On December 20, 2023 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will be participating in the 42nd Annual J.P. Morgan Healthcare Conference (Press release, Akoya Biosciences, DEC 20, 2023, View Source [SID1234638726]).

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Brian McKelligon, CEO, is scheduled to present on Wednesday, January 10th, 2024 at 3:45 p.m. PT.

A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

On December 20, 2023 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that the ongoing pivotal Phase 2 ENVASARC trial has enrolled more than 70 of the 80 planned patients in Cohort C of single agent envafolimab treatment at a dose of 600 mg subQ every three weeks (Press release, Tracon Pharmaceuticals, DEC 20, 2023, View Source [SID1234638725]).

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Additional safety and efficacy data were reviewed for 46 patients enrolled into cohort C who were the subject of the September independent data monitoring committee (IDMC) review. At that time, patients had completed a minimum of 12 weeks of efficacy evaluations and the objective response rate (ORR) was 13% by investigator review and 8.7% by blinded independent central review (BICR). Since then, an additional patient has achieved an objective response by investigator review, which increased the ORR by investigator review to 15%. The most recent objective response has not yet been confirmed by BICR and the patient remains on treatment. Median duration of response by BICR remains greater than six months. In addition, envafolimab remains well tolerated and grade > 3 related toxicity has not been reported to date.

"We continue to believe that these data position envafolimab to become a potentially compelling treatment option for patients with the refractory sarcoma subtypes of UPS and MFS based on the ORR and tolerability data to date," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "ENVASARC enrollment continues to be brisk, reflecting the high unmet need that exists for these patients."

Updated safety and efficacy data are expected in 1Q 2024, including in the more than 20 patients enrolled following the September IDMC review who will have had a minimum of 12 weeks of efficacy evaluations (two CT scans) at that time.

The primary endpoint of the ENVASARC study is achievement of an ORR in nine of 80 patients (11.25%) treated with envafolimab by BICR and median duration of response of greater than six months is a key secondary endpoint.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for envafolimab for patients with soft tissue sarcoma and fast track designation from the FDA for envafolimab for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

About ENVASARC (NCT04480502)

The ENVASARC Phase 2 pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. ENVASARC is enrolling patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. In Cohort C, a total of 80 patients will receive treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

On December 20, 2023 Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, reported that their sponsor client, CellVax Therapeutics Inc., has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for FK-PC101 (Press release, Theragent, DEC 20, 2023, https://theragent.com/cellvax-submits-ind-application-for-individualized-cell-based-immunotherapy-fk-pc101-with-support-of-theragent/ [SID1234638723]). CellVax and Theragent partnered in November of 2022, with CellVax seeking clearance to proceed with their Phase II adaptive design clinical trial.

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FK-PC101 is CellVax’s novel cancer immunotherapy, intended to treat prostate cancer patients who have a high risk of recurrence after prostatectomy. It consists of autologous human cancer cells that have been modified ex vivo to express major histocompatibility complex (MHC) II on their surface which are then irradiated to make them replication incompetent and delivered as an individualized immunotherapy. Fernando Kreutz, CEO at CellVax, stated, "We are proud and excited for this IND submission of FK-PC101. This submission signals the next step in our company’s journey, and we are eager to initiate this adaptative Phase 2 trial for prostate cancer patients upon FDA clearance. In the future, we envision the CellVax technology may also be used to treat patients with other types of cancer. We are also grateful to our CDMO partner, Theragent, whose expertise enabled this IND submission."

Theragent provided contract services to CellVax, including process optimization, assay development, and regulatory affairs support while preparing the IND package for this novel compound. Dr. Yun Yen, President and CEO of Theragent, said, "The preparation of the CellVax IND filing is another celebratory milestone in our company’s history as we continue to fulfill our mission: advancing novel cancer therapeutics for patients in need." In 2020, there were an estimated 3.3 million people living with prostate cancer in the United States, and almost a quarter of those patients experience recurrence after a prostatectomy. In 2023 alone, the American Cancer Society estimates there were 288,300 new cases of prostate cancer, demonstrating the acute need for this therapeutic.

FK-PC101 utilizes the patient’s own cells to create specific Tumor Presenting Cells (TPC), which are then formulated into an individualized cancer immunotherapy. "We are proud to support CellVax and nurture this important immunotherapy on its clinical journey," continued Jeff Masten, Theragent’s Chief Operating Officer. "We thank our incredible technical team who contributed to this project. It was a true team effort that demonstrates Theragent’s comprehensive scientific and regulatory capabilities, which uniquely position us to advance even the most complex cell therapy modalities from the bench to the clinic."

Following the IND submission, CellVax is expecting the FDA’s response by February 2024. The target start date for the patient recruitment is March of 2024. Approximately 230 patients will be recruited from 20 sites across the United States. Theragent will be responsible for end-to-end manufacturing, release, and disposition of all clinical material.

On December 20, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Robert M. Davis, chairman and chief executive officer, is scheduled to participate in a fireside chat at the Goldman Sachs Healthcare C-Suite Unscripted Conference on Thursday, Jan. 4, 2024, at 12:45 p.m. EST (Press release, Merck & Co, DEC 20, 2023, View Source [SID1234638722]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this webcast.

On December 20, 2023 GSK plc (LSE/NYSE: GSK) and Hansoh Pharma (HKEX: 03692), a Chinese biopharmaceutical company committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders, reported that they have entered into an exclusive license agreement for HS-20093, a B7-H3 targeted antibody-drug conjugate (ADC) utilising a clinically validated topoisomerase inhibitor (TOPOi) payload (Press release, GlaxoSmithKline, DEC 20, 2023, View Source [SID1234638721]). Under the agreement, GSK will obtain exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) to progress clinical development and commercialisation of HS-20093.

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Hesham Abdullah, SVP, Global Head Oncology, R&D, GSK, said: "B7-H3 is highly expressed in a broad range of solid tumours where there remains a significant need for novel treatment options. We look forward to progressing this potential new treatment across several indications and in future potential combination approaches with our established portfolio."

This agreement provides GSK with a second clinical-stage ADC that complements GSK’s existing capabilities and strengths in developing medicines to address unmet medical needs in various solid tumours. HS-20093 is currently being investigated in ongoing phase I and II trials in China. Data from the ARTEMIS-001 phase I trial (NCT05276609), for HS-20093 in advanced solid tumours, was presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in which initial clinical activity was observed in small cell lung cancer, non-small cell lung cancer and sarcoma with multiple confirmed responses and a manageable safety profile.1

Eliza Sun, Executive Director of Board, Hansoh Pharma, said: "HS-20093 is a novel B7-H3 targeting antibody-drug conjugate showing encouraging early clinical signals in lung cancer. We are excited to enter this new license agreement with GSK, our existing licensee on HS-20089, furthering Hansoh’s goal of bringing a potentially transformative treatment option to cancer patients globally."

GSK plans to begin phase I trials for HS-20093 outside of China in 2024.

In October 2023, GSK and Hansoh entered into an agreement for HS-20089, a B7-H4 targeted ADC currently in phase II clinical trials in China. HS-20089 has best-in-class potential in ovarian and endometrial cancer with opportunities in other solid tumours.

Terms of the agreement
Under the terms of this agreement, GSK will pay $185 million upfront. In addition, Hansoh will be eligible to receive up to $1.525 billion in success-based milestones for HS-20093. Upon commercialisation of HS-20093, GSK will pay tiered royalties on global net sales outside of China’s mainland, Hong Kong, Macau, and Taiwan.

This agreement is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US.

About HS-20093
HS-20093 is a novel B7-H3-targeted antibody-drug conjugate composed of a fully humanised anti-B7-H3 monoclonal antibody covalently linked to topoisomerase inhibitor (TOPOi) payload. HS-20093 is being developed for the treatment of lung cancer, sarcoma, head and neck cancers and other solid tumours in multiple phase I and II clinical trials in China.