Phanes Therapeutics announces dose expansion in clinical study of spevatamig in combination with chemotherapy for treatment of biliary tract cancer

On April 7, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported the initiation of the dose expansion phase in their clinical study evaluating spevatamig in combination with chemotherapy for the treatment of biliary tract cancer (BTC), following dose-limiting toxicity (DLT) clearance at two dose levels.

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Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with Merck’s anti-PD-1 therapy, pembrolizumab.

Phanes is conducting clinical trials with spevatamig in multiple oncology indications, including a Phase 2 study evaluating the efficacy of spevatamig in combination with chemotherapy in first-line pancreatic ductal adenocarcinoma (PDAC) patients. As of March 2026, more than 160 patients globally have been dosed with spevatamig collectively in monotherapy and combination therapy settings. Three posters on spevatamig will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego. Presentation details can be found here: Phanes Therapeutics to present three clinical posters at AACR (Free AACR Whitepaper) 2026

(Press release, Phanes Therapeutics, APR 7, 2026, View Source [SID1234664214])

Anavex Life Sciences to Present at the 25th Annual Needham Virtual Healthcare Conference

On April 7, 2026 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer’s disease, Parkinson’s disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, reported that it will present at the 25th Annual Needham Virtual Healthcare Conference, April 13 – 16, 2026. President and Chief Executive Officer Christopher U. Missling, PhD and his management team will present the Company scheduled at 1:30 PM (ET) on Tuesday, April 14th, 2026.

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A live audio webcast will be accessible through the Investors section of the Company’s website at www.anavex.com. An archived edition of the session will be available later that day.

(Press release, Anavex Life Sciences, APR 7, 2026, View Source [SID1234664199])

Florida Cancer Specialists & Research Institute Phase 3 Trial Demonstrates Initial Clinical Benefit of Novel Immunotherapy For Advanced Non-Small Cell Lung Cancer

On April 7, 2026 Florida Cancer Specialists & Research Institute, LLC (FCS) reported key findings from stage 1 of the PRESERVE-003 Phase 3 clinical trial conducted with participation have shown that gotistobart, a novel CTLA-4 checkpoint-targeting immunotherapy, may offer improved effectiveness with fewer side effects in patients with metastatic non-small cell lung cancer (NSCLC). The global PRSERVE-003 trial is a multi-year, groundbreaking study evaluating gotistobart against the chemotherapy drug docetaxel in people with squamous NSCLC (sqNSCLC) whose disease has worsened after standard immunotherapy and chemotherapy.

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Gustavo A. Fonseca, MD, FACP, FCS director of research and clinical trials, said, "Lung cancer remains the leading cause of cancer deaths worldwide and treatment options have historically been limited. FCS clinical research is contributing to discoveries that are revolutionizing the treatment of these and other advanced cancers."

Patients with metastatic NSCLC were randomized into stage 1 of the study conducted from June 2023 to September 2024 in study centers in the U.S., Australia, China, Korea and the UK. Stage 1 aimed "to confirm the dose and assess the preliminary efficacy (primary outcome: overall survival; secondary outcomes: progression‑free survival, objective response rate and duration of response) and safety of gotistobart compared to docetaxel."

The trial has moved forward into its pivotal later stage where the findings will be confirmed in a larger population of patients with sqNSCLC. The authors note: "The primary endpoint of PRESERVE-003 is overall survival (OS), and secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and safety."

FCS provides ongoing access to more than 180 clinical trials within 29 FCS clinics statewide and early-phase Drug Development Units (DDUs) located in Sarasota and Central Florida. Research conducted at FCS is made possible in partnership with Sarah Cannon Research Institute, one of the world’s leading oncology research organizations conducting community-based clinical trials.

View the abstract: Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial

(Press release, Florida Cancer Specialists & Research Institute, APR 7, 2026, View Source;research-institute-phase-3-trial-demonstrates-initial-clinical-benefit-of-novel-immunotherapy-for-advanced-non-small-cell-lung-cancer-302735982.html [SID1234664215])

bioAffinity Technologies’ CyPath® Lung to be Featured at Cleveland Clinic Annual “Advances in Early Lung Cancer Detection” Symposium April 16

On April 7, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, reported that its CyPath Lung test will be featured at the invitation-only "Advances in Early Lung Cancer Detection" symposium at the Cleveland Clinic in Cleveland, Ohio, on April 16, 2026. Gordon Downie, MD, PhD, bioAffinity Technologies’ Chief Medical Officer, will be one of three panelists discussing lung nodule management and highlighting the benefits of using CyPath Lung to aid in the early detection of lung cancer in high-risk patients.

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The seventh annual Cleveland Clinic symposium brings together global leaders in the field of lung cancer, including physicians, advocacy organizations, researchers and industry, to accelerate the development and implementation of new technologies and methods to find lung cancer at the earliest stages when it is most treatable. This is bioAffinity Technologies’ seventh invitation to present before symposium attendees.

This year’s agenda addresses lung cancer risk assessment, emerging diagnostic technologies, screening biomarkers and artificial intelligence (AI) as well as the changing epidemiology of lung cancer.

"As the number of indeterminate pulmonary nodules discovered incidentally and by lung screening continues to grow, so does the accompanying need for noninvasive, scalable diagnostic solutions," Dr. Downie said. "CyPath Lung directly addresses many of the issues that will be discussed at the Cleveland Clinic’s symposium. Using our sputum-based diagnostic as an adjunct to the current standard of care for newly discovered non-calcified pulmonary nodules helps guide difficult clinical discussions, accelerates diagnosis and prevents unnecessary invasive procedures. Adding CyPath Lung to the diagnostic pathway provides actionable results to physicians, eases anxiety for patients, and can reduce costs to the healthcare system."

CyPath Lung is a noninvasive, cost-effective diagnostic test that uses flow cytometry and AI to analyze the lung microenvironment and identify cancer and cancer-related cells. Clinical data and case studies have shown its potential to detect cancer as early as Stage 1A, while a negative result can help avert unnecessary and often risky invasive procedures.

With both high sensitivity and specificity, CyPath Lung is a balanced test that supports clinical decision-making and is broadly applicable in high-risk patients, regardless of nodule size or prior cancer history. Initially designed to assist in the evaluation of indeterminate pulmonary nodules identified through screening or incidental imaging, CyPath Lung can also be used to monitor lung cancer survivors for recurrence.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to aid in the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that may indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. CyPath Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. Results may vary in broader clinical use.

(Press release, BioAffinity Technologies, APR 7, 2026, View Source [SID1234664200])

EQT Life Sciences to exit minority stake in Tubulis via sale to Gilead Sciences for up to USD 5.0 billion

On April 7, 2026 EQT Life Sciences reported that the LSP 7 fund ("EQT Life Sciences") has exited its minority stake in Tubulis (the "Company"), a Germany-based, clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs), through a sale to Gilead Sciences [Nasdaq: GILD].

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Tubulis’ lead asset, TUB-040, a NaPi2b-directed topoisomerase-I inhibitor (TOPO1i) ADC, is currently in Phase 1b/2 development for platinum-resistant ovarian cancer and non-small cell lung cancer (NSCLC). Gilead will also acquire TUB-030, a 5T4 targeted ADC, which has demonstrated promising initial clinical data across various solid tumor types as well as a next-generation ADC platform and a promising early pipeline.

EQT Life Sciences co-led the oversubscribed Series B2 financing in 2024, and since then, has helped Tubulis advance into a clinical-stage oncology player, progress its pipeline, and build a differentiated antibody-drug conjugate platform targeting solid tumors. Working closely with the management team, EQT Life Sciences supported this journey through active board involvement and strategic guidance, helping position Tubulis as a partner of choice in a rapidly growing and highly competitive field.

The transaction represents a strong and strategic outcome for LSP 7 and its co-investors, and reflects EQT Life Sciences’ ambition to back outstanding science early, helping companies scale through critical inflection points into globally relevant businesses. Today’s announcement also underscores the continued demand for innovative oncology platforms that can address significant unmet medical needs.

"From the outset, we believed our conjugation technology platforms could have broad impact across the ADC field, and the initial data from TUB-040 have reinforced that conviction," said Dominik Schumacher, PhD, Chief Executive Officer and Co-founder of Tubulis. "Joining Gilead allows us to build on this foundation within an organization that brings deep scientific expertise, global development capabilities, and the scale needed to translate innovation into medicines for patients worldwide. Through our existing collaboration, Gilead has already seen the potential of our technologies and together, we are well positioned to accelerate the development of our ADC pipeline. I’m deeply grateful to the Tubulis team, our Board of Directors, investors, and partners for their commitment and helping make this milestone possible."

"From day one, it was clear that Tubulis had both the science and the ambition to compete at the very highest level in oncology," said Christoph Broja, Partner at EQT Life Sciences and Board Director at Tubulis." A European-born platform with world-class talent and technology, this is exactly the kind of company EQT Life Sciences was built to back. Today’s announcement is a testament to that conviction, and we are proud to have supported its journey from Munich to the global stage"

Following the close of the transaction, Tubulis will operate as a dedicated ADC research organization within Gilead, with the Munich site serving as a hub for ADC innovation, building on its integrated discovery, manufacturing, and clinical capabilities to advance next generation ADCs.

Terms of the Transaction

Under the terms of the sale and purchase agreement, Gilead will acquire all of the outstanding equity of Tubulis for $3.15 billion in upfront cash consideration on a cash-free, debt-free basis, subject to customary adjustments, which is payable at closing, and up to $1.85 billion in contingent milestone payments. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions. The transaction is expected to close in the second quarter of 2026. Gilead plans to finance the transaction with a combination of cash on hand and senior unsecured notes.

Centerview Partners LLC and Allen & Company LLC are acting as financial advisors for Gilead. J.P. Morgan Securities LLC is acting as the exclusive financial advisor for Tubulis. Covington & Burling LLP, Arnold & Porter LLP, and Venable LLP are serving as legal counsel to Gilead. Goodwin Procter LLP and CMS Hasche Sigle are serving as legal counsel to Tubulis.

(Press release, Gilead Sciences, APR 7, 2026, View Source [SID1234664216])