On June 22, 2026 Pfizer Inc. (NYSE: PFE) reported topline results from the Phase 3 SigVie-002 study (previously known as Be6A Lung-01) evaluating sigvotatug vedotin, an investigational, potential first-in-class integrin beta-6 (IB6) directed antibody-drug conjugate (ADC). The study enrolled adults with locally advanced, unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) who had received one or more lines of prior therapy.

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In the overall population, sigvotatug vedotin did not show a statistically significant improvement in the primary endpoint of overall survival (OS) compared to docetaxel.
The safety profile of sigvotatug vedotin was manageable and consistent with prior studies.
Encouragingly, in patients who received only one prior line of systemic therapy, which represents two-thirds of the study population, a stronger trend was observed for OS and progression-free survival (PFS) for sigvotatug vedotin over docetaxel.
In the exploratory analysis, no clear IB6 expression-response relationship was observed.
Detailed results from SigVie-002 will be submitted for presentation at a future medical congress.

"Patients with previously treated advanced NSCLC are a historically difficult-to-treat population, and there is clearly more work to be done to improve the outcomes for this population," said Jeff Legos, Chief Oncology Officer, Pfizer. "Although the overall study results did not demonstrate superiority over docetaxel, it is encouraging that second-line patients treated with sigvotatug vedotin achieved strong efficacy outcomes compared to an established standard of care, alongside a manageable safety profile. This observed clinical benefit, along with our Phase 1 combination data in the first-line setting, reinforces our confidence in the potential of the sigvotatug vedotin program, including an ongoing Phase 3 trial in combination with pembrolizumab in first-line advanced NSCLC."

"It is important not to underestimate the activity of docetaxel as a comparator in this setting. Patients enrolled in this trial were heavily pre-treated, with most having previously received both platinum-based chemotherapy and immunotherapy, yet docetaxel continues to provide meaningful clinical benefit. Although the study did not meet its overall survival endpoint, in second-line patients the data suggest a clinically meaningful survival benefit for sigvotatug vedotin over docetaxel, supporting continued scientific evaluation of sigvotatug vedotin in earlier lines in combination with immunotherapy," said Solange Peters, M.D., PhD, Chair of Medical Oncology & Thoracic Cancers Clinic, Lausanne University Hospital, Switzerland. "The ability of sigvotatug vedotin to induce immunogenic cell death provides a strong rationale for combination approaches with immunotherapy, particularly in earlier treatment settings where immune competence is better preserved. In this context, the promising phase 1 efficacy signals observed in treatment-naïve patients with high PD-L1 expression warrant further evaluation and may represent a more effective clinical application of this strategy."

In NSCLC, IB6 is expressed on approximately 90% of tumors. IB6 is associated with poor prognosis. Sigvotatug vedotin is a novel ADC designed for high target selectivity of IB6 and rapid internalization, which may help limit binding to other integrins more likely to be expressed in normal tissues and potentially reduce off-target toxicity.

Pfizer is evaluating sigvotatug vedotin in several ongoing studies across multiple stages and patient populations in NSCLC and other solid tumors, including:

An ongoing Phase 3 study evaluating sigvotatug vedotin + pembrolizumab in 1L NSCLC with PD-L1 tumor proportion score (TPS) ≥50%; and
Exploration of sigvotatug vedotin in novel combinations, including with PF’4404, the novel bispecific antibody targeting PD-1 and VEGF, in early-stage lung cancers and other IB6-expressing tumors.
Since the acquisition of Seagen, Pfizer has continued to advance a broad ADC portfolio spanning marketed medicines and pipeline programs. Pfizer is progressing multiple differentiated ADC candidates, including fetrastobart vedotin, a PD-L1–directed ADC currently in Phase 3 in NSCLC, additional IB6-targeted ADCs with alternate payloads, and early-stage candidates exploring novel targets and payloads, including topoisomerase I (Topo1) inhibitors and novel auristatin-based payloads. This breadth reinforces the strength of Pfizer’s Oncology pipeline, including the potential for novel combinations with its investigational PD-1xVEGF bispecific antibody (PF-08634404), supporting the company’s goal of delivering 8 potential Oncology breakthroughs by 2030.

About the SigVie-002 Trial

SigVie-002 (NCT06012435) is an ongoing, open-label randomized, Phase 3, global study evaluating sigvotatug vedotin compared with docetaxel in adult participants with previously treated locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC). Patients were randomized to receive sigvotatug vedotin administered intravenously on Days 1 and 15 of each 28-day cycle or docetaxel administered intravenously on Day 1 of each 21-day cycle.

The primary endpoint of this trial is overall survival (OS). The study enrolled 703 participants. Descriptive, secondary endpoints include progression-free survival (PFS), confirmed objective response rate (ORR) and duration of response (DOR) per RECIST v1.1 as assessed by blinded independent central review (BICR).

For more information, visit ClinicalTrials.gov and reference NCT06012435.

(Press release, Pfizer, JUN 22, 2026, View Source [SID1234668897])

On June 22, 2026 Knoa Pharma LLC ("Knoa Pharma"), a public health-focused pharmaceutical company dedicated to supporting patients and improving public health, reported it will present its pipeline assets at the BIO International Convention 2026 in San Diego, Calif., on Tuesday, June 23, at 10:30 a.m. PT in Theatre 1. Knoa Pharma is actively seeking partnerships to advance the development of investigational therapeutics for multiple assets across several disease areas including genitourinary disorders, substance use disorders, and oncology.
The company is discussing two assets, sunobinop and tinostamustine, both of which could present substantial revenue opportunities.*

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Tinostamustine is a novel, first-in-class investigational drug combining DNA alkylating activity and HDAC inhibition in a single molecule. It has the potential to be a first-line agent to treat patients with glioblastoma (GBM), a highly aggressive form of brain cancer. In Phase 1 studies as an adjuvant to standard chemoradiation, tinostamustine showed promising activity in difficult-to-treat newly diagnosed patients. The drug has received orphan drug designation from FDA and has the potential to be the first new pharmacologic treatment option for GBM in more than 20 years. In Phase 1/2 clinical trials, tinostamustine has also shown promise in multiple other solid and hematological tumors.

Currently, tinostamustine is also a part of GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447), sponsored by the Global Coalition for Adaptive Research. This is a seamless phase 2/3 study conducted under a master protocol enabling multiple therapies or combinations of therapies to be evaluated simultaneously against a shared control arm. With its innovative design and efficient operational infrastructure, data from GBM AGILE can potentially be used as the foundation for new drug applications and registrations to the U.S. FDA and other health authorities.

Sunobinop is a novel, first-in-class nociceptin receptor agonist. The orally active investigational drug is in Phase 1/2 clinical development for multiple indications, including alcohol use disorder (AUD), interstitial cystitis/bladder pain syndrome (IC/BPS), and overactive bladder (OAB). Related to AUD, sunobinop is the only agent intended to address alcohol craving, consumption, and sleep issues; it has the potential to be the first new modality in AUD in almost 20 years. Related to OAB and IC/BPS, sunobinop is a novel, first-in-class agent that targets the sensory nerves in the bladder to affect urination and pain, in addition to reducing nocturia. Both conditions, OAB and IC/BPS, have significant unmet need.

"Our approach is grounded in rigorous R&D and a deep exploration of disease biology to advance innovative therapies for patients facing complex and underserved conditions," said Dr. Julie Ducharme, Chief Scientific Officer, Knoa Pharma. "There are meaningful opportunities to collaborate along the way, and we look forward to partnering with those who share our ambitions."

"At the BIO International Convention, we will showcase our promising pipeline assets that have potential to benefit patients with unmet medical needs," said David Saussy, Head of Licensing and Business Development at Knoa Pharma. "We look forward to and welcome the opportunity to engage with potential partners who share in our commitment to scientific innovation and developing meaningful treatment options."

Companies interested in learning more about Knoa Pharma’s pipeline and partnership opportunities are encouraged to connect with the team during the BIO International Convention 2026. For more information on pipeline products, e-mail [email protected]. View the BIO presentation here.

(Press release, Knoa Pharma, JUN 22, 2026, View Source [SID1234668895])

On June 22, 2026 The Ellison Medical Institute (EMI) reported it has entered into an exclusive license with UniQuest, the commercialization company of The University of Queensland (UQ), to advance QED-203, a promising new treatment for advanced and therapy-resistant prostate cancer, toward first-in-human studies.

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Developed from research conducted at UQ, QED-203 is a novel small molecule therapeutic designed to address significant unmet needs in metastatic castration-resistant prostate cancer (mCRPC).

Established in 2016, EMI is a Los Angeles-based clinical and research organization advancing cancer research, translational science, and drug development to accelerate the path from scientific discovery to patient impact.

Under the agreement, EMI will lead the continued development of QED-203, applying its integrated capabilities across AI-enabled discovery, translational research, human-relevant preclinical models, and in-house clinical expertise to prepare the program for clinical evaluation. In partnership with UQ, these efforts will reduce risk and accelerate progress toward first-in-human studies in early 2027.

Based on research led by Professor Greg Monteith from UQ’s School of Pharmacy and Pharmaceutical Sciences, QED-203 was developed at the Queensland Emory Drug Discovery Initiative (QEDDI), the small molecule drug discovery group of UniQuest.

The treatment is being developed for metastatic castration-resistant prostate cancer (mCRPC), an advanced form of the disease where patients often have limited treatment options after standard therapies stop working.

QEDDI Head Dr. Brian Dymock said QED-203 was a potential first-in-class therapy targeting TRPV6, a calcium ion channel associated with aggressive prostate cancer.

"Patients with metastatic castration-resistant prostate cancer often face very limited options once existing therapies stop working," Dr. Dymock said. "Our goal has been to develop a novel treatment approach that could ultimately improve clinical outcomes for patients with advanced and therapy-resistant disease."

Dr. Monteith said the deal marked an important milestone and built on more than 15 years of research into the role of calcium signaling in cancer progression.

"It reflects the collaborative work behind a completely new therapeutic approach for patients with advanced disease," Dr. Monteith said.

"We are excited to advance the development of QED-203 to address urgent unmet needs in metastatic prostate cancer and meaningfully benefit patients," said Dr. David Agus, Founding CEO of the Ellison Medical Institute. "EMI is uniquely positioned to push this work forward, with deep expertise in oncology and a translational mission built for programs like this. Together, with UniQuest, we’re bringing expertise and a shared sense of purpose needed to move this work forward for the patients and families who need it most."

UniQuest CEO Dr. Dean Moss said the deal highlighted the strength of QEDDI’s model for translating world-class research at UQ into commercial opportunities with the potential to deliver impact.

"This partnership demonstrates the value of building dedicated drug discovery and translation capability around outstanding university research and pairing it with a development partner equipped to advance promising programs toward the clinic," Dr. Moss said. "QEDDI was established to help transform promising discoveries from UQ into high-quality development candidates, and this partnership with EMI is a strong example of that model in action. Together, we aim to build on this promising science and leverage EMI’s integrated research and development engine to accelerate progress towards the clinic and, in time, to patients."

QED-203 has been supported by the Biomedical Translation Bridge (an initiative of the Medical Research Future Fund delivered by MTPConnect); the Critical Path Institute’s Translational Therapeutics Accelerator; and the National Health and Medical Research Council Development Grant scheme to fund key preclinical studies, manufacturing and safety activities.

(Press release, The Ellison Medical Institute, JUN 22, 2026, View Source [SID1234668894])

On June 22, 2026 ChemT Biotechnology, an AI-driven biotechnology company building the intelligence layer for biomanufacturing, reported it has closed a US$4 million seed round led by Wavemaker Ventures, the early-stage fund of Wavemaker Partners, with participation from co-investment partner SEEDS, an arm of SG Growth Capital, the investment platform of EDB and Enterprise Singapore. The round was further supported by notable investors across the United States and Asia, including Wavemaker 360 Health, Draper University Ventures, and Temasek Life Sciences Accelerator.

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Making biologics at scale is harder than it looks. Manufacturers face long development timelines, unpredictable yields, high costs, and processes that are difficult to scale, all of which slow the delivery of treatments to patients. At the heart of the problem is that we lack precise and tunable ways to manipulate cells – the mini factories where important biologics are made.

ChemT is taking a different approach. Unlike conventional AI drug discovery companies or lab automation tools, ChemT builds intelligence directly into the manufacturing process itself, helping companies better understand the cells behind biomanufacturing, and provides a new way to guide cell behavior for faster, more scalable, and reliable production.

At the heart of the company is CelMo, an AI-driven Virtual Cell platform trained on billions to trillions of proprietary biological sequencing reads and validated in the lab. CelMo is designed to simulate how cells respond to manufacturing conditions, genetic changes, and other stresses. By tracking which biological processes inside a cell are being activated, suppressed, or rewired, from growth and metabolism to stress response and productivity, CelMo builds a dynamic picture of how cell states shift throughout manufacturing. Built on this foundation are practical applications: identifying target cell pathways to improve manufacturing performance, designing small molecules to guide cell behavior, and supporting cell engineering using AI.

CelMo is already delivering results. In CHO cells, the cell type most commonly used to manufacture antibodies and therapeutic proteins, the platform has demonstrated a 50% increase in antibody output and a 40% reduction in production timelines.

ChemT’s flagship small molecule product, Chemplify, applies the same approach to T-cell manufacturing, a critical component of advanced cancer therapies. Chemplify has demonstrated 50% faster development, 3× scalability, 60% lower costs, and 10× higher cell expansion yield.

"This financing is a strong validation of our team, our technology, and our mission during a difficult funding environment for life sciences," said Jie Sun, co-founder and CEO of ChemT Biotechnology. "Within roughly a year and half of launch, we’ve built commercial partnerships with more than 40 pharmaceutical, biotech, and CDMO companies across the globe. The future of biomanufacturing will not be won by automation alone — it will require intelligence."

The financing will support the continued expansion of ChemT’s AI and experimental infrastructure, advancement of its AI-designed molecular products toward GMP standards and regulatory readiness, scaling of commercial partnerships, and further development of CelMo. ChemT plans to expand the platform beyond CHO cells and T cells into other cellular systems, including stem cells, NK cells (Natural Killer cells, used in next-generation cancer immunotherapies), and HEK cells (Human Embryonic Kidney cells, widely used in gene therapy and biologics production), enabling broader intelligent control across biomanufacturing workflows.

"Our customers come to us because they are stuck – development timelines stretch for years, processes break when you try to scale them," said Dr. Ling Wu, co-founder and President of ChemT Biotechnology. "CelMo is the cellular world model to understand what’s happening inside their cells and intervene intelligently. Our goal is to help make advanced medicines easier to manufacture, scale, and deliver to patients worldwide."

"Biomanufacturing has long been constrained by structural bottlenecks, rooted in the lack of computational understanding of how cellular networks behave inside bioreactors. ChemT addresses this through precision small molecules that modulate cellular behavior — giving manufacturers a new lever for faster, cheaper, and higher-yield production with consistent quality," said Paul Santos, Co-founder and Managing Partner of Wavemaker Partners. "We look forward to working with ChemT’s founding team, which brings together technical and commercial depth, scientific credibility, world-class bioprocess leadership, and capital efficiency — a rare combination that has already drawn early commercial partnerships from all over the world."

(Press release, ChemT Biotechnology, JUN 22, 2026, View Source [SID1234668890])

On June 22, 2026 Hamlet BioPharma AB (publ) reported the signing of a clinical trial agreement with the University of Iowa, one of the leading U.S. centers for bladder cancer research and therapy. The new study advances the clinical development of Alpha1H, a human breast milk derived treatment for bladder cancer, to include Carcinoma In Situ (CIS); a severe surface-spreading and therapy-resistant form of bladder cancer where patients may need to remove their bladders to avoid systemic disease.

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Professor O’Donnell, a key opinion leader and driver of the international bladder cancer therapy field, has identified a significant unmet medical need among patients with CIS and initiated discussions with Hamlet BioPharma and scientists at Lund University, regarding this clinical expansion of the Alpha1H drug development program. This collaboration follows an extensive scientific and clinical evaluation of Alpha1H by the University of Iowa, including review of published clinical data and the mechanism of action described in peer-reviewed publications.

Bladder cancer is one of the most common urological malignancies worldwide. A substantial proportion of patients experience recurrence following treatment, creating a significant need for new therapies that can reduce recurrence rates and preserve bladder function. The clinical study is planned to be conducted under Hamlet BioPharma’s existing Investigational New Drug (IND) application for Alpha1H in the United States through submission of a new clinical protocol amendment to the U.S. Food and Drug Administration (FDA).

"The signing of this agreement establishes a collaboration with the University of Iowa group, led by Professor O’Donnell, who are pioneers in the field and have defined multiple novel therapies in bladder cancer. Expanding the clinical indications to include CIS allows us to evaluate Alpha1H in a patient population with severe and resistant disease and a substantial unmet medical need," says Catharina Svanborg, Professor at Lund University and Chairman of the Board of Hamlet BioPharma.

"Despite advances in bladder cancer treatment, high recurrence rates remain a major challenge. Many patients with CIS have exhausted all available treatments, without a cure, and are faced with the prospect of bladder removal. Based on our evaluation of Alpha1H and the clinical results generated to date, we believe the Alpha1H treatment warrants further investigation in this patient group. We look forward to working with Hamlet BioPharma and the scientists at Lund University to explore the potential of Alpha1H in patients with treatment resistant CIS," says Michael O’Donnell, Professor and Director of Urologic Oncology at the University of Iowa.

(Press release, HAMLET Pharma, JUN 22, 2026, View Source [SID1234668884])