On August 13, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, reported financial results for the second quarter ended June 30, 2025, and provided several business updates (Press release, Immuneering, AUG 13, 2025, View Source [SID1234655196]).

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"We are excited to announce updated OS and PFS data from our ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients in the coming weeks. Last quarter we reported an exceptional 94% OS observed at 6 months in first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP. To put that in perspective, in the pivotal study of standard of care GnP, the 6-month OS was only 67%, and dropped rapidly to only 50% by 8.5 months," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. "Our exceptional 6-month overall survival data in first-line pancreatic cancer patients is generating strong interest from leading pharmaceutical companies and top-tier investors, and we look forward to sharing the latest results."

"We are busy preparing for our Phase 3 pivotal trial, and have now submitted our end of phase 2 meeting request to FDA. In addition, the granting of our composition of matter patent for atebimetinib by the United States Patent and Trademark Office (USPTO) was an important milestone for our company. We expect the long patent runway we are forging for atebimetinib will support our efforts to maximize its therapeutic potential across multiple indications," Zeskind concluded.

Corporate Highlights

Reported Positive Overall Survival Data for Atebimetinib from Ongoing Phase 2a Trial in First-Line Pancreatic Cancer Patients: In June, Immuneering shared exceptional data from its ongoing Phase 2a trial of atebimetinib in combination with modified mGnP in first-line pancreatic cancer. The company reported that 94% OS and 72% PFS were observed at 6 months (n=34; patients treated at the 320 mg once-daily dose of atebimetinib), with median OS and PFS not yet reached. A markedly favorable tolerability profile was also observed. All results were reported using a data cutoff date of May 26, 2025. Subject to regulatory feedback, the company plans to initiate a pivotal trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients in 2026.

Granted U.S. Composition of Matter Patent for Atebimetinib: In July, the company was granted a composition of matter patent for atebimetinib by the USPTO, which is expected to provide exclusivity into 2042, with subsequent opportunity for patent term extension. The patent is the first granted in the U.S. for a deep cyclic inhibitor, a once-daily pill that aims to drive longer-lasting benefit by outpacing resistance mechanisms that cause cancer drugs to stop working. Additional patent applications for atebimetinib are pending, directed to compounds, pharmaceutical compositions, and methods of use, with expiration expected into 2044.

Third-Line Pancreatic Cancer Patient Passes 18-month Mark on Atebimetinib Monotherapy: Today, Immuneering is providing an update on a pancreatic cancer patient in the third-line setting who has received atebimetinib monotherapy for more than 18 months as a participant in the company’s Phase 1 trial and who remains on treatment. The patient – who previously experienced disease progression on first-line FOLFIRINOX and second-line Gem/Cis/nab-Pac – has been on atebimetinib monotherapy at 240 mg once daily and has maintained a partial response, including a 34% reduction in target lesions (RECIST sum of longest diameters) for a confirmed partial response, and a 96% reduction in peak CA 19-9 levels. Treatment continued to be well tolerated by the patient, with a ~16% weight gain observed.
Near-Term Milestone Expectations

Immuneering is planning for several near-term milestones related to atebimetinib, including to:

Announce updated OS and PFS data from first-line pancreatic cancer patients (n = 34) treated with atebimetinib + mGnP in Q3 2025
Receive regulatory feedback on pivotal study plans in Q4 2025
Initiate pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026
Initiate additional atebimetinib clinical trial combination arms in 2026
Second Quarter 2025 Financial Highlights

Cash Position: Cash and cash equivalents as of June 30, 2025 were $26.4 million, compared with $36.1 million as of December 31, 2024.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2025 were $10.5 million, compared with $10.7 million for the quarter ended June 30, 2024. The decrease in R&D expenses was primarily attributable to decreases in spend for preclinical programs, decreases in clinical spend related to the IMM-6-415 program and decreases in personnel costs to support ongoing research and development activities, offset by higher clinical costs related to the Company’s lead atebimetinib program.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2025 were $4.3 million, compared with $4.3 million for the quarter ended June 30, 2024. The second quarter of 2025 costs were consistent with the comparable prior period.

Net Loss: Net loss attributable to common stockholders was $14.4 million, or $0.40 per share, for the quarter ended June 30, 2025, compared to $14.1 million, or $0.47 per share, for the quarter ended June 30, 2024.

2025 Financial Guidance

Based on cash and cash equivalents as of June 30, 2025, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2026.

On August 13, 2025 CIT Therapeutics, Inc. (CIT), a biotechnology company focused on developing next-generation small molecule therapies targeting SUMOylation for cancer treatment, reported a strategic partnership with the Institute for Follicular Lymphoma Innovation (IFLI) (Press release, Institute for Follicular Lymphoma Innovation, AUG 13, 2025, View Source [SID1234655218]). As part of this collaboration, IFLI will invest up to $2.5 million to support CIT’s clinical development efforts, particularly in follicular lymphoma.

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CIT is advancing a first-in-class, orally bioavailable small molecule that selectively inhibits the SUMO E1 enzyme through an allosteric covalent mechanism. This novel approach has demonstrated high specificity in proteome-wide analyses, offering a promising therapeutic strategy to both kill cancer cells and stimulate the immune system.

The investment from IFLI will support CIT’s upcoming Phase 1/1b clinical trial of its lead candidate, SB-4826, in patients with Non-Hodgkin Lymphoma, including those with relapsed or refractory follicular lymphoma.

This partnership underscores IFLI’s commitment to accelerating the development of transformative therapies for follicular lymphoma and related blood cancers. It also highlights CIT’s innovative platform as a potential game-changer in the oncology landscape.

"We are pleased to collaborate with CIT in their mission to improve outcomes for patients with follicular lymphoma," said Dave McCullagh, Managing Director of IFLI.

"This partnership represents a significant step forward in bringing SUMOylation-targeted therapies to the clinic. We are proud to support CIT in pioneering this new therapeutic modality. Inhibiting SUMOylation can reprogram tumor microenvironments, sensitize tumors to chemo and radiotherapy, and suppress oncogenic signaling" Michel Azoulay, MD, Chief Medical Officer of IFLI.

"Our vision is to transform cancer care by developing therapies that target novel biological mechanisms, which aligns with that of IFLI," said Yuan Chen, PhD, Founder and CEO of CIT Therapeutics and Professor and Chief in the Division of Surgical Sciences and Professor in the Division Surgical Oncology in the Department of Surgery at University of California, San Diego (UCSD) and Moores Cancer Center. "We are excited for this partnership and eager to start our clinical trial to deliver meaningful benefit to patients."

On August 13, 2025 ImmunityBio (NASDAQ: IBRX), a leading immunotherapy company, reported early findings from its QUILT-106 Phase I trial, showing highly promising complete responses in the first two patients treated to date with late-stage Waldenstrom macroglobulinemia (WM)—a type of non-Hodgkins lymphoma (NHL)—using its CD19 CAR-NK (CD19 t-haNK) natural killer cell therapy (Press release, ImmunityBio, AUG 13, 2025, View Source [SID1234655197]).

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QUILT-106 (NCT06334991) is a first-in-human trial evaluating the safety and preliminary efficacy of CD19 CAR-NK cell therapy alone and in combination with rituximab in patients with relapsed or refractory (R/R) CD19⁺CD20⁺ B-cell NHL. The disease remains challenging to treat, and WM is considered incurable with existing treatment options, making novel immunotherapies an important avenue of exploration for potential effective treatments.

In the first two evaluable patients with WM who were heavily pretreated, an entirely chemotherapy-free, immunotherapy regimen induced encouraging responses. Both patients tolerated the regimen with no significant toxicities. Notably, all infusions (including CAR-NK cells and cytokines) were administered in an outpatient setting. One patient achieved a complete response (CR) with CD19 CAR NK monotherapy, while the second patient achieved CR with CD19 CAR-NK in combination with rituximab. Remission was maintained and is ongoing for six months to date.

The open-label study sponsored by ImmunityBio and led by Dr. Glenda Gray, former President and CEO of the South African Medical Research Council (SAMRC) and current Chair of the Global Antibiotic Research and Development Partnership (GARDP), has enrolled 13 patients with NHL at three sites in South Africa. Of the patients enrolled so far, three have WM. Eligible study participants express CD19 and CD20, with active disease after ≥2 chemotherapy-based lines of treatment. All patients receive a lead-in cycle of CD19 CAR-NK cell monotherapy, followed by a 1-week safety observation pause, then a second cycle combining CD19 CAR-NK with rituximab. Key endpoints include safety/tolerability and objective response rate (ORR) by standard criteria.

"The preliminary findings we have submitted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting provides the first evidence that novel immunotherapy combinations without chemotherapy lymphodepletion can provide deep and durable remissions in WM even after multiple prior treatments," said Dr. Jackie Thomson, Wits University Donald Gordan Medical Center, Johannesburg, South Africa and the lead author of the paper. "Recruitment in this rare subset of lymphoma is ongoing to confirm these findings and to establish this chemo-free strategy as a viable treatment option for relapsed WM."

ImmunityBio’s CD19 CAR-NK Therapy

CD19 CAR-NK is a targeted high-affinity natural killer cell therapy – an off-the-shelf, allogeneic NK cell line engineered to express a CD19-specific chimeric antigen receptor (CAR) and a high-affinity CD16 (FcγRIIIa 158V) receptor. This design enables dual anti-tumor mechanisms: direct CAR-mediated cytotoxicity and augmented antibody-dependent cellular cytotoxicity when paired with anti-CD20 monoclonal antibody rituximab. Combining CD19 CAR-NK cells with rituximab could thereby target CD19⁺/CD20⁺ lymphoma cells to enhance tumor cell killing.

On August 13, 2025 Flatiron Health reported eight abstracts leveraging its high-quality multimodal data have been accepted for poster presentation and e-Poster presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain (Press release, Flatiron Health, AUG 13, 2025, View Source [SID1234655219]).

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"AI is a transformative force enabling scale, speed, and novel insights that were previously impossible. By harnessing advanced AI across our global network of more than five million people with cancer, we’re setting a new standard for real-world data at scale," said Nathan Hubbard, Chief Business Officer, Flatiron Health. "Our research at this year’s World Conference on Lung Cancer exemplifies how high-quality, multimodal real-world data combined with responsible AI practices can illuminate treatment patterns, measure effectiveness, and reveal where innovation is most urgently needed."

A highlight of Flatiron’s presence at WCLC 2025 is the first published research leveraging the Flatiron Health–Caris Life Sciences Clinical-Molecular Database (CMDB), the largest and most robust multimodal dataset of its kind, to identify a novel gene signature that predicts risk of liver metastasis in patients with advanced non-small cell lung cancer (NSCLC). By integrating high-quality clinical data with comprehensive molecular profiling, the research addresses a critical unmet need—providing clinicians with a new tool to identify high-risk patients and potentially enable more personalized surveillance and treatment strategies.

Additional highlights include:

a poster highlighting ongoing gaps in biomarker testing after assessing over 13,000 patients with NSCLC in the US and UK
a poster providing new insights into how NSCLC is managed in the UK, including details on the most commonly used treatments, patterns in biomarker testing, and overall survival outcomes
Schedule a meeting with Flatiron Health at WCLC 2025 and follow Flatiron Health on X and LinkedIn for more updates from #WCLC25.

Abstracts and Poster Presentations
A Novel Predictive Gene Signature for Liver Metastasis (LM) in NSCLC Using a Comprehensive Linked Clinical-Molecular Database
Partner: Caris Life Sciences
Poster
Session: P2.06 – Pathology and Biomarkers
Presentation Number: P2.06.45
Location: Exhibit Hall
Session Start/End: Monday, September 8, 10:30AM – 12PM

Real-world Biomarker Testing and Treatment Initiation in Patients with Resected Early-stage NSCLC (eNSCLC) in the US and UK
Poster
Session: P1.07 – Early-Stage Non-small Cell Lung Cancer
Presentation Number: P1.07.05
Location: Exhibit Hall
Session Start/End: September 7, 10:30AM – 12PM

Real-World Outcomes of Prophylactic Cranial Irradiation in Extensive-Stage Small Cell Lung Cancer Treated with First-Line Immunotherapy and Platinum-Etoposide
Poster
Session: P3.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: P3.13.10
Location: Exhibit Hall
Session Start/End: September 9, 10 – 11:30AM

Real-World Survival Outcomes in Non–Small Cell Lung Cancer: Insights from UK EHR-Derived Data
E-Poster
Session: EP.17 – Global Health, Health Services, and Health Economics
Presentation Number: EP.17.34

Disease Burden and rwPFS as a Surrogate Endpoint for rwOS in NTRK+ NSCLC and Other Advanced/Metastatic Solid Tumors
Partners: Bristol-Myers Squibb, University of Colorado Cancer Center
E-poster
Session: EP.12 – Metastatic Non-small Cell Lung Cancer – Targeted Therapy
Presentation Number: EP.12.23

Real-World Treatment Patterns in ES-SCLC Highlight Continued Unmet Medical Need in the Era of New Therapies: ESSENCE Study
Partners: Montefiore Medical Center, GSK, Rush University
E-poster
Session: EP.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: EP.13.25

Evolving Treatment Patterns in Early-Stage Non-Small Cell Lung Cancer in the United States
Partners: Lilly
E-poster
Session: EP.17 – Global Health, Health Services, and Health Economics
Presentation Number: EP.17.33

Real-World Treatment Patterns and Clinical Outcomes in Patients With Metastatic Neuroendocrine Neoplasms of the Lung (NEN-L)
Partners: Merck & Co
E-poster
Session: EP.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: EP.13.44

On August 13, 2025 Evotec reported half-year interim report for the year 2025 (Filing, 3 mnth, JUN 30, Evotec, 2025, AUG 13, 2025, View Source [SID1234655617]).

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