On November 11, 2024 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole-tumor derived immunotherapies, reported an oral presentation and two poster presentations at the 2024 Society for NeuroOncology (SNO) 29th Annual Meeting in Houston, Texas, from November 21-24, 2024 (Press release, Imvax, NOV 11, 2024, View Source [SID1234648092]). Separately, the Company will also host a symposium focused on the development of IGV-001 for the treatment of newly diagnosed glioblastoma.

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Imvax will present blinded safety data from the Company’s ongoing randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM). The Phase 2b study to assess the safety and efficacy of IGV-001 in patients with ndGBM (NCT04485949) has completed enrollment and top-line results are expected to be presented in mid-2025. Imvax will also present follow-on data from its Phase 1b study of IGV-001 in patients with ndGBM, as well as preclinical data of IGV-001 in combination with checkpoint inhibitors.

The details of the oral presentation and two poster presentations are below:

Title: Early safety data from a randomized, multicenter, double-blind, phase 2b study of IGV-001, an autologous cell immunotherapy, versus placebo, in newly diagnosed glioblastoma (ndGBM)
Number: CTIM-14
Timing: November 22, 7:25 p.m. – 7:35 p.m. CST
Presenter: Brad Elder, M.D.

Title: Long-term survivors from a Phase 1b study of IGV-001 in patients with newly diagnosed glioblastoma
Number: CTIM-11
Timing: November 21-22, 7:30 p.m. – 9:30 p.m. CST
Presenter: Raul-Perez Olle, M.D., Ph.D.

Title: IGV-001: A biologic-device combination product elicits potent anti-GBM responses as a monotherapy and in combination with check point inhibition
Number: IMMU-30
Timing: November 21-22, 7:30 p.m. – 9:30 p.m. CST
Presenters: Jenny Zilberberg, Ph.D. & Mark A. Exley, Ph.D.

On Friday, November 22, 2024, from 12:45 p.m. – 1:45 p.m. CST, Raul Perez-Olle, M.D., Ph.D., SVP, Head of Clinical Development and Medical Affairs at Imvax, Brad Zacharia, M.D., M.S., FAANS, Associate Professor of Neurosurgery and Otolaryngology at Penn State Health, and Brad Elder, M.D., Director, Neurosurgical Oncology, and Associate Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center, will host a symposium, entitled "Development of IGV-001 for the treatment of newly diagnosed glioblastoma," focused on Imvax’s proprietary Goldspire platform and the development of IGV-001 for the treatment of ndGBM. Register for the session here.

About IGV-001

IGV-001 is an autologous biologic-device combination product derived from Imvax’s proprietary Goldspire immuno-oncology platform for solid tumors, which involves a unique approach to inducing a broad and durable immune response against tumors. Phase 1 studies showed that IGV-001 was safe and well tolerated, and a Phase 1b ndGBM study also yielded several efficacy signals, including significant improvements in PFS, OS, radiographic evidence of tumor response, and multiple biomarker changes that supported the presence of an immune response (Andrews DW, et al., Clin Cancer Res. 2021;27(7):1912-1922). In ten Stupp-eligible ndGBM patients in the highest dose cohort treated with IGV-001, median PFS was 17.1 months, compared with 6.5 months in historical standard-of-care (SOC) treatment, and median OS was 38.2 months, compared with 16.2 months in historical SOC.

On November 11, 2024 Optic, a digital biology company redefining drug discovery with AI, reported a collaboration with Vindur Tx, an early-stage oncology therapeutics venture (Press release, Optic AI, NOV 11, 2024, View Source [SID1234648091]). This collaboration will leverage Optic’s proprietary generative AI platform to identify novel highly selective kinase inhibitors and develop more effective treatments against cancer.

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According to the agreement, Vindur Tx will pay Optic up to $17.5 million for its proprietary technology to explore new ways of addressing previously "undruggable" targets in difficult-to-treat cancers. This approach could lead to new and more effective treatments.

"Working with BIOPTIC has been a revelation. They delivered highly selective ligands in record time, significantly accelerating our research. We’re thrilled with the results and the potential impact on our projects," said Vindur Tx co-founder Deniz Kural, PhD.

Optic’s AI platform BIOPTIC speeds up the drug discovery process by utilizing an ultra-high-performance proprietary AI screening platform for testing billions of compounds in minutes. This helps explore the previously inaccessible vast chemical space to find novel drug candidates faster.

AI-aided drug discovery can save biotechs up to 70% in costs. For early-stage biotech startups this means they can extend their runway, spending more time testing promising drug candidates and getting them to patients sooner.

"Even though there are more and more targeted cancer drugs, many of them fail during clinical trials due to the lack of efficacy and toxicity," said Optic CEO Andrey Doronichev. "The industry has been focusing on a tiny portion of the chemical space which proves unproductive. BIOPTIC platform allows researchers to screen vast uncharted chemical space to identify novel chemical scaffolds that would not only help improve efficacy and mitigate ADME-Tox issues but also provide better patentability."

Optic’s team consists of world-class experts in AI and drug discovery, with a proven track record of developing innovative AI solutions at companies like Google, Novartis, Insilico Medicine, AtomWise, and Neurolink. The company’s platform has already demonstrated its ability to generate high-potency novel small molecule hits across a diverse set of targets in several research collaboration projects with top US academia labs.

On November 11, 2024 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that preliminary results from its Phase I/II clinical trial TACTIC-3 (NCT05862324) investigating the safety and efficacy of autologous TAC01-CLDN18.2 in subjects with Claudin 18.2 positive solid tumors, were presented in a poster and an oral presentation at the 39th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, held November 6-10 in Houston (Press release, Triumvira Immunologics, NOV 11, 2024, View Source [SID1234648090]).

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Ecaterina E. Dumbrava, MD, Assistant Professor in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, presented promising preliminary clinical data from TACTIC-3 showing the positive safety profile and encouraging therapeutic potential of TAC01-CLDN18.2 at lower dosages, even among patients who have undergone multiple prior treatments. Dr. Dumbrava’s late-breaking abstract was selected for an oral presentation during the "Biotech Breakthroughs – Solid Tumor IO at the Tipping Point" session on Friday, November 8, and displayed during a Poster session on Saturday, November 9.

"As an emerging biomarker, Claudin 18.2 offers a promising target for cellular therapies due to its selective expression in certain advanced solid tumors, including, but not limited to, gastric and pancreatic cancers," said Dr. Dumbrava. "These initial data on TAC01-CLDN18.2, a new T-cell therapy approach designed to address the needs of patients with solid tumors expressing Claudin 18.2 are promising. Because this is a patient population with limited treatment choices, I look forward to the full results of the clinical trial TAC01-CLDN18.2’s potential to improve patient outcomes."

Key Preliminary Findings

The first two dose cohorts of Phase I have been completed, with no reported dose-limiting toxicities (DLT), showing a favorable safety profile.

All TAC-related adverse events were low-grade, and no cytokine release syndrome was reported. One subject in cohort 2 experienced a grade 1 neurotoxicity, which resolved the same day without intervention. Six subjects reported a total of 6 serious adverse events, none related to TAC01-CLDN18.2.

An 83% disease control rate was observed at first tumor assessment in the six eligible subjects for efficacy assessment.

One subject in cohort 1 with heavily pre-treated pancreatic adenocarcinoma with high Claudin 18.2 expression has an ongoing, confirmed partial response in the target lesion. The subject received a second dose approximately five months after the initial dose and has remained on treatment for nearly eight months with ongoing therapy. An efficacy assessment was conducted in early November 2024, three months after the second dose was administered, and in addition to an ongoing partial response in the target lesion, revealed a complete response in the patient’s non-target lesion. The incremental response observed following the administration of a second dose highlights the potential benefits of re-treating patients with Claudin 18.2 positive solid tumors with TAC01-CLDN18.2.
Oral Presentation Details:

Title: A phase 1/2 study evaluating the safety and efficacy of autologous TAC T cells in subjects with claudin 18.2+ advanced solid tumors

Authors: Ecaterina E. Dumbrava, Syma Iqbal, Simon Turcotte, Gregory Botta, Benjamin Schlechter, Geoffrey Ku, Peter Hosein, Sam Saibil, Miriam Gavriliuc, Maria Apostolopoulou, Mobolaji Giwa, Kara Moss, Swaminathan Murugappan, Davendra Sohal

Session: Biotech Breakthroughs – Solid Tumor IO at the Tipping Point

Oral Presentation Date: Friday, November 8, 2024, between 1:45 p.m. and 3:20 p.m. CDT

Abstract Number: 1472

Abstract Type: Late-Breaking Abstract

Abstracts are currently available on the SITC (Free SITC Whitepaper) website.

On November 11, 2024 STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, reported that it presented promising data from its Phase 1 clinical study evaluating its METTL3 RNA methyltransferase inhibitor, STC-15, at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, held in Houston, US, from 6-10 November 2024 (Press release, STORM Therapeutics, NOV 11, 2024, View Source [SID1234648089]).

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The Phase 1 clinical study enrolled 42 patients across five dose escalation cohorts ranging from 60mg to 200mg and explored daily and thrice weekly oral dosing regimens. Data presented at SITC (Free SITC Whitepaper) follows the Company’s presentation at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in October 2024.

The presentation at SITC (Free SITC Whitepaper) titled, ‘Phase 1 dose escalation and cohort expansion study evaluating safety, PK, PD and clinical activity of STC-15, a METTL3 inhibitor, in patients with advanced malignancies’, showed:

Gene expression pathways related to Interferon (IFN) signalling, response to virus and dsRNA binding were enriched in patients with longer duration of STC-15 treatment
Tumor regressions were achieved at all dose levels, 60 mg – 200 mg three times a week (TIW), with three sustained Partial Responses (PRs) at 60 mg, 100 mg, and 200 mg TIW in multiple tumor types
Treatment emergent adverse events, including target-related AE’s (e.g. platelet reductions, rash, pruritis) were mainly mild, transient and well managed with supportive care and were not treatment limiting
No maximum tolerated dose established up to 200 mg TIW
Evidence of M1 macrophages in the TME, consistent with preclinical data
Robust METTL3 target engagement indicated by rapid and long-lasting m6A inhibition
Kyriakos P. Papadopoulos, Co-Director of Clinical Research at START San Antonio, principal investigator for the STC-15 Phase 1 study and lead author of the SITC (Free SITC Whitepaper) presentation, said: "The ability to activate the innate immune system while maintaining tolerability and efficacy is what is truly unique about STC-15. STC-15 targets METTL3, initiating a novel immunologic mechanism that demonstrates remarkable safety for an immuno-oncology drug. The early efficacy and safety data in the advanced cancer setting supports further clinical development in Phase 2, in multiple tumor types."

Jerry McMahon, Chief Executive Officer at STORM Therapeutics, said: "STC-15 is first in its class – first to target METTL3, and first to target a RNA methyltransferase. We are pleased to report encouraging signs of clinical activity and corresponding upregulation of the gene pathways associated with the METTL3 mechanism of action. We look forward to developing and progressing our product into a Phase 2 study following these positive results."

On November 11, 2024 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the selection of IDE034, a potential first-in-class B7H3/PTK7 topo-I-payload BsADC, as a development candidate and the exercise of its option for an exclusive worldwide license from Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315) for potential first-in-class B7H3/PTK7 BsADC program (Press release, Ideaya Biosciences, NOV 11, 2024, View Source [SID1234648088]).

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"We are pleased to nominate development candidate IDE034, a promising potential first-in class B7H3/PTK7 topo-I-payload bispecific ADC, which has demonstrated robust monotherapy tumor regressions in multiple preclinical models. The co-expression of B7H3/PTK7 in several solid tumors, including double-digit percent prevalence in lung, colorectal, and head and neck cancers, highlights the potential addressable market, both as monotherapy and in combination with PARG inhibitor IDE161," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences. "We are excited to nominate our 6th development candidate in IDE034 and this program achieves several strategic objectives for IDEAYA, including the potential for monotherapy activity, application in multiple priority solid tumor types of lung and colorectal cancer, and the ability to enable wholly-owned rational combinations with our internal pipeline," said Yujiro S. Hata, Chief Executive Officer and Founder, IDEAYA Biosciences.

"We are excited to have IDEAYA exercise their option to license the worldwide rights to our B7H3/PTK7 BsADC IDE034 with a proprietary topoisomerase linker-payload. This important milestone in our partnership further validates Biocytogen’s RenLite platform and brings us one step closer to making an impact on patients with solid tumors. We look forward to our continued partnership with IDEAYA as they advance this program to the clinic," added Dr. Yuelei Shen, President and CEO of Biocytogen.

IDEAYA is targeting an Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) in 2025 for IDE034, subject to satisfactory completion of ongoing preclinical and IND-enabling studies, to enable first-in-human study initiation.

The option was exercised for an exclusive worldwide license from Biocytogen pursuant to the option and license agreement between IDEAYA and Biocytogen. IDEAYA will pay Biocytogen upfront and option exercise fees, along with additional development and regulatory milestone payments, commercial milestone payments, and royalties on net sales, totaling $406.5 million, including up to $100 million in development and regulatory milestone payments.

B7H3/PTK7 has been reported to be co-expressed in multiple solid tumor types, including in lung, colorectal, and head and neck cancers at approximately 30%, 46% and 27%, respectively, based on the Human Protein Atlas database.