1stOncology™: Cancer Intelligence Service – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Genmab Announces Completion of Tender Offer for Outstanding Common Shares of Merus N.V. and Commencement of Subsequent Offering Period

On December 12, 2025 Genmab A/S (Nasdaq: GMAB) ("Genmab") reported that the conditions, including the minimum tender condition, to the previously announced tender offer (the "Offer") by Genmab Holding II B.V., a wholly owned subsidiary of Genmab ("Purchaser"), to acquire all the issued and outstanding common shares of Merus N.V. (Nasdaq: MRUS) ("Merus") for $97 per common share in cash have been satisfied. The transaction meaningfully accelerates Genmab’s shift to a wholly owned model, expanding and diversifying the company’s revenue, driving sustained growth into the next decade and contributing to Genmab’s evolution into a biotechnology leader.

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 Merus acquisition marks a pivotal step in the delivery of Genmab’s long-term strategy and strengthens our path to becoming a global biotechnology leader with sustained growth and profitability. We are energized by the potential of petosemtamab to meaningfully impact the lives of people with head and neck cancer. Backed by our track record of successful development and commercial execution, we look forward to unlocking petosemtamab’s full potential and delivering on its promise to patients," said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab.

The addition of petosemtamab, Merus’ lead asset, to Genmab’s promising late-stage pipeline is a compelling strategic fit with Genmab’s portfolio and aligns with Genmab’s expertise in antibody therapy development and commercialization in oncology. Based on this successful track record in late-stage development and excellence in commercial execution, Genmab expects to launch petosemtamab in 2027, subject to clinical results and receipt of regulatory approvals. Genmab also intends to broaden and accelerate petosemtamab’s development with potential expansion into other lines of therapy. Following the initial approval of petosemtamab, Genmab believes that petosemtamab will be accretive to EBITDA with at least one-billion-dollar annual sales potential by 2029, with multi-billion-dollar annual revenue potential thereafter.

At 5:00 p.m. New York City time on December 11, 2025 (the "Expiration Time"), the Offer and withdrawal rights expired as scheduled. The depositary for the Offer has advised Genmab and Purchaser that, as of the Expiration Time, a total of 71,463,077 of Merus’ issued and outstanding common shares, constituting 94.2% of its issued and outstanding common shares, had been validly tendered pursuant to the Offer and not properly withdrawn. Effective at 12:01 a.m. New York City time on December 12, 2025, Purchaser accepted for payment, and expects to promptly pay for, all Merus common shares validly tendered and not properly withdrawn pursuant to the Offer.

Subsequent Offering Period
Genmab also announced that, as previously disclosed, Purchaser is providing a subsequent offering period of ten business days (the "Subsequent Offering Period"), commencing today, December 12, 2025, that will expire at 5:00 p.m., New York City time on December 29, 2025. During the Subsequent Offering Period, Purchaser will offer to purchase additional common shares at the same consideration of $97.00 per share, less any applicable withholding taxes and without interest. All Common shares validly tendered during the Subsequent Offering Period will be immediately accepted and promptly paid for by Purchaser.

Following completion of the Subsequent Offering Period, Genmab and Purchaser intend to complete the acquisition of 100% of Merus through a series of previously disclosed back-end transactions. Merus shareholders who do not tender their common shares of Merus in the Offer will receive payment for their common shares following the completion of these transactions (subject to applicable withholding taxes and without interest).

(Press release, Genmab, DEC 12, 2025, View Source [SID1234661377])

NiKang Therapeutics Presents Discovery of NKT5097, a First-in-Class, Highly Potent and Selective, Orally Bioavailable CDK2/4 Dual Degrader for Cancer Therapy at SABCS 2025

On December 11, 2025 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to bring transformative therapies to patients in need, reported the presentation of detailed preclinical data on NKT5097 at the 2025 San Antonio Breast Cancer Symposium (SABCS 2025) being held December 9-12, 2025, in San Antonio, TX. NKT5097 is a first-in-class, orally bioavailable small molecule engineered to selectively degrade CDK2 and CDK4 simultaneously, offering potential therapeutic benefits for patients with HR+ breast cancer and tumors driven by aberrant CDK2/cyclin E pathway activation.

NiKang has initiated a Phase 1, open-label, dose escalation study of NKT5097 as a single agent. This first-in-human study (NCT07029399) is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of NKT5097 in patients with advanced or metastatic solid tumors, with a focus on breast cancer and tumors with CCNE1 amplification.

"We are excited to share these compelling preclinical data for NKT5097 at this year’s SABCS," said Zhenhai Gao, Ph.D., co-founder, president and CEO of NiKang. "Our research has centered on designing a molecule that selectively degrades CDK2 and CDK4 while sparing CDK1, CDK6, CDK7, and CDK9, with the goal of significantly reducing the gastrointestinal and hematologic toxicities associated with currently approved CDK4/6 inhibitors and addressing emerging resistance mechanism. NKT5097 represents the first compound from our industry-leading CDK2/4 degrader portfolio. Its unique ability to simultaneously degrade both CDK2 and CDK4 offers a promising therapeutic strategy that may deliver deeper and more durable clinical benefits for patients."

Poster Presentation Details:

Title:

Discovery of NKT5097: a first-in-class, highly potent and selective, orally bioavailable CDK2/4 dual degrader for cancer therapy

Presenter:

Ke Liu

Abstract Number:

847

Presentation Number:

PS4-04-30

Date and Time:

Thursday, December 11, 2025, 5:00 PM – 6:30 PM

About NKT5097

NKT5097 is a first-in-class, highly potent and selective, orally bioavailable CDK2/4 dual degrader, designed to achieve sustained inhibition of the CDK2 and CDK4 pathway. By maximizing selective suppression of these pathways, NKT5097 has the potential to harness the full therapeutic benefits of CDK2 and CDK4 inhibition. NKT5097 is currently under evaluation in a Phase 1 clinical study in advanced or metastatic solid tumors as a single agent (NCT07029399).

(Press release, NiKang Therapeutics, DEC 11, 2025, View Source [SID1234661388])

New Publication Demonstrates the Importance of NeXT Personal Ultrasensitive Detection of Residual Disease in Lung Cancer

On December 11, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the publication of one of the largest and most comprehensive patient cohorts to date from the landmark TRACERx study, in the journal Cell. The study, titled "Longitudinal ultrasensitive ctDNA monitoring for high-resolution lung cancer risk prediction," demonstrates the clinical importance of ultrasensitive, tumor-informed molecular residual disease (MRD) testing in stage I to III non-small cell lung cancer (NSCLC).

The study, led by Professor Charles Swanton at the Francis Crick Institute and University College London (UCL) in collaboration with Personalis, analyzed 431 NSCLC patients tracked for a median of > 5 years using the NeXT Personal test. It demonstrated that the NeXT Personal test allows for highly sensitive detection of small traces of circulating tumor DNA (ctDNA) in blood samples from lung cancer diagnosis through to surveillance, even in hard-to-detect subtypes.

Key Findings:

Comprehensive Cancer Detection From Diagnosis Through Surveillance: NeXT Personal demonstrated exceptional sensitivity and specificity for detecting residual and recurrent cancer throughout the patient course at diagnosis (pre-surgery), post-surgical (landmark), during adjuvant, and during long-term surveillance monitoring, with many of the detections (~36-43%) in the ultrasensitive range.
Cancer Detection Ahead of Imaging: Cancer was detected a median of ~5 to ~9 months and up to ~57 months ahead of standard of care imaging post-surgery and during surveillance.
Ultrasensitive Detection and Risk Stratification: The study demonstrated NeXT Personal detection of ctDNA pre-treatment, post-surgery, and during surveillance was associated with higher risk of relapse and worse overall survival. The study also identified an intermediate risk patient subgroup with ultrasensitive ctDNA detections that can benefit from close clinical follow-up.
Therapy Monitoring: Patients who did not clear their ctDNA during adjuvant chemotherapy were > 5 times more likely to relapse than those who cleared their ctDNA.
The study utilized Personalis’ NeXT Personal technology, which leverages whole-genome sequencing and proprietary noise suppression to detect ctDNA at levels down to ~1 PPM. The Cell publication highlights that a significant portion of relapsing patients presented with ctDNA levels in the ultrasensitive range, detections which can be missed with less sensitive tests.

"This latest TRACERx study underscores the critical role of ultrasensitive ctDNA monitoring in early-stage lung cancer," said Professor Charles Swanton, Director of the Cancer Research UK Lung Cancer Centre of Excellence and Chief Clinician at Cancer Research UK. "The ability to detect residual disease at extremely low levels allows us to detect traces of cancer earlier after surgical resection in the adjuvant setting and more effectively identify patients at risk for relapse. It also allows us to see how patients are responding to adjuvant therapy with more accuracy, paving the way for more personalized, data-driven treatment strategies."

Richard Chen, M.D., Chief Medical Officer and Executive VP of R&D at Personalis, added: "This publication in Cell confirms that NeXT Personal’s high test-sensitivity and specificity are not just technical specifications, they are key to unlocking clinical utility. By pioneering ultrasensitive MRD testing, we are leading the way in enabling the next generation of cancer care and giving physicians the tools they need to better guide treatment decisions throughout the patient journey."

This publication joins a list of other leading publications this year in Nature Medicine and Annals of Oncology for NeXT Personal, showing the importance of ultrasensitive MRD testing in lung cancer and other cancer types.

(Press release, Personalis, DEC 11, 2025, View Source [SID1234661387])

Intensity Therapeutics, Inc. to Present Two Posters at the 2025 San Antonio Breast Cancer Symposium

On December 11, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, reported it will present two posters at the San Antonio Breast Cancer Symposium ("SABCS"), in San Antonio, TX being held at the Henry B. Gonzalez Convention Center.

On Friday, December 12, 2025 at 12:30 PM CST, Andreas Müller, M.D., from the Department of Medicine at the Kantonsspital Winterthur, Switzerland and Head of the Breast Center will present on behalf of the Swiss Cancer Institute abstract #1589 PS5-08-16, titled, Intratumoral Injections of INT230-6 Prior to Neoadjuvant Immuno-chemotherapy in Early-Stage Triple Negative Breast Cancer (TNBC): Early observations from INVINCIBLE-4-SAKK 66/22 (NCT06358573), a Phase II Randomized Clinical Trial. Today, December 11, 2025 at 5 PM CST, Lewis H. Bender, M.S., M.A., M.B.A., Intensity Therapeutics Founder, President and CEO, will present abstract #801 Poster PS4-10-15, titled, Accelerating an Anthracycline-Free Future: A New Drug in Clinical Testing Offers Patients Hope for Safer, More Effective Breast Cancer Therapy Combinations.

INVINCIBLE-4 Study Observations

The INVINCIBLE-4 study was activated in 2024. Fourteen patients have been treated to date with 7 in each cohort. Observations to date include the following:

The safety data for the patients who received INT230-6 plus SOC ("Cohort A"), continues to be favorable compared to the standard of care ("SOC") alone ("Cohort B")
Seven patients have been treated per cohort (14 patients total); there were nine grade 3 or higher adverse events in the INT230-6 plus SOC and 20 events in the SOC alone through November 10th (see Figure below)

Cohort A – Experimental

Cohort B – SOC

(N=7)

SOC

Term

Grade 3

Grade 4

Overall

Grade 3

Grade 4

Overall

Blood and Lymphatic System Disorders

Anemia

1 (14.3 %)

Febrile neutrogenia

2 (28.6 %)

Ear and Labyrinth Disorders

Vertigo

1 (14.3 %)

General Disorders and Administration Site Conditions

Fatigue

1 (14.3 %)

Injection Site Reaction

4 (57.1 %)

Infections and Infestations

Catheter Related Infection

1 (14.3 %)

Infected Seroma

1 (14.3 %)

Skin Infection

1 (14.3 %)

Urinary Tract Infection

1 (14.3 %)

Investigation

Alanine Aminotransferase Increased

1 (14.3 %)

Creatinine Increased

1 (14.3 %)

GGT Increased

1 (14.3 %)

Neutrophil Count Decreased

2 (28.6 %)

1 (14.3 %)

2 (28.6 %)

3 (42.9 %)

Metabolism and Nutrition Disorders

Anorexia

1 (14.3 %)

Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps)

Disease Progression

1 (14.3 %)

Nervous System Disorders

Guillain-Barre Syndrome

1 (14.3 %)

Imunotherapy Related Encephalitis

1 (14.3 %)

Renal and Urinary Disorders

Chronic Kidney Disease

2 (28.6 %)

TOTAL

A patient with a 2.2 cm tumor who received one dose of INT230-6 showed skin irritation at the time of surgery. However, skin and adipose tissue necrosis on MRI scans were observed in some patients who received two doses, thereby requiring more surgery. As a result, the protocol is being modified to administer a single dose at lower volumes for each tumor size. If tumor necrosis is observed on MRI after the first dose of INT230-6 prior to the start of SOC, then a second dose will not be made.

Potential Phase 3 Clinical Study Design

If safety and efficacy trends continue in the INVINCIBLE-4 Study, a Phase 3 clinical study design may include a treatment arm using INT230-6 and SOC without anthracycline compounds such as doxorubicin, a highly cardiotoxic agent. Doxorubicin is often referred to by patients and physicians as "the red devil" because of its red color and harsh effects.

In today’s presentation, Mr. Bender discusses a potential Phase 3 clinical study concept using INT230-6 with SOC with and without doxorubicin compared to SOC alone . Currently, the SOC treatment includes immunotherapy (pembrolizumab), an anthracycline (usually doxorubicin), carboplatin, cyclophosphamide, and taxane. Depending on the strength of the pCR data from the INVINCIBLE-4 Study and a lead-in cohort of patients in a potential Phase 3 trial, a three-arm randomized, controlled Phase 3 trial could be 1) INT230-6 with SOC, 2) current SOC, and 3) INT230-6 with SOC without the anthracycline.

Christine Handy, a patient advocate and co-author on the poster number PS4-10-15 noted, "I have experienced permanent cardiotoxicity using the red devil, doxorubicin, when treated for my breast cancer and know full well how that agent can disrupt the lives and health of those fighting cancer. Patients can be harmed by the treatment for this potentially deadly disease and often have to make a difficult choice as some fear the harmful effects of therapy as much as the cancer itself. I am encouraged by companies such as Intensity Therapeutics with new concepts for improving safety and efficacy for patients and am excited by the early observations of this new and novel drug treatment."

Mr. Bender concluded, "Triple Negative Breast Cancer is one of the most aggressive and difficult to treat breast cancer subtypes. While our INVINCIBLE-4 Study is still early, we are encouraged by the observed safety as reported in the PS5-8-16 poster and pCR results received to date when our drug is combined with SOC immunochemotherapy. These new safety results are consistent with the data from pre-clinical and clinical data when our drug is combined with immunotherapies. We look to restart patient enrollment in INVINCIBLE-4 study using the modified dosing regimen to improve our results as soon as possible. Should the safety and pCR results remain favorable, we plan to approach regulatory authorities with a Phase 3 study design that could yield a safer, more effective presurgical dosing regimen with good cosmetic outcomes for patients. Subject to regulatory agreement, using pCR as the surrogate endpoint could allow for an accelerated approval of a TNBC regimen without the red devil in a timeframe sooner than current trials that are evaluating event free survival."

About Triple Negative Breast Cancer in the Presurgical Setting

Women with aggressive forms of breast cancer, such as Triple Negative Breast Cancer ("TNBC"), are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of recurrence. Approximately 11-17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, the majority of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates are 65%, with rates generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 80% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.

About a Potential INT230-6 Approval Pathway in the Presurgical Setting

The U.S Food and Drug Administration ("FDA") instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. Pathological complete response ("pCR") is an accepted FDA accelerated approval criterion for approval in high-risk breast cancer, such as TNBC subtype. Pathological complete response is defined as the absence of residual invasive and in situ cancer after evaluation of the complete resected breast specimen and lymph nodes following completion of neoadjuvant systemic therapy. If a product is approved using pCR, companies must still seek full approval using event free survival as an endpoint.

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

(Press release, Intensity Therapeutics, DEC 11, 2025, View Source [SID1234661386])

Anixa Biosciences Announces Positive Phase 1 Data for Investigational Breast Cancer Vaccine; Primary Endpoints Were Met and Immune Response Observed in 74% of Participants

On December 11, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported the presentation of final data from the Phase 1 clinical trial of its investigational breast cancer vaccine (NCT04674306) at the 2025 San Antonio Breast Cancer Symposium (SABCS). The trial was conducted in collaboration with Cleveland Clinic and funded by a grant from the U.S. Department of Defense.

Final Phase 1 findings showed the investigational vaccine met all major primary endpoints, was safe and well tolerated at the maximum tolerated dose (MTD), and elicited protocol-defined immune responses in 74% of participants. The presentation, titled "Final Results of a Phase I Trial of Alpha-lactalbumin (aLA) Vaccine for Breast Cancer," was delivered by Justin Johnson, Ph.D., Program Manager at Cleveland Clinic and co-inventor of the breast cancer vaccine technology. The SABCS poster presentation is available at View Source

"Triple-negative breast cancer remains one of the most challenging subtypes to address, and Phase 1 trials are an important step in determining whether a new approach can be administered safely and activate the immune system as intended," said G. Thomas Budd, M.D., of Cleveland Clinic’s Cancer Institute and principal investigator of the study. "In this trial, the investigational α-lactalbumin vaccine was safe and well tolerated at the maximum tolerated dose and generated protocol-defined immune responses in 74% of participants—results that support continued clinical evaluation."

Topline Phase 1 results:

All major primary endpoints were met
74% of participants demonstrated protocol-defined immune responses; α-lactalbumin (aLA)-specific T cell responses were observed per protocol-defined criteria
Vaccine was safe and well tolerated at the MTD, with adverse events primarily injection-site irritation
Preliminary Immunohistochemistry (IHC) of primary tumors showed aLA expression ranging from absent to strong; analyses correlating expression to immune response and clinical outcomes are ongoing
Participants will be followed for five years after completing the study
Combination of Keytruda and the vaccine also generated antigen-specific T cell responses and showed no major additional side effects
Data will inform planned Phase 2 study design, including a potential Phase 2 combination study with Keytruda in the neoadjuvant setting among newly diagnosed breast cancer patients
The Phase 1 study evaluated safety and monitored immune response to an investigational vaccine targeting α-lactalbumin (aLA). The trial enrolled 35 participants across three cohorts: Cohort Ia (n=26), women who completed standard-of-care treatment, including surgery, for early-stage TNBC within three years and were tumor-free but at elevated risk of recurrence; Cohort Ib (n=4), cancer-free women with BRCA1, BRCA2, or PALB2 mutations who elected preventive mastectomy and were vaccinated prior to surgery; and Cohort Ic (n=5), women with TNBC receiving pembrolizumab (Keytruda) in the adjuvant (post-surgery) setting, with evaluation of safety of combination administration and immune responses.

In Cohort Ia, at the MTD, the vaccine was reported as safe, with no flu-like symptoms (fever and myalgias), no abnormal clinical laboratory tests, and no other observed adverse side effects in this cohort; the primary notable adverse event was injection-site irritation. Participants demonstrated aLA-specific T cell responses, including production of interferon gamma and interleukin-17.

In Cohort Ib, safety and tolerability were similar to Cohort Ia. Immunohistochemistry analyses of resected breast tissue are ongoing and will be presented in a future scientific presentation.

In Cohort Ic, a key objective was to assess whether administration of the investigational vaccine in combination with pembrolizumab could create intolerable side effects. No major adverse side effects were reported; as in other cohorts, the primary adverse event was injection-site irritation. Two participants experienced Grade 3 adverse events consisting of greater irritation at an injection site.

The investigational vaccine targets α-lactalbumin, a lactation protein generally expressed in the breast during lactation but not at other times in life or in other normal tissues. In many breast cancers, malignant cells express α-lactalbumin. The vaccine is designed to activate the immune system to direct cytotoxic T cells toward tumor cells expressing α-lactalbumin, with the goal of providing preemptive immune protection against emerging tumors that express this antigen.

The vaccine is based on preclinical research led by the late Vincent Tuohy, Ph.D., who served as the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic.

"It was Dr. Tuohy’s hope that this vaccine would demonstrate the potential of immunization as a new way to combat breast cancer, and that a similar approach could someday be applied to other types of malignancies," said Dr. Johnson. "Our findings that the majority of participants across all three cohorts demonstrated an immune response to α-lactalbumin is an encouraging sign."

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "We are very encouraged that the final Phase 1 data met all major primary endpoints, with the vaccine demonstrating a favorable tolerability profile at the MTD and protocol-defined immune responses in the majority of participants. We appreciate the support provided through the U.S. Department of Defense grant that enabled this study in collaboration with Cleveland Clinic, and we look forward to engaging with regulators and advancing plans for a Phase 2 study."

(Press release, Anixa Biosciences, DEC 11, 2025, View Source [SID1234661385])