On October 8, 2026 Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, reported that it has initiated dosing in an acute myeloid leukemia (AML) cohort of the ongoing Phase 1 study of STX-0712, the Company’s investigational therapeutic designed to deplete disease-driving CCR2-positive malignant monocytes and CCR2-positive bone marrow progenitors. The cohort will enroll patients with relapsed/refractory monocytic or monocytic-predominant AML.

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"Initiating dosing in the AML cohort marks an important milestone for STX-0712 and represents the next step in the development of our Phase 1 study in hematologic malignancies," said Philip Vickers, President and CEO of Solu Therapeutics. "Given the emerging data we have seen in chronic myelomonocytic leukemia and that a significant subset of AML is also driven by CCR2-positive monocytes and progenitors, we’re excited to evaluate STX-0712 as a monotherapy in this setting. With limited treatment options for patients with relapsed or refractory disease, we look forward to building a broader clinical dataset and further defining the therapeutic potential of STX-0712."

The Phase 1 study (NCT06950034) is an open-label, multicenter study evaluating the safety, tolerability, recommended Phase 2 dose and preliminary antitumor activity of STX-0712 as monotherapy in patients with relapsed/refractory chronic myelomonocytic leukemia (CMML) and AML.

About STX-0712

STX-0712 is an investigational Cytotoxicity Targeting Chimera (CyTAC) targeting the G Protein-Coupled Receptor CCR2, a selective marker expressed at high levels on malignant monocytes and bone marrow blasts, which are key drivers of disease in chronic myelomonocytic leukemia (CMML), acute myeloid leukemia (AML), and other hematologic cancers. Designed to selectively eliminate CCR2-positive cells, STX-0712 has the potential to offer a more targeted and effective treatment option with minimal effects on non-malignant cells.

STX-0712 has received Fast Track Designation from the U.S. Food and Drug Administration, and is currently being evaluated in a Phase 1 study in patients with relapsed/refractory CMML and AML.

(Press release, Solu Therapeutics, OCT 8, 2026, View Source [SID1234673297])

On October 8, 2026 NovaBridge Biosciences (NASDAQ: NBP) reported that updated results from the Phase 1b combination study of givastomig, a Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy (mFOLFOX6) in participants with previously untreated, HER2-negative, CLDN18.2-positive, and PD-L1-positive locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (GEA), will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026. ESMO (Free ESMO Whitepaper) Congress 2026 is scheduled to take place October 23-27, 2026, in Madrid, Spain.

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"Patients with metastatic gastroesophageal adenocarcinoma continue to need more effective treatment options, particularly those whose tumors express lower levels of CLDN18.2," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. "Givastomig is designed to amplify T-cell activity where CLDN18.2 is expressed. The data we plan to share at ESMO (Free ESMO Whitepaper) will provide a more mature view of the safety, efficacy and durability observed to date in combination with nivolumab and chemotherapy. These findings further strengthen our confidence in the program as we advance toward registrational development in first-line metastatic gastroesophageal adenocarcinoma."

Presentation Details
Title: Expanded Safety and Efficacy of Givastomig, a Claudin 18.2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in 1L Metastatic Gastroesophageal Carcinoma (mGEC)
Presentation Number: 2945P
Presenter: Samuel J. Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital
Date: Sunday, October 25, 2026
Time: 12:00 p.m. – 12:45 p.m. CET
Location: Poster Area, Hall 5

About Givastomig
Givastomig (TJ033721 / ABL111), a potential first-in-class Conditional T-cell Engager and Immune Amplifier (CTIA), is a Claudin 18.2 × 4-1BB bispecific antibody. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for potential treatment of gastroesophageal adenocarcinoma, its current lead indication. Givastomig also has potential applicability across other Claudin 18.2+ gastrointestinal malignancies including biliary tract cancer and pancreatic ductal adenocarcinoma.

Givastomig is being evaluated in a global, randomized Phase 2 study (NCT07432295), following positive topline results from a Phase 1b multicenter, open-label study in first-line metastatic gastroesophageal adenocarcinoma. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to givastomig for the treatment of previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinoma in combination with nivolumab and chemotherapy.

(Press release, NovaBridge Biosciences, OCT 8, 2026, View Source [SID1234673296])

On October 8, 2026 aiPTO TechBio reported a preprint [link] describing DELPHAI (Deep Explainable Perturbation Heterogeneity-Aware Inference), its virtual tumor model for perturbation prediction. In two independent benchmarking frameworks (Wei et al., Nature Methods 2026; Radig et al., Genome Biology 2026), DELPHAI achieved the #1 ranking on differentially expressed gene (DEG) recovery, outperforming state-of-the-art virtual cell models. It predicts drug responses for previously unseen, out-of-distribution patients, with biologically explainable outputs.

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Executive Summary

#1-Ranked AI Model: First on DEG recovery in two independent benchmarks, and first overall in scPerturBench’s out-of-distribution setting.
Fitness Gating Architecture: Natively models cell-type-specific survival, addressing a key limitation of existing models, which assume all cells survive treatment.
Living + Virtual Tumor Moat: Coupled to aiPTO’s proprietary Individualized Patient Tumor Organoid (IPTO) platform (500+ patients across 40+ CNS tumor subtypes; Peng et al., Cell Stem Cell 2025).
Value Thesis: A predictive preclinical platform that targets a leading cause of clinical attrition, tumor heterogeneity and resistance, to de-risk and accelerate pharma R&D.
The Industry Challenge: The "Scale Gap" in Virtual Cell Modeling

The convergence of AI and biomedicine has ignited a surge in virtual cell modeling. However, the field faces a fundamental scale gap: state-of-the-art models predict how isolated single cells behave, rely heavily on cell-line data, and implicitly assume that every cell survives treatment.

Real human tumors are not single cells or uniform cell lines; they are complex, heterogeneous ecosystems. Under therapy, drugs deplete sensitive populations while sparing resistant clones that ultimately drive relapse. A model that cannot predict cell survival cannot predict how a patient’s tumor responds.

The Technology Solution: Bridging to Virtual Tumors via Fitness Gating

DELPHAI addresses this bottleneck by integrating a novel "Fitness Gating" mechanism into its neural architecture. By learning cell-specific survival directly from data, DELPHAI identifies which cell populations a drug depletes, predicting shifts in tumor composition alongside single-cell transcriptomic responses.

Having validated the architecture on public benchmarks, aiPTO is now training DELPHAI on single-cell drug-perturbation data generated by its proprietary IPTO platform, which retains each patient’s native tumor microenvironment. The result is a closed-loop living+virtual tumor platform: the living model generates patient-tumor data, the virtual model learns from it, and its predictions are tested back in the living model. This moves the field from virtual cells trained on cell lines to virtual tumors trained on real patient tissue.

Investment Perspective: A Living + Virtual Tumor Platform De-Risking Precision Oncology

aiPTO is not building isolated algorithms; it is building a drug-response AI model for precision oncology grounded in proprietary patient-tumor data. The platform is designed to predict tumor-microenvironment shifts, target engagement, resistance, and counter-resistance opportunities before clinical trials begin. By targeting a leading cause of oncology trial failure, unmapped tumor heterogeneity and resistance, it offers pharma partners a scalable, defensible way to de-risk drug discovery.

(Press release, AIPTO Techbio, OCT 8, 2026, View Source [SID1234673295])

On October 8, 2026 Vir Biotechnology, Inc. (Nasdaq: VIR) reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN dual-masked T-cell engager (TCE), for the treatment of late-line metastatic castration-resistant prostate cancer (mCRPC). VIR-5500 is being co-developed by Astellas Pharma Inc. and Vir Biotechnology through a global strategic collaboration.

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"Receiving Fast Track designation reflects the potential of VIR-5500 to address an area of serious unmet need in late-line mCRPC and the strong momentum we have achieved with Astellas as we prepare to enter pivotal Phase 3 development in 2027," said Marianne De Backer, President and Chief Executive Officer of Vir Biotechnology. "We look forward to working with the FDA to rapidly advance the development of VIR-5500 for people living with mCRPC."

"People living with advanced prostate cancer need new treatment options that can offer meaningful and durable benefit," said Moitreyee Chatterjee-Kishore, Executive Vice President and Head of Oncology Development, Astellas. "This Fast Track designation reinforces the importance of advancing VIR-5500 with urgency, and we are committed to exploring its potential to make a meaningful difference for patients and their families."

FDA Fast Track designation is intended to facilitate and expedite the development and review of drugs to treat serious conditions and fill an unmet need.

VIR-5500 is being evaluated in a Phase 1 study across six dose-expansion cohorts. The monotherapy dose-expansion cohorts include patients with taxane naïve mCRPC, radioligand therapy naïve mCRPC and radioligand therapy exposed mCRPC. The combination regimen dose-expansion cohorts include VIR-5500 in combination with enzalutamide in early-line mCRPC, VIR-5500 in combination with docetaxel in early-line mCRPC and VIR-5500 in combination with darolutamide in metastatic hormone sensitive prostate cancer (mHSPC). Phase 1 data reported earlier this year showed VIR-5500 was generally well tolerated and exhibited promising anti-tumor activity in patients with mCRPC. Phase 3 trials are anticipated to begin in 2027.

About VIR-5500

T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. VIR-5500 is an investigational PRO-XTEN dual-masked TCE currently being evaluated in an open-label, non-randomized Phase 1 clinical trial (NCT05997615) designed to assess the safety, pharmacokinetics and preliminary efficacy in participants with metastatic castration-resistant prostate cancer (mCRPC).

VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN masking technology. The PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, enabling killing of cancer cells by T-cells. By confining the activity to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with unmasked TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing for less frequent dosing regimens.

About PRO-XTEN Dual-masked T-cell Engagers (TCEs)

T-cell engagers (TCEs) are powerful anti-tumor agents designed to direct the immune system, specifically T-cells, to destroy cancer cells. TCEs have become an important treatment option for blood cancers, but their usage in solid tumors has been limited due to toxicity. The universal PRO-XTEN masking technology is designed to extend the half-life of the molecule and to keep TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By extending the half-life and confining activity to the tumor microenvironment, the PRO-XTEN technology could limit toxicity, widen the therapeutic index of TCEs, and potentially enable less frequent dosing regimens.

About Advanced Prostate Cancer

Prostate cancer remains a significant global health burden, representing the second leading cause of cancer-related mortality in men behind lung cancer.1 While diagnostic and therapeutic advances like androgen-directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).2 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. The majority of these patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC).3 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.4 There is a critical need for safer, more effective and precisely targeted therapies capable of improving long term disease control and quality of life across the prostate cancer continuum.

(Press release, Vir Biotechnology, OCT 8, 2026, View Source [SID1234673294])

On October 8, 2026 Vir Biotechnology, Inc. (Nasdaq: VIR) reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN dual-masked T-cell engager (TCE), for the treatment of late-line metastatic castration-resistant prostate cancer (mCRPC). VIR-5500 is being co-developed by Astellas Pharma Inc. and Vir Biotechnology through a global strategic collaboration.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Receiving Fast Track designation reflects the potential of VIR-5500 to address an area of serious unmet need in late-line mCRPC and the strong momentum we have achieved with Astellas as we prepare to enter pivotal Phase 3 development in 2027," said Marianne De Backer, President and Chief Executive Officer of Vir Biotechnology. "We look forward to working with the FDA to rapidly advance the development of VIR-5500 for people living with mCRPC."

"People living with advanced prostate cancer need new treatment options that can offer meaningful and durable benefit," said Moitreyee Chatterjee-Kishore, Executive Vice President and Head of Oncology Development, Astellas. "This Fast Track designation reinforces the importance of advancing VIR-5500 with urgency, and we are committed to exploring its potential to make a meaningful difference for patients and their families."

FDA Fast Track designation is intended to facilitate and expedite the development and review of drugs to treat serious conditions and fill an unmet need.

VIR-5500 is being evaluated in a Phase 1 study across six dose-expansion cohorts. The monotherapy dose-expansion cohorts include patients with taxane naïve mCRPC, radioligand therapy naïve mCRPC and radioligand therapy exposed mCRPC. The combination regimen dose-expansion cohorts include VIR-5500 in combination with enzalutamide in early-line mCRPC, VIR-5500 in combination with docetaxel in early-line mCRPC and VIR-5500 in combination with darolutamide in metastatic hormone sensitive prostate cancer (mHSPC). Phase 1 data reported earlier this year showed VIR-5500 was generally well tolerated and exhibited promising anti-tumor activity in patients with mCRPC. Phase 3 trials are anticipated to begin in 2027.

About VIR-5500

T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. VIR-5500 is an investigational PRO-XTEN dual-masked TCE currently being evaluated in an open-label, non-randomized Phase 1 clinical trial (NCT05997615) designed to assess the safety, pharmacokinetics and preliminary efficacy in participants with metastatic castration-resistant prostate cancer (mCRPC).

VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN masking technology. The PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, enabling killing of cancer cells by T-cells. By confining the activity to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with unmasked TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing for less frequent dosing regimens.

About PRO-XTEN Dual-masked T-cell Engagers (TCEs)

T-cell engagers (TCEs) are powerful anti-tumor agents designed to direct the immune system, specifically T-cells, to destroy cancer cells. TCEs have become an important treatment option for blood cancers, but their usage in solid tumors has been limited due to toxicity. The universal PRO-XTEN masking technology is designed to extend the half-life of the molecule and to keep TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By extending the half-life and confining activity to the tumor microenvironment, the PRO-XTEN technology could limit toxicity, widen the therapeutic index of TCEs, and potentially enable less frequent dosing regimens.

About Advanced Prostate Cancer

Prostate cancer remains a significant global health burden, representing the second leading cause of cancer-related mortality in men behind lung cancer.1 While diagnostic and therapeutic advances like androgen-directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).2 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. The majority of these patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC).3 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.4 There is a critical need for safer, more effective and precisely targeted therapies capable of improving long term disease control and quality of life across the prostate cancer continuum.

(Press release, Vir Biotechnology, OCT 8, 2026, View Source [SID1234673294])