On April 29, 2026 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported the development and peer-reviewed validation of a new predictive signature to inform therapy selection in glioblastoma (GBM) patients. The study, published in Neuro-Oncology Advances, describes the development and evaluation of the model in a cohort of more than 5,800 GBM patients. The Caris AI Insights in Glioblastoma is featured on the Caris Molecular Tumor Board Report, an innovative profiling report that provides additional insight into tumor biology and is available upon request with no additional tissue required when ordering MI Cancer Seek.

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Caris Life Sciences continues to advance precision oncology by integrating multimodal real-world datasets, available with its proprietary CodeAI platform, enabling the creation of Caris AI Insights, an engine that utilizes Whole Exome Sequencing (WES), Whole Transcriptome Sequencing (WTS), and clinical data to generate deeper biological understanding and more actionable insights for clinicians and researchers.

GBM is the most common and aggressive brain cancer, with patients typically surviving around 12 months despite treatment. Current treatments include surgery to remove the tumor, radiation and chemotherapy with temozolomide (TMZ). Unfortunately, nearly half of GBM patients do not respond to TMZ and many develop resistance that leads to recurrence. Determining whether TMZ will benefit the patient is a critical step in treatment and provides insight for developing new therapies for patients who do not respond favorably.

The novel signature, developed by Caris using multimodal molecular and clinical data, is an AI-derived model designed to infer O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status from NGS data. MGMT promoter methylation is an established biomarker associated with response to TMZ therapy in GBM patients that is commonly assessed using pyrosequencing. In the peer-reviewed validation study, the signature demonstrated high concordance with pyrosequencing-based MGMT assessment and improved discrimination of overall survival outcomes across MGMT-defined patient subgroups, while also addressing variability in MGMT classification associated with traditional testing methods. These findings show that Caris’ proprietary AI signature can complement existing testing approaches and provide additional clinical insight for isocitrate dehydrogenase (IDH)-wild type GBM patients treated with TMZ.

"The Caris AI Insights signature for GBM showcases Caris’ advanced AI capabilities in our pursuit of improving cancer patient outcomes," said Caris President David Spetzler, MS, PhD, MBA. "With peer-reviewed validation demonstrating strong concordance with traditional testing approaches and clearer prognostic stratification, we believe that this signature can complement existing testing methods to improve clinical insight for glioblastoma patients treated with TMZ."

The model was trained to predict MGMT promoter methylation status, as measured by a pyrosequencing assay, using tumor profiling data from the MI Cancer Seek NGS assay, which also has FDA-approved CDx indications. As reported in the study, the signature was developed using a clinico-genomic dataset of 5,841 patients and further evaluated in a prospective cohort of more than 3,400 cases. The model stratified patients into distinct survival groups based on the signature score, with higher scores associated with significantly longer overall survival in TMZ-treated patients.

(Press release, Caris Life Sciences, APR 29, 2026, View Source [SID1234664912])

On April 29, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Mexican Institute of Industrial Property (IMPI) has issued Patent Number 432748, covering key aspects of the Company’s breast cancer vaccine technology.

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"This newly issued patent continues the broad international recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue clinical development in the U.S., our growing international patent estate further strengthens our ability to pursue global opportunities and potentially partner with larger pharmaceutical companies for worldwide commercialization."

Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, represents a novel approach to the prevention and treatment of breast cancer. Anixa’s vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein vaccine strategy aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue. The vaccine was invented at Cleveland Clinic, and this patent—along with others related to this technology—has been exclusively licensed to Anixa Biosciences. Positive Phase 1 results showed that the vaccine met all primary endpoints, was safe and well tolerated at the maximum tolerated dose, and elicited protocol-defined immune responses in 74% of participants across all doses tested. Based on these findings, Anixa is moving forward with preparations for a Phase 2 clinical trial.

This patent issuance builds upon the Company’s broad and expanding intellectual property portfolio, extending foundational patent protection for the breast cancer vaccine program into the 2040s in multiple jurisdictions throughout the world. By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies.

(Press release, Anixa Biosciences, APR 29, 2026, https://www.prnewswire.com/news-releases/anixa-biosciences-announces-issuance-of-mexican-patent-covering-breast-cancer-vaccine-technology-302756543.html [SID1234664911])

On April 29, 2026 Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) reported the European Commission (EC) has granted marketing authorization for POHERDY (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to PERJETA (pertuzumab) in Europe, for all indications of the reference product.1

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"As the first, and currently the only, pertuzumab biosimilar in Europe, the EC’s approval of POHERDY marks an important milestone in expanding access to treatments for patients with certain HER2-positive breast cancers, particularly as breast cancer is the most commonly diagnosed cancer among women in the European Union," said Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, at Organon.2,3 "Organon’s growing global portfolio of biosimilars reinforces our ongoing commitment to supporting the sustainability of health care systems while advancing women’s health through access to quality medicines."3,4

"Building on POHERDY’s FDA approval in the United States as the country’s first pertuzumab biosimilar, this EU approval further expands our growing portfolio of approved biosimilar medicines in markets around the world and is a testament to our strong collaboration with Organon," said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. "Guided by our commitment to scientific excellence and product quality, we are working to expand access to additional treatment options for the benefit of patients and the health care system."

In Europe, POHERDY is indicated in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for metastatic disease. POHERDY is also indicated for use in combination with trastuzumab and chemotherapy as (i) neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence and (ii) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.

POHERDY was approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and comparative clinical studies demonstrating that POHERDY is a biological medicine highly similar to the reference product based on a totality of evidence, including analytical, pharmacokinetic, efficacy, safety, and immunogenicity data (the intrinsic ability of proteins and other biological medicines to cause an immune response).5

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including POHERDY. The agreement covers exclusive global commercialization rights except for China.6

About POHERDY (pertuzumab) in the E.U.

Early breast cancer

Poherdy is indicated for use in combination with trastuzumab and chemotherapy in:

the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)
Metastatic breast cancer

Poherdy is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

For more information please visit: Poherdy | European Medicines Agency (EMA)

(Press release, Shanghai Henlius Biotech, APR 29, 2026, View Source [SID1234664910])

On April 29, 2026 Pinetree Therapeutics, Inc. ("Pinetree"), a biotechnology company pioneering next-generation targeted protein degradation approaches for cancer and other serious diseases, reported that AstraZeneca (LSE/STO/NYSE: AZN) has exercised its option under the companies’ previously announced agreement to obtain an exclusive global license to develop and commercialize PTX-299, a first-in-class bispecific antibody degrader targeting EGFR.

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The option exercise follows encouraging preclinical progress and represents an important milestone in the collaboration between the two companies. Under the terms of the agreement, AstraZeneca will assume responsibility for global development and commercialization of the therapeutic candidate.

"This milestone marks an important validation of our AbReptor platform," said Hojuhn Song, Ph.D., Founder and CEO of Pinetree Therapeutics. "We are pleased that AstraZeneca has exercised its option to advance PTX-299, and we look forward to seeing them continue the development of this promising therapeutic candidate. By combining Pinetree’s breakthrough protein degradation platform with AstraZeneca’s global expertise in cancer drug development, we believe that PTX-299 has the potential to bring a meaningful new treatment option to patients with EGFR-driven cancers."

EGFR plays a critical role in the growth and survival of cells in multiple tumor types. While EGFR-targeted therapies have transformed patient outcomes, resistance can develop, highlighting the need for new therapeutic strategies. By leveraging Pinetree’s antibody-based protein degradation technology, PTX-299 is designed to selectively eliminate disease-driving EGFR proteins rather than simply inhibiting their activity, potentially overcoming key resistance mechanisms.

The therapeutic candidate was developed using AbReptor, Pinetree’s proprietary multispecific antibody-based targeted protein degradation platform. In contrast to conventional monoclonal antibodies that rely on functional inhibition, AbReptor drives the active removal of disease-associated proteins through targeted degradation. By enabling the elimination of membrane-bound and extracellular targets, this platform extends beyond the limitations of traditional inhibition-based antibody therapies.

Under the terms of the agreement, AstraZeneca’s exercise of the option triggers a $25 million option closing payment to Pinetree. Pinetree is also eligible to receive potential future development, regulatory, and commercial milestone payments and tiered royalties on global net sales if the product is successfully developed and commercialized. The total potential value of the agreement exceeds $500 million.

(Press release, PineTree Therapeutics, APR 29, 2026, View Source [SID1234664909])

On April 29, 2026 D3 Bio Inc., a global clinical-stage biotechnology company dedicated to developing innovative oncology therapeutics, reported new phase 2 clinical data from its lead asset elisrasib (D3S-001), a next-generation KRAS G12C inhibitor, alongside additional clinical and preclinical results from its KRAS-focused pipeline. The phase 2 studies demonstrate that elisrasib delivers broad antitumor activity across multiple KRAS G12C-mutant solid tumors, including NSCLC, CRC, and PDAC.

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Phase 2 data for elisrasib were shared as oral presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 during both the Clinical Plenary Session (Abstract CT020) and the Clinical Trials Mini-Symposium (Abstract CT303) in San Diego, CA.

Extensive and Durable Clinical Activity Observed Across Indications

In 2L+ KRAS G12Ci-naïve NSCLC (n=68), elisrasib demonstrated robust efficacy at the RP2D (600 mg QD) with an ORR of 58.8%, median duration of response (mDoR) of 16.5 months, and mPFS of 12.2 months. Among late-line NSCLC patients refractory to prior KRAS G12C inhibitor therapy (n=31), an ORR of 32.3%, mDoR of 15.6 months, and mPFS of 8.1 months were recorded. In previously treated CRC, elisrasib showed significant efficacy as both monotherapy (n=32, ORR 46.9%, mDoR 13.1 months, and mPFS 9.5 months) and in combination with cetuximab (n=29, ORR 62.1%, mDoR 7.0 months, and mPFS 8.2 months). Further studies are planned to evaluate optimized combination strategies to enhance the durability of response in CRC. For late-line PDAC, monotherapy (n=20) achieved an ORR of 65.0%, mDoR of 10.8 months, and mPFS of 13.5 months.

Favorable Safety Profile

Elisrasib was well-tolerated across NSCLC, CRC, and PDAC populations. Grade 3 or higher treatment-related adverse events (TRAEs) ranged between 8.7% and 15.6% across these indications. Combination therapy with cetuximab was associated with a higher incidence of Grade 3 TRAEs, which were manageable and largely attributed to cetuximab. Only one transient, asymptomatic Grade 4 hypokalemia event was reported, with no other Grade 4 or 5 TRAEs observed.

Expert Commentary

"Elisrasib demonstrates the ability to provide deeper, longer-lasting tumor responses, even in cases where first-generation KRAS G12C inhibitors failed. Overall, these findings indicate that elisrasib may significantly improve treatment for lung cancer patients with KRAS G12C mutations," stated Professor Byoung Chul Cho, MD, PhD, Yonsei Cancer Center, Yonsei University College of Medicine, Korea, and lead study investigator. "Among patients whose disease progressed on first-generation inhibitors, we found five cases of KRAS gene amplification, an important mechanism of evasion of KRAS G12C inhibitor efficacy. Out of those five KRAS amplification cases, four experienced tumor shrinkage, three showed a clinical response, and the disease control rate was 100%, indicating elisrasib’s effectiveness in this biomarker-defined group."

Additional D3 Bio Presentations at AACR (Free AACR Whitepaper) 2026

D3 Bio also presented advancements in its KRAS program, notably:

First-in-human phase 1 investigation of D3S-002, a selective ERK1/2 inhibitor, in advanced solid tumors with MAPK pathway mutations — Poster (Abstract CT060)
Clinical pharmacokinetic modeling of D3S-003, an oral dual-state KRAS G12D inhibitor — Poster (Abstract 1831)
D3S-003: An allele-specific, orally available KRAS G12D (OFF/ON) inhibitor with best-in-class potential — Poster (Abstract 4569)
"We are encouraged by the consistent and robust clinical activity exhibited by elisrasib across various KRAS G12C–mutant tumors, reinforcing the strength and momentum of D3 Bio’s expanding KRAS pipeline," commented Dr. George Chen, Founder, Chairman and Chief Executive Officer of D3 Bio. "These data suggest elisrasib may become a foundational therapy for KRAS G12C mutant cancers."

About Elisrasib (D3S-001)

Elisrasib is a next-generation KRAS G12C inhibitor designed for rapid, complete, and selective target engagement. It covalently binds the GDP-bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, complete KRAS G12C engagement at clinically relevant exposures, and CNS penetration capability. Elisrasib is currently being evaluated globally in a Phase 2 monotherapy and combination trial across KRAS G12C–mutant solid tumors including NSCLC, CRC, and others.

Key Publications:

Cancer Discovery

Nature Medicine (2025) 31(8):2768–2777

About D3S-002

D3S‑002 is a selective ERK1/2 inhibitor purposely designed for combination approaches, providing vertical MAPK‑pathway inhibition to enhance efficacy and overcome acquired resistance, particularly in tumors previously treated with KRAS G12C inhibitors.

Key Publication:

Cancer Res 1 April 2023; 83 (7_Supplement): 5501.

About D3S-003

D3S‑003 is a differentiated KRAS G12D inhibitor targeting both active (ON) and inactive (OFF) conformations, addressing one of the most common KRAS mutations. This program expands D3 Bio’s multi-allele KRAS portfolio, aiming to provide innovative therapies for diverse KRAS-driven malignancies.

(Press release, D3 Bio, APR 29, 2026, View Source [SID1234664908])