Oncolytics Biotech® Reports FDA Regulatory Milestone and Strong Clinical Progress in Randomized RAS-Mutant MSS Colorectal Cancer Trial

On July 13, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, reported a clinical and regulatory update on REO 033, the Company’s randomized controlled study evaluating pelareorep in combination with folinic acid, fluorouracil and irinotecan ("FOLFIRI") and bevacizumab for the second-line treatment of patients with Rat Sarcoma ("RAS")-mutant, microsatellite stable ("MSS") metastatic colorectal cancer.

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REO 033 builds upon the previously reported REO 022 study, which more than doubled historical standard-of-care benchmarks across progression-free survival, overall survival, duration of response, and objective response rate.1-4 Based on these data, pelareorep has received Fast Track designation from the U.S. Food and Drug Administration ("FDA") for this indication. The multi-part randomized REO 033 study is designed to prospectively validate these encouraging findings against a contemporary control arm while advancing pelareorep toward a potential registration pathway. The Company continues to make rapid operational progress in Part A of REO 033 (n=60 patients), with approximately half of the planned clinical sites activated by the end of July, and more than 20 patients have been pre-identified across participating centers. The remaining sites are expected to be activated by the end of August, positioning the study for accelerated enrollment during the second half of 2026. Most recently, global lead principal investigator Dr. Sanjay Goel and his team opened enrollment at Rutgers Cancer Institute of New Jersey.

"The magnitude and durability of the efficacy observed in REO 022 warrant earnest evaluation in a randomized setting," said Dr. Sanjay Goel, Global Lead Principal Investigator for REO 033 and Professor of Medicine and Director of the Phase I Program at Rutgers Cancer Institute of New Jersey. "It is encouraging to see REO 033 expanding rapidly across leading academic centers, and I believe this study has the potential to further define the role of pelareorep in RAS-mutant MSS metastatic colorectal cancer."

The Company also announced that it will hold a Type D meeting with the FDA in the first half of August 2026 to discuss the registrational design for REO 033 through the addition of Part B of the study. Building on the currently enrolling Part A of the study, this new registration-directed Part B would preserve the core design elements of REO 033 while increasing enrollment and incorporating blinded independent central review to support both a potential accelerated approval and a traditional full approval within the same study. The Company intends to align with the FDA on a registrational pathway that preserves the operational efficiencies already established through REO 033 while maintaining continuity with the existing clinical program under a prospectively agreed regulatory framework.

"Launching a global randomized study with multiple high-quality sites in a short period of time reflects the operational capabilities of our clinical organization and our investigators," said Jared Kelly, Chief Executive Officer of Oncolytics. "Just as importantly, our ongoing interactions with the FDA have enabled us to focus on efficiently transitioning REO 033 into a registration-directed program built upon the existing trial infrastructure. We believe this strategy has the potential to significantly reduce development timelines while maintaining scientific rigor as we work to bring a much-needed immunotherapeutic option to patients in a treatment landscape that desperately needs innovation."

The Company believes this approach provides the opportunity to generate early randomized efficacy data from Part A while simultaneously positioning Part B as a potential registrational study without the need to initiate a separate registrational trial. It also expects to report an initial tumor response update from patients enrolled in Part A by year-end 2026 and, subject to FDA feedback, initiate enrollment in Part B of the study during the first quarter of 2027.

About REO 033
REO 033 is a multi-part randomized controlled clinical trial evaluating pelareorep in combination with FOLFIRI and bevacizumab versus FOLFIRI and bevacizumab alone in patients with second-line RAS-mutant, microsatellite stable metastatic colorectal cancer (link to study on ClinicalTrials.gov). The study is designed to confirm the encouraging efficacy signals observed in REO 022 while generating the controlled clinical data necessary to support future regulatory interactions and potential registration.

(Press release, Oncolytics Biotech, JUL 13, 2026, View Source [SID1234669170])

Jemperli (dostarlimab) achieves sustained clinical complete responses in dMMR/MSI-H locally advanced rectal cancer

On July 13, 2026 GSK plc (LSE/NYSE: GSK) reported positive interim results from the registrational phase II AZUR-1 trial of Jemperli (dostarlimab) in patients with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer. The single arm trial met its primary objective, showing a meaningful and sustained clinical complete response rate at 12 months (cCR12).

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These results support the potential for dostarlimab, if approved, to become the first immunotherapy capable of eliminating or delaying the need for chemotherapy, radiation and surgery for some patients in this population.

Rectal cancer, a type of bowel cancer, affects around 730,000 people globally each year1 and approximately 5-10% of all rectal cancers have the dMMR/MSI-H subtype2. Current standard of care typically includes chemotherapy, radiation, and surgery3. While often effective, these treatments can profoundly impact a patient’s quality of life, potentially leading to lifelong use of a colostomy bag, significant physiological dysfunction, and infertility4,5,6.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data demonstrate that some patients may be able to avoid those interventions while remaining free of detectable signs of cancer."

AZUR-1 results represent a substantial improvement compared to the historical standard of care7 and build on earlier research conducted in collaboration with Memorial Sloan Kettering Cancer Center, which first demonstrated the potential for dostarlimab to achieve clinical complete responses without other treatments in patients with dMMR/MSI-H locally advanced rectal cancer.

In interim data, the safety and tolerability profile of dostarlimab was consistent with its well-characterised and manageable safety profile observed across solid tumours.

Dostarlimab has received both Breakthrough Therapy and Fast Track designations from the US Food and Drug Administration (FDA) in this setting. GSK plans to share interim AZUR-1 data with global regulatory authorities to support review. Detailed results will be presented at a future scientific congress.

About stage II/III dMMR/MSI-H locally advanced rectal cancer
Around 5–10% of rectal cancers are mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H)8. These tumours have a specific genetic characteristic where they are unable to properly repair DNA damage, leading to an accumulation of mutations. This unique biological feature often makes them highly responsive to immunotherapies like dostarlimab9,10. These biomarkers are most commonly found in colorectal, endometrial and other gastrointestinal cancers, but can also be present in other solid tumours11.

About AZUR-1
AZUR-1 is a global, open-label, single-arm, registrational phase II trial evaluating dostarlimab monotherapy in patients with stage II/III dMMR/MSI-H locally advanced rectal cancer. The trial was designed to assess sustained clinical complete responses for 12 months (cCR12) and determine whether dostarlimab alone could enable patients to avoid chemotherapy, radiation and/or surgery. A total of 154 participants received nine cycles of dostarlimab over six months, administered as a 500 mg intravenous infusion every three weeks.

About Jemperli (dostarlimab)
Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immuno-oncology-based research and development programme. A robust clinical trial programme includes studies of Jemperli alone and in combination with other therapies in gynaecologic, colorectal and head and neck cancers, as well as where there are opportunities for transformational outcomes.

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli.

More information about Jemperli, its indications and complete important safety information is available at EU product information12 and US product information13. Jemperli is not currently approved anywhere in the world for rectal cancer.

(Press release, GlaxoSmithKline, JUL 13, 2026, View Source [SID1234669169])

U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s New Drug Application for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma

On July 13, 2026 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma (RRMM). Mezigdomide is an oral cereblon E3 ligase modulator, or CELMoD, for the treatment of multiple myeloma. The FDA has granted a Prescription Drug User Fee Act (PDUFA) date of May 13, 2027 for this indication.

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"The FDA’s acceptance of our application for mezigdomide highlights the continued momentum of our targeted protein degradation programs, as we now have two distinct agents under review in relapsed or refractory multiple myeloma, which remains a persistent disease," said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. "We’re rapidly progressing the development of our CELMoD pipeline and are committed to leveraging this platform to bring the next wave of advances for patients in both hematologic malignancies and solid tumors."

The filing was based on positive results from the Phase 3 SUCCESSOR-2 trial (NCT05552976) showing MeziKd demonstrated a clinically meaningful and statistically significant improvement in progression-free survival (PFS) (95% CI: 18.0 months vs. 8.3 months [HR:0.48; p<0.0001]), representing a 52% reduction in the risk of disease progression or death compared with Kd in patients with relapsed or refractory multiple myeloma, including those at first relapse after prior treatment with an anti-CD38 monoclonal antibody and lenalidomide. The safety profile of MeziKd was consistent with that observed in prior studies of mezigdomide, as well as with the known safety profiles of the individual agents in the regimen. Results were recently presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting as a late-breaking oral presentation and published in The Lancet.

Bristol Myers Squibb thanks the patients and investigators involved with the Phase 3 SUCCESSOR-2 study.

About mezigdomide
Mezigdomide is an oral CELMoD specifically optimized to modulate cereblon for maximal and rapid degradation of Ikaros and Aiolos target proteins, leading to higher multiple myeloma cell killing and immune stimulation than traditional immunomodulatory agents. Pre-clinical data suggest mezigdomide enhances T cell function and prevents and reinvigorates an exhausted immune system.​ Mezigdomide is also being evaluated in the ongoing Phase 3 SUCCESSOR-1 trial vs. standard of care regimen in relapsed or refractory multiple myeloma.

About SUCCESSOR-2
There is a growing number of patients exposed and/or refractory to lenalidomide and anti-CD38 antibodies from first relapse. The SUCCESSOR-2 trial addressed this growing need. SUCCESSOR-2 (NCT05552976) is an inferential, seamless Phase 3, multicenter, randomized, open-label study evaluating the efficacy and safety of mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM).

The primary endpoint of the Phase 3 study is progression-free survival. Key secondary endpoints include overall survival, overall response rate, duration of response, time to progression, time to next treatment, minimal residual disease negativity, and health-related quality of life.

Dose optimization for mezigdomide occurred in stage 1. The mezigdomide dose selected for stage 2 of the study was 1.0 mg. In total, 479 patients (288 MeziKd at 1.0 mg of mezigdomide; 191 Kd) were included in the analysis. Across both arms, median age was 68 with 25.1% of patients ≥75 years old; median number of prior therapies was 2; 92.1% of patients were triple-class-exposed, with 85.8% refractory to an anti-CD38 monoclonal antibody and 75.8% to lenalidomide; 37.2% were exposed to pomalidomide and 7.3% to anti-BCMA treatment. At data cutoff, median follow-up was 10.6 months with 52.4% (MeziKd) and 31.4% (Kd) of patients still on treatment.

About Targeted Protein Degradation and CELMoD
Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered difficult to address. BMS is the only company that has successfully developed and commercialized protein degrader agents for the treatment of multiple myeloma. These agents, known as immunomodulatory drugs (IMiDs), helped establish the current standard of care in the treatment of this disease, which remains without a cure. BMS is building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including CELMoD, ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach enables matching the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provides more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology.

(Press release, Bristol-Myers Squibb, JUL 13, 2026, View Source;Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-New-Drug-Application-for-Mezigdomide-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx [SID1234669168])

Agenus Announces Oversubscribed Private Placement of Up to $340 Million to Advance Registrational ROBBIN Trial of Neoadjuvant BOT+BAL in MSS Colon Cancer

On July 13, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported that it has entered into a securities purchase agreement for a private placement of approximately $85 million in upfront gross proceeds, before the deduction of private placement expenses, and up to an additional $255 million upon the full exercise of purchase warrants. The financing was led by Commodore Capital, with participation from RA Capital Management, TCGX, Invus, and Ligand Pharmaceuticals.

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The net proceeds of this financing are expected to support Agenus’ strategic prioritization of botensilimab and balstilimab (BOT+BAL) for the neoadjuvant treatment of microsatellite-stable (MSS) colon cancer, including advancement of ROBBIN1, the Company’s planned registrational Phase 3 neoadjuvant trial in microsatellite-stable (MSS) colon cancer. High-risk Stage II and Stage III MSS colon cancer affect an estimated 38,000 patients annually in the US and more than 200,000 patients worldwide,2 representing an estimated US addressable annual sales opportunity of more than $7 billion, with no new curative-intent therapies approved in more than 20 years.3

As described below, under the terms of the private placement, the Company will issue shares of its common stock (or, in lieu thereof, pre-funded warrants to purchase common stock) for approximately $85 million in upfront gross proceeds, before the deduction of private placement expenses, and an accompanying "Series A" purchase warrant and "Series B" purchase warrant that, if fully exercised, would provide an additional $255 million in gross proceeds, for a combined total of up to $340 million in gross proceeds. Assuming the exercise in full of the warrants, Agenus expects the financing to fund completion of ROBBIN, with runway through year-end 2031. The private placement is expected to close on or about July 15, 2026, subject to customary closing conditions. The upfront purchase price per share, along with the exercise prices for the Series A and Series B warrants, were all priced at a premium to the market closing price per share as of Friday, July 10th, 2026.

Agenus’ Strategic Prioritization of Neoadjuvant BOT+BAL

Across NEST and UNICORN, two independent Phase 2 studies evaluating neoadjuvant BOT+BAL in MSS colorectal cancer (CRC), BOT+BAL has produced deep, durable responses, including pathologic response (PR) in approximately 60-70% of patients, major pathologic response (MPR) in approximately 35-40% of patients and pathologic complete response (pCR) in approximately 30% of patients. Deep pathologic responses (MPR and pCR) in the neoadjuvant setting are positively correlated with event-free survival in many tumor types, including MSS colon cancer.4 With median follow-up of approximately 9 to 18 months, all treated patients remained disease free. This treatment effect has persisted in updates from NEST and UNICORN, and further details are anticipated to be published later this year. Together with observed circulating tumor DNA (ctDNA) clearance during treatment, these data support Agenus’ rationale for prioritizing neoadjuvant BOT+BAL development in the registrational ROBBIN study.5,6

ROBBIN is Agenus’ planned randomized global Phase 3 trial evaluating neoadjuvant BOT+BAL followed by standard of care versus standard of care alone in previously untreated high-risk Stage II and Stage III MSS colon cancer. The ROBBIN trial will enroll 850 patients, randomized 1:1, with event free survival (EFS) as its primary endpoint. Following interactions with the US Food and Drug Administration (FDA), Agenus has aligned with the FDA on key elements of the Phase 3 design, including the patient population, experimental regimen, control arm, primary endpoint, and interim analysis plan.

"We have seen neoadjuvant and perioperative immunotherapy improve outcomes in immunologically ‘hot’ or ‘warm’ tumors such as melanoma and lung cancer, but MSS colon cancer — a ‘cold’ tumor — has resisted standard checkpoint inhibitors. BOT was engineered to overcome that resistance and has produced deep pathologic responses with no recurrences reported in the NEST and UNICORN studies. With the ROBBIN trial, we are bringing this regimen to patients with high-risk Stage II and Stage III MSS colon cancer, where treating an intact tumor gives BOT+BAL its greatest opportunity to generate a durable immune response and improve long-term outcomes," said Dr. Steven O’Day, Chief Medical Officer of Agenus.

In connection with its strategic prioritization of neoadjuvant BOT+BAL in MSS colon cancer, Agenus plans to discontinue financial support for the ongoing BATTMAN Phase 3 study in late-line metastatic MSS CRC. Agenus will honor its obligations to patients currently receiving treatment and will work closely with the Canadian Cancer Trials Group (CCTG) and participating investigators to manage this transition responsibly. The Company remains deeply grateful to the clinicians, site teams, CCTG, and patients who have contributed to advancing BOT+BAL in late-stage disease.

"Since Agenus was founded 32 years ago, our mission has been to harness the immune system to improve outcomes and, where possible, cure cancer," said Garo H. Armen, Ph.D., Founder, Chairman and Chief Executive Officer of Agenus. "Our plan to prioritize neoadjuvant BOT+BAL in MSS colon cancer reflects both the strength of the emerging clinical evidence and the opportunity to bring this important combination regimen to patients where it may have the greatest impact. With ROBBIN, we are advancing a randomized global trial designed to confirm the rapid and deep activity observed across the NEST and UNICORN trials."

Upcoming ROBBIN catalysts include the following:


First patient dosed: anticipated in Q1 of 2027


Interim pathologic response data: anticipated in second half of 2027


Interim analysis of EFS: anticipated in second half of 2029


Final analysis of EFS: anticipated in second half of 2030

Conference Call and Webcast

Agenus will host a conference call and live webcast today at 8:30am ET to discuss the financing and ROBBIN trial strategy. The call will feature Myriam Chalabi, M.D., Ph.D., of the Netherlands Cancer Institute, a leading investigator in neoadjuvant immunotherapy for colorectal cancer, and Pashtoon Kasi, M.D., M.S. of City of Hope Hospital, who will provide independent clinical perspectives on the program.

To access the live webcast, please https://bit.ly/3TfulyN | Passcode: 460308

Participants may also join by dialing (309) 205-3325 and using Webinar ID: 973 3388 7478. A replay of the webcast will be available on the Agenus website at View Source following the event.

Up To $340 Million Private Placement

Under the terms of the securities purchase agreement announced today, the Company has agreed to issue and sell (i) 23,035,227 shares of the Company’s common stock (or, in lieu thereof, pre-funded warrants to purchase shares of common stock, with an exercise price of $0.01 per share), (ii) accompanying Series A purchase warrants to purchase 21,144,277 shares of common stock, with an exercise price of $4.02 per share and (iii) accompanying Series B purchase warrants to purchase 33,797,214 shares of common stock, with an exercise price of $5.03 per share. The combined effective purchase price per share (or pre-funded warrant to purchase one share) and accompanying Series A purchase warrant to purchase approximately 0.91791 shares of common stock and Series B purchase warrant to purchase approximately 1.46720 shares of common stock, is $3.69 (less the exercise price of the pre-funded warrant, if applicable).

Each pre-funded warrant will be exercisable immediately and will not expire until exercised in full. Each pre-funded warrant will contain customary beneficial ownership limitation provisions.

Each Series A purchase warrant will be exercisable immediately and will expire upon the earlier of the fifth anniversary of the private placement closing date and the date that is 30 days following the day that the Company publicly discloses (either by press release or Current Report of Form 8-K) that at least 60 patients have been dosed in the Phase 3 clinical trial of the Company’s BOT+BAL combination product candidate for the neoadjuvant treatment of colon cancer (the "ROBBIN" trial). Each Series B purchase warrant will be exercisable immediately and will expire upon the earliest of (i) the fifth anniversary of the private placement closing date, (ii) the date that is 30 days following the day that the Company publicly discloses (either by press release or Current Report of Form 8-K) pathologic response data for at least 50 patients that were dosed with BOT+BAL in the Phase 3 clinical trial of the Company’s BOT+BAL combination product candidate for the neoadjuvant treatment of colon cancer (the "ROBBIN" trial) and (iii) unless the holder thereof shall at such time have exercised in full the Series A purchase warrant held by such holder, 12:01 a.m. (New York City time) on the date immediately following the expiration date of the Series A purchase warrant

Pursuant to the terms of the securities purchase agreement, the Company has also agreed to increase the size of its board of directors to nine directors, including two newly created Class III directorships under the Company’s certificate of incorporation, and, promptly following a designation notice made by Commodore Capital Master LP, cause two individuals designated by Commodore Capital Master LP to be appointed to serve as directors in the newly created Class III directorships.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and will be sold in a private placement pursuant to Regulation D of the Securities Act. The securities being issued in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Concurrently with the execution of the securities purchase agreement, the Company and the investors also entered into a registration rights agreement pursuant to which the Company has agreed to register the resale of the shares of common stock sold in the private placement and the shares of common stock issuable upon exercise of the pre-funded warrants, the Series A purchase warrants and the Series B purchase warrants sold in the private placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the foregoing securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Agenus, JUL 13, 2026, View Source [SID1234669167])

Antengene Announces Receipt of USD 60 Million Upfront Payment from UCB

On July 13, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies, reported that the company has received a USD 60 million upfront payment from UCB. This payment is made pursuant to the worldwide exclusive license agreement for ATG-201, a CD19/CD3 bispecific T-cell engager (TCE) antibody, entered into between the parties in March 2026.

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ATG-201 is a CD19 targeting bispecific TCE incorporating steric hindrance masking technology, designed to eliminate CD19-expressing B cells. This bispecific interaction with T and B cells through CD3 and CD19 has demonstrated potential in treating B cell-driven diseases by leveraging the body’s own immune system for precise and potent action.

Under the agreement, Antengene grants UCB a worldwide exclusive license to further develop, manufacture, and commercialize ATG-201, along with access to its associated manufacturing technology.

China’s National Medical Products Administration (NMPA) approved in June this year the Investigational New Drug (IND) application for the Phase I ATTRACT study of ATG-201 for the treatment of B cell related autoimmune diseases. Antengene is progressing the Phase I study of ATG-201 in China and concurrently preparing for its clinical development in Australia.

The receipt of the upfront payment from this license agreement with UCB has further strengthened Antengene’s cash position, providing robust financial support for the advancement of our innovative drug pipeline and accelerating benefits to more patients.

Under the terms of the global exclusive license agreement Antengene is eligible for additional near-term milestone payments of USD 20 million subject to certain conditions. The agreement also includes the potential for future success-based development and commercial milestone payments, as well as tiered royalties on future net sales.

(Press release, Antengene, JUL 13, 2026, View Source [SID1234669160])