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.

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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)

(N=7)

SOC

Term

Grade 3

Grade 4

Overall

Grade 3

Grade 4

Overall

Blood and Lymphatic System Disorders

Anemia

1 (14.3 %)

1 (14.3 %)

Febrile neutrogenia

2 (28.6 %)

2 (28.6 %)

2 (28.6 %)

2 (28.6 %)

Ear and Labyrinth Disorders

Vertigo

1 (14.3 %)

1 (14.3 %)

General Disorders and Administration Site Conditions

Fatigue

1 (14.3 %)

1 (14.3 %)

Injection Site Reaction

4 (57.1 %)

4 (57.1 %)

Infections and Infestations

Catheter Related Infection

1 (14.3 %)

1 (14.3 %)

Infected Seroma

1 (14.3 %)

1 (14.3 %)

Skin Infection

1 (14.3 %)

1 (14.3 %)

Urinary Tract Infection

1 (14.3 %)

1 (14.3 %)

Investigation

Alanine Aminotransferase Increased

1 (14.3 %)

1 (14.3 %)

Creatinine Increased

1 (14.3 %)

1 (14.3 %)

GGT Increased

1 (14.3 %)

1 (14.3 %)

Neutrophil Count Decreased

2 (28.6 %)

2 (28.6 %)

1 (14.3 %)

2 (28.6 %)

3 (42.9 %)

Metabolism and Nutrition Disorders

Anorexia

1 (14.3 %)

1 (14.3 %)

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

Disease Progression

1 (14.3 %)

1 (14.3 %)

Nervous System Disorders

Guillain-Barre Syndrome

1 (14.3 %)

1 (14.3 %)

Imunotherapy Related Encephalitis

1 (14.3 %)

1 (14.3 %)

Renal and Urinary Disorders

Chronic Kidney Disease

2 (28.6 %)

2 (28.6 %)

TOTAL

7

2

9

17

3

20

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])

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).

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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])

On December 11, 2025 Innovent Biologics (SSE: 688428; HKSE: 09969), a high-tech biopharmaceutical company, reported that its independently developed next-generation TRK inhibitor, Enoxin ( zolectretinib, ICP-723), has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult and adolescent patients aged 12 years and older with solid tumors harboring NTRK fusion genes. This marks the approval of China’s first independently developed next-generation TRK inhibitor for market launch.

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In a pivotal registrational clinical trial for patients with NTRK fusion-positive solid tumors, zoletrazinib demonstrated excellent efficacy and safety as a broad-spectrum anticancer drug regardless of tumor type. Registry results showed an overall response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, a 24-month progression-free survival (PFS) rate of 77.4%, and a 24-month overall survival (OS) rate of 90.8%.

As a new generation TRK inhibitor independently developed in China, zoletrazinib is more effective than first-generation TRK inhibitors. It not only provides long-term deep remission but also exhibits strong penetrating brain activity and good overall safety. Furthermore, data shows that it can overcome resistance to first-generation TRK inhibitors. The once-daily oral administration of two tablets also offers great convenience to patients.

Professor Zhang Yizhuo of Sun Yat-sen University Cancer Center stated, "NTRK fusion-positive tumors often progress rapidly and have limited treatment options. Zoletratinib has demonstrated remarkable efficacy, especially in adolescent patients where the overall response rate (ORR) reached 100% . Clinically, zolectratinib’s onset of action is significantly faster than traditional chemotherapy, with many patients observing significant tumor shrinkage within one to two cycles, providing a valuable treatment window for critically ill patients. Furthermore, the duration of zolectratinib’s effective response is long; the longest response we have observed clinically has exceeded 36 months, offering hope for longer survival to patients with solid tumors."

Professor Luo Zhiguo of Fudan University Cancer Hospital stated, "Most of the patients enrolled in our center are sarcoma patients. Zoletratinib achieved an overall response rate (ORR) of 89.5% in patients with soft tissue sarcoma , demonstrating excellent efficacy. Furthermore, its high selectivity significantly reduces off-target toxicity and exhibits good safety, allowing patients to use the medication long-term without affecting their quality of life. For patients with solid tumors requiring long-term treatment, the efficacy and safety advantages of zoletratinib can help them live longer and better."

Professor Wang Qiming of Henan Cancer Hospital emphasized, "Zoletratinib also demonstrates excellent efficacy in NTRK fusion-positive lung cancer patients, with an overall response rate (ORR) of 88.9%, bringing more hope to lung cancer patients. Simultaneously, zolectratinib exhibits remarkable brain-penetrating activity, achieving a 100% intracranial objective response rate (IC-ORR) and a 100% 12-month intracranial sustained response rate (IC-DOR), achieving strong control of brain lesions. From a molecular mechanism perspective, zolectratinib’s unique structure enables it to penetrate the blood-brain barrier and maintain effective therapeutic concentrations in cerebrospinal fluid, providing a new treatment option for patients with brain metastases."

Professor Chen Libo of Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University stated, " The overall response rate (ORR) for thyroid cancer patients enrolled with zoletrinib was 100% . Patients enrolled in our center have maintained continuous remission for two years, demonstrating the superior efficacy of zoletrinib compared to first-generation TRK inhibitors. Furthermore, as a new generation TRK inhibitor, zoletrinib offers new hope for resistant patients. With its excellent efficacy and good tolerability, zoletrinib can provide long-term, sustained, deep remission for patients with NTRK fusion-positive solid tumors."

Dr. Cui Jisong, co-founder, chairman, and CEO of InnoCare Pharma, said, "Zoletratinib is InnoCare Pharma’s third approved innovative drug and our first approved innovative drug in the field of solid tumors. As a broad-spectrum anticancer drug that is not limited to any type of tumor, zoletratinib has significant clinical implications for patients with NTRK fusion-positive solid tumors. We would like to express our special thanks to the doctors, patients, partners, and employees who participated in this clinical trial for their support, and also to the regulatory agencies for their professional and efficient approval process, which allows more patients with solid tumors to receive better treatment earlier. We believe that zoletratinib, as the first independently developed and approved TRK inhibitor in China, will bring new hope to patients with solid tumors in China."

Zolectretinib has been included in the "Pilot Program for Encouraging the Development of Pediatric Anti-tumor Drugs (Starlight Program)" by the China National Medical Products Administration. Innovent Biologics expects to submit an NDA application for zolectretinib for the treatment of pediatric patients (aged 2 to 12) soon.

NTRK fusion genes are present in various types of tumors and have been found in more than 26 types of solid tumors [1] . It is estimated that there are 6,500 new cases of tumors carrying NTRK fusion genes in China each year. These patients have short survival, rapid disease progression and high disability rate. However, due to the low popularity of the current gold standard detection method – next-generation sequencing (NGS), diagnosis is delayed, so there is still an unmet clinical need. The emergence of the broad-spectrum anticancer drug zoletrinib has brought new treatment options to patients.

(Press release, InnoCare Pharma, DEC 11, 2025, View Source [SID1234663149]).

On December 10, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported it will present data on potential treatments for pancreatic and gastric/gastroesophageal junction (G/GEJ) cancer at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium taking place January 8-10, 2026 in San Francisco, California. Highlights include a late-breaking oral presentation of cohort results from the Phase 2 ILUSTRO study of first-line zolbetuximab in combination with chemotherapy and immunotherapy in claudin 18.2-positive, HER2-negative, locally advanced or metastatic G/GEJ cancer, as well as new Phase 1 data from ASP3082 (setidegrasib), an investigational KRAS G12D targeted protein degrader, in pancreatic cancer.

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Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas
"At Astellas, we are harnessing next-generation treatment modalities and a precision biomarker-driven approach to deliver treatments that make a meaningful difference for patients with gastrointestinal cancers. We’re excited to share data at ASCO (Free ASCO Whitepaper) GI from our growing portfolio of assets in GI cancers – which showcase our commitment to better understanding how to treat these diseases – including emerging data from zolbetuximab as well as progress on ASP3082 (setidegrasib), our investigational KRAS G12D targeted protein degrader. Together with the passionate GI cancer community of patients, physicians, and advocates, we are working to transform outcomes for patients and pave the future of cancer care."

Astellas Presentations at ASCO (Free ASCO Whitepaper) GI 2026

Zolbetuximab

Presentation Title

Presenter

Presentation Details

Phase 2 ILUSTRO trial of first-line
zolbetuximab plus mFOLFOX6 and
nivolumab in patients with claudin
18 isoform 2-positive, human
epidermal growth factor receptor 2-
negative, locally advanced or
metastatic gastric or
gastroesophageal junction
adenocarcinoma

K. Shitara

Type: Oral presentation

Abstract Number: LBA284

Date: January 8, 2026,
8:47 a.m. – 8:57 a.m. PST

Determinants of biomarker testing
and treatment selection by
oncologists caring for patients with
gastric or gastroesophageal
junction adenocarcinoma

R. Fuldeore

Type: Poster

Abstract Number: 453

Date: January 8, 2026,
11:30 a.m. – 1:00 p.m.;
6:00 p.m. – 7:00 p.m. PST

Zolbetuximab + pembrolizumab
and chemotherapy as first-line
treatment for patients with
CLDN18.2-positive, HER2-
negative, PD-L1-positive locally
advanced unresectable or
metastatic G/GEJ
adenocarcinoma: Phase 3, double-
blind, randomized trial (LUCERNA)

K. Shitara

Type: Poster

Abstract Number: TPS473

Date: January 8, 2026,
11:30 a.m. – 1:00 p.m.;
6:00 p.m. – 7:00 p.m. PST

Assessment of the impact of proton
pump inhibitor exposure on
survival outcomes in patients with
gastric or gastroesophageal
junction adenocarcinoma treated
with zolbetuximab plus
chemotherapy

A. Yamada

Type: Poster

Abstract Number: 349

Date: January 8, 2026,
11:30 a.m. – 1:00 p.m.;
6:00 p.m. – 7:00 p.m. PST

A real-world study of claudin 18.2
association with molecular
subtypes, mutations/biomarkers,
immune landscapes, and gene
signatures and prognostic value in
pancreatic ductal adenocarcinoma

G. Zhang

Type: Poster

Abstract Number: 744

Date: January 9, 2026,
11:30 a.m. – 1:00 p.m.;
5:00 p.m. – 6:00 p.m. PST

Treatment patterns and outcomes
of patients diagnosed with
metastatic pancreatic
adenocarcinoma

R. Fuldeore

Type: Poster

Abstract Number: 685

Date: January 9, 2026,
11:30 a.m. – 1:00 p.m.;
5:00 p.m. – 6:00 p.m. PST

ASP3082 (setidegrasib)

Presentation Title

Presenter

Presentation Details

Efficacy and safety of setidegrasib
(ASP3082) monotherapy or in
combination with mFOLFIRINOX in
patients with pancreatic ductal
adenocarcinoma

A. Kasi

Type: Poster

Abstract Number: 704

Date: January 9, 2026,
11:30 a.m. – 1:00 p.m.;
5:00 p.m. – 6:00 p.m. PST

Phase 1 evaluation of setidegrasib
(ASP3082), a first-in-class selective
protein degrader, in patients with
KRAS G12D-mutant pancreatic
ductal adenocarcinoma:
Pharmacokinetics and biomarker
insights

W. Park

Type: Poster

Abstract Number: 775

Date: January 9, 2026,
11:30 a.m. – 1:00 p.m.;
5:00 p.m. – 6:00 p.m. PST

(Press release, Astellas, DEC 10, 2025, View Source [SID1234661353])

On December 10, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company developing first-in-class therapies for difficult-to-treat cancers, reported a clinical supply agreement with BeOne Medicines, a global oncology company. This agreement will supply a global, multi-center Phase 1b/2a clinical trial to evaluate Senhwa’s lead compound Pidnarulex (CX-5461) in combination with BeOne’s tislelizumab, a PD-1 inhibitor, in patients with advanced solid tumors, including pancreatic ductal adenocarcinoma (PDAC) and immune checkpoint inhibitor (ICI)-refractory melanoma.

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This agreement represents a significant milestone for Senhwa as CX-5461 enters the immuno-oncology field, and it also underscores the company’s commitment to advancing strategic combination therapies that break through the limitations of immunotherapy —bringing new hope to cancer patients worldwide.

Senhwa Biosciences: Driving a New Era in Immuno-Oncology

"This agreement represents a major step forward for Senhwa as we expand into the heart of immuno-oncology," said Benny T. Hu, Chairman of Senhwa Biosciences. "By leveraging the unique mechanism of action of CX-5461 in modulating the tumor microenvironment, we hope to discover and confirm new treatment options for patients who do not currently benefit from existing treatment options, while increasing international recognition and building long-term strategic value for the company," added by Chairman Hu.

Under the terms of the agreement, BeOne Medicines will provide tislelizumab for the combination study, while Senhwa will supply CX-5461 and lead clinical and regulatory operations. The study will enroll patients at multiple sites in the United States and Taiwan, assessing safety, tolerability, and preliminary efficacy of the CX-5461 plus tislelizumab combination.

By modulating the tumor microenvironment, CX-5461 breaks through the barriers of immunotherapy, opening new possibilities for cancer treatment

Discovered and developed by Senhwa, CX-5461 is the world’s first G-quadruplex stabilizer with significant clinical data—a novel therapeutic class designed to selectively disrupt genomic stability in tumor cells through replication stress induction.

Recent preclinical and clinical findings suggest that CX-5461 not only exerts direct cytotoxic activity but also modulates the tumor microenvironment, enhancing immune recognition and response.

By converting immunologically "cold" tumors into "hot" ones, CX-5461 may sensitize previously resistant tumors to checkpoint blockade and broaden the clinical utility of immunotherapy.

The "cold-to-hot" tumor concept represents one of the most promising frontiers in cancer immunology. CX-5461’s differentiated mechanism positions Senhwa to play a leading role in improving the efficacy of the immune checkpoint inhibitors approved by FDA with only 20-30% response rates.

Global Immunotherapy Market: Expanding Horizons

According to Precedence Research, the global cancer immunotherapy market is expected to grow from USD 136.4 billion in 2025 to USD 338.4 billion by 2034, representing a compound annual growth rate (CAGR) of 10.65%. Similarly, Grand View Research projects that the broader immunotherapy market will exceed USD 486 billion by 2030.

As major pharmaceutical companies approach a looming patent cliff—most notably with the immune checkpoint inhibitor blockbuster KEYTRUDA, which is expected to lose its exclusivity in 2028—the industry is ramping up efforts to secure next-generation immuno-oncology assets through strategic partnerships, mergers, and acquisitions.

With its differentiated pipeline, established collaboration with the U.S. National Cancer Institute (NCI), and now entering the supply agreement with BeOne Medicines, Senhwa Biosciences is uniquely positioned at the intersection of scientific innovation and global capital markets. The company aims to play a pivotal role in the next wave of expansion and innovation in precision medicine and immuno-oncology by partnering with global pharmaceutical companies and to drive sustainable growth and long-term value creation for its stakeholders.

(Press release, Senhwa Biosciences, DEC 10, 2025, View Source [SID1234661354])