On February 26, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy (Press release, Regeneron, FEB 26, 2025, View Source [SID1234650637]). The target action date for the FDA decision is July 30, 2025 .

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Acceptance of the BLA resubmission follows the achievement of an FDA-mandated enrollment target for the Phase 3 confirmatory trial in R/R FL ( OLYMPIA -1). This was the sole approvability issue identified by the FDA in the complete response letter associated with the previous submission. The BLA resubmission is supported by data from the Phase 1 and pivotal Phase 2 trials (ELM-1 and ELM-2), which demonstrated an overall response rate of 80% (n=103), with 74% (n=95) achieving a complete response. Serious adverse events occurred in 67% of patients; those occurring in ≥10% of patients included cytokine release syndrome, COVID-19 and pneumonia.

Odronextamab is approved as Ordspono in the European Union for the treatment of R/R FL or diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy although its safety and efficacy have not been fully evaluated by any other regulatory authority. For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu.

About FL
FL is one of the most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). While FL is a slow-growing subtype, it is an incurable disease, and most patients will relapse after initial treatment. It is estimated that approximately 122,000 FL cases are diagnosed globally every year with more than 13,600 FL cases anticipated in the U.S. in 2025.

About the Odronextamab Clinical Development Program
Odronextamab is a CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to investigate the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies previously treated with CD20-directed antibody therapy.

ELM-2 is an ongoing, open-label, multicenter Phase 2 trial investigating odronextamab across five independent disease-specific cohorts, including DLBCL, FL, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-NHL. The primary endpoint is objective response rate according to the Lugano Classification as assessed by independent review committee, and secondary endpoints include complete response, progression-free survival, overall survival and duration of response. The pivotal results in FL were published in the Annals of Oncology.

Odronextamab is being investigated in a broad clinical development program exploring its use as a monotherapy as well as in combination regimens in several types of B-NHLs in earlier lines of therapy. In FL, odronextamab is being evaluated as a monotherapy against rituximab plus standard-of-care chemotherapies in a Phase 3 confirmatory trial ( OLYMPIA -1) and in combination with chemotherapy against rituximab plus standard-of-care chemotherapies in a separate Phase 3 trial ( OLYMPIA -2). For more information on Regeneron’s clinical trials in blood cancer, visit the clinical trials website or contact via [email protected] or +1 844-734-6643.

On February 26, 2025 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported that management will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Wednesday, March 5, at 1:10 p.m. ET (Press release, Arcellx, FEB 26, 2025, View Source [SID1234650653]).

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A live webcast of this discussion will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.

On February 26, 2025 Starpharma (ASX: SPL, US OTC: SPHRY), an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, reported its Interim Report and Half-Year Financial Results for the period ended 31 December 2024 (H1 FY25) (Press release, Starpharma, FEB 26, 2025, View Source [SID1234650765]).

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Starpharma’s Chief Executive Officer, Cheryl Maley, commented:
"In the first half of FY25, Starpharma has made good progress in executing our strategy, aimed at maximising the value of our DEP assets, accelerating early asset development, and building longterm sustainability. I know our internal progress may not always be evident externally, but I can vouch for the dedication and hard work of everyone at Starpharma as we work towards achieving our strategic objectives.

"We have made important progress in advancing our DEP clinical assets, particularly DEP SN38, which has shown promising clinical outcomes in patients with high unmet need. A key regulatory milestone during the period was the recent meeting with the US Food and Drug Administration (FDA) regarding DEP SN38. The FDA provided feedback on the path to market for DEP SN38, confirming that the 505(b)(2) regulatory approval pathway is appropriate for DEP SN38 and the potential for Fast Track designation and accelerated approval. The positive response from the US regulator increases our confidence in the potential of DEP SN38 for treating platinum-resistant ovarian cancer. During the six months to December, our partner engagement through ongoing meetings and conference participation highlighted the importance of FDA feedback to potential partners for the commercialisation of DEP SN38.

On February 26, 2025 Tyercan reported that its independently developed first-in-class drug, Tye1001, reported clinical trial approval from China’s NMPA, following its approval by the US FDA on July 12, 2024 (Press release, Shanghai Medicilon, FEB 26, 2025, View Source [SID1234651889]). This marks a significant milestone of dual approval in both China and the US.

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As Tyercan’s partner, Medicilon delivered comprehensive GLP-compliant preclinical services, including pharmacodynamics, pharmacokinetics, and safety assessment, accelerating the R&D process.

Tye1001: Redefining Targeted Tumor Therapy
Tye1001 is a novel anti-tumor protein drug for advanced solid tumors and lymphomas. It consists of a highly potent and toxic small-molecule toxin conjugated to a specific drug carrier. The drug primarily targets solid tumors through the EPR effect in tumor vasculature and specific receptors on cell surfaces. It enters tumor cells via endocytosis, degrades in lysosomes, and releases the toxin small-molecule, which targets cell microtubules to inhibit tumor growth.

Preclinical data shows that Tye1001 has broad anti-tumor activity, with significant efficacy in various mouse models of gastric cancer, lymphoma, nasopharyngeal cancer, and others. Its high safety profile offers a promising new treatment option for patients and strong scientific support for future clinical development.

The dual approval of Tye1001 in China and the US not only highlights Tyercan ‘s R&D strength but also demonstrates its innovation in the PDC field and leadership in tumor-targeted therapy.

Medicilon’s XDC R&D Platform: Accelerating Preclinical R&D and Dual Submissions
Medicilon’s close collaboration with Tyercan played a key role in Tye1001’s success. Tye1001 is a coupling drug based on the presence of corresponding endogenous protein, with high potential interference and high bioanalytical challenges, Medicilon’s analytical scientists overcame complex bioanalytical challenges through innovative tool antibody development and validation strategies.

It is also worth mentioning that Medicilon’s solid and comprehensive preclinical research capabilities, which have successfully helped 28 ADC drugs to be approved in the clinic, have laid a solid foundation for Tye1001’s dual reporting and approval in China and the US.

As one of China’s earliest CROs to offer full-service preclinical research compliant with both Chinese GLP and U.S. GLP standards, Medicilon has contributed to approximately 520 IND approvals, including 86 U.S. FDA approvals and 60 dual submissions (data as of the end of 2024).

Medicilon congratulates Tailikon on Tye1001’s dual IND approvals and looks forward to its continued success in clinical trials. Medicilon will continue to enhance its integrated preclinical R&D platform, empowering pharmaceutical companies to overcome drug R&D challenges.

On February 26, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported has it has dosed its final patient in the third cohort of its ongoing Phase 1 clinical trial evaluating its novel chimeric antigen receptor-T cell (CAR-T) therapy for recurrent ovarian cancer (Press release, Anixa Biosciences, FEB 26, 2025, View Source [SID1234650622]). The study is being conducted through a research partnership with Moffitt Cancer Center ("Moffitt"). The fourth cohort is expected to commence after a 30-day verification that there continue to be no adverse effects experienced by the third cohort.

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The third cohort in the trial received a dose of one million CAR-positive cells per kilogram of patient weight, which represents a tenfold increase compared to the first cohort. This escalation is an important step in evaluating the safety and efficacy of CAR-T therapy for ovarian cancer patients. The fourth cohort will increase the dosage by another factor of three.

Anixa’s FSHR-mediated CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells. The first-in-human trial (NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor efficacy.

Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "With the completion of the third cohort, we are gaining important insights into the potential of CAR-T therapy for ovarian cancer. Increasing the dose is a key step in evaluating the therapy’s effectiveness while ensuring patient safety. Additionally, the recent approval of our protocol amendment allows eligible patients to receive a second dose if they may benefit from it. This amendment also expands enrollment criteria to include rare ovarian cancer subtypes, making the therapy accessible to more patients. Now, all eligible participants can receive a second dose without requiring separate IND approvals, helping us better assess the full potential of this treatment. As we move forward with the fourth cohort, we remain committed to advancing our CAR-T program with the goal of improving treatment options for ovarian cancer patients."