On January 9, 2026 Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, reported new data from a post hoc analysis of the eNRGy trial (NCT02912949), evaluating zenocutuzumab in patients with advanced neuregulin 1 fusion-positive (NRG1+) pancreatic adenocarcinoma (PDAC) and cholangiocarcinoma (CCA) who continued therapy beyond progression. Results were presented in a poster session at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in San Francisco, California.

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"These findings highlight an important therapeutic opportunity for patients with NRG1 fusion-positive pancreatic and biliary cancers, which are often difficult to treat," said Alison M. Schram, MD, Memorial Sloan Kettering and lead author of the presentation. "In this analysis, zenocutuzumab provided ongoing benefit after radiographic progression, including multi-year disease control in some patients."

The new analysis examined efficacy and safety of zenocutuzumab in 17 patients with NRG1+ gastrointestinal tumors (12 PDAC, 5 CCA) who received at least three doses of therapy after experiencing progressive disease, including oligoprogressive, mixed, or otherwise indolent progression patterns. Across the subset zenocutuzumab showed an overall response rate (ORR) of 35%, with one complete response, five partial responses, and eight patients achieving stable disease; the clinical benefit rate, defined as complete/partial response or stable disease for at least 24 weeks, was 65%. Treatment was generally well tolerated, and no patients discontinued therapy due to adverse events.

"The durability of benefit with zenocutuzumab is not typically seen in these diseases and it speaks directly to the biological relevance of HER3 inhibition in NRG1-driven tumors," said Pritesh J. Gandhi, Chief Development Officer, Partner Therapeutics. "Importantly, zenocutuzumab was able to maintain disease control even after patients met the conventional definition of progression—sometimes for years— without introducing new safety concerns."

The data illustrate that several patients remained on zenocutuzumab well beyond progression, including multiple patients who continued treatment for more than one- or two-years post-progression. Median total therapy duration was 11 months with a median of two months on therapy after progression, and an upper range exceeding 35 months.

"Well-tolerated, targeted therapies improve outcomes for patients. PanCAN strongly recommends biomarker testing to guide treatment options," said Anna Berkenblit, MD, Chief Scientific and Medical Officer, PanCAN. "For NRG1 fusion-driven pancreatic cancer, zenocutuzumab is an important step closer to a world in which all patients with pancreatic cancer will thrive."

In December 2024, zenocutuzumab-zbco (BIZENGRI) received U.S. Food and Drug Administration accelerated approval for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. The indications were approved under accelerated approval based on ORR and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

For more information on the eNRGy trial and zenocutuzumab-zbco, please visit www.partnertx.com.

About NRG1 Gene Fusions

NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions). The chimeric ligands bind to HER3, triggering HER2/HER3 heterodimerization and activate downstream signaling pathways that cause cancer cells to grow and proliferate. Zenocutuzumab-zbco is a bispecific antibody that blocks HER2/HER3 dimerization and NRG1 fusion interactions with HER3, resulting in the suppression of these pathways. Comprehensive molecular testing, notably tissue-based RNA next generation sequencing, is essential to identify rare and actionable gene fusions like NRG1.

About BIZENGRI (zenocutuzumab-zbco)

INDICATIONS

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

BOXED WARNING: EMBRYO-FETAL TOXICITY

Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception.

WARNINGS AND PRECUATIONS

Infusion-Related Reactions/Hypersensitivity/Anaphylactic Reactions

BIZENGRI can cause serious and life-threatening infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions. Signs and symptoms of IRR may include chills, nausea, fever, and cough.

In the eNRGy study, 13% of patients experienced IRRs, all were Grade 1 or 2; 91% occurred during the first infusion.

Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor patients closely for signs and symptoms of infusion reactions during infusion and for at least 1 hour following completion of first BIZENGRI infusion and as clinically indicated. Interrupt BIZENGRI infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis reactions.

Interstitial Lung Disease/Pneumonitis

BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis.

In the eNRGy study, ILD/pneumonitis occurred in 2 (1.1%) patients treated with BIZENGRI. Grade 2 ILD/pneumonitis (Grade 2) resulting in permanent discontinuation of BIZENGRI occurred in 1 (0.6%) patient. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold BIZENGRI in patients with suspected ILD/pneumonitis and administer corticosteroids as clinically indicated.

Permanently discontinue BIZENGRI if ILD/pneumonitis ≥ Grade 2 is confirmed.

Left Ventricular Dysfunction

BIZENGRI can cause left ventricular dysfunction.

Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including BIZENGRI. Treatment with BIZENGRI has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment.

In the eNRGy study, Grade 2 LVEF decrease (40%-50%; 10 – 19% drop from baseline) occurred in 2% of evaluable patients. Cardiac failure without LVEF decrease occurred in 1.7% of patients, including 1 (0.6%) fatal event.

Before initiating BIZENGRI, evaluate LVEF and monitor at regular intervals during treatment as clinically indicated. For LVEF of less than 45% or less than 50% with absolute decrease from baseline of 10% or greater which is confirmed, or in patients with symptomatic congestive heart failure (CHF), permanently discontinue BIZENGRI.

Embryo-Fetal Toxicity

Based on its mechanism of action, BIZENGRI can cause fetal harm when administered to a pregnant woman. No animal reproduction studies were conducted with BIZENGRI. In post marketing reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In animal models, studies have demonstrated that inhibition of HER2 and/or HER3 results in impaired embryo-fetal development, including effects on cardiac, vascular and neuronal development, and embryolethality. Advise patients of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of BIZENGRI. Advise females of reproductive potential to use effective contraception during treatment with BIZENGRI and for 2 months after the last dose.

ADVERSE REACTIONS

NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC

Serious adverse reactions occurred in 25% of patients with NRG1 gene fusion positive NSCLC who received BIZENGRI. Serious adverse reactions in ≥ 2% of patients included pneumonia (n=4) dyspnea and fatigue (n=2 each). Fatal adverse reactions occurred in 3 (3%) patients and included respiratory failure (n=2), and cardiac failure (n=1). Permanent discontinuation of BIZENGRI due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of BIZENGRI included dyspnea, pneumonitis and sepsis (n=1 each).

In patients with NRG1 gene fusion positive NSCLC who received BIZENGRI, the most common (>20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (35%), increased alanine aminotransferase (30%), decreased magnesium (28%), increased alkaline phosphatase (27), decreased phosphate (26%), diarrhea (25%), musculoskeletal pain (23%), increased gamma-glutamyl transpeptidase (23%), increased aspartate aminotransferase (22%), and decreased potassium (21%).

NRG1 Gene Fusion Positive Unresectable or Metastatic Pancreatic Adenocarcinoma

Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI.

There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure.

In patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were increased alanine aminotransferase (51%), diarrhea (36%), increased aspartate aminotransferase (31%), increased bilirubin (31%), decreased phosphate (31%), increased alkaline phosphatase (28%), decreased sodium (28%), musculoskeletal pain (28%), decreased albumin (26%), decreased potassium (26%), decreased platelets (26%), decreased magnesium (24%), increased gamma-glutamyl transpeptidase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%).

(Press release, Partner Therapeutics, JAN 9, 2026, View Source [SID1234661909])

On January 9, 2026 Pierre Fabre Laboratories and Iktos, a global leader in Artificial Intelligence (AI) and Robotics on drug discovery, reported an integrated drug discovery collaboration to identify and develop novel small-molecule drug candidates in oncology. This initiative reflects both companies’ commitment to advancing oncology research by integrating complementary strengths across computational design, medicinal chemistry, biology, medical science and preclinical development.

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Under the terms of the agreement, Iktos will leverage its AI-driven generative design platform to accelerate the discovery of optimized small-molecule candidates against an undisclosed oncology target. Pierre Fabre Laboratories will contribute its extensive knowledge in oncology research and preclinical development to guide the selection, evaluation, and progression of candidate molecules.

Financial terms of the agreement are not disclosed but include an upfront and several milestone payments.

"This collaboration with Iktos marks an important milestone in our journey to build an AI-powered R&D engine at Pierre Fabre Laboratories" said Audrey Kauffmann, Head of Data Science and Biometry at Pierre Fabre Medical Care R&D. "By integrating Iktos’ generative AI and automated chemistry technologies into our research platforms, we are taking a step toward realizing our data and AI strategy. This cooperation exemplifies our ambition to leverage cutting-edge innovation to improve the quality and probability of success in drug discovery, while accelerating the delivery of meaningful advances for patients in oncology."

"We are delighted to start a drug discovery collaboration with Iktos", said Olivier Geneste, Head of Drug Discovery at Pierre Fabre Medical Care R&D. "Thanks to its well-established expertise in generative AI coupled to automated chemistry, we strongly believe that Iktos will help us in accelerating and derisking the discovery of innovative therapeutics targeting a highly valuable oncology target to serve unmet cancer patients’ needs."

"We are delighted to initiate this collaboration with Pierre Fabre Laboratories, a company with a distinguished track record in oncology," said Yann Gaston-Mathé, Co-founder and CEO of Iktos. "This collaboration exemplifies the powerful complementarity between Iktos’ generative AI and automated chemistry technologies and Pierre Fabre’s deep scientific and clinical development expertise. Together, we intend to create the optimal framework to rapidly and efficiently progress innovative small-molecule candidates in oncology, with the aim of bringing meaningful therapeutic advances to patients worldwide."

About the Pierre Fabre Laboratories R&D pipeline:

Pierre Fabre Laboratories has expanded its efforts in precision oncology by adding several assets to its R&D pipeline. PFL-241 and PFL-721, two mutant-selective EGFR inhibitors, are being developed for the treatment of EGFR-driven non-small cell lung cancer (NSCLC) patients. PFL-002 is undergoing clinical testing in solid tumors driven by MET genetic alterations. The pan-RAF inhibitor exarafenib is being developed to expand targeted therapy options for RAS/RAF-driven solid tumors. Moreover, pre-clinical candidates for various oncology targets are sought to be identified in collaboration with Vernalis Ltd. Furthermore, a collaboration with RedRidge Bio is underway to identify and develop biparatopic antibodies for multiple targets in precision oncology, dermatology, and rare diseases. These new additions to the discovery and clinical development portfolio complement Pierre Fabre Laboratories’ existing precision oncology portfolio targeting BRAF, MEK, HER2, as well as EBV-driven post-transplant lymphoproliferative disorder.

(Press release, Pierre Fabre, JAN 9, 2026, View Source [SID1234661908])

On January 9, 2026 iOnctura, a clinical-stage biopharmaceutical company developing precision oral small molecules for neglected and hard-to-treat cancers, reported that its Chief Executive Officer, Catherine Pickering, will present at the 44th Annual J.P. Morgan Healthcare Conference, taking place January 12–15, 2026, in San Francisco, California.

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Dr. Pickering will present on Thursday, January 15, 2026 at 11:00 PST. The presentation will highlight iOnctura’s clinical progress with a focus on its lead program, roginolisib, the first allosteric modulator of PI3Kδ.

Recognized as the world’s largest and most influential healthcare investment conference, the J.P. Morgan Healthcare Conference is an invite-only event that serves as a vital forum for innovation and capital formation across the pharmaceutical and biotechnology sectors. Participation reflects iOnctura’s growing visibility within the global oncology ecosystem and underscores the company’s progress towards advancing transformative targeted therapies for patients with cancer.

"We are honored to be invited to present at this year’s J.P. Morgan Healthcare Conference," said Catherine Pickering, CEO and co-founder of iOnctura. "This recognition reflects the increasing interest in our science-driven approach and the meaningful clinical advances we have achieved with roginolisib. We look forward to sharing our progress and engaging with partners committed to transforming cancer care."

Members of the management team will also be available for one-on-one meetings with investors and partners during the conference.

(Press release, iOnctura, JAN 9, 2026, View Source [SID1234661907])

On January 9, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported the first clinical data evaluating spevatamig in combination with chemotherapy in frontline (1L) treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The data was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) 2026; Abstract #709. This marks the first public release of Phanes’ clinical trial data from their ongoing U.S. multi-center study with spevatamig.

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The TWINPEAK study (NCT05482893) is an ongoing multi-cohort Phase 1 monotherapy dose escalation, and Phase 2 combination expansion and dose optimization study in patients with GI carcinomas. Combination expansion cohorts include various combinations with chemotherapy and/or an immune-checkpoint inhibitor. As of December 12, 2025, 107 patients have been treated with spevatamig in the US collectively in monotherapy and combination settings. Of these patients, 42 with 1L mPDAC have been treated with spevatamig + GnP across several dosing regimens. Data from the 2 mg/kg weekly (QW) + GnP regimen was presented at ASCO (Free ASCO Whitepaper) GI 2026, with data from dosing regimens >2 mg/kg QW spevatamig + GnP still maturing. Of note:

Spevatamig has demonstrated a favorable safety profile. In monotherapy, no CRS or DLTs were observed. The maximum tolerated dose (MTD) has not been reached in either the monotherapy or combination therapy setting. No Grade ≥ 3 treatment-emergent anemia, neutropenia or thrombocytopenia were observed during the study.
At 2 mg/kg QW spevatamig + GnP dose level, the rates of anemia, neutropenia and thrombocytopenia were comparable to those observed in the GnP treatment arms from pivotal trials. No Grade ≥ 3 treatment-emergent nausea or vomiting events were reported, and no dose reductions or treatment discontinuations due to nausea or vomiting occurred. No CRS was observed.
In the 2 mg/kg QW spevatamig + GnP 1L mPDAC dosing regimen (n=15), the DCR was 93% and the ORR was 40% (6/15 achieved partial response, with 1 patient pending confirmation).
The median progression-free survival (mPFS) was 7.3 months with a 6-month PFS rate of 59%. The median overall survival (mOS) was 13.2 months and still maturing while 6-month OS rate was 93%.
Responses were observed across CLDN18.2 scores ≥ 10% (≥ 2+ staining). Of note, 85% of patients screened met this CLDN18.2 threshold requirement.
Phanes’ data of spevatamig featured at ASCO (Free ASCO Whitepaper) GI 2026 can be found here: View Source

ABOUT SPEVATAMIG
Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with Merck’s anti-PD-1 therapy, pembrolizumab.

The multi-center Phase 1/2 clinical trial of spevatamig (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of spevatamig in patients with advanced gastric, gastroesophageal junction, pancreatic ductal or biliary tract adenocarcinomas. The Phase 2 study of spevatamig has begun in China.

(Press release, Phanes Therapeutics, JAN 9, 2026, View Source [SID1234661906])

On January 9, 2026 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology Company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that the Company has entered into a $60 million equity line of credit (ELOC) agreement with Yorkville Advisors Global, LP, strengthening the Company’s financial flexibility as it continues to advance its clinical and preclinical pipeline of multispecific anti-cancer agents that are differentiated by design.

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The facility provides Aptevo with access to capital, allowing the Company to raise funds incrementally, at its discretion, and under market-based conditions. Further, an ELOC offers affordable capital financing with minimal fees and no warrants. Proceeds from the ELOC will be used to support ongoing clinical development, advance preclinical programs, and fund general corporate purposes.

"This agreement offers added flexibility and control over how and when we access capital," said Daphne Taylor, Chief Financial Officer at Aptevo. "Importantly, the fully leveraged facility plus cash on hand is sufficient to fund us for three years, into 2029. During this time, we plan to continue generating clinical data and advancing differentiated assets across the portfolio focusing on execution and value creation."

The ELOC complements Aptevo’s existing capital resources and is designed to support the Company’s disciplined approach to balance sheet management, while preserving optionality around future strategic and growth decisions.

Under the terms of the agreement, Aptevo has the right, but not the obligation, to sell shares to the counterparty from time to time, subject to customary conditions and limitations. The Company is not required to draw on the facility and retains full discretion over its use.

Aptevo’s portfolio includes five CD3-engaging assets anchored by mipletamig, a first-in-class CD123 x CD3 bispecific currently being evaluated in RAINIER, a Phase 1b/2 trial for frontline AML. In total, mipletamig has been evaluated in more than 100 patients across three trials, where mipletamig has consistently demonstrated high remission rates and a favorable safety and tolerability profile, with no observed events of cytokine release syndrome in frontline patients treated to date.

Building on this clinical validation, Aptevo has built a portfolio of tumor-directed CD3 programs, including bispecific candidates APVO442 (PSMA × CD3) for prostate cancer and APVO455 (Nectin-4 × CD3) for solid tumors, as well as trispecific candidates APVO451 and APVO452. All incorporate the Company’s proprietary application and unique use of the CRIS-7-derived CD3 binding domain, designed to enable tumor-focused immune activation with the potential for meaningful antitumor activity while also prioritizing safety and tolerability.

(Press release, Aptevo Therapeutics, JAN 9, 2026, View Source [SID1234661905])