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.

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

                  Schedule Your 30 min Free Demo!

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])

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.

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

                  Schedule Your 30 min Free Demo!

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])

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].

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

                  Schedule Your 30 min Free Demo!

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])

On April 7, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on promising new therapies in oncology and obesity, reported broad alignment with the U.S. Food and Drug Administration (FDA) on the registration path for CRB-701, the Company’s next-generation, highly stable Nectin-4 targeting ADC, in head and neck squamous cell carcinoma (HNSCC) and cervical cancer. Corbus also announced that Dr. Dominic Smethurst, MA, MRCP is stepping down from his role as Chief Medical Officer; his last day with the company will be June 30, 2026.

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

                  Schedule Your 30 min Free Demo!

The agreed upon second-line registrational study designs for CRB-701 include:

HNSCC: a single, randomized controlled study exploring the efficacy and safety of CRB-701 compared to physicians’ choice chemotherapy with potential accelerated approval using objective response rate (ORR) as the primary endpoint and potential full approval granted on overall survival (OS) benefit.
Cervical cancer: a single, randomized controlled study exploring the efficacy and safety of CRB-701 compared to physicians’ choice of chemotherapy or Tivdak with potential accelerated approval using ORR as the primary endpoint and potential full approval granted on OS benefit.
Continued interactions with the FDA planned to finalize the protocols and statistical analysis plans for the registrational studies.

Updated clinical data from the Phase 1/2 study of CRB-701 in both HNSCC and cervical cancer will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held May 29 – June 2 in Chicago. Data will include clinical response durability as well as HNSCC patient subgroup analysis. Corbus previously presented dose optimization data from the study, including encouraging efficacy and safety findings, at the 2025 European Society for Medical Oncology Congress (ESMO 2025). The company also anticipates reporting data with CRB-701 in combination with Keytruda in first-line HNSCC patients in Q4 2026 to support potential further registration-enabling trials.

"We’re pleased to share this important regulatory update as we continue to progress CRB-701 as a novel oncology therapeutic to address unmet medical needs for patients. We look forward to sharing updated monotherapy data on CRB-701 at ASCO (Free ASCO Whitepaper) and expect to initiate a registrational study for CRB-701 in second-line HNSCC in mid-2026," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus.

Dr. Cohen continued, "This milestone marks an important transition from clinical proof of concept to pending late-stage registrational development and the potential for regulatory submission of CRB-701. This year we will be adding several key new senior leaders to best prepare us for this critical next phase. We are very grateful for Dr. Smethurst’s contributions to advance our pipeline programs through early development, well positioning Corbus for continued success."

About CRB-701
CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer. CRB-701 is licensed from CSPC Megalith Biopharmaceutical Co. Ltd. China.

(Press release, Corbus Pharmaceuticals, APR 7, 2026, View Source [SID1234664201])

On April 7, 2026 Singlomics Biopharmaceuticals, an innovative clinical-stage biopharmaceutical company focused on the discovery and development of antibody therapeutics for oncology, inflammation, and autoimmune diseases, reported that the first patient has been dosed in its Phase I clinical trial of DXP-106, a potential best-in-class IL-1RAP monoclonal antibody, in China.

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

                  Schedule Your 30 min Free Demo!

DXP-106 has previously received Investigational New Drug (IND) approvals from both the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). The ongoing first-in-human Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of DXP-106 in patients with advanced solid tumors.

"Dosing of the first patient in our Phase I trial represents a key milestone as we advance DXP-106 into clinical development globally," said Dr. Qian Shi, Chief Executive Officer of Singlomics. "IL-1RAP is a compelling target in oncology and immune-related diseases. DXP-106 is designed to function through both directly killing tumor cells by ADCC, and inhibit MDSCs in tumor microenvironment via inhibition of multiple IL-1 superfamily signaling pathways. It has demonstrated strong anti-tumor activity in preclinical studies. We look forward to generating initial clinical data and exploring potential global partnering opportunities to accelerate development."

DXP-106 is a humanized monoclonal antibody that specifically binds to a differentiated epitope on IL-1RAP domain 2, enabling simultaneous blockade of IL-1, IL-33, and IL-36 signaling pathways. This multi-pathway inhibition approach may provide broader anti-tumor activity and improved therapeutic benefit.

IL-1RAP is broadly expressed across tumor cells, stromal cells, and immune cells within the tumor microenvironment, and plays a central role in tumor progression, immune evasion, and chronic inflammation. Elevated IL-1 pathway signaling has been associated with poor clinical outcomes across multiple cancer types, supporting IL-1RAP as a promising therapeutic target.

Singlomics is advancing a differentiated pipeline of antibody therapeutics leveraging its proprietary single-cell sequencing and AI-enabled antibody engineering platform. The Company is actively seeking global partnerships for selected programs.

About DXP-106: IL-1RAP mAb

DXP-106 is a humanized IL-1RAP monoclonal antibody targeting a unique epitope on domain 2 of IL-1RAP, enabling inhibition of three key IL-1 superfamily signaling pathways. In preclinical in vitro and in vivo tumor models, DXP-106 demonstrated robust anti-tumor activity and favorable developability, supporting its potential as a best-in-class therapeutic.

(Press release, Singlomics Biopharmaceuticals, APR 7, 2026, View Source [SID1234664217])