On May 2, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that its management team is scheduled to present at the BofA Securities 2025 Health Care Conference on Wednesday, May 14, 2025, at 8:00 am PT/11:00 am ET (Press release, Agios Pharmaceuticals, MAY 2, 2025, View Source [SID1234652475]).

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The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

On May 2, 2025 Genmab A/S (Nasdaq: GMAB) reported its intention to submit in the first half of 2025 a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab, a bispecific antibody being investigated in combination with rituximab and lenalidomide (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), following at least one prior systemic therapy (Press release, Genmab, MAY 2, 2025, View Source [SID1234652444]).

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The decision to submit the sBLA is supported by positive topline results from the Phase 3 EPCORE FL-1 trial evaluating epcoritamab plus R2 versus R2 alone in adult patients with R/R FL. Based on an interim analysis conducted by an Independent Data Monitoring Committee (IDMC) review, the study met one of its dual primary endpoints of ORR (Complete Response plus Partial Response, p-value < 0.0001). The safety profile of epcoritamab plus R2 in adult patients with R/R FL was consistent with the known safety profiles of the individual regimens (epcoritamab and R2) and as presented in the U.S. prescribing information for epcoritamab. No new safety signals were observed. The full results will be submitted later this year for presentation at an upcoming medical congress and discussed with global regulatory authorities.

"We are pleased with the strength of the data that allows us to submit a supplemental Biologics License Application in accordance with the U.S. FDA’s Project Frontrunner, which supports our commitment to advance novel medicines to patients who need them. The interim topline results demonstrate the potential of this investigational epcoritamab combination regimen to treat relapsed or refractory follicular lymphoma patients," said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab. "This milestone represents our commitment to the ongoing development of epcoritamab, with our partner AbbVie, and we look forward to seeing the full results from the study."

Use of epcoritamab plus R2 in R/R FL is not approved in the U.S., in the EU or in any other territory. The safety and efficacy of epcoritamab for use as a combination therapy in FL have not been established. Epcoritamab is currently approved by the FDA under Accelerated Approval as a monotherapy for the treatment of adults with R/R FL after two or more lines of systemic therapy.

About Follicular Lymphoma (FL)
FL is typically an indolent (or slow-growing) form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL accounting for 20-30 percent of all cases.i About 15,000 people develop FL each year in the U.S.ii and it is considered incurable with current standard of care therapies.iii Patients often relapse and, with each relapse the remission and time to next treatment is shorter.iv Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25 percent of FL patients.v

About the EPCORE FL-1 Trial
EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The dual primary endpoints are ORR and progression-free survival assessed by independent review committee (IRC) per Lugano criteria.

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vi

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

On May 1, 2025 Nutcracker Therapeutics, Inc., a contract, research, development and manufacturing organization (CRDMO) with a next ​generation RNA precision manufacturing platform, reported its participation in two premier industry events this May: the 3rd mRNA Process Development & Manufacturing Summit Europe in Berlin and the 2025 TIDES USA Conference in San Diego (Press release, Nutcracker Therapeutics, MAY 1, 2025, View Source [SID1234652469]). The company will also serve as an Official Expertise Partner for the Process Development & Manufacturing Summit Europe and an Associate Sponsor of TIDES USA.

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3rd mRNA Process Development & Manufacturing Summit Europe

Location: Hotel Palace Berlin, Berlin, Germany

Dates: May 6–8, 2025

Nutcracker Therapeutics’ Director of Biochip Research and Development, Babak Sanii, will present the company’s approach to rapid, personalized mRNA manufacturing using its proprietary NMU-Symphony platform. The talk will highlight how the company’s fully integrated, end-to-end microfluidic manufacturing process enables the production of personalized cancer therapies (PCTs) in as little as three weeks — from RNA design to patient-ready injectable vials. The use of single-use biochips ensures a closed, sterile system that eliminates the risk of patient-to-patient cross-contamination, supporting both scalability and safety in PCTs.

Presentation Title: End-to-End Microfluidic Manufacturing of Personalized Cancer Treatments

Presenter: Babak Sanii, director of biochip research and development
Date & Time: May 8, 2025, at 2:00 PM (local time)
Session: Scaling mRNA Manufacturing: Seamless Transitions from Lab to Market to Ensure Consistent Quality for Meeting Growing mRNA Vaccine & Therapeutic Demands
2025 TIDES USA

Location: Manchester Grand Hyatt San Diego, San Diego, CA

Dates: May 19–22, 2025

At TIDES USA, Colin McKinlay, senior director of chemistry and delivery technologies, will showcase Nutcracker Therapeutics’ suite of proprietary technologies, including BaseCracker for antigen construct design, CodonCracker for RNA sequence optimization, and its novel Nutshell delivery vehicles — all key elements in assembling PCTs. These tools are seamlessly integrated into NMU-Symphony, which enables fully enclosed synthesis of RNA drugs with quality, speed, and scalability.

Presentation Title: mRNA Manufacturing on the NMU-Symphony — A Rapid End-to-end Platform for the Design, Microfluidic Synthesis, and Delivery of Personalized Cancer Therapeutics

Presenter: Colin McKinlay, senior director, chemistry and delivery technologies
Date & Time: May 21, 2025, at 1:30 PM (local time)
For more information about these conferences, please visit the mRNA Process Development and Manufacturing Summit Europe and the TIDES USA websites. In addition, please visit Nutcracker Therapeutics’ CRDMO webpage for more information about its services.

On May 1, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that its management team is scheduled to participate and present at the following investor conferences in May (Press release, Verastem, MAY 1, 2025, View Source [SID1234652468]):

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H.C. Wainwright 3rd Annual BioConnect Investor Conference: Fireside chat on Tuesday, May 20 at 12:00 pm ET
2025
RBC Capital Markets Global Healthcare Conference: Fireside chat on Tuesday, May 20 at 3:35 pm ET
Alliance Global Partners/A.G.P.’s Annual Healthcare Company Showcase: Virtual fireside chat on Wednesday, May 21 at 10:20 am ET
A live webcast of the fireside chats can be accessed under events on Verastem Oncology’s website at www.verastem.com. A replay of the webcasts will be archived on the website for approximately 90 days following the presentation.

On May 1, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company tackling some of the toughest challenges in cancer treatment, reported that Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in a fireside chat at The Citizens Life Sciences Conference on Thursday, May 8, 2025, at 10:00 a.m. ET in New York, NY (Press release, Nuvation Bio, MAY 1, 2025, View Source [SID1234652467]).

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A live webcast of the presentation will be available on the Nuvation Bio website at View Source An archived recording will be available for 90 days following each event.