On September 21, 2026 Vironexis Biotherapeutics reported encouraging clinical results from the ongoing SENTRY-CD19 study of VNX-101, its investigational, one-time in vivo immunotherapy, in patients with relapsed or refractory CD19-positive hematologic malignancies. VNX-101 is designed to turn a patient’s own liver into a "biofactory" capable of producing GP101, a CD19/CD3 bispecific T-cell–engaging protein, following a single administration.

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Among the first three patients with relapsed/refractory (R/R) ALL who were antibody negative at baseline, all three achieved measurable residual disease (MRD)-negative complete responses following a single administration of VNX-101. All three MRD-negative complete responses were confirmed by clonoSEQ. In addition, one of the three patients who also had extensive extramedullary disease achieved a complete response at all disease sites on PET imaging by 28 days.

Importantly, the responses observed to date in these three patients have shown encouraging durability in this difficult-to-treat population. The patients all remain MRD-negative, with the first patient showing complete response through Day 260, at which point the treating physician elected to proceed to hematopoietic stem cell transplantation while the patient was in MRD-negative complete response. Additionally, the T-cell-engaging protein was still detected at therapeutic levels post transplant, proving durability through at least 9 months post infusion.These observations are particularly notable given that VNX-101 is administered once, rather than through repeated or continuous protein infusions.

"While early, these results are highly encouraging after delivering just a single, off-the-shelf administration of VNX-101, which enables the body to produce a CD19/CD3 T-cell–engaging protein," said Samit Varma, Chief Executive Officer of Vironexis. "These three patients have tried multiple lines of therapy and, sadly, exhausted available treatment options. We believe the depth, consistency, and emerging durability of these responses provide important clinical validation of our in vivo therapeutic protein platform, and compelling proof of concept for its potential to transform the body into a meaningful, durable source of highly active cancer therapeutics."

Mr. Varma continued, "Further, we believe VNX-101 has achieved an important first for the field: demonstrating that a systemically delivered, one-time in vivo therapy can translate into clinical antitumor activity in patients with blood cancer and extramedullary disease."

The safety profile observed to date is consistent with the potent immune activation expected from a CD19/CD3 T-cell-engaging therapy and is informing ongoing dose optimization. Immune-mediated events, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), were observed during dose escalation and completely resolved with standard of care. The Company continues to evaluate dose and treatment-management approaches as part of the ongoing study.

The broader SENTRY-CD19 study has dosed nine patients at sites in the U.S., across multiple CD19-positive hematologic malignancies, including ALL, diffuse large B-cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia. Based on the emerging clinical profile, Vironexis intends to prioritize development of VNX-101 in antibody-naïve relapsed/refractory ALL.

International expansion is also underway, with SENTRY-CD19 study sites in South Korea approved and expected to activate in the coming weeks.

Board Appointments

Vironexis also announced today the appointments of Kevin Sharer, former Chief Executive Officer of Amgen, as Chairman of the Company’s Board of Directors, and Nobel Prize laureate James Allison, Ph.D. to its Scientific Advisory Board. Dr. Allison is the Regental Professor and Chair of Immunology, Vice President of Immunobiology and Founding Director of the James P. Allison Institute at The University of Texas MD Anderson Cancer Center.

Mr. Sharer commented, "I’m delighted to join Vironexis’ Board of Directors as Chairman at this exciting time for the company, as it unveils highly encouraging initial clinical data demonstrating the potential of its revolutionary new approach to one-time, off-the-shelf in vivo immunotherapy. I look forward to contributing my experience as Vironexis continues to build momentum advancing VNX-101 and its broader pipeline targeting cancer and other serious diseases."

About VNX-101

VNX-101 is an investigational, one-time in vivo immunotherapy designed to enable the body to produce GP101, a CD19/CD3 T-cell–engaging protein, following a single administration. By delivering the genetic instructions for therapeutic protein production directly in vivo, Vironexis is developing an approach intended to combine the potency of T-cell-engaging therapeutics with the potential convenience and durability of a one-time treatment. VNX-101 has received U.S. FDA Fast Track, Orphan Drug, and Rare Pediatric Disease designations.

About the SENTRY-CD19 Clinical Trial

The SENTRY-CD19 Clinical Trial [NCT06533579] is a Phase 1/2, first-in-human, open-label, dose-escalating study designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19 positive hematologic malignancies. The trial is currently active across nine national clinical sites, with the core principal site at UT MD Anderson Cancer Center. Visit the clinicaltrials.gov listing for more information on the trial.

(Press release, Vironexis Biotherapeutics, SEP 21, 2026, View Source [SID1234670983])

On September 21, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that its pivotal registrational Phase IIb study of opamtistomig (LBL-024), the Company’s proprietary PD-L1/4-1BB bispecific antibody, as monotherapy for patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC), has been selected as a Late-Breaking Abstract (LBA) and Proffered Paper presentation at the ESMO (Free ESMO Whitepaper) Congress 2026.

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The selection highlights the clinical importance and scientific interest of the study and further demonstrates the growing international recognition of opamtistomig and Leads Biolabs’ clinical development capabilities. Notably, three Company-sponsored studies have been selected for Proffered Paper presentations at ESMO (Free ESMO Whitepaper) 2026, spanning EP-NEC and multiple myeloma.

Pivotal Phase IIb Study of Opamtistomig in Advanced EP-NEC Selected as Late-Breaking Abstract

The pivotal, registrational Phase IIb study is evaluating the efficacy and safety of opamtistomig monotherapy in patients with advanced EP-NEC who have received at least two prior lines of systemic therapy. The study generated key clinical data supporting the Company’s recent New Drug Application (NDA) submission to the National Medical Products Administration (NMPA).

Study Title:
Opamtistomig (LBL-024) monotherapy in advanced extra-pulmonary neuroendocrine carcinoma (EP-NEC) after >2 prior lines of therapies: results from a pivotal, registrational Phase IIb study of a novel PD-L1×4-1BB bispecific antibody

Presentation Type: Late-Breaking Abstract (LBA) / Proffered Paper

Principal Investigator: Professor Lin Shen, Peking University Cancer Hospital

Presenter: Dr. Ming Lu, Peking University Cancer Hospital

Presentation Time: 10:15-10:25, local time, 26 October

The ESMO (Free ESMO Whitepaper) 2026 LBA presentation will provide the pivotal clinical results from this study, offering further insights into the efficacy and safety profile of opamtistomig in this high unmet-need patient population.

Three Proffered Paper Presentations at ESMO (Free ESMO Whitepaper) 2026

In addition to the EP-NEC pivotal study, two other Leads Biolabs studies have been selected for Proffered Paper presentations at ESMO (Free ESMO Whitepaper) 2026:

A pivotal registrational Phase IIb study of opamtistomig monotherapy in advanced EP-NEC, also selected as a Late-Breaking Abstract;
A Phase Ib/II study of opamtistomig in combination with chemotherapy as first-line treatment for advanced EP-NEC; and
A Phase I study of LBL-034 in patients with relapsed/refractory multiple myeloma (RRMM).
The selection of three studies for Proffered Paper presentations underscores the breadth of Leads Biolabs’ clinical development portfolio and its continued focus on advancing innovative therapies across areas of significant unmet medical need.

Broad ESMO (Free ESMO Whitepaper) 2026 Representation Across the Pipeline

In addition, four other Company-sponsored studies have been selected for poster presentations at ESMO (Free ESMO Whitepaper) 2026, covering clinical research of opamtistomig in biliary tract cancer (BTC), a mechanistic study in microsatellite-stable colorectal cancer (MSS CRC), and several meta-analyses.

Together, these presentations span clinical development, translational research and evidence synthesis, reflecting the breadth of Leads Biolabs’ oncology research portfolio and its commitment to generating high-quality clinical and scientific evidence.

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "The selection of our pivotal study of opamtistomig in advanced EP-NEC as a Late-Breaking Abstract at ESMO (Free ESMO Whitepaper) 2026 represents important recognition of the scientific and clinical interest in this program and the significant unmet need faced by patients with advanced EP-NEC. The selection of three Company-sponsored studies for Proffered Paper presentations further reflects the strength and breadth of our clinical development portfolio.

Opamtistomig is a cornerstone of our IO 2.0 strategy, and we are advancing its development across multiple tumor types and treatment settings. We remain focused on translating our differentiated PD-L1/4-1BB bispecific antibody approach into meaningful clinical benefits for patients and on advancing innovative treatment options for patients with cancer worldwide."

About EP-NEC

Neuroendocrine carcinoma (NEC) is a highly malignant, immunologically "cold" tumor, accounting for approximately 10% to 20% of neuroendocrine neoplasms. NEC may arise in various organs, including the lung, gastrointestinal tract and bladder. NEC can be classified into pulmonary NEC and extrapulmonary NEC. EP-NEC shares the highly aggressive and metastatic characteristics of small cell lung cancer (SCLC), progresses rapidly, and most patients with NEC present with advanced-stage disease or distant metastases at diagnosis. Systemic treatment options for NEC are limited, with suboptimal efficacy and poor prognosis.

There are currently no therapies specifically approved by regulatory authorities worldwide for EP-NEC. First-line treatment for advanced EP-NEC primarily consists of platinum-based chemotherapy, with an objective response rate (ORR) of approximately 30% to 50% and a median overall survival (mOS) of only around one year. There is no standard treatment following progression on first-line therapy. Second-line treatment options may include oxaliplatin-based FOLFOX, irinotecan-based FOLFIRI, CAPTEM with or without bevacizumab, or temozolomide monotherapy. However, the efficacy of these treatment options remains limited, with an ORR of approximately 10% to 25% and an mOS of approximately eight months. Accordingly, there remains a substantial unmet medical need for patients with advanced EP-NEC, underscoring the urgent need for new and effective treatment options.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Currently, opamtistomig is being evaluated in 14 indications, including one pivotal single-arm registrational study, one confirmatory Phase III study, and nine proof-of-concept studies, covering major indications such as NSCLC and multiple cold tumors. To date, opamtistomig has demonstrated robust antitumor activity across seven tumor types—extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), and ovarian cancer (OC)—highlighting its clinical value and broad therapeutic promise.

Developed using Leads Biolabs’ proprietary X-Body bispecific platform, opamtistomig is designed to simultaneously block PD-1/PD-L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors and potentially offering durable survival benefits.

Recognizing its clinical potential, opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) in November 2024. Additionally, in January 2026, opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission, further underscoring its potential to address unmet medical needs in this patient population. In July 2026, its New Drug Application (NDA) was granted priority review designation by the NMPA, followed by NDA acceptance in August 2026, positioning opamtistomig as a potential world’s first approved 4-1BB-targeting antibody, the first approved agonist antibody, and the first approved treatment for EP-NEC.

(Press release, Nanjing Leads Biolabs, SEP 21, 2026, View Source [SID1234670982])

On September 21, 2026 PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, reported the successful completion of the End-of-Phase 1 (EOP1) meeting with the U.S. Food and Drug Administration (FDA) and the receipt of FDA Fast Track designation for LYT-200 in combination with a hypomethylating agent (HMA) for the treatment of relapsed/refractory (R/R) high-risk myelodysplastic syndromes (HR-MDS). LYT-200 targets galectin-9, an important oncogenic driver and potent immunosuppressor, and is being advanced by PureTech’s Founded Entity, Gallop Oncology (Gallop). PureTech intends to leverage external capital to support the continued development of LYT-200 through the completion of the Phase 2 trial and expects to secure capital in the first half of 2027.

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"Our productive End-of-Phase 1 meeting with the U.S. FDA provides a clear path to advance LYT-200 into Phase 2 development," said Eric Elenko, PhD, Acting Chief Executive Officer of Gallop Oncology and Co-founder of PureTech. "The STRIDE-MDS trial will seek to confirm the unprecedented clinical activity observed in Phase 1b, while its randomized, double-blind design will enable a clear assessment of the contribution of effect of LYT-200. Additionally, the inclusion of two doses is intended to fulfill the dose-selection requirements in accordance with FDA’s Project Optimus. With its mutation-agnostic approach and potential to benefit a broad range of patients, LYT-200 could represent an important new treatment option for R/R HR- MDS."

The Study of Two Regimens Investigating Dose and Efficacy of LYT‑200 in Relapsed/Refractory High-Risk MDS (STRIDE-MDS) will be a randomized, double-blind, placebo-controlled Phase 2 trial enrolling approximately 125 patients with R/R HR-MDS. Patients will be randomized 2:2:1 to receive LYT-200 at 12 mg/kg plus an HMA, LYT-200 at 7.5 mg/kg plus an HMA, or placebo plus an HMA, respectively. The trial will assess the efficacy of LYT-200 as measured by the rate of complete and partial responses to support dose selection.

"R/R HR-MDS remains an area of profound unmet need, particularly for the vast majority of patients without an actionable mutation," said Aleksandra Filipovic, MD, PhD, Chief Medical Officer of Gallop Oncology. "Galectin-9 represents a compelling therapeutic target because of its role as both an oncogenic driver and potent immunosuppressor, and its elevated expression in HR-MDS is associated with shorter survival. By addressing the foundational biology – independent of a specific genetic mutation – LYT-200 has the potential to offer a new approach for a broad population of patients, and we welcome the opportunity Fast Track designation provides to work more closely with the U.S. FDA as we advance its development."

The EOP1 meeting was supported by positive topline data from the completed Phase 1b trial evaluating LYT-200 in combination with an HMA (azacitidine or decitabine) in heavily pretreated patients with R/R HR-MDS. In that trial, LYT-200 demonstrated compelling clinical efficacy and a consistent safety profile in patients with R/R HR-MDS, all of whom had relapsed or become refractory to prior treatment with an HMA. Efficacy evaluable1 patients receiving LYT-200 (12 mg/kg) in combination with an HMA (n=11) demonstrated:

27.3% complete response rate
36.3% complete response + partial response rate
9.1% partial response rate
9.1% marrow complete response rate
45.5% overall response rate
18% conversion to transplant rate
No dose-limiting toxicities
No myeloid suppression
"Patients with higher-risk MDS who relapse or become refractory to HMA treatment have very limited therapeutic options and poor outcomes, and the literature and clinical practice suggest that fewer than 5% of these patients typically respond to retreatment with an HMA rechallenge," said Amer Zeidan, MBBS, MHS, Professor of Medicine at Yale University, Chief of the Division of Hematologic Malignancies at Yale Cancer Center, who will be the Global Principal Investigator of the Phase 2 STRIDE-MDS trial. "Against this backdrop, the clinical activity observed with LYT-200 in combination with an HMA in the Phase 1b study is particularly encouraging. STRIDE-MDS will allow us to further evaluate this activity in a randomized, placebo-controlled study."

Fast Track designation is a process designed to facilitate the development and expedite the review of drugs that target serious conditions with unmet medical need. Drugs receiving Fast Track designation may benefit from more frequent interactions with the U.S. FDA throughout development.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are a group of serious blood cancers characterized by ineffective blood cell production in the bone marrow, leading to anemia, infections, and bleeding complications.2, 3 MDS affects approximately 60,000-170,000 people in the United States, with an estimated 30-40% of patients diagnosed with the more aggressive form of the disease known as high-risk (HR) MDS.2, 4 HR-MDS is associated with poor outcomes, with median survival typically less than two years following diagnosis.

The current standard frontline treatments for HR-MDS are hypomethylating agents (HMAs), such as azacitidine and decitabine; however, most patients do not respond to these therapies or eventually stop benefiting from them.5 Once the disease becomes relapsed or refractory (R/R), outcomes are especially poor, with survival often limited to only a few months.5,6

Treatment options for patients with R/R HR-MDS remain very limited. Only one therapy has been approved by the U.S. Food and Drug Administration specifically for R/R HR-MDS in the past two decades, and it targets a genetic mutation found in only approximately 3% of patients.5 As a result, there remains a significant unmet need for treatments for the overwhelming majority of patients with R/R HR-MDS.

About LYT-200

LYT-200 is a Phase 2-ready, fully human monoclonal antibody in development for the treatment of relapsed/refractory (R/R) high-risk myelodysplastic syndromes (HR-MDS). It is the most advanced therapeutic candidate targeting galectin-9, which is an important oncogenic driver and potent immunosuppressor that plays a central role in some of the most difficult-to-treat cancers. With its mutation-agnostic, dual mechanism of action, LYT-200 is designed to address both the malignant cells and the immunosuppressive environment that sustain disease. LYT-200 has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of R/R HR-MDS in combination with a hypomethylating agent. LYT-200 has also been granted Fast Track designation from the U.S. FDA for the treatment of acute myeloid leukemia (AML).

(Press release, PureTech Health, SEP 21, 2026, View Source [SID1234670981])

On September 21, 2026 Mercy BioAnalytics, Inc. ("Mercy" or the "Company"), a pioneer in blood-based early cancer detection, reported that the U.S. Food and Drug Administration ("FDA") has approved the Company’s Investigational Device Exemption (IDE) application for the Evident Ovarian Cancer Screening Test. The approval allows Mercy to use the test in its pivotal SOARA Clinical Validation Study, a prospective clinical study designed to evaluate the safety of the test when used for ovarian cancer screening in average-risk women, following Institutional Review Board (IRB) approval.

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The study is expected to support the Company’s ongoing clinical and regulatory program for the Evident Ovarian Cancer Screening Test.

"FDA approval of our IDE application is an important milestone in advancing the Evident Test through the regulatory review process." said Dawn Mattoon, Ph.D., Chief Executive Officer of Mercy BioAnalytics. "We designed the SOARA study to build prospective evidence for our test as we continue working toward making earlier ovarian cancer detection available to more women."

Ovarian cancer remains among the most lethal gynecologic cancers and is frequently diagnosed at an advanced stage. There is currently no FDA-approved screening test for ovarian cancer. FDA previously granted Breakthrough Device Designation to Mercy’s ovarian cancer test.

The Evident Ovarian Cancer Screening Test is powered by Mercy’s patented Mercy Halo liquid biopsy platform, which uses biomarker colocalization to interrogate highly abundant, blood-based extracellular vesicles and particles that carry cancer-associated signatures from their cells of origin.

Approval of the IDE application permits Mercy to conduct the specified clinical investigation. It does not constitute FDA approval or clearance of the Evident Ovarian Cancer Screening Test.

(Press release, Mercy BioAnalytics, SEP 21, 2026, View Source [SID1234670980])

On September 21, 2026 AbbVie (NYSE: ABBV) and Iambic, a clinical-stage life sciences and technology company developing novel medicines through its AI-driven discovery and development platform, reported a multi-year collaboration to accelerate the discovery and development of small molecule therapies with first-in-class and best-in-class potential across immunology, neuroscience and oncology. The companies will leverage Iambic’s AI platform to improve the efficiency and success of identifying promising new drug candidates.

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"We are excited about the purpose-built AI capabilities Iambic is bringing to our Discovery scientists," said Nicholas Donoghoe, M.D., executive vice president and chief business and strategy officer, AbbVie. "We believe AI will be a powerful catalyst for scientific innovation across AbbVie. By equipping our teams with fit-for-purpose AI solutions, we can accelerate discovery, expand what is possible in R&D and significantly advance our commitment to making a remarkable impact for patients."

"Combining Iambic’s platform with the drug-hunting expertise of AbbVie scientists can help us make more precise decisions about the molecules we pursue," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "The goal of our collaboration with Iambic is to design better molecules more efficiently and improve our probability of success, ultimately to deliver breakthrough medicines for patients sooner."

In traditional small molecule discovery, scientists evaluate dozens of properties for each candidate individually. Iambic’s molecular superintelligence platform is powered by Enchant and NeuralPLexer, technologies designed to optimize the full range of candidate properties simultaneously, increasing the chance of making better molecules while reducing drug discovery timelines.

The collaboration will utilize Enchant v3, Iambic’s next-generation multimodal transformer model that combines biomedical data modalities from across the drug discovery process and enables many drug design hypotheses to be tested in parallel and at scale. Enchant v3 is designed to achieve industry-leading prediction accuracy across drug discovery and development and is trained on over 6,000 molecular properties.

"Iambic’s mission is to make better technology for better medicines — in our own hands and with partners," said Tom Miller, Ph.D., Co-Founder and CEO, Iambic. "We are eager to bring Iambic’s molecular superintelligence platform to bear alongside AbbVie’s world-class team to address unmet patient need. We anticipate an impactful collaboration — for Iambic, for AbbVie, and for the patients we serve."

Under the terms of the collaboration, Iambic will receive an upfront payment and is eligible to receive success-based milestone payments and tiered royalties on net sales from products generated from the collaboration.

(Press release, AbbVie, SEP 21, 2026, View Source [SID1234670979])