On January 13, 2026 Coherus oncology presented its corporate presentation.

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(Presentation, Coherus Oncology, JAN 13, 2026, View Source [SID1234662010])

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 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported it will expand the use of its proprietary AI-Immunology platform to also discover and develop new treatments for autoimmune diseases. Thus, Evaxion will in the future work within cancers, infectious and autoimmune diseases as its core disease areas.

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The expansion leverages the unique scalability of AI-Immunology and will increase the pool of diseases for which we can decode the immune system and potentially discover and develop new treatments. In turn, this will improve the quantity and quality of new programs within our pipeline, potentially available for partnership. Autoimmune diseases are characterized by high unmet medical need and offer significant partnership potential across all stages of drug development.

"Autoimmune diseases can be severely debilitating and even lethal, placing a substantial burden on patients, their families and on society across all stages of life. With AI-Immunology we have a unique technology and a platform that we know can deliver new treatment opportunities. By expanding the platform into autoimmune diseases, we have the potential to meaningfully improve the outcome for patients and unlock significant partnership value from the platform," says Helen Tayton-Martin, CEO at Evaxion.

We plan to expand and train AI-Immunology to be applicable to autoimmune diseases during the second half of 2026. Specifically, the AI-Immunology platform potentially allows for development of precision treatments targeting underlying disease mechanisms, in contrast to current treatment approaches that primarily address symptoms. The related work on the autoimmune disease application development is already included in Evaxion’s cashflow outlook and does not impact our cash runway, which still extends to the second half of 2027.

2026 company milestones
The expansion to autoimmune diseases represents a new strategic milestone for Evaxion in addition to other milestones for 2026 as outlined below. These reflect continued execution of our strategy of creating value from both our platform and pipeline assets through partnerships.

Milestone Target
EVX-01 Additional biomarker and immunogenicity data H1
AI-Immunology New application for autoimmune diseases H2
EVX-01 Three-year phase 2 clinical efficacy data H2
EVX-04 Regulatory filing for phase 1 trial H2
EVX-B4 Design and preclinical validation of antigens H2

(Press release, Evaxion, JAN 13, 2026, View Source [SID1234662011])

On January 13, 2026 Decoy Therapeutics, Inc. (Nasdaq: DCOY) (Decoy, or the Company), a preclinical biopharmaceutical that is engineering the next generation of peptide conjugate therapeutics, announces that the development of a flexible, globally accessible manufacturing platform for peptide-conjugate antivirals is a key ‘funded development’ of Decoy’s Global Access Commitment Agreement (GACA) with the Gates Foundation.

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"We are excited to enter this new phase of our work funded by the Gates Foundation to support making countermeasures for emerging pathogens accessible to people in low- and middle-income countries," stated Decoy Chief Scientific Officer Barbara Hibner. "This new capability will establish a distributed network of manufacturing facilities with the ability to respond rapidly to viral outbreaks anywhere in the world. It will also support Decoy’s future commercial efforts by providing the ability to manufacture our antiviral inhibitors, and ultimately other classes like peptide drug conjugates for oncology indications, for global markets."

Decoy is creating an easily transferable manufacturing capability for peptide-conjugate antiviral fusion inhibitors designed on its IMP3ACT platform that can rapidly advance therapeutic products from laboratory to commercial scale. This manufacturing capability will be designed to enable cost-efficient, rapid and repeatable scale-up on standard commercial peptide-synthesis machinery, thus enabling a network of global manufacturing facilities that can be flexibly configured to meet demand.

"Our proprietary IMP3ACT platform allows for the rapid computational design and manufacturing of innovative peptide-conjugate therapeutics that have broad activity across entire viral families, or even across multiple viral families," said Peter Marschel, Decoy Chief Business Officer. "Our vision, ‘design-for-manufacturing’, allows us to minimize the marginal cost and regulatory effort to scale-up manufacturing for new therapeutics. We see this as a key element of an end-to-end platform that can design, develop and commercialize novel peptide-conjugate therapeutics with unprecedented speed."

Decoy is working with a leading contract manufacturing organization based in the U.S. and Europe to establish the manufacturing capability. The platform will be validated using Decoy’s intranasal pan-coronavirus fusion inhibitor funded from the same grant, which demonstrates the ‘design-for-manufacturing’ capability of Decoy’s proprietary IMP3ACT platform. The intranasal pan-coronavirus inhibitor is being developed as a conveniently administered, broad-acting, antiviral to prevent and mitigate infections from multiple coronaviruses in immune-compromised and high-risk populations.

The Company is focused on advancing its pipeline of peptide conjugate therapeutics engineered through its IMP3ACT platform that reduces the complexity of drug development and manufacturing. During the next 12 months, Decoy expects to advance its lead asset, a pan-coronavirus antiviral, to the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), and to make progress on other programs including a novel broad-acting antiviral to treat flu, COVID-19 and respiratory syncytial virus (RSV), and a peptide drug conjugate targeting GI cancers.

About Decoy’s Peptide Conjugate Technology

Decoy’s drug design engine uses the power of computational tools and fast peptide synthesis technology pioneered in the laboratory of Brad Pentelute, Ph.D., Professor of Chemistry at MIT and Decoy co-founder, to rapidly engineer and synthesize novel antivirals that directly target highly conserved viral machinery. Its proprietary IMP3ACT peptide-conjugate drug design and manufacturing platform leverages machine learning (ML) and artificial intelligence (AI) tools. IMP3ACT allows for the rapid computational design and manufacturing of innovative peptide-conjugate therapeutics including rapid response to novel viral pathogens including H5N1 avian flu. Peptide conjugates are a new class of drug, perhaps best known for the popular diabetes and weight loss medications, that takes advantage of the strong activity and selectivity of peptides, and improves their targeting and durability by adding a lipid molecule. Decoy Therapeutics is expanding the use of this new drug class to indications including infectious diseases, cancer, and other therapeutic areas.

The IMP3ACT platform leverages peptide chemistry to design α-helical peptides using computational and ML tools. These peptides are transformed into multimeric conjugates by chemically linking a defined number of copies to lipids or other suitable membrane anchor moieties, enhancing their drug-like properties and dosing flexibility with extended pharmacokinetics. Decoy’s technology has produced peptide conjugates effective in vitro against multiple human coronaviruses, including all SARS-CoV-2 major variants of concern to date, and against RSV A, RSV B and hPIV3, and in vivo against the SARS-CoV-2 delta variant. By integrating machine learning algorithms in peptide design and synthesis, Decoy’s platform accelerates the creation of lead molecules for preclinical evaluation, simultaneously optimizing peptide conjugates for enhanced affinity, binding specificity, resistance to proteases, pharmacokinetic properties and manufacturability at early commercial scale.

On January 13, 2026 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported unaudited preliminary financial results for the fourth quarter and fiscal year 2025 ahead of its presentation at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026 at 7:30 a.m. Pacific Time (10:30 a.m. Eastern Time). The webcast can be accessed through Illumina’s website at investor.illumina.com.

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Preliminary fourth quarter 2025 results:
•Revenue of approximately $1.155 billion, up 5% from Q4 2024 (up 4% on a constant currency basis)
•Ex-China revenue of approximately $1.100 billion, up 7% from Q4 2024 (and on a constant currency basis)
•GAAP diluted EPS of $2.14 to $2.17 and non-GAAP diluted EPS of $1.27 to $1.30

Preliminary fiscal year 2025 results:
•Revenue of approximately $4.34 billion, flat compared to 2024 (and on a constant currency basis)
•Ex-China revenue of approximately $4.10 billion, up 2% from 2024 (and on a constant currency basis)
•GAAP diluted EPS of $5.42 to $5.45 and non-GAAP diluted EPS of $4.76 to $4.79

As previously announced, the company expects to report its full fourth quarter and fiscal year 2025 results following the close of market on Thursday, February 5, 2026. The unaudited results in this press release are preliminary and subject to the completion of accounting and annual audit procedures and are therefore subject to adjustment.

Statement regarding use of non-GAAP financial measures
The company reports non-GAAP results for diluted earnings per share, net income, gross margin, operating expenses, including research and development expense, selling general and administrative expense, legal contingency and settlement, and goodwill and intangible impairment, operating income, operating margin, gross profit, other income (expense), tax provision, constant currency revenue and growth, and free cash flow (on a consolidated and, as applicable, segment basis) in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include substantial charges such as amortization of acquired intangible assets among others that are listed in the reconciliations of GAAP and non-GAAP financial measures included in this press release, as well as the effects of currency translation. Management has excluded the effects of these items in non-GAAP measures to assist investors in analyzing and assessing past and future operating performance. Non-GAAP net income, diluted earnings per share and operating margin are key components of the financial metrics utilized by the company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

The company provides forward-looking guidance on a non-GAAP basis, including on a constant currency basis for revenue and revenue growth rates. The company is unable to provide a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures because it is unable to predict with reasonable certainty the impact of items such as acquisition-related expenses, fair value adjustments to contingent consideration, gains and losses from strategic investments, potential future asset impairments, restructuring activities, the ultimate outcome of pending litigation, and currency exchange rate fluctuations without unreasonable effort. These items are uncertain, inherently difficult to predict, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the company is unable to address the significance of the unavailable information, which could be material to future results.

(Press release, Illumina, JAN 13, 2026, View Source [SID1234662012])