On May 14, 2025 Genmab A/S (Nasdaq: GMAB) reported that it will present 14 abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy and in combination across disease settings in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) at the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Congress, being held in Milan, Italy, and virtually, June 12-15, 2025 (Press release, Genmab, MAY 14, 2025, View Source [SID1234653059]).

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Two oral presentations will feature data from the Phase 1/2 EPCORE NHL-2 trial evaluating epcoritamab plus rituximab and ifosfamide-carboplatin-etoposide (R-ICE) in patients with relapsed/refractory (R/R) DLBCL eligible for autologous stem cell transplantation, and the Phase 1/2 EPCORE NHL-5 trial evaluating epcoritamab plus polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) in previously-untreated patients with DLBCL. Additionally, results from the Phase 1/2 EPCORE NHL-1 and NHL-3 trials, including three years of follow-up in patients with R/R DLBCL and FL treated with epcoritamab monotherapy, will be presented as a poster.

All abstracts accepted for presentation have been published and may be accessed online via the EHA (Free EHA Whitepaper) Open Access Library.

"Together with AbbVie, we have made tremendous progress advancing our broad epcoritamab development program and we are pleased to share important results at EHA (Free EHA Whitepaper) 2025 evaluating epcoritamab in a variety of treatment settings and patient populations," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "The data presented at EHA (Free EHA Whitepaper) further reinforce our commitment to epcoritamab and its potential to become a core therapy across B-cell malignancies."

Several abstracts evaluating epcoritamab will also be presented at the 18th International Conference on Malignant Lymphoma (ICML), taking place June 17-21, 2025, in Lugano, Switzerland.

Abstracts accepted for presentation at EHA (Free EHA Whitepaper) include:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
S245 First Disclosure of Epcoritamab + R-ICE in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) Eligible for Autologous Stem Cell Transplantation (ASCT): EPCORE NHL-2 Oral Sunday, June 15
11:00-12:15 CEST
S247 Durable Efficacy with Fixed-Duration Epcoritamab + Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) for 1L Diffuse Large B-cell Lymphoma (EPCORE NHL-5) Oral Sunday, June 15
11:00-12:15 CEST
PF881 Epcoritamab Monotherapy Demonstrates Deep and Durable Responses at Three-Year follow-up in Patients with Relapsed/Refractory Follicular Lymphoma Poster Friday, June 13 18:30-19:30 CEST

PF885 Epcoritamab Plus Lenalidomide and Rituximab Achieves High Response Rates and Survival Benefits Compared with Usual Care in Relapsed/Refractory Follicular Lymphoma: A Comparative Analysis Poster Friday, June 13 18:30-19:30 CEST
PF920 Sustained Remission in R/R DLBCL with Epcoritamab Monotherapy: EPCORE NHL-1 3y Results and Novel Subgroup Analyses in Patients with Complete Response at 2y Poster Friday, June 13 18:30-19:30 CEST

PS1886 Matching-Adjusted Indirect Comparison of Epcoritamab with Rituximab + Lenalidomide vs Tafasitamab with Rituximab + Lenalidomide in Second-Line+ Follicular Lymphoma Poster Saturday, June 14 18:30-19:30 CEST

PS1898 Patient-Reported Outcomes in Patients with Relapsed/Refractory Follicular Lymphoma Treated with Epcoritamab within the Entire Study Cohort and in Patients with Symptoms at Baseline Poster Saturday, June 14 18:30-19:30 CEST

PS1968 Match-Adjusted Comparative Analysis of Epcoritamab + R-DHAX/C or R-ICE vs R-DHAX/C or R-ICE In 2L+ Transplant-Eligible Patients with Diffuse Large B-Cell Lymphoma Poster Saturday, June 14 18:30-19:30 CEST

PS1942 Match-Adjusted Comparative Analysis of the Efficacy Of Epcoritamab + R-Mini-CHOP vs R-Mini-CHOP in Previously Untreated Diffuse Large B-Cell Lymphoma Poster Saturday, June 14 18:30-19:30 CEST

PS1932 Treatment Outcomes in Newly Diagnosed Diffuse Large B-Cell Lymphoma Patients with High Cardiovascular Risk, and Treated with Non-Anthracycline Containing Regimens Poster Saturday, June 14 18:30-19:30 CEST

PS1944 Patient Preferences for Attributes of Bispecific Antibodies Indicated for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma in the United States Poster Saturday, June 14 18:30-19:30 CEST

PS1912 Circulating Tumour DNA-Directed Intervention with Epcoritamab Alone or in Combination with Lenalidomide and Rituximab is Feasible in the Early Post-CAR-T Population at High Risk of Relapse: Preliminary Data from EpLCART Poster Saturday, June 14 18:30-19:30 CEST

PS1979 Epcoritamab with Gemcitabine, Dexamethasone, and Cisplatin (Epco-GDP) in Relapsed, Refractory Large B-cell Lymphoma – An Interim Analysis of Phase II Multicenter Investigator-initiated Trial Poster Saturday, June 14
15:30-16:00 CEST
PS1892 Phase II Investigator-initiated Trial of Epcoritamab-Lenalidomide in Treatment Naïve Follicular Lymphoma Poster Saturday, June 14
18:30-19:30 CEST
The safety and efficacy of these investigational uses have not been established.

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.i

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 chemoimmunotherapy 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 14, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported the first patient has been dosed in RASolve 301, a global, randomized, open-label Phase 3 clinical trial. RASolve 301 will evaluate the safety and efficacy of daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor, in patients with previously treated, locally advanced or metastatic RAS mutant non-small cell lung cancer (NSCLC) compared to docetaxel chemotherapy (Press release, Revolution Medicines, MAY 14, 2025, View Source [SID1234653079]).

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RASolve 301 is anticipated to enroll approximately 420 patients with NSCLC worldwide who have received one to two prior lines of therapy for the treatment of advanced disease including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy. The pivotal clinical trial is designed to include a core population of patients with NSCLC carrying RAS mutations at position G12 (G12X), and an expanded population that also includes patients with tumors carrying other specific RAS mutations. The dual primary endpoints are progression-free survival (PFS) and overall survival (OS) in the core patient population. Key secondary endpoints include PFS, OS and objective response rate (ORR) in the expanded population.

"We are pleased that dosing is underway in the RASolve 301 Phase 3 clinical trial, an important step in developing daraxonrasib, a highly innovative compound that targets a diverse array of RAS mutations that drive tumor growth in 30% of NSCLC cases," said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "For the vast majority of these RAS cancer drivers, there are currently no approved targeted drugs that can be used in place of chemotherapy. In this trial we are collaborating with physicians globally to evaluate the potential of daraxonrasib as a new therapy for people living with RAS mutant lung cancer."

The company’s decision to evaluate daraxonrasib as a monotherapy in this NSCLC setting was informed by early evidence from a single-arm trial showing the compound had an acceptable safety profile and encouraging antitumor activity. Daraxonrasib is also being evaluated in the RASolute 302 clinical trial, which is a global, randomized Phase 3 trial evaluating daraxonrasib versus standard of care chemotherapy in second-line patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).

About Non-Small Cell Lung Cancer and RAS Mutations
More than 197,000 people are diagnosed with non-small cell lung cancer (NSCLC) in the U.S. each year.1 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies. RAS mutations are among the most common oncogenic drivers in NSCLC, occurring in approximately 30% of cases.2 A significant challenge in treating NSCLC is its genetic diversity, with different mutations including RAS G12X, G13X and Q61X each playing a crucial role in the development and progression of NSCLC in this patient population.

About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. Daraxonrasib suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X that are common drivers of major cancers including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

On May 14, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, reported full results from the Phase 2 Endocrine Optimization Pilot (EOP) sub‑study within the I‑SPY 2 TRIAL evaluating low‑dose oral (Z)‑endoxifen (10 mg daily) as a neoadjuvant treatment in 20 women with stage II/III estrogen‑receptor–positive (ER+), HER2‑negative breast cancer (Press release, Atossa Therapeutics, MAY 14, 2025, View Source [SID1234653098]).

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Key Findings:

Primary feasibility goal surpassed – 95 percent of participants (19/20) completed at least 75 percent of planned dosing, far exceeding the predefined 75 percent threshold.
Early anti‑proliferative activity – Median Ki‑67 fell from 10.5 percent at baseline to 5 percent by Week 3 (prior to ovarian suppression); 65 percent of patients achieved Ki‑67 ≤ 10 percent at that time point, and suppression was maintained at surgery.
Robust imaging response – Median functional tumor volume (FTV) measurement (performed at baseline, week 3, week 12, and at surgery) decreased 77.7 percent (range 9.0 cc → 1.2 cc) from baseline to surgery, and the longest tumor diameter from baseline to preoperative MRI was reduced by 36.8 percent.
Well‑tolerated safety profile – Adverse events were predominantly Grade 1; vasomotor symptoms (hot flushes) and fatigue were most common. Only three Grade 3 events (two skin infections, one post‑procedural infection) occurred in a single patient and were deemed unrelated to study drug; no Grade 4 or Grade 5 events were reported.
Pathologic Findings:
No participants achieved a pathologic complete response (pCR), and residual cancer burden (RCB) classes skewed toward RCB‑II/III, indicating moderate to extensive residual disease. This result was anticipated based on earlier window‑of‑opportunity (neoadjuvant) studies that showed significant pathologic clearance typically requires higher systemic exposures to (Z)-endoxifen (> 500 ng/mL) to enable inhibition of PKCβ1 in addition to ERα. The 10 mg dose in this pilot was intentionally selected to establish tolerability and early biologic activity in the endocrine‑naïve setting; therefore, limited pCR rates at this dose are consistent with prior dose–response observations.

"These results show that even at a low capsule strength (Z)‑endoxifen is bioactive, producing rapid Ki‑67 suppression and meaningful tumor shrinkage, while remaining highly tolerable. The study strengthens our scientific hypothesis that dual targeting of ERα and PKCβ1 is key to inducing a pathological response," said Steven Quay, M.D., Ph.D., President and Chief Executive Officer of Atossa. "Importantly, it paves the way for our ongoing I‑SPY 2 cohorts evaluating higher, potentially PKCβ1‑engaging doses of (Z)‑endoxifen alone and in combination with the CDK4/6 inhibitor abemaciclib, where we aim to translate early biomarker gains into deeper pathologic responses."

Atossa is actively enrolling participants into an additional I‑SPY 2 cohort testing (Z)‑endoxifen at a 40 mg daily dose and in combination with abemaciclib, with and without ovarian function suppression. Top‑line data from these arms are expected beginning in 2026.

About (Z)-Endoxifen
(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator (SERM) with demonstrated ability to inhibit—and potentially degrade—estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets protein kinase C beta 1 (PKCβ1), an oncogenic signaling protein, at clinically achievable blood levels. Importantly, (Z)-endoxifen seems to deliver comparable or superior bone-protective effects relative to tamoxifen, while exhibiting minimal or no endometrial proliferative activity—addressing key limitations of current standard-of-care therapies.

Atossa is developing a proprietary oral formulation of (Z)-endoxifen that is enteric-coated to bypass stomach acid, which would otherwise convert the active (Z)-isomer to its inactive (E)-form. This innovation ensures optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa’s (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer.

Atossa is prioritizing the development of (Z)-endoxifen for the treatment of metastatic breast cancer, where novel therapeutic options are urgently needed. The compound is currently being evaluated in three Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and two in women with ER+/HER2- breast cancer, including the EVANGELINE trial and the combination I-SPY study. Atossa’s (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including three recently issued U.S. patents and numerous pending applications worldwide.

On May 14, 2025 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines, reported its first quarter financial results and provided a business update (Press release, Cyclacel, MAY 14, 2025, View Source [SID1234653165]).

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"As part of the Company’s efforts to reduce operating costs it has determined to focus on the development of the plogosertib ("plogo") clinical program only. Accordingly, on March 10, 2025, the Company repurchased certain assets related to plogo from Cyclacel Limited for approximately $0.3 million in cash, to allow us to continue our efforts on developing an alternative salt, oral formulation of plogosertib with improved bioavailability," said Datuk Dr. Doris Wong, Chief Executive Officer. "Cyclacel Limited’s other drug development program, fadraciclib, is being marketed for sale by that entity’s liquidator in the U.K. pursuant to creditors voluntary liquidation of Cyclacel Limited announced in the London Gazette on January 31, 2025."

"Upon the commencement of the liquidation of Cyclacel Limited, the Company lost operational and strategic control over Cyclacel Limited and thus its financial results have been deconsolidated from the Company effective January 31, 2025; as a result, the Company anticipates a significant decrease to research and development expenses for the year ended December 31, 2025 as we focus on plogo and have no further expenditures related to fadraciclib," said Kiu Cu Seng, Chief Financial Officer. "The deconsolidated of our former subsidiary, Cyclacel Limited, resulted in a gain on deconsolidation, and thus an increase in stockholders’ equity of approximately $5.0 million, which we have reported in the Company’s Form 10-Q for the three months ended March 31, 2025."

Due to the current difficult economic environment and our lack of funding to implement our business plan, we have begun to analyze strategic alternatives available to the Company to continue as a going concern. Such alternatives include raising additional debt or equity financing or consummating a merger or acquisition with a partner that may involve a change in our business plan. As a result, the Company entered into an Exchange Agreement with FITTERS Diversified Berhad on April 6, 2205, to exchange all of the ordinary shares owned by FITTERS in exchange for approximately 19.99% of the Company’s common stock to acquire FITTERS’ wholly-owned subsidiary, Fitters Sdn. Bhd., a Malaysia-based private limited company specializing in supplying, and trading various protective and fire safety equipment.

Financial Highlights

As of March 31, 2025, cash and cash equivalents totaled $3.5 million, compared to $3.2 million as of December 31, 2024.

Net cash used in operating activities was $3.3 million for the three months ended March 31, 2025,. The Company estimates that its current cash resources will fund planned programs into the second quarter of 2025.

Research and development expenses were $0.8 million for the three months ended March 31, 2025, as compared to $2.8 million for the same period in 2024. Expenditure for the transcriptional regulation program ceased as a result of the Company’s UK subsidiary, Cyclacel Limited, being liquidated on January 24, 2025. Research and development expenses relating to plogosertib decreased by $0.6 million relative to the respective comparative period whilst we continue to explore and develop an alternative salt, oral formulation with improved bioavailability.

General and administrative expenses increased by approximately $2.6 million from $1.6 million for the three months ended March 31, 2024 to $4.2 million for the three months ended March 31, 2025, due to several one-time costs associated with the change of control of the Company; primarily stock compensation expense of $1.4 million, D&O insurance costs of $0.7 million, compensation expense of $0.3 million and legal costs of $0.1 million.

Total other (expense) income, net, for the three months and year ended March 31, 2025, were $5.0 million, compared to $0.1 million for the same period of the previous year, primarily due to a $5.0 million gain on deconsolidation of the UK subsidiary.

United Kingdom research & development tax credits for the three months ended March 31, 2024, were $1.4 million. There were no research and development tax credits for the three months ended March 31, 2025, following the liquidation of the UK subsidiary and the subsequent loss of eligibility for recoverable tax credits as a result thereof.

Net loss for the three months ended March 31, 2025, was $0.1 million (including stock-based compensation expense of $1.6 million), compared to $2.9 million (including stock-based compensation expense of $0.2 million) for the same period in 2024.

On May 14, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies for cancer and autoimmune diseases, reported new preclinical data from its INB-619 program at the 2025 American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting (Press release, In8bio, MAY 14, 2025, View Source [SID1234653060]). The data shows that INB-619, a CD-19 targeted γδ TCE, successfully eliminated disease-causing B cells in blood samples from patients with active Systemic Lupus Erythematosus (SLE, or Lupus).

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These findings highlight the potential of INB-619 as a novel treatment option for autoimmune diseases, where harmful B cells secrete antibodies that drive inflammation and tissue damage. Unlike traditional TCEs that target CD3 and can often trigger severe side effects, INB-619 harnesses the unique properties of γδ T cells to selectively clear B cells while minimizing inflammatory responses.

William Ho, Chief Executive Officer of IN8bio, commented, "Our findings show that INB-619 not only eliminates pathogenic B cells, but also expands γδ T cell levels, which are often reduced in patients with chronic disease. This represents a fundamentally different approach to immune modulation – one that could potentially lead to safer, more effective treatments for autoimmune diseases and beyond."

Highlights from the Preclinical Data:

INB-619 demonstrated complete, targeted depletion of B cells in lupus patient-derived samples.
IN8bio’s γδ TCE successfully expands both Vδ1+ and Vδ2+ subtypes of γδ T cells, which are critical for targeting both circulating and tissue-resident B cells to potentially achieve deeper B cell depletion.
Unlike conventional CD3-based TCEs, INB-619 did not trigger significant release of inflammatory cytokines such as IL-6, which are commonly associated with serious toxicities, including CRS.
The study reinforces the potential of γδ T cell engagers as a safer, more precise immunotherapy platform for autoimmune diseases.
With these encouraging results, IN8bio continues to explore potential partnerships and additional autoimmune and cancer indications where γδ T cell biology and B cell targeting intersect.