On March 22, 2023 Quince Therapeutics, Inc. (Nasdaq: QNCX), a biotechnology company focused on acquiring, developing, and commercializing innovative therapeutics that transform patients’ lives, reported that it received an unsolicited offer to acquire the company from Echo Lake Capital (Press release, Quince Therapeutics, MAR 22, 2023, View Source [SID1234629185]). Quince’s Board of Directors, consistent with its fiduciary responsibilities, will carefully review and evaluate the proposal to determine the course of action it believes is in the best interests of the company and its stockholders. Quince stockholders need not take any action at this time.

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On March 22, 2023 Avenge Bio, Inc. ("Avenge" or the "Company"), a biotechnology company developing the LOCOcyte Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, reported their posters were selected for presentation at the Society of Gynecologic Oncology’s (SGO) 2023 Annual Meeting on Women’s Cancer in Tampa, Florida on March 25-28, 2023 and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 in Orlando, Florida on April 14-19, 2023 (Press release, Avenge Bio, MAR 22, 2023, View Source [SID1234629183]).

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AVB-001, developed in the LOCOcyte platform, consists of proprietary engineered allogeneic human cells. The cells are encapsulated in a pro-inflammatory biomaterial that are delivered to the local tumor environment and generate high, sustained concentrations of human IL-2. The product initiates a robust and durable, local and systemic immune response while avoiding toxicities associated with systemic immunotherapies.

Avenge’s most advanced product candidate, AVB-001, produces native IL-2 immunotherapy and is initially being studied in metastatic peritoneal cancers such as ovarian cancer. Avenge has additional pipeline candidates for the treatment of a wide range of cancers including pancreatic, lung and breast cancers.

Presentation Details:

Conference: Society of Gynecologic Oncology’s (SGO) 2023 Annual Meeting on Women’s Cancer
Location: Tampa Convention Center | Tampa, FL | Exhibit Hall
Session Title: Poster Session 1
Poster Number: 1271
Poster Title: Favorable preclinical efficacy and safety profile of AVB-001, a novel IL-2 cell-based immunotherapy that eradicates ovarian cancer in mouse tumor models and supports first-in-human clinical development
Author: Guillaume Carmona, PhD (Avenge Bio, Inc.)
Date: Sunday, March 26, 2023
Time: 2:00-3:00 PM ET

Conference: American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023
Location: Orange County Convention Center | Orlando, FL | Room W414
Session Type: Methods Workshop (WM007) – Emerging Platforms for Cancer Immunotherapy
Session Title: Developing clinically translatable cytokine factories for cancer immunotherapy
Session Chair & Presenter: Omid Veiseh, PhD (Rice University)
Date: Saturday, April 15, 2023
Time: 12:30-1:00 PM ET

Conference: American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023
Location: Orange County Convention Center | Orlando, FL | Poster Section 46
Session Title: Phase I Clinical Trials in Progress
Poster Number: 10
Abstract Presentation Number: CT122
Poster Title: A phase 1/2 open-label, multicenter, dose escalation and expansion study of AVB-001, an intraperitoneally administered, cell-generated, human IL-2 immunotherapy in patients with platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube
Author: Shannon N. Westin, MD, MPH (MD Anderson Cancer Center)
Date: Monday, April 17, 2023
Time: 1:30-5:30 PM ET

Conference: American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023
Location: Orange County Convention Center | Orlando, FL | Poster Section 35
Session Title: Late-Breaking Research: Immunology I
Poster Number: 17
Abstract Presentation Number: LB101
Poster Title: Cell-generated IL12 combined with PD-1 inhibition produces local and abscopal immune activation to eradicate metastatic melanoma and pancreatic cancer
Author: Amanda Nash, BS (Rice University)
Date: Monday, April 17, 2023
Time: 9:00 AM-12:30 PM ET

The posters will be available on the Presentations and Publications section of www.avengebio.com following the conference.

About LOCOcyte Platform

Our LOCOcyteTM allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverage three unique advantages:

Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy,
Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and
The immunomodulator trains the patient’s immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity.

On March 22, 2023 Biosion USA, Inc. (Biosion), a global R&D biotechnology company, reported the upcoming presentations of non-clinical data from its oncology pipeline, including BSI-507: anti-PD1ⅹanti-PVRIG bispecific antibody and BSI-508: anti-PD1ⅹanti-CD47 bispecific antibody, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held from April 14 to 19, 2023 (Press release, Biosion, MAR 22, 2023, View Source [SID1234629182]).

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BSI-507, a First-in-Class Bispecific Antibody Targeting PD1 and PVRIG for Cancer Immunotherapy

BSI-507, a first-in-class anti-PD1ⅹanti-PVRIG bispecific antibody, discovered through Biosion’s H³ antibody discovery platform, is able to block both PD-1 and PVRIG pathways to enhance reversal of T cell inhibition. BSI-507 demonstrates favorable biophysical and functional characteristics, supporting the initiation of development activities including manufacturing and IND-enabling studies.

More details：View Source!/10828/presentation/3434

BSI-508, a Novel Bispecific Fusion Molecule Targeting PD1 and CD47 for Cancer Immunotherapy

BSI-508 is a novel anti-PD1ⅹanti-CD47 bispecific fusion molecule combining both T-cell activation and macrophage mediated phagocytosis together for superior tumor killing. BSI-508 was discovered through Biosion’s H³ antibody discovery platform. BSI-508 demonstrates favorable biophysical and functional characteristics, supporting the initiation of development activities including manufacturing and IND-enabling studies.

More details：View Source!/10828/presentation/3654

On March 22, 2023 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported its 2022 Annual Results (Press release, Carsgen Therapeutics, MAR 22, 2023, View Source [SID1234629181]).

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Business Highlights

Zevor-cel (CT053) NDA was accepted by the NMPA (Oct 2022) with priority review granted.
CT041 entered confirmatory Phase II clinical trial in China.
AB011 completed the enrollment for Phase I monotherapy and combination with chemotherapy.
Multiple data disclosure in academic journals and conferences, including Nature Medicine, Haematologica, Frontiers in Immunology, ASCO (Free ASCO Whitepaper) 2022, 7th CAR-TCR summit, ASH (Free ASH Whitepaper) 2022, ASCO (Free ASCO Whitepaper) GI 2023.
Collaboration agreement for zevor-cel commercialization in mainland China with Huadong Medicine.
Collaboration agreement for the evaluation of AB011 with Roche.
CARsgen’s RTP Manufacturing Facility in the U.S. started GMP production of autologous CAR T cell products and released the first GMP batch.
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, said, "In 2022, we have achieved important milestones in the clinical and regulatory advancements of our pipeline products, development of innovative technologies, expansion of global manufacturing capacities, business development, etc. Looking forward, we are embarking on an even more exciting journey. We are confident that CARsgen is well positioned to strengthen the leadership in CAR T-cell therapies globally, powered by our differentiated pipeline product candidates, dedicated team efforts, and the high operational efficiencies."

Zevor-cel is an upgraded fully human, autologous BCMA CAR T-cell product candidate for the treatment of R/R MM. China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) and has granted the priority review in October 2022. Updates from the Phase 2 study in the U.S. (NCT03915184) were presented orally at the 7th Annual CAR-TCR Summit and the updates from the pivotal Phase II study in China (NCT03975907) were provided in poster presentations at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022. An update from China investigator-initiated trials was published in Haematologica in August 2022. CARsgen plans to submit a Biologics License Application (BLA) to the U.S. FDA in 2024.

For CT041, the first-in-class CAR T-cell product candidate against CLDN18.2, a confirmatory Phase II clinical trial for advanced GC/GEJ in China is ongoing. A Phase 2 clinical trial in the U.S. is expected to initiate in the first half of 2023. Updates from the Phase 1b study in the U.S. (NCT04404595) and the Phase Ib/II study in China (NCT03975907) were provided in poster presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2022. An update from a China IIT was published in Nature Medicine in May 2022. CARsgen plans to submit an NDA to the NMPA in China in the first half of 2024 and plans to submit the BLA to the U.S. FDA in 2025.

AB011 is a humanized monoclonal antibody product candidate that targets CLDN18.2. CARsgen has completed the enrollment for the Phase I monotherapy and combination with chemo therapies. Updates from Phase I study (AB011-ST-01; NCT04400383) were provided in poster presentations at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium in January 2023.

On top of these existing clinical programs, CARsgen will actively explore the treatment with innovative CAR T-cell products for the earlier lines of therapies. CARsgen has also been taking efforts to develop innovative technologies and product candidates that will better address the challenges with existing cell therapy products.

2022 is an important year for CARsgen for the expansion of manufacturing capacities outside of China. CARsgen’s state-of-the-art GMP Manufacturing Facility in Research Triangle Park (RTP), Durham, has started GMP production of autologous CAR T cell products and successfully released the first GMP batch for the clinical trials in September 2022. The RTP Manufacturing Facility will continue to support CARsgen’s ongoing clinical studies and the early commercial launch overseas.

For business development, CARsgen entered into a collaboration agreement Huadong Medicine Co., Ltd. (SZ. 000963) for the commercialization of zevor-cel in mainland China. CARsgen will continue to be responsible for the development, regulatory approval, and manufacturing of zevor-cel in mainland China. In January 2023, CARsgen announced a collaboration agreement with F. Hoffmann-La Roche Ltd ("Roche") to evaluate CARsgen’s investigational drug AB011 in combination with atezolizumab, Roche’s PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with GC/GEJ. CARsgen looks forward to establishing more collaborations with industry partners and academic institutes to develop and advance innovative cell therapies and technologies, benefiting cancer patients worldwide.

On March 22, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), reported it has entered a research agreement with Georgetown University focused on the evaluation of the Company’s lead HDAC6 inhibitor candidate, SP-2-225, evaluating the anti-tumor effect of the combination of SP-2-225 and RT in a syngeneic breast cancer model (Press release, Shuttle Pharmaceuticals, MAR 22, 2023, View Source [SID1234629178]). The pre-clinical work outlined in the research agreement with Georgetown will support the Company’s IND-enabling studies in 2023 with a goal to submit an investigational new drug application (IND) for the selective HDAC6 inhibitor and initiation of a Phase I clinical trial in 2024.

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Shuttle Pharmaceuticals has a longstanding strategic relationship with Georgetown University having been founded by Georgetown University Medical School faculty members. Alejandro Villagra, Ph.D., an associate professor at Georgetown University and member of the Shuttle scientific advisory board, will lead research efforts under the agreement. Dr. Villagra has expertise in cellular signaling pathways, epigenetics and immunology.

SP-2-225 is Shuttle Pharma’s pre-clinical class IIb selective HDAC inhibitor under development for regulating the immune system after RT. With the introduction of check-point inhibitors, CAR-T therapies and personalized medicine in cancer, regulation of the immune response following RT is of significant clinical and commercial interest.

Shuttle Pharma’s platform of sensitizers offers a pipeline of product candidates designed to address the urgent clinical need for new radiation sensitizer agents. In addition to the HDAC inhibitor candidates, the Company’s pipeline includes Ropidoxuridine, its lead clinical sensitizer drug candidate, to sensitize rapidly growing cancer cells which is advancing towards Phase II clinical testing in brain cancer patients undergoing radiation therapy.

"We are excited to extend and strengthen our collaboration with Dr. Villagra and Georgetown University to further evaluate our lead HDAC6 inhibitor candidate, SP-2-225," commented Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. "Our goal is to build upon our leadership position in radiation sensitization, a market which is experiencing dynamic growth through the development of new radiation technology, the introduction of new agents, and growth in the number of diagnosed patients who may benefit from these treatments."