Merck Enters into Exclusive Global License Agreement with SciBrunch Therapeutics for SPR2015, an Investigational Oral KRAS G12D (ON) Inhibitor

On September 28, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and SciBrunch Therapeutics Co., Ltd. ("SciBrunch"), reported that they have entered into an exclusive global license agreement for SPR2015, an investigational preclinical oral KRAS G12D (ON) inhibitor.

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"Evidence continues to accumulate for the therapeutic potential of targeting the KRAS pathway, a well-characterized factor in tumor cell growth," said George Addona, senior vice president, discovery, preclinical development and translational medicine, Merck Research Laboratories. "This agreement complements and diversifies our expanding pipeline of precision targeted candidates with SPR2015, a potent engineered inhibitor for one of the most prevalent mutant forms of KRAS found in human cancers."

Under the agreement, SciBrunch has granted Merck exclusive rights to develop, manufacture and commercialize SPR2015 worldwide. SciBrunch will receive an upfront payment of $400 million and is eligible to receive payments associated with the achievement of certain milestones related to development, commercialization and other activities across multiple indications. The total potential aggregate value of the transaction, including the upfront payment, is $2.13 billion. The transaction has closed.

"Since our founding, SciBrunch has remained focused on advancing innovative therapies targeting the RAS pathway and is committed to delivering transformative treatment options for patients with pancreatic, colorectal, lung, and other major malignant tumors," said Tao Hu, founder, chairman and chief executive officer of SciBrunch. "This agreement with Merck not only validates the R&D strength of our platform but also underscores the potential of SPR2015 in addressing longstanding unmet medical needs in oncology. We are excited that Merck, a global leader in oncology, will take SPR2015 forward."

Merck will record a pre-tax charge of $400 million, or approximately $0.13 per share, to be included in GAAP and non-GAAP results in the third quarter of 2026 related to this transaction.

About SPR2015

SPR2015 is a potent and selective novel investigational preclinical molecular glue KRAS G12D (ON) inhibitor that has demonstrated nanomolar antiproliferative activities in various KRAS G12D-mutant cell lines while maintaining good selectivity over KRAS wildtype cells. KRAS G12D is the most common oncogenic RAS mutation in human tumors which results from a substitution of glycine with aspartate at position 12. This change leaves KRAS active and continuously signaling for cell proliferation and survival. In addition, SPR2015 has demonstrated compelling antitumor efficacy as a monotherapy across multiple in vivo cell-derived and patient-derived xenograft (CDX/PDX) models, as reported in preclinical data presented at the 2026 AACR (Free AACR Whitepaper) Annual Meeting.

(Press release, Merck & Co, SEP 28, 2026, View Source [SID1234671112])

Immuneering Presents Data at 2026 AACR Conference on Pancreatic Cancer Supporting Atebimetinib’s Mechanisms Designed to Extend Survival in Pancreatic Cancer

On September 28, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported the presentation of new data at the 2026 AACR (Free AACR Whitepaper) Conference on Pancreatic Cancer in San Diego, California. The findings, presented by Peter Vu, M.D., MHA, UC San Diego Health, support a potential dual mechanism of action through which atebimetinib may improve survival in pancreatic cancer by both reducing tumor volume and preserving body mass.

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"We designed atebimetinib to do several important things at the same time: to shrink tumors and to counteract the tumor-driven weight loss (known as cachexia) that harms many cancer patients, all while minimizing side effects," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. "We already reported that 84% of evaluable patients treated with atebimetinib + mGnP have stable or increasing weight. Now we can add that these pancreatic cancer patients in our study were twice as likely to have stable or increasing weight as those in a benchmark study, and the patients in our study with stable or increasing weight had longer overall survival than those who lost weight. We believe reduction in tumor volume, maximization of tolerability, and preservation of body mass all contributed to the compelling 17.3-month median overall survival we reported at ASCO (Free ASCO Whitepaper) 2026 in 55 first-line pancreatic cancer patients treated with atebimetinib + mGnP in our Phase 2a study. We are excited to now be evaluating atebimetinib + mGnP in our ongoing Phase 3 MAPKeeper 301 clinical trial, which is actively enrolling first-line pancreatic cancer patients."

"Cachexia is an especially important problem in pancreatic cancer and can have a profound impact on patients’ survival and quality of life," said Peter Vu, M.D., MHA, UC San Diego Health and lead author of the poster. "In this exploratory analysis, patients who maintained their weight at three months had longer overall survival than those who lost weight, and two-thirds of patients with anorexia symptoms at baseline reported improvement while on treatment. Having enrolled a number of patients on this study, I’ve been encouraged by how well the combination has been tolerated. These findings support further study of whether atebimetinib may benefit patients beyond conventional measures of tumor response, and I’m hopeful the Phase 3 MAPKeeper 301 trial will help define its role as a new treatment option for pancreatic cancer."

The poster, entitled "Atebimetinib Reduces Tumor Volume and Preserves Body Mass: A Dual Mechanism for Extended Survival in Pancreatic Cancer," evaluated the relationship between body mass preservation, tumor volume reduction and overall survival in first-line pancreatic cancer patients treated with atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) in a single-arm Phase 2a study, using exploratory, post-hoc analyses with the same data cutoff date as the ASCO (Free ASCO Whitepaper) presentation (April 24, 2026). Highlights of the data include:

Median overall survival of 17.3 months was previously reported in 55 first-line pancreatic cancer patients treated with atebimetinib + mGnP, and 84% of evaluable patients had stable or increased weight at three months. In the new analysis presented at AACR (Free AACR Whitepaper) Pancreatic Cancer 2026, the proportion of patients demonstrating stable or increasing weight was approximately two-fold higher among atebimetinib + mGnP-treated patients evaluable for weight trajectory analysis (n=23) compared with patients from a published benchmark study (Fuller S, et al, JNCI, 117:8, 2025, 1729–1732, View Source). Median weight trajectory stabilized during atebimetinib treatment.
Among first-line pancreatic cancer patients treated with atebimetinib + mGnP, those with stable or increased weight at three months had significantly longer overall survival than patients who experienced weight loss at three months (HR=3.13; p=0.049). Median overall survival had not been reached in the weight-stable or weight-gain group after median follow-up of 15.2 months.
Among patients with low baseline scores of 37 or below on the FAACT-Anorexia Cachexia Subscale (ACS), 66% achieved an improvement of at least four points on this patient-reported outcome while on treatment. These improvements were observed across a range of RECIST responses.
The analysis also evaluated the relationship between tumor volume reduction and overall survival. Overall survival among patients with deeper tumor volume reductions, defined as a sum of longest diameters (SLD) reduction of at least 30%, was comparable to overall survival among patients with moderate tumor volume reductions of between 0% and 30%. Median overall survival was not reached in either group. In contrast, median overall survival was reached among patients without a measured reduction in SLD. The findings suggest that achieving tumor volume reduction may be more important to overall survival than the depth of tumor reduction and that clinically meaningful benefit may extend to patients whose tumor shrinkage does not meet the threshold for a RECIST partial response.
Following presentation, the poster will be available on the publications section of Immuneering’s website at View Source

Atebimetinib in combination with mGnP is currently being evaluated in a Phase 3 MAPKeeper 301 clinical trial in patients with first-line pancreatic cancer (NCT07562152).

(Press release, Immuneering, SEP 28, 2026, View Source [SID1234671111])

EORTC presents new results in neuro-oncology at EANO

On September 28, 2026 EORTC reported important new results from its studies at the 2026 congress of EANO, the European Association of Neuro-oncology, held in Rome in late September. EANO is Europe’s multidisciplinary neuro-oncology organisation representing all medical and scientific disciplines involved in the prevention, diagnosis, and treatment of tumours of the central and peripheral nervous system including neurology, neurosurgery, radiation oncology, medical oncology, paediatric neuro-oncology, and neuropathology.

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Major trial answers a longstanding question in atypical meningioma care
Trial chief investigator Dr Michael D Jenkinson, from the University of Liverpool, Liverpool, UK, presented ROAM/EORTC 1308, which looked at people with an atypical meningioma, a type of tumour arising from the coverings of the brain. Even when these tumours are completely removed by surgery, they can grow back.

The study set out to look at whether giving radiotherapy shortly after surgery was better than careful monitoring with regular scans. A total of 157 patients from 12 countries took part. Half received radiotherapy after surgery, and half were monitored without immediate further treatment. After five years about 80% of patients who received radiotherapy were alive without the tumour having returned, compared with about 62% of those who were simply monitored. Overall, the tumour returned in 11 of 78 patients given radiotherapy, and in 24 of 79 patients under observation.

Most patients did not develop serious long-term side effects, although moderate or severe late effects linked to radiotherapy occurred in five patients. Reported quality of life was not worse in the radiotherapy group. These results suggest that radiotherapy should be considered after complete removal of an atypical meningioma. The best choice will differ from person to person and should be discussed with the specialist team, taking account of the expected benefit, possible side effects, general health and personal preferences, the researchers say. However, the study was not large enough to give a clear answer about whether radiotherapy helps people live longer.

Dr Jenkinson said: "For patients and their families, one of the hardest questions to address after surgery is whether additional treatment is needed. This trial shows that radiotherapy after complete removal of an atypical meningioma can significantly reduce the chance of the tumour coming back, while maintaining quality of life and causing very few long-term side effects."

IDH-mutant Glioma
Results from the phase III INDIGO trial have shown that patients with IDH-mutant diffuse gliomas who took vorasidenib while being monitored ("watch and wait") after biopsy or resection, but before starting standard radiochemotherapy, had improved progression-free survival. Vorasidenib is an oral, targeted inhibitor of mutant IDH1 and IDH2. Its use as maintenance therapy after radiochemotherapy remains unclear.

The VIGOR trial (EORTC-2427-BTG; NCT06809322) is an intergroup trial led by the EORTC conducted together with COGNO1 and the Canadian Clinical Trials Group and will enroll 468 adults with grade 2 or 3 IDH-mutant astrocytoma who have completed standard radiochemotherapy. Half will receive daily 40g vorasidenib, and half a placebo for up to five years until unacceptable toxicity, or withdrawal of patient consent occurs. Enrolment started in January 2026 and patients will be recruited from multiple international territories including Europe, Australia, and Canada. After completion of the study treatment or following its discontinuation, participants will be followed up until the end of study visit, death, consent withdrawal or lost to follow-up, whichever occurs first. While the trial’s main goal is to see whether vorasidenib delays the tumour from growing back or progressing, it will also investigate overall survival, side effects, quality of life, neurocognition and other aspects of translational research.

"If it shows benefit, vorasidenib could join the standard treatments already being used for this tumour type," said the study co-coordinator Dr Marjolein Geurts, from the Erasmus MC Cancer Institute, Rotterdam, The Netherlands, presenting the trial.

Dr Matthias Preusser, from the Medical University of Vienna, Austria the coordinator of the VIGOR trial, said: "We are grateful for the support of our investigator network and the trust placed in us by our patients, which allowed us to successfully activate the trial and establish a very satisfying pace of recruitment."

The trial received funding from Servier.

Diffuse Glioma Quality of life
Patients with diffuse glioma often experience a wide range of symptoms, such as fatigue, difficulty thinking clearly, and physical weakness, that affect their quality of life. However, how these symptoms relate to each other and their precise effect on quality of life remain unclear. Results from an EORTC study using data from nearly 2,840 patients across seven European trials can now help clarify the interrelationships between symptoms.

Using a statistical technique called network analysis, the researchers investigated how symptoms, functional abilities, and clinical factors such as age, tumour grade, and steroid use relate to each other. They found that clinical factors such as tumour grade and type of surgery, although closely linked to each other, were only weakly linked to how patients felt or functioned in their daily lives. Consistent with this finding, symptom interconnectedness (global strength) did not differ between networks stratified by disease severity, disease phase, or physical functioning. In contrast, the number of interconnections was higher among patients with cognitive complaints and those with high fatigue levels.

Presenting the results, Ms Maxine Gorter, from the Amsterdam Cancer Centre, The Netherlands said: "These findings suggest that fatigue and cognitive problems may be especially important targets for doctors to address in these patients, since improving them could have benefits for other symptoms and overall quality of life."

RTQA in glioblastoma
EORTC Fellow Dr Raffaella De Pietro presented results from the ARGOS, a post hoc radiotherapy quality assurance (RTQA) analysis of the phase III EORTC-1709-BTG /CCTG CE.8 (MIRAGE) trial. RTQA is an essential component of radiotherapy trials, helping to ensure treatment consistency and the reliability of trial results.

MIRAGE evaluated the addition of the proteasome inhibitor marizomib to standard temozolomide-based chemoradiotherapy in patients with newly diagnosed glioblastoma. The ARGOS analysis investigated whether RTQA compliance and radiation dose to brain tissue outside the planning target volume (PTV – the area requiring treatment plus a safety margin to account for small variations in patient positioning) – were associated with survival outcomes and overall toxicity burden. The analysis included 672 patients. RTQA compliance was not significantly associated with the outcomes that were evaluated. However a higher mean dose to the uninvolved brain, defined as the whole brain minus the PTV, showed exploratory associations with worse overall and progression-free survival, and a greater toxicity burden.

"These findings underline the importance of evaluating uninvolved brain dose metrics as potential RTQA endpoints in glioblastoma radiotherapy" says Dr De Pietro. "Reducing unnecessary radiation exposure to healthy brain tissue may also help preserve future treatment options, including re-irradiation in the event of recurrence."

(Press release, EORTC, SEP 28, 2026, View Source [SID1234671110])

Lantheus Announces First Patient Dosed in SPARROW Phase 2/3 Registrational Trial in Prostate Cancer

On September 28, 2026 Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that the first patient has been dosed in SPARROW NCT07831824, a Phase 2/3 registrational trial evaluating LNTH-2401 (68Ga-DOTA-RM2). LNTH-2401 is an investigational gallium-68-labeled positron emission tomography (PET) imaging agent that targets the gastrin-releasing peptide receptor (GRPR), a biomarker that is highly expressed in many prostate cancers.

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SPARROW is an open-label, non-randomized, multicenter Phase 2/3 study that includes an initial Phase 2 dose optimization period followed by a Phase 3 diagnostic performance period. The Phase 3 co-primary endpoints are sensitivity and specificity of LNTH-2401 PET/CT imaging compared with histopathology. The Phase 3 portion of the trial is expected to enroll approximately 400 participants and will evaluate diagnostic performance, safety and tolerability.

"Accurate characterization of disease remains critically important in prostate cancer, particularly as treatment decisions become increasingly personalized," said Harshad R. Kulkarni, MD, Chief Medical Advisor at BAMF Health and a principal investigator in the SPARROW study. "We are pleased to have dosed the first patient at BAMF Health, where our integrated molecular imaging, radiopharmacy and clinical trials infrastructure supports the evaluation of emerging radiopharmaceutical technologies. GRPR represents a promising and biologically distinct target in prostate cancer, and SPARROW will help define the role GRPR-targeted PET may play in disease detection and characterization."

GRPR is highly expressed in many primary prostate cancers and has a biologic expression pattern distinct from PSMA. Emerging research suggests GRPR-targeted imaging may provide additional insight in certain tumors that are not optimally characterized using PSMA-directed approaches alone.1

"Dosing the first patient in SPARROW represents a significant step forward for our pipeline and underscores our commitment to advancing innovative radiopharmaceuticals across the prostate cancer care continuum," said Ludger Dinkelborg, Head of Research and Development at Lantheus. "As the leader in prostate cancer PSMA PET imaging, LNTH-2401 has the potential to expand our understanding of prostate cancer biology through a complementary imaging target. This program reflects our broader strategy to build a focused pipeline of differentiated radiodiagnostics that may support more informed clinical decision-making."

About SPARROW
SPARROW is an open-label, non-randomized, multicenter Phase 2/3 clinical trial evaluating investigational 68Ga-LNTH-2401 PET/CT imaging in prostate cancer. The study consists of a Phase 2 dose optimization period followed by a Phase 3 diagnostic performance period.

During Phase 2, up to 12 imaging-evaluable participants with newly diagnosed or biochemically recurrent prostate cancer will receive 68Ga-LNTH-2401 PET/CT imaging to determine the optimal administered activity and imaging time window. Phase 2 will also assess biodistribution, radiation dosimetry, image quality, safety and tolerability. Data from participants with GRPR-positive lesions are expected to support selection of the administered activity and imaging time window for Phase 3.

During Phase 3, approximately 400 participants with newly diagnosed prostate cancer who are at least high risk or have suspected metastatic disease and are eligible for radical prostatectomy with pelvic lymph node dissection will undergo 68Ga-LNTH-2401 PET/CT imaging using the optimized imaging parameters selected during Phase 2.

The Phase 3 co-primary endpoints are participant-level sensitivity and specificity of 68Ga-LNTH-2401 PET/CT imaging compared with histopathology. Secondary diagnostic performance assessments include positive predictive value (PPV), negative predictive value (NPV), regional detection performance, comparative summaries versus conventional imaging and/or PSMA PET imaging where applicable, and assessment of inter-reader and intra-reader agreement. Safety and tolerability will also be evaluated.

(Press release, Lantheus, SEP 28, 2026, View Source [SID1234671109])

Link Cell Therapies Initiates Clinical Dosing with Logic-Gated CAR-T Therapy, Expands Executive Leadership, and Upsizes Series A Financing to $90 Million

On September 28, 2026 Link Cell Therapies ("Link"), an oncology cell therapy company utilizing its proprietary logic-gating technology to develop next-generation CAR-T therapeutics for solid tumors and hematologic malignancies, reported that it has initiated clinical dosing for its lead program, LNK001. The company also announced three additions to its executive leadership team and a $30 million expansion of its Series A financing.

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Initiated clinical dosing of LNK001
LNK001 is being evaluated in a Phase 1 study in patients with advanced or metastatic clear cell renal cell carcinoma ("RCC"). Clinical dosing has begun at MD Anderson Cancer Center.

LNK001 requires the co-expression of two antigens, CAIX and ENPP3, which are both highly expressed in most RCC tumors. CAIX has long been among the most attractive targets in RCC, but conventional CAR-T cells directed against it have been limited by on-target, off-tumor toxicity in the biliary epithelium, where CAIX is also expressed. By gating CAR-T activity on both antigens, LNK001 is designed to preserve the antitumor potential of CAIX targeting while sparing the healthy tissue that has constrained single-antigen approaches.

LNK001 is manufactured at CTMC, a joint venture between Resilience and The University of Texas MD Anderson Cancer Center. Additional clinical trial details are available at View Source

Leadership additions
Jie D’Elia, Ph.D., joins as Chief Executive Officer and a member of the Board of Directors. Dr. D’Elia was previously the CEO of SystImmune, Inc., a clinical-stage biopharmaceutical company focused on developing novel multi-specific antibodies and antibody-drug conjugates ("ADCs"). Before SystImmune, she spent eleven years at Bristol Myers Squibb ("BMS"), most recently as Senior Vice President of Business Development, Oncology, Hematology, and Cell Therapy. During her tenure at BMS, she made significant impact to BMS’s pipeline evolution through multiple strategic partnerships and acquisitions in therapeutic areas ranging from oncology, hematology, cardiovascular, virology, and cell therapy. Prior to BMS, Dr. D’Elia served as the Vice President and Global Head of Business Development at Simcere Pharmaceutical, and held roles at AstraZeneca, Boston Consulting Group and Baxter Healthcare. Over the course of her career, she has led more than $40 billion in strategic partnerships and acquisitions. Dr. D’Elia holds a Ph.D. from the College of Pharmacy at the University of Texas at Austin and an MBA from Columbia Business School.

Brian Slingerland becomes Executive Chair. Brian co-founded Link in 2022 with Robbie Majzner, M.D., and Crystal Mackall, M.D., and has served on the Board of Directors. He previously co-founded and was the CEO of Stemcentrx, a next-generation ADC company that pursued novel targets with limited or no normal tissue expression, including DLL3 and SEZ6, and built the industry’s first end-to-end ADC GMP manufacturing facility. Abbvie acquired Stemcentrx in 2016 for $6.2 billion, which at the time was the largest private acquisition of all time in biotechnology. Prior to founding Stemcentrx, Brian was a Founding Partner at Qatalyst Partners and Vice President at Goldman Sachs where he helped companies raise private venture capital, execute IPOs and other financings, advised on mergers and acquisitions, and gained valuable experience working with CEOs at various stages of development. Brian has held other biotechnology CEO roles, including of recently acquired Convergent Genomics, and Everest Detection, and served on the Boards of Directors and provided initial capital to multiple biotech companies including Enliven Therapeutics (Nasdaq: ELVN). Brian is a graduate of Virginia Tech.

Friedrich Graf Finckenstein, M.D., joins as Chief Medical Officer. Dr Graf Finckenstein is a physician-scientist with decades of experience in clinical medicine, cancer research and drug development. Most recently, as Chief Medical Officer of Iovance Biotherapeutics he progressed the clinical portfolio of Tumor Infitrating Lymphocyte (TIL) therapies across indications and next generation products and contributed to the approval of AMTAGVI (lifileucel) in the US, Canada and Australia as the first approved cell therapy for a solid tumor. Before Iovance, he was Global Head of Oncology Translational Medicine at Roche Pharma Research and Early Development (pRED) in Basel, Switzerland. Earlier, he held clinical leadership roles at BMS, spanning early through late-stage development, including contributions to the approval of Opdivo (nivolumab) in lung cancer. He holds a medical degree from the University of Hamburg, is a board-certified pediatrician and has conducted laboratory cancer research at the Ludwig Institute, San Diego Branch, the Children’s Hospital Los Angeles and the University of Hamburg.

"From the beginning, our vision has been to translate this breakthrough science into therapies that can make a profound difference for people impacted by cancer," said co-founder Robbie Majzner, M.D., of the Dana-Farber Cancer Institute and Harvard Medical School. "Bringing in leaders with the experience, commitment and passion to advance our technology and execute at scale gives me tremendous confidence that we can realize that vision."

Abraham Bassan, Member of the Link Board of Directors and Partner at Samsara BioCapital, says "We are excited about the strength and depth of the leadership team at Link. Their broad experience and commitment to advancing our science puts the company in an excellent position to develop a new generation of impactful medicines for patients."

Series A expansion to fund pipeline programs
Link’s previously announced $60 million Series A financing led by Johnson & Johnson, through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc., with participation from founding investors Samsara BioCapital and Sheatree Capital, as well as Wing Venture Capital and new investors including BMS, Kyowa Kirin, Sherpa Healthcare Partners, Western Technology Investment and the MD Anderson Cancer Focus Fund, was upsized to $90 million.

The additional capital will support clinical and preclinical development of additional logic gated CAR-T programs. Link’s second solid tumor indication is colorectal cancer, where the company intends to begin a first-in-human trial in 2027 using a novel target pair co-expressed in the majority of colorectal tumors but absent from normal healthy tissues. Additional CAR-T programs in solid and hematologic cancers are in earlier development and will be advanced internally or through partnerships.

"Link’s logic-gate platform can make CAR-T broadly viable in solid tumors," said Dr. D’Elia. "A targeting approach that reliably distinguishes tumor from healthy tissue is what allows CAR-T to pursue in solid tumors the kind of deep and durable responses it has achieved in hematologic cancers. This financing lets us advance a pipeline built on that approach across additional tumor types."

(Press release, Link Cell Therapies, SEP 28, 2026, View Source [SID1234671107])