On December 17, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, reported that it has agreed with AstraZeneca to monetize a portion of Compugen’s rilvegostomig future royalties. Compugen has amended the exclusive license agreement with AstraZeneca, previously entered into in March 2018, to strengthen Compugen’s balance sheet and advance its innovative and differentiated immuno-oncology pipeline.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key Transaction Highlights:
•
$65 million upfront payment and a potential additional $25 million upon the next milestone payment on BLA acceptance, for a portion of Compugen’s existing royalty interest in rilvegostomig
•
Compugen shall retain the majority of its future royalties and remain eligible for tiered royalties of up to mid-single digits on future sales and potential future regulatory and commercial milestones of up to $195 million (amount includes the $25 million stated above)

About Rilvegostomig:
•
AstraZeneca is developing rilvegostomig, a first-in-class dual-checkpoint bispecific that delivers co-ordinated PD-1 and TIGIT blockade on the same immune effector cell, restoring antitumor immune activity and supporting the potential for durable, long-term outcomes. The TIGIT component of rilvegostomig is derived from Compugen’s fully owned COM902 which is one of only two clinical-stage Fc-reduced anti-TIGIT monoclonal antibodies currently in development
•
AstraZeneca is advancing rilvegostomig in a broad development program including 11 ongoing Phase 3 trials in patients with lung, gastrointestinal, and endometrial cancers

"This strategic agreement with AstraZeneca reflects the potential significant value of rilvegostomig and Compugen’s differentiated Fc-reduced approach to TIGIT inhibition," said Eran Ophir, Ph.D., President and CEO of Compugen. "This non-dilutive transaction strengthens our financial position and is expected to extend our cash runway into 2029 assuming no further cash inflows. This agreement enables us to continue advancing our innovative and differentiated immuno-oncology pipeline, while retaining significant upside from rilvegostomig’s potential success, representing a key long-term value driver for Compugen and our shareholders."

(Press release, Compugen, DEC 17, 2025, View Source [SID1234661501])

On December 17, 2025 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that it is on track to dose the first patient in its planned global Phase 3 registrational trial in first line pancreatic cancer patients in mid-2026, evaluating atebimetinib (320 mg QD) in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared with gemcitabine and nab-paclitaxel (GnP) alone.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Notably, the company completed its End-of-Phase 2 (EOP2) interactions with the U.S. Food and Drug Administration (FDA) and received scientific advice from the European Medicines Agency (EMA). Immuneering achieved alignment with both agencies on the key elements of the company’s proposed Phase 3 trial.

"We are very pleased with our interactions with both the FDA and EMA, which we believe speaks to the compelling data we have generated to date in first-line pancreatic cancer, as well as the strength and simplicity of our proposed Phase 3 trial for atebimetinib," said Ben Zeskind, Ph.D., Co-Founder and Chief Executive Officer of Immuneering. "Importantly, the regulators’ feedback supports our trial design and key primary endpoint of overall survival, and we are confident that our team is well-positioned to begin dosing patients in this global registrational trial in mid-2026. We are also thrilled to expand the planned trial to 510 patients, which gives more first-line pancreatic cancer patients the opportunity to participate, and further increases statistical robustness. In addition, we are excited to provide an update on overall survival in the Phase 2a trial in the coming weeks."

MAPKeeper 301 is designed as a global Phase 3 trial that will evaluate atebimetinib (320 mg QD) in combination with mGnP, compared to standard of care GnP alone, in first-line metastatic pancreatic ductal adenocarcinoma. The primary endpoint of the trial is overall survival, and secondary endpoints include progression-free survival, overall response rate, disease control rate, and quality of life measurements. Immuneering plans to enroll a total of approximately 510 patients in the Phase 3 trial.

The company expects to dose the first patient in mid-2026 and share topline results from the trial in mid-2028. Immuneering also reiterated management’s belief that the company’s current cash and cash equivalents, based on current operating plans, are sufficient to fund operations into 2029.

"The constructive guidance from both agencies validates our scientific approach and our understanding of the unmet need in first-line metastatic pancreatic cancer," said Igor Matushansky, M.D., Ph.D., Chief Medical Officer of Immuneering. "We look forward to advancing atebimetinib into Phase 3 and working with investigators worldwide to bring this potentially transformative therapy to patients as expeditiously as possible."

"New therapies for pancreatic cancer are urgently needed," said Eileen M. O’Reilly, MD, FASCO, Winthrop Rockefeller Endowed Chair in Medical Oncology at Memorial Sloan Kettering Cancer Center. "The phase IIa data of atebimetinib and chemotherapy shows a promising signal. I am excited to see this combination move forward to a randomized phase III evaluation."

(Press release, Immuneering, DEC 17, 2025, View Source [SID1234661502])

On December 17, 2025 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported positive topline results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The trial showed KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv), given as neoadjuvant and adjuvant treatment (before and after surgery), demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rates versus neoadjuvant chemotherapy and surgery.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The persistent risk of recurrence in cis-eligible patients with muscle-invasive bladder cancer, despite recent advances, underscores the continued need for effective perioperative treatments," said Dr. Matthew Galsky, Lillian and Howard Stratton Professor of Medicine, director of genitourinary medical oncology, Mount Sinai Tisch Cancer Center, and KEYNOTE-B15 principal study investigator. "The strength of these data demonstrates that pembrolizumab plus enfortumab vedotin—given before and after surgery—has the potential to significantly improve survival outcomes."

The trial, evaluating Merck’s KEYTRUDA, an anti-PD-1 therapy, plus Padcev, an antibody-drug conjugate (ADC), was conducted in collaboration with Pfizer and Astellas and builds on the clinical success of this combination in locally advanced or metastatic urothelial cancer (la/mUC) and cisplatin-ineligible MIBC.

"For people living with muscle-invasive bladder cancer, treatment decisions often need to be made earlier, when the opportunity to change the course of the disease is greatest," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "These results reinforce our conviction that moving KEYTRUDA into earlier stages of cancer care can make a meaningful difference for patients. By exploring combinations with ADCs in the perioperative setting, we aim to improve survival expectations for people facing muscle-invasive bladder cancer."

The safety profile of KEYTRUDA plus Padcev in this study was consistent with the known safety profiles of each agent. No new safety signals were identified with the combination. The companies plan to share these results with regulatory authorities worldwide for potential regulatory filings and will present the data at an upcoming medical meeting.

KEYTRUDA plus Padcev is currently approved for the treatment of adult patients with la/mUC in the U.S., the European Union (EU), Japan and several other countries around the world. KEYTRUDA plus Padcev is also approved in the U.S. for the treatment of adult patients with MIBC who are ineligible for cisplatin-based chemotherapy. KEYTRUDA as monotherapy is also approved in the U.S., EU, Japan and other countries for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer (NMIBC).

Three additional Phase 3 studies are currently evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic. Two of these studies are in MIBC including KEYNOTE-866 (NCT03924856) and KEYNOTE-992 (NCT04241185). KEYTRUDA is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in KEYNOTE-676 (NCT03711032).

About KEYNOTE-B15/EV-304

KEYNOTE-B15, also known as EV-304, is an open-label, randomized Phase 3 trial (ClinicalTrials.gov, NCT04700124) evaluating perioperative KEYTRUDA in combination with Padcev and surgery (radical cystectomy and pelvic lymph node dissection) versus neoadjuvant chemotherapy (gemcitabine plus cisplatin) and surgery in patients with MIBC who are cisplatin-eligible. The trial enrolled 808 patients who were randomized to receive either:

Four cycles (each cycle length is 21 days) of neoadjuvant KEYTRUDA intravenous (IV) infusion plus enfortumab vedotin IV infusion, followed by surgery, followed by 13 cycles of adjuvant KEYTRUDA IV infusion plus five cycles of enfortumab vedotin IV infusion, or;
Four cycles (each cycle is 21 days) of standard of care neoadjuvant chemotherapy followed by surgery.
The primary endpoint is EFS, defined as the time from randomization to the first occurrence of the following events: radiographic disease progression precluding radical cystectomy and pelvic lymph node dissection, failure to undergo surgery in participants with residual disease, gross residual disease left behind at time of surgery, local or distant recurrence based on blinded independent central review or death due to any cause. The key secondary endpoints are OS and pCR rate.

About bladder cancer

In 2022, bladder cancer changed the lives of more than 600,000 people around the world. According to some clinical practice guidelines, about 25% of newly diagnosed bladder cancer cases are MIBC. The standard of care for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which is shown to prolong survival. However, nearly half of patients who undergo this standard treatment experience recurrence.

(Press release, Merck & Co, DEC 17, 2025, View Source [SID1234661503])

On December 17, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported positive results from the Emory University physician-sponsored Phase 1 clinical trial conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta led by pediatric oncologist, Tobey MacDonald, MD, who discovered STAT3 is critical to certain childhood brain tumors and currently serves as Professor of Pediatrics and Director of the Pediatric Neuro-Oncology Program.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

WP1066 is Moleculin’s flagship Immune/Transcription Modulator designed to stimulate the immune response to tumors by inhibiting the errant activity of regulatory T cells while also inhibiting key oncogenic transcription factors, including p-STAT3 (phosphorylated signal transducer and activator of transcription 3), c-Myc (oncogene driving many aggressive cancers) and HIF-1α (hypoxia-inducible factor 1α). These transcription factors are widely sought targets because of their role in cancer cell survival and proliferation, angiogenesis (coopting vasculature for blood supply), invasion, metastasis, and inflammation associated with tumors.

"The results of this first-in-child trial show some encouraging signals of activity in a highly aggressive chemotherapy resistant brain cancer, such as partial tumor response in a diffuse intrinsic pontine glioma (DIPG) patient and clear anti-tumor immune changes," said Dr. MacDonald.

For the Phase 1 trial, 10 children were treated with WP1066 twice daily for 14 days to determine the maximum feasible dose. Compassionate use treatment in three children with high-grade glioma was also evaluated. Results showed there was no significant toxicity, and a maximum feasible dose was determined. Importantly, WP1066 suppressed the expression of STAT3, inhibiting its activity and demonstrating anti-tumor immune responses.

While the preclinical efficacy of WP1066 had been previously demonstrated, and its effectiveness had been studied among adults, this trial was the first to test it in children. Dr. MacDonald and his team recruited pediatric patients with high-grade glioma, which include diffuse midline glioma (DMG) and DIPG, and account for most pediatric brain tumor-related deaths. Both DMG and DIPG have an average survival rate of nine to 11 months following diagnosis. Additionally, patients with relapsed medulloblastoma and ependymoma who have no accepted standard therapy following a relapse were also included in the study. Thus, Dr. MacDonald’s research helps fill a critical need to identify new treatment options for patients with these incurable tumors.

Mr. Walter Klemp, Chairman and CEO of Moleculin, "We are very encouraged by the positive results from our Phase 1 clinical trial evaluating WP1066 in children with recurrent malignant brain tumors. These early data show that WP1066 has the ability to activate meaningful anti-tumor immune responses, an important proof of mechanism in a patient population with extremely limited treatment options. While still early, these findings reinforce the potential of WP1066 as a novel immunomodulatory approach for some of the most difficult-to-treat pediatric brain cancers. We are deeply grateful to Dr. MacDonald and his team, and the patients and families who participated in this study. We look forward to the continued advancement of WP1066 as a potential therapy that can make a real difference for children facing these devastating diseases."

Results from the study were recently published in the Journal of Clinical Investigation Insight. For more information about the WP1066 Phase 1 clinical trial, visit clinicaltrials.gov and reference identifier NCT04334863.

The results of this study are the foundation of the Phase 2 concept Dr. MacDonald’s team would like to pursue in a follow-up trial. The current study was funded by Peach Bowl LegACy Fund and CURE Childhood Cancer.

(Press release, Moleculin, DEC 17, 2025, View Source [SID1234661504])

On December 17, 2025 NanOlogy, LLC, a clinical-stage oncology company, reported the appointment of David Arthur as Chief Executive Officer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This appointment reflects a pivotal step in NanOlogy’s commitment to accelerating development of its LSAM drug portfolio including its development program targeting Diffuse Intrinsic Pontine Glioma (DIPG), a devastating pediatric brain cancer with limited treatment options.

David brings over 35 years of pharmaceutical experience spanning product development, strategy, operations, and commercialization. Most recently, as CEO of Salarius Pharmaceuticals, Inc., David built Salarius into a multiproduct clinical stage oncology company and successfully took the company public with a listing on the NASDAQ exchange. Prior to his biotechnology CEO roles, David spent over 20 years in a variety of executive roles with Eli Lilly and Boehringer Ingelheim.

"We believe David is a great addition to the team and will accelerate our existing drug development activities, business development plans, and new drug development programs. NanOlogy has completed clinical trials in 6 solid tumors with our LSAM investigational drugs, and we look forward to identifying development partners to advance these therapies," said H. Paul Dorman, founder and Chairman of NanOlogy. "We are also completing Investigational New Drug enabling studies for the treatment of a rare pediatric brainstem tumor and plan to submit the IND to the Food and Drug Administration in mid-2026. David’s expertise and abilities will strengthen the organization to rapidly advance these programs and identify strategic and financial partners to help execute our strategy."

"I am extremely impressed by the progress NanOlogy has made in drug development and the potential for these intratumoral drugs, along with other local routes of administration like inhalation, to improve treatment outcomes achieved with systemic cancer treatments," said David Arthur. "My goal will be to rapidly build upon this progress and execute a strategy that benefits cancer patients and creates value for shareholders."

(Press release, NanOlogy, DEC 17, 2025, View Source;utm_medium=rss&utm_campaign=nanology-appoints-david-j-arthur-as-chief-executive-officer-to-drive-clinical-development-of-its-large-surface-area-microparticle-lsam-investigational-drug-portfolio [SID1234661505])