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

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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 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that Guardant360 CDx has received CE-marking under Europe’s in Vitro Diagnostic Medical Devices Regulation as a companion diagnostic (CDx) to identify patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer who may benefit from treatment with ETCAMAH (camizestrant), AstraZeneca’s next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. Approval in Europe reinforces Guardant Health’s commitment to enabling practice-changing ongoing monitoring across the world’s largest healthcare markets.

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With Guardant 360 CDx, clinicians can test for ESR1 mutations in tumors through a simple blood draw, ahead of disease progression. This approach reinforces the transformative role of liquid biopsy in guiding therapy decisions earlier in a breast cancer patient’s journey. The European approval follows prior regulatory approvals of Guardant360 CDx as a companion diagnostic for ETCAMAH in the United States and Japan.

"Guardant360 CDx offers molecular insights that can support informed treatment decisions for patients with advanced breast cancer, addressing the disease before it gets out of control," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "What is even more exciting is that we see tremendous potential for this type of testing protocol to transform the treatment of other cancer types to change the future of oncology."

This approval marks a significant milestone for the company, representing the third CDx approval for ETCAMAH and the 31st CDx approval for Guardant Health. The company continues to expand the platform’s reach and increasing clinical utility.

About Guardant360 CDx

Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer.

(Press release, Guardant Health, OCT 8, 2026, View Source [SID1234673293])

On October 8, 2026 SOPHiA GENETICS (NASDAQ: SOPH) and Myriad Genetics, Inc., (NASDAQ: MYGN) reported a collaboration to advance new prostate cancer-specific genomic instability score (PrGIS) technology to support precision oncology approaches with AstraZeneca (LSE/STO/NYSE: AZN). PrGIS is a novel biomarker signature designed to assess chromosomal instability associated with homologous recombination deficiency (HRD) in prostate cancer patients. The collaboration aims to advance PrGIS in clinical trials and expand access to precision oncology medicines through potential companion diagnostic solutions.

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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

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Myriad developed PrGIS to support HRD as an actionable biomarker in prostate cancer, where HRD is emerging as an important prognostic and predictive biomarker. The proprietary MyChoice CDx test which is currently available as a companion diagnostic in ovarian cancer, will produce the PrGIS score and is being advanced for prostate cancer as a new indication.

"This collaboration showcases Myriad’s biopharma capabilities to support development of precision oncology treatments," said Lou Welebob, Senior Vice President, Companion Diagnostics, Myriad Genetics. "PrGIS is designed to provide biopharma partners with a platform that may support patient stratification in clinical trials and help accelerate companion diagnostic development for precision oncology therapies."

As part of the collaboration, SOPHiA GENETICS is developing its solid tumor application for Extended Homologous Recombination Solution into a decentralized companion diagnostic solution. The solution will incorporate Myriad’s PrGIS technology and aim to expand patient access to PrGIS in global markets. SOPHiA GENETICS’ technology-agnostic, cloud-based platform offers local laboratory testing across a global network of more than 1,000 connected institutions in over 75 countries.

"Precision medicine has a geographic problem because breakthrough therapies developed in major markets often remain inaccessible to patients in the rest of the world," said Jess Lambe, VP & Managing Director of BioPharma Business Development, SOPHiA GENETICS. "By pairing Myriad’s world-class biomarker innovation with SOPHiA GENETICS’ global network, we are working toward a solution for this. Together, we’re building a new model for companion diagnostic deployment that could help innovative therapies reach the right patients locally, expanding access to care where it matters the most."

Upcoming ESMO (Free ESMO Whitepaper) data to highlight PrGIS as a novel biomarker in prostate cancer
Myriad also plans to present PrGIS research, co-authored with AstraZeneca, at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026. The research is expected to further characterize the biomarker and support its validation. Full data will be available following the ESMO (Free ESMO Whitepaper) embargo period.

(Press release, Myriad Genetics, OCT 8, 2026, View Source [SID1234673291])