On January 13, 2026 Ipsen (Euronext: IPN; ADR: IPSEY) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for IPN60340 in combination with venetoclax and azacitidine (Ven-Aza) in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults. IPN60340 is an investigational first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer. Breakthrough Therapy Designation is intended to expedite the development and review of medicines for serious or life-threatening conditions with evidence of a substantial clinical improvement. IPN60340 previously received Orphan Drug Designations from the U.S. Food and Drug Administration and European Medicines Agency in July 2025.

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"This Breakthrough Therapy Designation recognizes both the urgent need for new treatment options for people living with acute myeloid leukemia and the promising data seen so far in the development program for IPN60340," said Christelle Huguet, PhD, EVP and Head of R&D, Ipsen. "We look forward to working closely with the FDA as we advance to the next stage of clinical development and continue to deliver medicines with the potential to be transformative to people living with cancer."

This Breakthrough Therapy Designation is based on data from the Phase I/II EVICTION trial. Updated clinical data orally presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) (n=57)1 from the EVICTION trial showed treatment with IPN60340 in combination with Ven-Aza achieved very encouraging high responses. In this single-arm trial, treatment with IPN60340 and Ven-Aza (n=38), resulted in a near doubling of the complete response relative to those seen in historical standard of care data across all molecular subtypes in newly diagnosed patients including sub-types typically less responsive to standard of care (Ven-Aza).1,2 IPN60340 in combination with Ven-Aza was also shown to be well tolerated, underscoring IPN60340’s potential as a novel immunotherapy to improve outcomes for patients with AML. Based on these preliminary data, we look forward to discussing the design of the Phase II/III development plans with the FDA for IPN60340 in H1 2026.

About the EVICTION trial

EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical trial of IPN60340 (ICT01) in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options, as well as newly-diagnosed AML. More information on the EVICTION trial can be found at clinicaltrials.gov (NCT04243499).

About IPN60340 (ICT01)

IPN60340 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that promotes the recognition and elimination of tumor cells by γ9δ2 T cells, which are responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by IPN60340 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia and lymphomas) and are also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). Binding to BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. By altering the conformation of BTN3A, IPN60340 promotes this binding, thereby selectively activating circulating γ9δ2 T cells. This leads to migration of γ9δ2 T cells out of the circulation and into the tumor tissue, and triggers a downstream immunological cascade through secretion of pro-inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of IPN60340 have been shown in patients across several cancer indications. IPN60340 is an investigational therapy under evaluation for people 75 years or older living with acute myeloid leukemia who due to comorbidities are prevented from receiving treatment with intensive chemotherapy.

(Press release, Ipsen, JAN 13, 2026, View Source [SID1234662014])

On January 13, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported positive results from its ANKTIVA (nogapendekin alfa inbakicept) clinical program in non-small cell lung cancer (NSCLC) based on two studies, QUILT-2.023 and QUILT-3.055. Across 151 patients spanning first-, second-, and later-line disease, ANKTIVA demonstrated statistically significant immune restoration and a consistent association between lymphocyte recovery and improved survival in checkpoint-experienced patients.

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Checkpoint inhibitors such as pembrolizumab (Keytruda) and nivolumab (Opdivo) have transformed the treatment landscape for lung cancer; however, clinical benefit is often transient, and effective treatment options remain limited once patients progress following standard-of-care chemo-radiation and checkpoint inhibition.

QUILT-2.023 and QUILT-3.055 were designed to test the hypothesis that disease recurrence after checkpoint therapy reflects immune exhaustion and lymphocyte depletion, and that restoration of immune competence through activation of natural killer cells and CD8* cytotoxic T cells with ANKTIVA, in combination with checkpoint inhibitors, could improve outcomes.

"Today, the default standard of care for these patients remains cytotoxic chemotherapy such as docetaxel, which is associated with substantial toxicity and limited survival benefit," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "Large, randomized trials have demonstrated median overall survival of approximately nine months with docetaxel. The results from these studies support a potential paradigm shift toward what we define as Immunotherapy 2.0, which is the coordinated activation of the innate immune system through natural killer cells and the adaptive immune system through T cells to restore immune competence and extend survival."

Detailed results from QUILT-2.023 and QUILT-3.055 are being prepared for peer-review publication and future scientific presentations and serve as foundational safety and efficacy data demonstrating meaningful clinical benefit in patients with NSCLC who have failed all standards of care including checkpoint inhibitors.

The combination of ANKTIVA plus checkpoint inhibitor therapy is protected by multiple issued patents, including U.S. Patent Nos. 9,925,247 and 11,071,774, with patent terms extending into 2032–2039.

About QUILT-2.023

QUILT-2.023 (NCT03520686) is a Phase 3, open-label, multicohort study evaluating ANKTIVA in combination with approved checkpoint inhibitor–based regimens as first-line treatment for patients with advanced or metastatic NSCLC. The study included three randomized cohorts and one exploratory cohort, each analyzed independently.

The primary randomized cohort enrolled patients with stage III or IV squamous or nonsquamous NSCLC with PD-L1 expression ≥1% and no prior systemic therapy for advanced disease. Patients were randomized 1:1 to CPI alone or CPI plus ANKTIVA. Stratification factors included CPI regimen, ECOG performance status, histology, and PD-L1 tumor proportion score. The primary endpoint was progression-free survival assessed by RECIST v1.1, with longitudinal absolute lymphocyte count prospectively incorporated as a key biological endpoint.

Enrollment was closed early following changes in the first-line NSCLC treatment landscape. All analyses were conducted according to the finalized protocol and statistical analysis plan.

About QUILT-3.055

QUILT-3.055 (NCT03228667) is a Phase 2b, multicohort, open-label study evaluating the addition of nogapendekin alfa inbakicept to continued PD-1/PD-L1 inhibitor therapy in patients with advanced solid tumors who progressed after prior checkpoint inhibition. The study enrolled heavily pretreated patients, including second- and later-line NSCLC.

Patients continued the same checkpoint inhibitor to which they had previously responded or stabilized, with ANKTIVA administered subcutaneously in repeated six-week cycles. The primary objective prospectively linked immune biology to clinical outcomes by evaluating overall survival in relation to absolute lymphocyte count response, defined as achieving or maintaining a mean on-treatment ALC ≥1,000 cells/µL. Secondary endpoints included objective response rate, progression-free survival, duration of therapy, and safety.

(Press release, ImmunityBio, JAN 13, 2026, View Source [SID1234662013])

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])

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 Coherus oncology presented its corporate presentation.

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