On January 13, 2026 Immunofoco, a clinical-stage biotechnology company advancing innovative CAR-T cell therapies for solid tumors, reported clinical data from its Phase I/IIa study of IMC002, a VHH-based anti-CLDN18.2 CAR-T therapy, in patients with advanced gastric cancer and gastroesophageal junction cancer (GC/GEJ). The data were presented as a poster (Abstract No. 398) at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI 2026).

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The study is a multicenter, open-label, dose-escalation Phase I/IIa trial designed to evaluate the safety, tolerability, and preliminary efficacy of IMC002 in patients with CLDN18.2-positive, locally advanced or metastatic GC/GEJ who had failed at least two prior lines of systemic therapy. The results presented at ASCO (Free ASCO Whitepaper) GI 2026 focus on the GC/GEJ cohort.

As of the data cutoff on August 8, 2025, 16 patients had received a single infusion of IMC002 and were included in the safety analysis, with 15 patients evaluable for efficacy. IMC002 demonstrated a favorable and manageable safety profile, with no dose-limiting toxicities observed during the dose-escalation phase. Cytokine release syndrome (CRS) occurred in all patients but was limited to Grade 1 or 2, and no Grade ≥3 CRS, ICANS, or treatment-related deaths were reported.

In evaluable patients, IMC002 achieved an objective response rate (ORR) of 66.7% (10/15). Survival data were immature at the time of analysis, with a median progression-free survival (mPFS) of 7.0 months (95% CI: 3.9, NA) and a median overall survival (OS) of 10.3 months (95% CI: 6.1, NA).

Notably, one patient in the 2.5×10⁸ CAR-T cell dose cohort achieved a complete response (CR) and has remained tumor-free for 60 weeks, demonstrating antitumor activity following IMC002 treatment in a heavily pretreated setting.

Further analyses indicated that IMC002 provided clinically meaningful PFS benefits in third-line and later-line GC/GEJ patients, comparing favorably with historical outcomes reported for this population. Together with its well-tolerated safety profile, these findings support the continued clinical development of IMC002 and its potential evaluation in earlier-line treatment settings.

"IMC002 demonstrated a controllable safety profile and encouraging antitumor activity in patients with advanced gastric and gastroesophageal junction cancers, including those who had failed multiple prior lines of therapy," said Professor Jianming Xu, corresponding author of the study and Professor at the First Medical Center of the Chinese PLA General Hospital. "Of particular clinical significance, one patient achieved a complete response lasting for more than one year. These findings provide important clinical evidence supporting the application of CLDN18.2-targeted CAR-T therapy in solid tumors, and the favorable safety profile also opens the possibility for future exploration in earlier-line settings and strategies aimed at long-term clinical benefit."

IMC002 is a novel CLDN18.2-targeted CAR-T cell therapy incorporating a highly specific VHH domain, designed to enhance tumor targeting while maintaining a favorable safety profile in solid tumors. Based on the encouraging results from this Phase I/IIa study, a Phase III randomized controlled trial of IMC002 in late-line GC/GEJ patients has been initiated.

The presentation at ASCO (Free ASCO Whitepaper) GI 2026 highlights Immunofoco’s continued progress in advancing CAR-T cell therapies for solid tumors and underscores the therapeutic potential of CLDN18.2-targeted approaches in addressing significant unmet medical needs in advanced gastrointestinal cancers.

(Press release, Immunofoco, JAN 13, 2026, View Source;highlighting-a-durable-complete-response-beyond-one-year-and-a-66-7-orr-in-advanced-gcgej-302659498.html [SID1234662026])

On January 13, 2026 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 key milestones achieved during 2025 and outlines strategic priorities for 2026.

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2025 Key Highlights and 2026 Outlook and Strategic Priorities

INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer and SOC alone.
In September 2025, a pathological complete response was observed in the first patient evaluated in Cohort A, where each patient receives one or two doses of INT230-6 eight days apart, followed by the SOC. Some patients in Cohort A began to experience localized skin irritation, prompting a temporary pause in new patient enrollment. As a result, the protocol is being modified to administer one or two doses at lower volumes for each tumor size.

In December 2025, early observations data from the INVINCIBLE-4 Study were presented at the San Antonio Breast Cancer Symposium, showing favorable safety, with 50% fewer grade 3 or higher adverse events observed in the INT230-6 cohort compared to the standard of care neoadjuvant chemotherapy alone cohort. The INVINCIBLE-4 study was initiated in late 2024, and 14 patients have been treated, with 7 in each cohort.

The Company plans to file a protocol amendment with the regulatory agencies for this revision in dosing in the first quarter of 2026, and expects to reinitiate enrollment for the now 61-patient study in the first quarter of 2026, as seven additional patients will be added to cohort A.
INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes.
In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Before this pause, the trial had enrolled 21 patients. The Company continues to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its third-party contract research organizations at significantly reduced ongoing costs during this pause.

The Company has prioritized reinitiating patient enrollment and site activations during 2026 once sufficient funding is obtained.
Potential New Phase 3 Breast Cancer Study: The clinical study could be with INT230-6 plus standard of care, potentially also using biomarkers to assess the need for anthracyclines (doxorubicin) for the treatment of neoadjuvant Triple Negative Cancer (assuming sufficient funding has already been obtained for the reinitiation of the Phase 3, sarcoma INVINCIBLE-3 Study).
If safety and efficacy trends continue in the INVINCIBLE-4 Study, a Phase 3 clinical study design in the US and other countries using INT230-6 with the current standard of care may be initiated contingent on obtaining sufficient incremental funding.
Peer-Reviewed Publication in a Lancet journal: Validate Clinical Potential
In October 2025, Intensity announced publication of its Phase 1/2 clinical study evaluating INT230-6 in the Lancet Discovery Science journal, eBioMedicine (volume 121). The manuscript reported a 75% disease control rate and a median overall survival of 11.9 months in patients with advanced solid tumors, with a median overall survival of 21.3 months observed in a subset of sarcoma patients. At least 20% of patients receiving a dose greater than 40% of their total tumor burden had abscopal effects where uninjected tumors shrank. Exploratory analyses further demonstrated potential to improve disease control rates and overall survival, especially when treating higher percentages of tumor burden. There was also evidence of systemic immune engagement, reinforcing INT230-6’s differentiated mechanism of action.

During 2026, the Company will continue to pursue an aggressive peer-reviewed publications strategy for its completed metastatic and breast cancer studies.
Strengthened Balance Sheet, Extended Runway into the Second Quarter of 2027:
The Company raised over $20 million in gross proceeds during 2025 through two public offerings, one registered direct offering, and ATM issuances. These successful capital-raising efforts strengthened Intensity’s balance sheet and extended its current operating runway into the second quarter of 2027, providing flexibility to advance certain clinical programs without near-term financing pressure.

The Company plans to maintain a disciplined operating approach in 2026 and will seek to opportunistically raise additional capital during 2026 to reinitiate patient enrollment and site activations in the INVICIBLE-3 Study, and to potentially initiate a new Phase 3 Breast Cancer Study.
Business Development: Continuing to pursue discussions with potential pharmaceutical partners to potentially accelerate the development and commercialization of our new drug.
Intensity Therapeutics Founder, President, and CEO Lewis H. Bender stated, "We enter our next phase of development with a clinically validated scientific foundation and a capital position that supports disciplined execution. A peer-reviewed publication in eBioMedicine, a Lancet Discovery Science journal, reinforced the clinical potential of INT230-6. At the same time, our successful capital raising efforts provided the resources to advance our programs well into 2027. Our focus remains on generating high-quality clinical data, additional peer-review publications, advancing regulatory engagement, and allocating capital with intention as we progress INT230-6 across multiple development pathways, in an attempt to build long-term shareholder value through consistent execution."

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, JAN 13, 2026, View Source [SID1234662025])

On January 13, 2026 Akeso, Inc. (9926.HK) reported the presentation of a real-world study at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), comparing cadonilimab plus chemotherapy against a PD-1 inhibitor plus chemotherapy for the first-line (1L) treatment for advanced gastric (G) or gastroesophageal junction (GEJ) cancer with PD-L1 CPS <5 (a propensity-matched, retrospective cohort study).

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The study results showed that the cadonilimab regimen, compared to the PD-1 monoclonal antibody regimen, significantly prolonged patients’ overall survival (OS) and progression-free survival (PFS). Both OS (HR=0.49, P=0.025) and PFS (HR=0.43, P=0.006) demonstrated statistically significant improvements. The full study has been accepted for publication in the Journal of Gastrointestinal Oncology.

These real-world findings are highly consistent with the "all-comer benefit" profile previously observed for cadonilimab in the Phase III registrational trial COMPASSION-15. This real-world, head-to-head comparison further underscores cadonilimab’s potential to elevate the standard of cancer immunotherapy and address clinical challenges unresolved by single-target PD-1 inhibitors. Based on the data from the pivotal Phase III COMPASSION-15 study, cadonilimab received approval in China in September 2024 for the first-line treatment of advanced gastric cancer across all patient subgroups and this indication was added to cadonilimab’s list of covered indication under National Reimbursement Drug List (NRDL), effective 2026.

Anti-PD-1 antibodies combined with chemotherapy is the international standard of care for advanced gastric cancer. However, its efficacy is significantly limited in patients with PD-L1-low (CPS < 5) or negative (CPS < 1) expression, where these patients constitute nearly half of all advanced gastric cancer cases. As a result, the U.S. Food and Drug Administration (FDA) restricted all approved first-line PD-1 inhibitors for advanced gastric cancer to only PD-L1-positive patients in 2024. This aligns with recommendations from leading guidelines, such as those of the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), which prioritize PD-1-based regimens for patients with PD-L1 CPS ≥5. Consequently, PD-L1-low or -negative advanced gastric cancer remains a major unmet clinical need globally due to thelack of effective immunotherapy options. A recent real-world study provides new evidence addressing this challenge.

In this retrospective analysis, patients with PD-L1-low (CPS < 5) advanced G/GEJ cancer received first-line therapy with either cadonilimab plus chemotherapy or a PD-1 inhibitor plus chemotherapy. With a median follow-up of 11.0 months as of February 28, 2025, the results showed that the cadonilimab-based regimen achieved statistically significant and clinically meaningful improvements in both PFS and OS compared to the PD-1 inhibitor-based regimen.

Some Key Findings from the Study published at GI-ASCO:

Significant PFS and OS Improvement: Among PD-L1-low patients, the cadonilimab group achieved a median OS of 14.3 months, significantly longer than the 10.3 months observed in the PD-1 inhibitor group (OS HR=0.49, p=0.025), representing a 51% reduction in the risk of death. The median PFS was also extended to 9.3 months compared to 5.8 months in the control group (PFS HR=0.43, p=0.006), corresponding to a 57% reduction in the risk of disease progression or death.
Higher Objective Response Rate (ORR): The objective response rate was superior in the cadonilimab group compared to the PD-1 inhibitor group (73.3% vs. 57.1%) for PD-L1-low patients.
Manageable Safety and Good Tolerability: The incidence of any-grade adverse events was comparable between the two groups, and no statistically significant difference observed in the rate of grade 3-4 adverse events between the two groups.
Akeso is actively advancing several prospective head-to-head Phase III registration studies with cadonilimab, aiming to elevate current standard immunotherapies. Notably, the international multi-center Phase III registration study COMPASSION-37, evaluating cadonilimab plus chemotherapy versus the PD-1 inhibitor nivolumab plus chemotherapy for first-line treatment of advanced gastric cancer, received approval from the U.S. FDA to initiate at the end of 2025. This milestone marks a new phase in the global development of cadonilimab.

(Press release, Akeso Biopharma, JAN 13, 2026, View Source [SID1234662024])

On January 13, 2026 Rakuten Medical, Inc. and LOTTE Biologics reported that they have signed a biopharmaceutical contract manufacturing agreement during the J.P. Morgan Healthcare Conference in San Francisco to strengthen Rakuten Medical’s production capabilities for its innovative oncology therapy, Alluminox platform-based photoimmunotherapy.

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Under the agreement, LOTTE Biologics will provide advanced manufacturing services for monoclonal antibody intermediates and their conjugates, supporting Rakuten Medical’s global clinical development and future commercialization.

Rakuten Medical’s proprietary photoimmunotherapy technology is designed to selectively target cells in solid tumors, by combining cell-targeting moieties, such as antibodies, with light-activatable agents, enabling focal and selective destruction of solid tumor cells upon light exposure.

In Japan, the therapy is approved for recurrent head and neck cancer, and its footprint has expanded steadily, through broader site adoption and sustained year–over–year growth in treatment numbers. In parallel, a global Phase 3 clinical trial is underway in the United States, Taiwan region and Japan, with plans to start treatment in Ukraine and Poland soon.

Rakuten Medical also plans to initiate a Phase 1 clinical trial in Japan for other solid tumors beyond head and neck cancer this year. These clinical and commercial dynamics are driving increased demand for Rakuten Medical’s bioconjugates.

LOTTE Biologics has been expanding its capabilities as a global contract development and manufacturing organization (CDMO), particularly in the field of monoclonal and multispecific antibodies, antibody-drug conjugates (ADCs), and advanced bioconjugation services. LOTTE Biologics will support the production of monoclonal antibody intermediates and their conjugates for Rakuten Medical’s programs, through its specialized ADC manufacturing facility at the Syracuse Bio Campus in New York. The facility is equipped with dedicated ADC production capabilities and advanced bioconjugation technologies, enabling the company to deliver high-quality manufacturing services while meeting global regulatory requirements and ensuring stable supply for customers worldwide.

(Press release, Rakuten Medical, JAN 13, 2026, View Source [SID1234662023])

On January 13, 2026 Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, reported key strategic priorities and clinical development updates for its innovative drug pipelines including antibody-drug conjugates (ADCs) and multi-specific antibodies (msAbs) at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California. The company also highlighted plans to expand its manufacturing and R&D capabilities to support long-term growth, enhance supply resilience and reinforce its long-term commitment to the U.S. market.

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The presentation, composed of two sections— ‘From Biosimilar Excellence to Next-Gen Innovative Therapeutics’ and ‘Scaling Our U.S. Presence with a Next-Gen Manufacturing and R&D Hub’—was delivered on the conference’s Main Track. Celltrion’s Chief Executive Officer Jin-Seok Seo and Senior Executive Vice President Hyuk-Jae Lee outlined the company’s innovative drug pipeline, with plans to submit up to 16 investigational new drug (IND) applications by 2028, including up to 10 ADCs, 4 msAbs, 1 recombinant protein, and 1 peptide. In its biosimilar business, Celltrion aims to commercialize up to 18 products by 2030 and 41 products by 2038.

The company’s ADC candidates are designed to target solid tumor cancers; with IND applications for CT-P70, CT-P71 and CT-P73 accepted by the U.S. Food and Drug Administration (FDA) in 2025. CT-P70, a novel ADC candidate being developed for the treatment of non-small cell lung cancer (NSCLC), recently received Fast Track designation from the U.S. FDA, enabling expedited interactions throughout the development process and the potential for accelerated regulatory review.

Celltrion is advancing a portfolio of msAbs that are designed to selectively target cancer cells or are activated only under specific conditions. Celltrion received an IND approval from the U.S. FDA for CT-P72, a tetravalent bispecific antibody being developed to target human epithelial growth factor receptor 2 (HER2) and cluster of differentiation 3 (CD3).

"We have made significant progress and see compelling opportunities ahead. Building on our company’s global footprint in biosimilar excellence, Celltrion is accelerating its transition toward next-generation innovative therapeutics," said Jin-Seok Seo, Chief Executive Officer at Celltrion. "Our expanding pipeline of ADCs and msAbs, grounded in deep antibody expertise, underscores our commitment to delivering meaningful value to patients worldwide. We aim to redefine the standard of care in oncology and beyond, while creating long-term sustainable value through scientific excellence and bold innovation."

To reinforce the company’s U.S. manufacturing capabilities, Celltrion recently completed the strategic acquisition of a former Eli Lilly manufacturing facility located in Branchburg, New Jersey, securing 66,000L of drug substance (DS) capacity. The company plans to sequentially increase capacity to a total of 132,000L by 2030, while also extending its capabilities to include drug product (DP) facilities. Through this acquisition, Celltrion plans to ensure long-term supply chain resilience eliminating the tariff and trade risks, ultimately strengthening its competitiveness in the U.S. market.

"The acquisition of the U.S. manufacturing facility represents a pivotal step in strengthening our global supply chain and solidifying our presence in the U.S. market," said Hyuk-Jae Lee, Senior Executive Vice President at Celltrion. "By securing large-scale DS capacity in the U.S., we are enhancing supply stability, mitigating trade and tariff risks, and establishing a solid foundation for expanded R&D collaboration and innovation in the region."

(Press release, Celltrion, JAN 13, 2026, View Source [SID1234662022])