On September 17, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported that the phase III CELESTIMO study evaluating Lunsumio (mosunetuzumab) in combination with lenalidomide versus MabThera/Rituxan (rituximab) plus lenalidomide in people with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one prior line of treatment met its primary endpoint. Results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS). Overall survival (OS) data were immature at the time of interim analysis. The safety profile of the Lunsumio and lenalidomide combination was consistent with the known profiles of the individual study medicines, with no new safety signals identified. Data from the study will be submitted to health authorities and presented at an upcoming medical meeting.

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"People living with relapsed or refractory follicular lymphoma need treatment options that provide meaningful clinical benefit and minimal disruptions to everyday care," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "The CELESTIMO results indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey."

CELESTIMO is a confirmatory study required to convert the accelerated approval/conditional marketing authorisation of Lunsumio monotherapy for third-line or later (3L+) FL to full approval, as well as to secure an indication in second-line or later (2L+) FL.

Lunsumio is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme. It is designed with the unique needs and preferences of patients in mind, offering the possibility of outpatient treatment and flexibility between intravenous and subcutaneous administration routes. Lunsumio is already approved for people with 3L+ FL in 60 countries worldwide and has been used to treat over 3,800 patients.1

With the longest follow-up data of any bispecific antibody in lymphoma and a broad clinical development programme spanning multiple disease settings, including both FL and diffuse large B-cell lymphoma (DLBCL), Lunsumio is helping redefine care across B-cell malignancies. The U.S. Food and Drug Administration (FDA) recently accepted the supplemental Biologics License Application (sBLA) for Lunsumio in combination with Polivy (polatuzumab vedotin) for 2L+ DLBCL based on the SUNMO study, and results from CELESTIMO support continued expansion of Lunsumio and lenalidomide into earlier FL treatment, with the phase III MorningLyte study ongoing in first-line FL.

About the CELESTIMO study
CELESTIMO [NCT04712097] is a phase III trial evaluating the efficacy and safety of Lunsumio (mosunetuzumab) in combination with lenalidomide vs. MabThera/Rituxan (rituximab) plus lenalidomide in people with relapsed or refractory follicular lymphoma (FL) who have received at least one line of prior systemic therapy. It is a confirmatory study required to convert the accelerated approval/conditional marketing authorisation of Lunsumio monotherapy for third-line or later FL to full approval, as well as to secure an indication in second-line or later FL.

About follicular lymphoma
Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.2 It typically responds well to treatment but is often characterised by periods of remission and relapse.3 The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis.4 It is estimated that more than 110,000 people are diagnosed with FL each year worldwide.5

About Lunsumio (mosunetuzumab)
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate malignant B cells. Lunsumio is currently approved as a fixed-duration monotherapy for the treatment of adult patients with third-line or later relapsed or refractory follicular lymphoma (FL) in both intravenous and subcutaneous (Lunsumio VELO) formulations. A robust, global development programme is ongoing to explore the clinical utility of Lunsumio earlier in the disease course and in novel combinations, including the phase III CELESTIMO trial in second-line or later FL.

(Press release, Hoffmann-La Roche, SEP 17, 2026, View Source [SID1234670922])

On September 17, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, reported that the Hong Kong Intellectual Property Department has granted a patent for the Company’s proprietary platform technology for predicting the likelihood of lung cancer using flow cytometry and fluorescent markers to characterize cell populations in sputum.

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"The grant of this patent in Hong Kong and the 2025 patent we received from China strengthen the intellectual property protection for our technology in Asia, a region with a substantial burden of lung cancer," said Maria Zannes, President and CEO of bioAffinity Technologies. "With an estimated 1.6 million new lung cancer cases diagnosed annually across Asia,1 the region represents a significant potential market for noninvasive technologies like CyPath Lung that support earlier detection and more informed clinical decision-making that can lead to better patient outcomes."

Hong Kong Patent No. HK40048460, titled "System and Method for Determining Lung Health," covers, as described in the patent claims, the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum. The patented technology is the scientific foundation underlying CyPath Lung, which remains the centerpiece of the Company’s commercial efforts, providing physicians with a noninvasive tool to assess the likelihood of malignancy in lung nodules detected by low-dose CT scans and incidental imaging.

The Hong Kong patent complements bioAffinity’s expanding global patent estate, which now covers multiple patents and pending applications in the United States and other international jurisdictions, including Australia, Canada, China, the European Union, Japan, Mexico and Singapore. Together, these patents safeguard the core technology that powers the CyPath Lung test and other diagnostics in the Company’s pipeline.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve 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 indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. These clinical performance data relate to CyPath Lung’s use in the detection setting and have not been separately validated for post-treatment surveillance. The high NPV may help inform physician decision-making when evaluating whether further invasive procedures are warranted. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

(Press release, BioAffinity Technologies, SEP 17, 2026, View Source [SID1234670921])

On September 16, 2026 GenScript reported interim report ended June 2026.

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(Presentation, GenScript, SEP 16, 2026, View Source [SID1234670918])

On September 16, 2026 Theolytics, a clinical-stage biotechnology company developing next-generation oncolytic immunotherapies, reported that members of its senior leadership team will participate in a series of upcoming investor, partnering and scientific conferences, as growing clinical and industry interest in oncolytic viruses highlights their potential as a new generation of cancer immunotherapies.

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Theolytics will participate in the following events:

LSX Congress USA – September 23-24, 2026, Boston, MA, USA
Presentation: Growth Showcase – September 23 at 2.30 EST
BioCentury Grand Rounds Europe – September 23–25, 2026, Amsterdam, the Netherlands
Presentation: September 23 at 10.20 CET
ESMO Congress – October 23-27, 2026, Madrid, Spain
LSX Inv€$tival Showcase – November 16, 2026, London, UK
Presentation: Biotech Growth stage – November 16 at 10.30 UK
London Life Sciences Week – November 16-20, 2026, London, UK
David Apelian, CEO of Theolytics, said: "Recent clinical and regulatory progress is providing exciting validation of oncolytic viruses as an emerging new class of cancer immunotherapy. At Theolytics, we are building on this momentum by leveraging Adenovo, our proprietary 100,000,000 variant adenoviral library and platform, which is designed to overcome the major barriers that have historically limited the potential of oncolytic viruses, including IV delivery and sustained activity within stroma-rich solid tumours. These upcoming conferences provide an excellent opportunity to discuss the progress of our lead clinical product THEO-260 which is being administered intravenously in ovarian cancer patients in the OCTOPOD IV Study and exhibits 3 unique modes of action; 1) killing of cancer cells, 2) killing of stroma-producing cancer associated fibroblasts (CAFs), and 3) induction of anti-tumour immunity against cancer cells and CAFs."

Growing momentum in oncolytic immunotherapy

Recent advances have renewed interest in the potential of oncolytic viruses to treat cancer, including an important new US product approval and the potential for another oncolytic virus-based therapy to reach the US market in 2027. Alongside direct tumour-cell killing, increasing understanding of oncolytic virus biology has highlighted their potential to remodel the tumour microenvironment, turn immunologically "cold" tumours "hot" and stimulate local and systemic anti-tumour immune responses. This provides opportunities both as monotherapy and in combination with other cancer immunotherapies.

Theolytics is pioneering a differentiated approach to oncolytic immunotherapy, developing targeted adenoviral candidates designed for both direct and intravenous delivery and designed for sustained activity within the challenging microenvironment of stroma-rich tumours. Dense tumour stroma is an important feature of several major and difficult-to-treat cancers, including ovarian, colorectal and pancreatic ductal adenocarcinoma, as well as triple-negative breast cancer.

Theolytics’ lead candidate, THEO-260, is being evaluated in two clinical trials in patients with advanced ovarian cancer: through intravenous (IV) administration in the OCTOPOD-IV study in the UK, Spain and Canada (NCT06618235); and through intraperitoneal (IP) administration in the OCTOPOD-IP study at The University of Texas MD Anderson Cancer Center in the US (NCT07211659).

With funding secured from leading life sciences investors, together with an additional €8 million in non-dilutive funding from Horizon Europe, the European Union’s flagship research and innovation funding programme, Theolytics is well positioned to advance the clinical development of THEO-260 and explore the broader potential of its next-generation oncolytic immunotherapy platform across stroma-rich solid tumours.

(Press release, Theolytics, SEP 16, 2026, View Source [SID1234670914])

On September 16, 2026 Abalos Therapeutics reported the publication of two peer-reviewed studies in the medical journal Viruses showcasing the anti-tumor and immunostimulatory properties of its proprietary AdaptInnate approach to treating solid tumors. Preclinical mechanistic and in vivo data demonstrate how tumor-adapted mutations in the glycoprotein (GP) of lymphocytic choriomeningitis virus (LCMV) can influence tumor tropism, immune activation and anti-tumor activity. Together, these findings add to the strong scientific rationale supporting Abalos’ AdaptInnate approach, which leverages the unique properties of the non-lytic arenavirus lymphocytic chorimeningitis virus (LCMV) to trigger both adaptive and innate immune responses against the patient’s tumor, including distant metastases. Abalos is currently advancing ABX-001, its first candidate leveraging the AdaptInnate approach, in a Phase 1 study in patients with relapsed or refractory solid tumors.

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The publications, entitled "Mutations at Positions 181 and 185 Within the LCMV GP Protein Increase Tumor Cell Infectivity, Limit Induction of Type I Interferon, and Accelerate T Cell Activation" and "Lymphocytic choriomeningitis virus bearing GPC mutations for enhanced tumor tropism and strong anti-tumor activity," characterize the tumor-adapted I181M and R185W glycoprotein (GP) mutations and provide evidence that these naturally occurring adaptations enhance tumor specificity and penetration, promote increased T-cell recruitment and activation, and remodel the tumor microenvironment toward a more immunogenic state. Importantly, in vivo studies demonstrated a favorable safety profile of the mutated virus, where treatment was associated with only minimal adverse effects. Preclinical findings also demonstrated anti-tumor activity across diverse tumor immune landscapes and support the potential for future development in combination with checkpoint inhibition and adoptive T-cell therapy.

"These studies deepen our understanding of how defined modifications to LCMV can increase tumor tropism and activate immune responses, two hallmarks of our AdaptInnate approach. The preferential replication of the virus within tumors following a single systemic administration, coupled with the strong local T-cell responses observed in these studies, validate the on-target mechanism and limited off-tumor exposure," said Jörg Vollmer, Chief Scientific Officer of Abalos Therapeutics. "These insights further reinforce the potential of this approach to generate durable and highly specific anti-tumor immune responses across tumors with diverse immune profiles, helping address key challenges faced by patients with cancers that remain insufficiently responsive to existing immunotherapies."

The new findings corroborate Abalos’ previously published work in Cell Reports Medicine, which characterized the company’s lead candidate ABX-001. Collectively, these studies strengthen the scientific rationale underlying Abalos’ AdaptInnate approach, which uses systemically administered, non-lytic arenaviruses designed to selectively target solid tumors and trigger body-wide durable innate and adaptive immune responses enabled by sustained viral activity in tumor and immune cells without destroying them.

"We are continuing to add important mechanistic evidence supporting our differentiated AdaptInnate approach and its potential to harness the immune-activating properties of arenaviruses to drive targeted and durable immune responses against tumors," said Gerben Moolhuizen, Chief Executive Officer of Abalos Therapeutics. "With initial clinical data for our lead candidate ABX-001 on the horizon, we are on the cusp of bringing a novel drug modality from promising preclinical data to first-in-human evaluation, further defining the therapeutic power of this approach in cancer patients with limited treatment options."

The Phase 1 clinical trial (NCT07231458) is a first-in-human, open-label, multicenter study evaluating the safety, tolerability and preliminary anti-tumor activity of ABX-001 in patients with refractory or relapsed advanced solid tumors. The study’s early efficacy endpoints include overall response rate (ORR), as well as changes in target lesion size. Patient recruitment has been completed, and topline data are expected in 2027.

(Press release, Abalos Therapeutics, SEP 16, 2026, View Source [SID1234670913])