bringing better therapeutic options to patients living with advanced breast cancer, as well as other malignancies."

Carrick has raised a total of $60 million from the Series C financing and Pfizer investment. The Company recently announced Pfizer Inc. has made a $35 million investment in Carrick. Carrick will maintain full economic ownership and control of samuraciclib and the rest of its pipeline.

On December 1, 2022 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") is pleased to report the successful sterile and bacteria-free test-run production of BVX-0918, the Company’s bi-haptenized autologous ovarian cancer vaccine (Press release, BioVaxys Technology, DEC 1, 2022, View Source [SID1234624659]).

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The complete manufacturing of BVX-0918 from a cancer patient’s ovarian tumor now validates the production protocols that had been in development over the past few months for the successful extraction of tumor cells, the cryo-packaging and cryo-preservation of tumor cells, identification of ovarian cancer cells as the components of the vaccine using specially developed monoclonal antibodies and flow cytometry, sterility processes, and development of the process for double haptenization of the ovarian tumor cells used in the vaccine.

The production protocols have reduced the time needed to haptenize the tumor cells by fifty percent having established a semi-automatic technique for mechanically extracting tumor cells from a tumor mass, resulting in a time savings for GMP manufacturing.

The next steps include further optimization of the vaccine production process, finalizing the protocol for GMP manufacturing of BVX-0918, followed by transfer of the production protocol to larger scale manufacturing and GMP validation for submission of a CTA to EU regulatory authorities. The CTA is the European equivalent of the FDA’s Investigational New Drug application, or IND, which is filed to seek approval for a clinical study.

BioVaxys President and Chief Operating Officer Kenneth Kovan stated, "BioVaxys has successfully met a major manufacturing milestone by establishing the process to take surgically excise ovarian cancer cells from a cancer patient, conjugate two haptens, and manufacture a sterile and bacteria-free complete vaccine. The next steps now involve GMP product characterization and applying analytical methods to validate that each step of BVX-0918 production is under GMP conditions to the satisfaction of EU regulatory authorities. We have completed the clinical study protocol, and our EU clinical development and marketing partner, Procare Health Iberia, has selected a CRO and already begun meeting with prospective Spanish Phase I study investigators."

On December 1, 2022 bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and targeted cancer treatment, reported that David Elzi, Ph.D., bioAffinity Vice President of Research, will discuss his research into a possible mechanism by which the knock down of two genes kills cancer cells with little or no effect on normal cells at Cell Bio, a joint meeting of the American Society for Cell Biology (ASCB) and European Molecular Biology Organization (EMBO), in Washington, D.C., on Dec. 3-7, 2022. Dr. Elzi’s research supports the Company’s development of broad-spectrum cancer therapeutics.

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Dr. Elzi will present a poster titled "Reassessing Cobalamin Requirements in Cell Culture" on Monday, Dec. 5, 2022, from 12:15 p.m. to 1:45 p.m. EST at the Walter E. Reed Convention Center in Washington, D.C.

"bioAffinity’s research is important in better understanding the foundation of our therapeutic platforms as it examines one potential mechanism for how silencing the genes CD320 and LRP2 together kills cancer cells but leaves normal cells unharmed," Dr. Elzi said.

"We previously reported on the Company’s design and use of siRNAs to kill multiple cancers at the cellular level, including prostate, lung, breast, brain and skin cancers, without harm to normal cells," said bioAffinity President and CEO Maria Zannes. "We have reported on how to deliver the potential therapy. Dr. Elzi’s recent research that will be presented next week at Cell Bio looks at why it works."

Cell Bio 2022, the joint meeting of the ASCB and EMBO, will showcase a diverse global community of the brightest minds in cell biology in person, Dec. 3-7, 2022, in Washington, D.C. The unique meeting focuses on cell biology as the fundamental basis of biology as well as sessions on emerging interdisciplinary topics.

On December 1, 2022 Alentis Therapeutics, the Claudin-1 company, reported that Alberto Toso, Head of Oncology, will present a poster at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress in Geneva, Switzerland (and virtually), from 7-9 December 2022 (Press release, Alentis Therapeutics, DEC 1, 2022, View Source [SID1234624656]).

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The poster, CLAUDIN-1 Targeting Antibodies in Solid Tumors: from ALE.C04 to CLAUDIN-1 Oncology Platform, presents evidence that non-junctional Claudin-1 is overexpressed in different solid tumors, drives T-cell exclusion and resistance to checkpoint inhibitors (CPI). Importantly, the use of non-junctional Claudin-1-targeting monoclonal antibody ALE.C04 restored T-cell infiltration and CPI efficacy in a pre-clinical mouse tumor model.

ALE.C04, Alentis’ lead oncology asset, is the first potential treatment to target CLDN1 to open up the mechanical barrier that characterizes immune-excluded CLDN1+ tumors, thus making the tumors vulnerable to treatment. Based on Alentis’ pre-clinical data, rationale and safety profile, the company plans a Phase 1b trial with ALE.C04 in combination with CPIs in solid tumors, expected to initiate in the second half of 2023.

In November 2022, Alentis published pre-clinical proof-of-concept data, showing Claudin-1 monoclonal antibodies as potential first in-class compounds for HCC, in The Journal of Hepatology: View Source

Poster presentation details are listed below:

Poster title: CLAUDIN-1 Targeting Antibodies in Solid Tumors: from ALE.C04 to CLAUDIN-1 Oncology Platform (Abstract #193P)

Presenter: Alberto Toso, Head of Oncology, Alentis Therapeutics

Authors: A. Toso 1 , G. Teixeira 1 , T. Zimmermann 1 , D. Schmitter 1 , M. Meyer 1 , M. Muller 2 , L. Mailly 2 , T. Baumert 2 , R. Iacone 1 1 Oncology, Alentis Therapeutics AG, Allschwil, Switzerland, 2 UMR_S1110, Institut de Recherche sur les Maladies Virales et Hépatiques, Strasbourg, France

Date: Thursday, 8th December 2022

Time: 12:30-13:15 CET

Location: Foyer ABC

Register to join the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress’ digital platform, here.