On April 22, 2026 Amplia Therapeutics limited (ASX:ATX | OTCQB:INNMF), ("Amplia" or the "Company") reported that an oral presentation highlighting mature data from the Company’s ACCENT trial in metastatic pancreatic cancer is being delivered today at the annual meeting of the AACR (Free AACR Whitepaper). The presentation includes more detailed analysis of the recently reported data from the ACCENT study, which is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapy.

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The presentation is included as part of a mini-symposium entitled Advances in Precision Oncology being held in the San Diego Convention Center, San Diego USA, and will be delivered by Amplia’s Director of Translational Biology, Dr Terrie-Anne Cock, at 3:44 pm local time. A copy of the slides is included with this announcement.

The key points from the presentation are:

Narmafotinib displays a manageable toxicity profile, with no significant tolerability burden over chemotherapy alone
Independent (central) reading of data identified 5 confirmed Complete Responses (CR’s) from 64 patients, an 8% CR rate compared to a 0.2% rate for chemotherapy alone
A response rate of 36% is observed (23 of 64 patients); 42% if unconfirmed responses included
A Disease Control Rate (DCR) of 70% was determined, compared to 50% for chemotherapy alone
Median overall survival (mOS) was found to be 11.1 months, while median progression-free survival (mPFS) was 7.7 months, both showing improvements of over two months compared to chemotherapy alone
A trend to improved Overall Survival is observed when comparing Stable Disease, Partial Response and Complete Response patients
The combined efficacy data is superior to chemotherapy alone across all measures despite the intermittent narmafotinib dosing schedule employed (12 days of each 28 day treatment cycle)
Subsequent trials will employ a daily dosing regimen of narmafotinib given the tolerability observed to date, which may lead to improved responses

Dr Chris Burns, CEO and Managing Director of Amplia, commented, "These extremely promising clinical responses demonstrate the potential narmafotinib has in the treatment of this terrible disease. We are now focused on building on this promising data with additional clinical studies, including a pivotal study based on the ACCENT trial, as well as combination studies with the exciting new class of drugs called kRAS inhibitors."

(Press release, Amplia Therapeutics, APR 22, 2026, View Source [SID1234664708])

On April 22, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported new preclinical data for BBO-11818, a selective, orally bioavailable non-covalent inhibitor that targets mutant KRAS in both the ON (active GTP-bound) and OFF (inactive GDP-bound) states with robust anti-tumor activity in KRAS-mutant preclinical models. The data underscore BBO-11818’s differentiated activity across multiple KRAS-mutant cancer types. The data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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"BBO-11818 addresses a significant unmet need by targeting multiple KRAS variants for which no approved therapies exist, including KRASG12D and KRASG12V," said Pedro J. Beltran, PhD, Chief Scientific Officer of BBOT. "Its ability to inhibit KRAS in both its inactive and active states drives potent tumor regressions in pancreatic, lung, and colorectal cancer models — and its efficacy is meaningfully amplified in combination with BBO-10203, cetuximab, and anti-PD-1, underscoring its potential as a combination backbone in KRAS-mutant cancers."

Highlights from the poster include:

BBO-11818 potently inhibits ERK phosphorylation and proliferation in KRAS-dependent cell lines in vitro.
BBO-11818 demonstrates robust efficacy in KRASG12D and KRASG12V CDX models.
BBO-11818 exhibits in vivo combination effect with BBO-10203, a RAS:PI3K⍺ breaker, and cetuximab in KRAS-mutant CDX and PDX models.
BBO-11818 also shows combination benefit with anti-PD-1 treatment, resulting in complete tumor regressions and the induction of an adaptive immune response in the CT26 syngeneic model.
The presentation is titled "BBO-11818: an orally bioavailable, highly potent and selective non-covalent pan-KRAS (ON) and (OFF) inhibitor with robust anti-tumor activity in KRAS-mutant preclinical models." A copy of the poster will be available on the "Publications" page of the BBOT website following the conference.

About BBO-11818
BBO-11818 is a selective, orally bioavailable non-covalent inhibitor that targets KRAS in both the ON and OFF states, has high selectivity over HRAS and NRAS, and displays strong activity in KRAS-mutant preclinical models, including KRASG12D and KRASG12V. In addition, it potently suppresses MAPK signaling and inhibits cell proliferation in KRAS-mutant cell lines. BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial in subjects with locally advanced unresectable or metastatic KRAS-mutant solid tumors.

(Press release, BridgeBio Oncology Therapeutics, APR 22, 2026, View Source [SID1234664707])

On April 22, 2026 Flatiron Health reported its presence at the ISPOR—The Professional Society for Health Economics and Outcomes Research Annual Meeting happening from May 17-20, 2026, in Philadelphia, Pennsylvania. Flatiron’s high-quality real-world data and innovative research capabilities are featured across 18+ research acceptances, including seven Flatiron authored research posters as well as a panel presentation "Beyond Black Boxes: Transparent, Validated LLM Workflows for Accelerating Global HTA Submissions and Decisions."

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Flatiron’s presence at ISPOR 2026 closely follows the publication of the Validation of Accuracy for LLM/ML-Extracted Information and Data (VALID) Framework in the Journal of Clinical Oncology Clinical Cancer Informatics.The framework represents the first and most comprehensive, peer-reviewed approach to evaluating the quality and reliability of real-world data extracted by large language models and machine learning—establishing new industry standards for data integrity in oncology research.

"The rapid advancements of large language models and AI-enabled tools have required an incredibly thoughtful approach to data validation and research methodologies," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "Flatiron’s presence at ISPOR reflects our commitment to advancing the field with high-fidelity, decision-ready real world evidence, reinforcing our position as the gold standard in oncology intelligence and a trusted partner for high-stakes clinical and research decisions."

Research highlights include:

Research assessing an LLM-approach that integrates PSA and imaging data to derive real-world progression events in prostate cancer with accuracy and completeness
A study building and evaluating four different digital-twin modeling approaches to predict survival in patients with advanced non-small cell lung cancer
An application of the newly published VALID framework to assess quality of an LLM-derived prostate cancer real-world dataset
A collaborative pilot project led by Friends of Cancer Research that demonstrated success of real-world data supported external-control arms depends on the quality of data, consistent methodology, and attentive planning.
Join Flatiron Health at booth #316 Follow Flatiron Health on X and LinkedIn for more updates from #ISPORAnnual.

Speaking Sessions

Beyond Black Boxes: Transparent, Validated LLM Workflows for Accelerating Global HTA Submissions and Decisions
Moderator: Beth Devine
Speakers: Bill Malcolm, Tim Reason, Lockwood Taylor
Speaking Session Date/Time: Wednesday, May 20, 10:00–11:00 AM ET

Abstracts and Poster Presentations

Assessing quality of a LLM-derived prostate cancer (PC) real-world dataset: an application of the validation of accuracy for LLM/ML-extracted information and data (VALID) framework
Patrick J. Ward, Yunzhi Qian, Eunice A. Hankinson, Aaron Dolor, Melissa Estevez
Poster Session: Poster Session 2
Poster Code: MSR65
Poster Session Date/Time: Monday, May 18, 4:00 PM – 7:00 PM

Real-world treatment patterns and outcomes in patients with =2 lines of therapy for recurrent or progressive endometrial cancer
Rachel Bhak, Neeraj N. Iyer, Audrey Hopkins, Murat M. Ikiisik, Edward Kavalerchik, Mala Talekar, Xinye Li, Nada Boualam, Prakirthi Yerram, Fernanda Musa
Author affiliations: Genmab, Providence-Swedish Cancer Institute, Flatiron Health
Poster Session: 2
Poster Code: HSD38
Poster Session Date/Time: Monday, May 18, 4:00 PM – 7:00 PM

Impact of telemedicine encounters on survival outcomes: A time-varying cox analysis using EHR-derived data
Deepika Paratane, Blythe Adamson, Antal T. Zemplenyi
Author affiliations: University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Flatiron Health
Poster Session: 3
Poster Code: HSD60
Poster Session Date/Time: Monday, May 18, 10:30 – 1:30 PM

Customization of a large language model approach to capture PSA and imaging derived real-world progression events in prostate cancer
Kelly Magee, Patrick Ward, PhD, Wanjing Chen, Eunice Hankinson, Aaron Dolor
Poster Session: Poster Session 4
Poster Code: RWD123
Poster Session Date/Time: Tuesday, May 19, 4:00 PM – 7:00 PM

Evaluating model performance for between-country survival transportability
Mohamed S. Ali, Harlan Pittell, Elsie Horne, Philani Mpofu, Qianyi Zhang, Blythe Adamson
Poster Session: Poster Session 4
Poster Code: MSR169
Poster Session Date/Time: Tuesday, May 19, 4:00 PM – 7:00 PM

From real-world data (RWD) to digital twins: Building models for patient-level counterfactual prediction in oncology
Sandra Griffith, Joe Manfredonia, Marcello Ricottone, Richard Knoche, Aaron B. Cohen, Jacqueline Law, Melissa Estevez
Poster Session: Poster Session 5
Poster Code: MSR219
Poster Session Date/Time: Wednesday, May 20, 9:00 AM – 11:30 AM

External control arm feasibility across external data sources in oncology: Methodological and regulatory considerations
Bernat Navarro, Kawther Abdilleh, Amy Alabaster, Peter Ansell, Li Chen, Gregory S. Calip, Ruthanna Davi, Janet Espirito, Laura L. Fernandes, Sebastian Zavala Hoffmann, Patricia Luhn, Xinran Ma, Patricia Prince, Mark Riffon, Xiang Yin, Mark Stewart, Hillary Andrews, Jeff Allen
Author Affiliations: Friends of Cancer Research, Pancreatic Cancer Action Network, ConcertAI, AbbVie, Amgen, Medidata, Ontada, COTA Healthcare, iOMEDICO, Genentech, Flatiron Health, Aetion/Datavant, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)
Poster Session: Poster Session 5
Poster Code: RWD154
Poster Session Date/Time: Wednesday, May 20, 9:00 AM – 11:30 AM

(Press release, Flatiron Health, APR 22, 2026, View Source [SID1234664706])

On April 22, 2026 Vyome Holdings, Inc. ("Vyome") (Nasdaq: HIND) reported its full Phase 2 investigator initiated study results and preclinical data supporting the efficacy and safety of VT-1953 as a potential treatment for symptoms of Malignant Fungating Wounds (MFW) at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, on April 21, 2026.

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MFWs are non-healing wounds that occur in ~10% of advanced cancer patients (~65K patients in the U.S. alone each year). Patients suffer symptoms such as severe ‘rotten meat’ malodor, pain, which negatively impacts quality of life. Patients feel ashamed of the malodor and socially withdraw. There are currently no FDA approved drugs to treat these symptoms of MFW.

Vyome is developing VT-1953 as a first in class treatment for symptoms of MFW. VT-1953 acts by dual mechanism of action, inhibiting DNA Gyr and modulating MD2/TLR interactions, an inflammatory signal. In the Ph2 study, advanced cancer patients with MFW who scored at a median 0.5 (corresponding to extreme malodor that is detected 6-10ft away with dressing on) at start of treatment with VT-1953 improved (P=0.0020) to a median score of 4 (mild odor detectable up close only after removing dressing) by Day 14 on a TELER scale of 0-5 scored by clinical investigator (Primary endpoint). MFW patients treated with the vehicle as a control arm showed no improvement in malodor (median score remained the same on Day 14 as Day 1; P=0.9999). VT-1953 treatment was significantly superior to the control arm (P = 0.0015).

On a secondary endpoint, where patients were asked to score the impact of malodor on their life, 70% of patients treated with VT-1953 reported an improvement to a score range of 3 to 5 by Day 14 from a baseline score of 0, as compared with 0% of patients in the vehicle-treated arm (P = 0.0256).

Patients were also asked to score the level of malodor on a 10-point visual analog scale, where 0 was no smell, while 10 was the worst smell. Treatment with VT-1953 gel treatment group improved the median score from 7.5 at the start of treatment to 2.5 by Day 14, a significant improvement (p=0.0020) from baseline. Patients treated with the vehicle reported an increase (worsening) in median malodor score from 6.0 at baseline to 7.0 by Day 14 (p=0.0625). Patients treated with VT-1953 also reported a clinically significant 2-point improvement in lesion pain by Day 14 (p= 0.0020) as scored using a 10-point VAS scale, while patients treated with vehicle reported no improvement from baseline score. Treatment did not change exudate levels. There were no treatment-associated adverse effects reported.

"These compelling Phase 2 results, where treatment with VT-1953 resulted in clinically meaningful improvements in malodor and pain symptoms associated with MFW and quality of life of patients, provide a strong rationale to advance VT-1953 into registrational studies. To be able to be close to loved ones rather than socially withdraw due to the shame of malodor can be meaningful to a cancer patient," said Dr. Shiladitya Sengupta, co-founder of Vyome and associate professor of medicine at Harvard Medical School.

"We are delighted with the Phase 2 data," said Venkat Nelabhotla, CEO of Vyome. "The highly statistically significant results, far exceeding the standard threshold of P<0.05, offer us a high degree of confidence as we design the registrational studies. It also means we need fewer patients to power the study. VT-1953 can be a transformative treatment for patients with MFW, who currently have no FDA-approved choices. Recent independent third-party analysis estimates the total addressable U.S. MFW market to be approximately USD 2.2 billion. We are pleased to have presented this data at the prestigious AACR (Free AACR Whitepaper) conference."

(Press release, Vyome Therapeutics, APR 22, 2026, View Source [SID1234664705])

On April 22, 2026 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage immunotherapy company developing first-in-class logic-gated therapies for solid tumors, reported the acceptance of three abstracts for presentation during the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) taking place May 29 – June 2, 2026, in Chicago.

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A2 Bio will present two posters from the ongoing phase 1/2 EVEREST-2 study: The first provides the safety and efficacy of A2B694, a logic-gated mesothelin (MSLN)-targeted Tmod chimeric antigen receptor T-cell (CAR T) therapy. The second is a trials-in-progress poster about A2B543, which uses the same logic-gated construct as A2B694 but also includes a membrane-tethered IL-12 booster. A third poster describes modules based on IL-12 and other molecules that boost potency and preserve selectivity of Tmod-based precision cell therapies. Titles of accepted abstracts are available online on the ASCO (Free ASCO Whitepaper) website.

Poster Presentation Details

Abstract Title

Presenting Author

Abstract Number

Poster Board Number

Poster Presentation Date/Time

Poster Session

Initial safety and efficacy of A2B694, a logic-gated mesothelin (MSLN)-targeted Tmod chimeric antigen receptor T-cell (CAR T) therapy in patients with advanced solid tumors with HLA-A*02 loss of heterozygosity (LOH)

Julian R. Molina, M.D., Ph.D.

Mayo Clinic

Rochester, Minn.

8579

369

Sunday, May 31, 2026

9:00 AM-12:00 PM CDT

Lung Cancer—Non-Small Cell Metastatic

A logic-gated chimeric antigen receptor T-cell (CAR T) therapy with an armored, membrane-tethered IL-12 booster in patients with advanced solid tumors with HLA-A*02 loss of heterozygosity (LOH): EVEREST-2, a Phase 1/2 study

Salman R. Punekar, M.D.

NYU Langone Health

New York

TPS2673

459a

Saturday, May 30, 2026

1:30 PM-4:30 PM CDT

Developmental Therapeutics— Immunotherapy

Influence of onboard, tethered IL-12 on potency of the Tmod NOT gate and selectivity

Jushen Liang

A2 Biotherapeutics,

Agoura Hills, Calif.

2562

352

Saturday, May 30, 2026

1:30 PM-4:30 PM CDT

Developmental Therapeutics— Immunotherapy

About EVEREST-2

The EVEREST-2 master protocol (NCT06051695) is a seamless Phase 1/2 study evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2), autologous logic-gated investigational cell therapies developed from the A2 Bio proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets MSLN and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. A2B543 contains the same Tmod construct as A2B694 with an added mem-IL-12 booster. The EVEREST-2 study is recruiting patients with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression.

About the Tmod Platform

Invented at A2 Bio, the Tmod platform is a precision-targeting cellular system, designed with logic-gate technology to enable immune cells to unequivocally differentiate tumors from normal tissues. The system consists of activator and blocker receptors. The activator recognizes antigens on tumor cells and triggers their destruction, while the blocker recognizes antigens on normal cells and protects them. This novel blocker technology enables precise, personalized, and effective T-cell targeting specifically against tumors.

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com.

(Press release, A2 Biotherapeutics, APR 22, 2026, View Source [SID1234664704])