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Anixa Biosciences Announces Presentation of its Ovarian Cancer CAR-T Therapy Clinical Trial at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer

On March 30, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that Dr. Robert Wenham, Chair of the Gynecologic Oncology Department at Moffitt Cancer Center and principal investigator for the Company’s ongoing ovarian cancer CAR-T therapy Phase 1 trial, will be presenting at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, being held April 10 – 13, 2026, in San Juan, Puerto Rico.

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Dr. Wenham’s presentation, titled "Phase 1 clinical trial of autologous T cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor (FSHR) in recurrent ovarian cancer," will discuss the clinical trial design and objectives, as well as the current status of Anixa’s ongoing Phase 1 clinical trial of lira-cel.

The SGO Annual Meeting on Women’s Cancer stands as the foremost educational and scientific gathering for professionals dedicated to the treatment and care of individuals with gynecologic cancer, bringing together global experts in gynecologic oncology to share the latest scientific advancements, participate in educational programs, and network with peers.

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells, but not in healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.

(Press release, Anixa Biosciences, MAR 30, 2026, View Source [SID1234664016])

Insilico Medicine Announces Global R&D Collaboration with Lilly

On March 29, 2026 Insilico Medicine ("Insilico", HKEX: 3696), a clinical-stage biotechnology company powered by generative artificial intelligence (AI) and automation, reported a drug discovery collaboration with Eli Lilly and Company ("Lilly") that uses Insilico’s AI engine to accelerate the discovery and development of novel therapeutics across multiple therapeutic areas.

The agreement grants Lilly an exclusive worldwide license for the development, manufacturing, and commercialization of potentially best-in-class, novel oral therapeutics in preclinical development for certain indications. In addition, Insilico and Lilly will collaborate on multiple R&D programs focused on targets selected by Lilly, by combining Insilico’s state-of-the-art Pharma.AI platforms with Lilly’s development capabilities and deep disease-area expertise.

"From its inception, Insilico Medicine has been developing deep learning for end-to-end drug discovery. By deploying frontier AI technologies that scale from biomarkers to life models, world models of human and animal life, we can identify multi-purpose targets driving multiple diseases at the same time," said Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine. "Working with Lilly, we aim to deliver transformative therapies that treat diseases with high unmet need. This collaboration is a testament to the power of AI in tackling the most complex challenges in human health."

Under the terms of the agreement, Insilico is eligible to receive an $115 million upfront payment, followed by development, regulatory, and commercial milestones that could bring the total deal value to approximately $2.75 billion, plus tiered royalties on future sales.

"Insilico’s AI-enabled discovery capabilities represent a powerful complement to Lilly’s deep expertise in clinical development across multiple therapeutic areas," said Andrew Adams, Group Vice President of Molecule Discovery at Lilly. "This collaboration allows us to explore novel mechanisms and accelerate the identification of promising therapeutic candidates across multiple disease areas."

(Press release, Insilico Medicine, MAR 29, 2026, View Source [SID1234664001])

ENHERTU® Followed by THP Approved in China as the First and Only HER2 Directed ADC for the Neoadjuvant Treatment of HER2 Positive Breast Cancer

On March 27, 2026 Daiichi Sankyo reported ENHERTU (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) has been approved in China for the neoadjuvant treatment (before surgery) of adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) stage 2 (high risk) or stage 3 breast cancer. This indication was granted conditional approval based on the DESTINYBreast11 phase 3 trial, which showed an improvement in pathologic complete response (pCR) rate. Full approval will depend on whether ongoing adjuvant studies confirm long-term clinical benefit in patients with early or locally advanced breast cancer.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN).

Breast cancer is the second most common cancer in women in China, with approximately 357,000 cases of breast cancer diagnosed and nearly 75,000 deaths in 2022. 1 Approximately one in five cases of breast cancer is considered HER2 positive, a breast cancer subtype which is often associated with aggressive disease and poor prognosis. 2,3 For patients with HER2 positive early breast cancer, reaching a pCR with neoadjuvant treatment is the earliest indicator of improved long-term survival.4 However, approximately half of patients who receive neoadjuvant treatment do not reach pCR, putting them at increased risk of disease recurrence.

The conditional approval of ENHERTU by China’s National Medical Products Administration (NMPA) is based on results from the DESTINY-Breast11 phase 3 trial presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and simultaneously published in the Annals of Oncology.

In DESTINY-Breast11, ENHERTU followed by THP demonstrated a statistically significant and clinically meaningful improvement in pCR rate compared to dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) in patients with high-risk HER2 positive early-stage breast cancer. The pCR rate with ENHERTU followed by THP was 67.29% compared to 56.25% with ddAC-THP, representing an improvement of 11.17% (95% confidence interval [CI]: 3.95-18.28; p=0.003). Similar improvement in pCR rate was observed across most prespecified subgroups, including hormone receptor positive and negative patients. At the time of the analysis, the secondary endpoint of event-free survival (EFS) was not mature (4.5% maturity at data cut-off). However, an early analysis showed a trend favoring ENHERTU followed by THP versus ddAC-THP (hazard ratio [HR]=0.56; 95% CI: 0.26-1.17). Efficacy results were consistent in the China subgroup.

"In patients with high-risk HER2 positive early-stage breast cancer, effective neoadjuvant treatment is critical to lower the risk of disease recurrence and maximize the chance of cure while potentially enabling less intensive surgery," said Professor Jiong Wu, Secretary of the Party Committee of Fudan University Shanghai Cancer Center and China leading primary investigator of the DESTINY-Breast11 trial. "Findings from DESTINY-Breast11 showed that approximately 67% of patients had a pathologic complete response with ENHERTU followed by THP, suggesting a potential new standard of care in this setting."

"As the first approval of ENHERTU globally for the neoadjuvant treatment of HER2 positive early-stage breast cancer and the first HER2 directed antibody drug conjugate approved in China in this setting, ENHERTU followed by THP offers patients in China a new treatment option with the opportunity to reach a pathologic complete response and the potential for improved long-term outcomes," said Michio Hayashi, China President, Daiichi Sankyo. "This third approval of ENHERTU in the last three months and seventh approval in three years reinforces the rapid progress we are making in bringing ENHERTU to more patients in China, where there is a high incidence of breast cancer and a continued need for new treatment approaches."

"ENHERTU followed by THP is the first treatment regimen in more than a decade to demonstrate a clinically meaningful improvement in pathologic complete response and safety in the neoadjuvant setting for patients with HER2 positive early-stage breast cancer, underscoring the significance of this new approval," said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. "ENHERTU is already an important option in the metastatic setting, and this decision will bring it into earlystage disease where cure is possible."

The safety profile of ENHERTU followed by THP in DESTINY-Breast11 was consistent with the known profiles of each individual therapy with no new safety concerns identified. The most common grade 3 or 4 adverse reactions in patients that received at least one dose of ENHERTU 5.4 mg/kg followed by THP in DESTINY-Breast11 (N=320) were neutropenia (13.8%), diarrhea (5.9%), increased transaminases (5.0%), leukopenia (4.4%), nausea (1.9%), peripheral neuropathy (1.9%) and anemia (1.6%). Grade 5 adverse reactions occurred in 0.3% of patients, including interstitial lung disease (ILD; 0.3%). The most frequent adverse reactions associated with permanent discontinuation were peripheral neuropathy (2.2%), ILD (1.9%) and increased transaminases (1.3%).

An application for ENHERTU followed by a taxane, trastuzumab and pertuzumab (THP) also is under review in the U.S. for the neoadjuvant treatment of patients with HER2 positive early-stage breast cancer based on the results from the DESTINY-Breast11 trial.

About DESTINY-Breast11
DESTINY-Breast11 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of neoadjuvant ENHERTU (5.4 mg/kg) monotherapy or ENHERTU followed by THP compared to ddAC-THP in patients with high-risk HER2 positive early-stage breast cancer.

Patients were randomized 1:1:1 to receive either eight cycles of ENHERTU monotherapy; four cycles of ENHERTU followed by four cycles of THP; or four cycles of ddAC followed by four cycles of THP.

The primary endpoint of DESTINY-Breast11 is rate of pCR (absence of invasive disease in the breast and lymph nodes). Secondary endpoints include EFS, invasive disease-free survival, overall survival and safety.

DESTINY-Breast11 enrolled 927 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

About Neoadjuvant HER2 Positive Early Breast Cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 10 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.10 In China, breast cancer is the second most common cancer in women.1 Approximately 357,000 cases of breast cancer were diagnosed in China in 2022, with nearly 75,000 deaths.1

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.3 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer. 3 Approximately one in five cases of breast cancer is considered HER2 positive.2

Approximately one in three patients with HER2 positive early-stage breast cancer is considered high-risk, meaning they are more likely to experience disease recurrence and have a poor prognosis.11 For patients with HER2 positive early breast cancer, reaching pCR with neoadjuvant treatment is the earliest indicator of improved long-term survival.4 However, approximately half of patients who receive neoadjuvant treatment do not reach pCR, putting them at increased risk of disease recurrence.

The current standard of care in the HER2 positive neoadjuvant setting in China consists of a combination regimen of carboplatin, trastuzumab, pertuzumab and a taxane.

(Press release, Daiichi Sankyo, MAR 27, 2026, View Source(5.4%20mg/kg)%20followed%20by%20THP%20is,HER2%20positive%20(IHC%203+%20or%20ISH+)%20stage [SID1234665018])

Agni Bio Selected to Present AGB101 (Vβ17 x DLL3) Poster at AACR Annual Meeting 2026

On March 27, 2026 Agni Bio, Inc., a biotechnology company developing next-generation immunotherapies, reported that it has been selected to present a poster highlighting its AGB101 (Vβ17 x DLL3) program at the AACR (Free AACR Whitepaper) Annual Meeting 2026 in the Late Breaking Poster Session, taking place April 17–22, 2026 in San Diego and hosted by the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

The poster will feature preclinical data for AGB101, a first-in-class Vβ17 x DLL3 bispecific antibody designed to selectively redirect a defined subset of cytotoxic memory T cells to tumors. Agni Bio plans to initiate a Phase 1 clinical trial of AGB101 in the second half of 2026.

Key Highlights from the Poster Presentation:

Novel mechanism of action: AGB101 selectively engages Vβ17 T cell receptor (TCR)–expressing T cells, a memory T cell subset with enhanced cytotoxicity, persistence, and resistance to exhaustion.
Targeted tumor approach: The molecule targets DLL3, a solid tumor lineage antigen highly expressed in small cell lung cancer (SCLC) and other neuroendocrine tumors.
Selective immune activation: Unlike CD3-directed bispecific antibodies which non-selectively redirects the majority of T cells, AGB101 selectively redirects and expands Vβ17 cells to drive DLL3-dependent cytotoxicity.
Reduced cytokine release profile: Preclinical studies with AGB101 demonstrate lower levels of release of pro-inflammatory cytokines (including TNF-α, IL-4, and IL-1β) while maintaining cytotoxic effector function (Granzyme B), suggesting the potential for an improved safety profile relative to CD3-based approaches.
Robust anti-tumor activity: AGB101 achieved potent and durable cytotoxicity in vitro and demonstrated complete tumor regressions in multiple DLL3-positive in vivo models.
Durable and memory-driven responses: Data show selective expansion (up to 10–15-fold) of Vβ17 T cells with a strong CD8+ bias and enhanced anti-tumor activity upon tumor rechallenge.
"AGB101 represents a fundamentally new approach to T cell redirection by selectively harnessing a highly functional subset of memory T cells," said Matt Lorenzi, PhD, Chief Scientific Officer and Board Member of Agni Bio. "We believe this strategy has the potential to overcome key limitations of first-generation T cell engagers, including toxicity and limited durability, and we are excited to advance this program into the clinic later this year."

AGB101 is part of Agni Bio’s Vβ17 platform of TCR-directed bispecific antibodies designed to improve the precision and effectiveness of immune engagement in cancer and autoimmune therapies.

(Press release, Agni Bio, MAR 27, 2026, View Source [SID1234664176])

OnKure Therapeutics Announces Oversubscribed $150 Million Private Placement to Advance Next-Generation PI3Kα Pan-Mutant Selective Inhibitor Candidates in Breast Cancer and Vascular Anomalies

On March 27, 2026 OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, reported that it has entered into a securities purchase agreement for a private placement with certain institutional and accredited healthcare investors, raising gross proceeds of approximately $150 million.

OnKure intends to use the net proceeds from the private placement to fund the preclinical and clinical development of its next-generation PI3Kα pan-mutant-selective inhibitor candidates in breast cancer and vascular anomalies, as well as for working capital and general corporate purposes. The private placement is being led by new investor, Access Biotechnology, with participation from other new and existing investors, including BVF Partners LP, RA Capital Management, Trails Edge Capital Partners, Coastlands Capital, StepStone Master G, L.P., Vivo Capital, ADAR1 Capital Management, Foresite Capital, Adage Capital Partners LP, Vestal Point Capital, Acorn Bioventures, Logos Capital and Prosight Capital.

"This transformational financing enables us to advance the development strategy for our next‑generation PI3Kα pan‑mutant selective inhibitor candidates, which represent a defining phase of our mutation‑selective strategy. We appreciate the significant commitment by the participating specialist biotech investors who believe in the potential of our PI3Ka pan-mutant portfolio," said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. "We believe the clinical experience generated from the PIKture‑01 trial provided important validation of our approach to selectively targeting PI3Kα while avoiding class‑limiting toxicities predictably seen by insufficiently selective inhibitors. These insights directly informed the design of our pan‑mutant programs, defining the high bar attributes of our molecules. With the additional capital raised through this private placement, we are focused on leveraging our chemistry platform and clinical insights into PI3Kα signaling into differentiated, next-generation candidates for breast cancer and vascular anomalies, with the goal of delivering medicines that offer meaningful improvements in efficacy and tolerability for patients."

Next-Generation PI3Kα Pan-Mutant Programs

The portfolio includes two next-generation PI3Kα pan-mutant programs, OKI-345 in breast cancer and OKI-355 in vascular anomalies. These candidates are designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses, both as monotherapy and in combination regimens. The pan-mutant candidates are designed to have minimal drug-drug interaction potential, supporting broad combinability with current standards of care. Together with a commanding intellectual property estate, OnKure believes it is well positioned to address a significant unmet need across various PI3Kα-driven indications.

PI3Kα mutations represent the most common driver alterations in key subtypes of vascular anomalies, where PIK3CA variants lead to dysregulated signaling that promotes abnormal cell growth, proliferation, and survival. OnKure believes that OKI-355 has significant potential to address this large and underserved patient population as a differentiated systemic chronic therapy.

OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for each of OKI‑345 and OKI‑355 in the first half of 2027.

PIKture‑01 Trial and OKI-219 Update

The PIKture-01 trial is a global, multi-center, dose-escalation, first-in-human phase 1a/1b study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of OKI-219 as monotherapy and in combination with other anti-cancer drugs for the treatment of HR+ and HER2+ advanced breast cancer. As of March 26, 2026, the PIKture-01 trial has completed enrollment in single-agent OKI-219 dose escalation (n=38) and OKI-219 + fulvestrant dose escalation (n=33). Phase 2 dose evaluation in the OKI-219 + tucatinib and trastuzumab triplet and the OKI-219 + ribociclib and fulvestrant triplets will be completed in 2026. Given the progress of the Company’s PI3Kα pan-mutant inhibitors, OnKure is not planning to pursue further clinical development of OKI-219 independently at this time. Mature data from PIKture-01 will be presented by the end of the year.

Additional information about PIKture-01 may be found at www.ClinicalTrials.gov, using Identifier: NCT06239467.

Private Placement and Appointment of Liam Ratcliffe to Board of Directors

Pursuant to the terms of the securities purchase agreement, OnKure has agreed to sell an aggregate of 26,713,636 shares of its Class A common stock ("Common Stock") at a purchase price of $4.15 per share and, in lieu of Common Stock, pre-funded warrants to purchase 9,430,959 shares of Common Stock at a purchase price of $4.1499 per pre-funded warrant. The pre-funded warrants have an exercise price of $0.0001 per share and will be immediately exercisable. The private placement is expected to close on March 31, 2026, subject to satisfactory closing conditions. With the net proceeds from the private placement, OnKure expects to extend its cash runway into 2029.

In conjunction with the financing, Liam Ratcliffe, M.D., Ph.D., Head of Biotechnology, Access Biotechnology will join OnKure’s Board of Directors. Andrew Phillips, Ph.D., OnKure’s Chairman of the Board of Directors, commented, "we are grateful for the commitment of our new and existing investors to the growth of OnKure. We are very pleased to welcome Liam to our Board of Directors. Liam is a well-respected leader who brings a remarkable track record of accomplishment to our Board."

Leerink Partners is acting as lead placement agent for the financing. Evercore ISI, LifeSci Capital, and Oppenheimer & Co. are serving as co-placement agents for the financing.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering. The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (Securities Act), or any state securities laws, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of Common Stock and the Common Stock issuable upon exercise of the pre-funded warrants, in each case sold under the terms of the securities purchase agreement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, OnKure Therapeutics, MAR 27, 2026, View Source [SID1234663992])