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 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the development of targeted radiotherapeutics for cancer, reported plans to highlight the company’s 2026 strategic initiatives at the upcoming Biotech Showcase, taking place January 12-15, 2026, in San Francisco during the 44th Annual JP Morgan Healthcare Conference. James Caruso, president and CEO of Cellectar, will present a corporate update on Tuesday, January 14, 2025, at 1:30 pm Pacific Time.

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2025 Achievements

Received feedback from the SAWP supporting a Conditional Marketing Authorization (CMA) filing for iopofosine I 131 in WM based upon our CLOVER WaM study
U.S. Food and Drug Administration (FDA) granted Break Through Designation (BTD) for iopofosine I 131 in relapsed/refractory WM
Confirmed traditional accelerated approval pathway with the FDA for iopofosine I 131 in WM
Presented compelling data from the CLOVER-2 Phase 1b study in relapsed/refractory pediatric high-grade glioma (pHGG), demonstrating extended progression-free survival and favorable safety profile
Initiated a Phase 1b clinical study for CLR 125, an Auger-emitting iodine-125 program for the treatment of triple-negative breast cancer (TNBC)
Strengthened supply chain through strategic supply agreements for our next generation Auger- and alpha-emitting radiotherapeutics
Raised approximately $15.2 million through financings and warrant exercises to support pipeline development and regulatory milestones

CEO Commentary

"Our priorities are clear: secure European conditional marketing approval for iopofosine I 131 for WM in early 2027 with commercialization to follow, further validate our PDC platform by executing on our Phase 1b study evaluating CLR 125 for TNBC, and advance our regulatory strategy with the FDA for iopofosine I 131 approval in the U.S. With an established iopofosine I 131 regulatory strategy for both EMA and FDA, and promising data across our pipeline, we are entering 2026 with strong momentum and multiple opportunities," said James Caruso, president and CEO of Cellectar. "We believe these initiatives position Cellectar to deliver meaningful therapies for patients and create significant value for shareholders."

2026 Strategic Initiatives

Regulatory Milestones:
Submit CMA application to EMA for iopofosine I 131 in WM in 3Q 2026, with potential European market approval in early 2027
Advance NDA preparations for U.S. accelerated approval
Clinical Development:
Enroll patients in the Phase 1b study of CLR 125 in TNBC with interim data expected in mid-2026
Present final findings and subset analysis from the CLOVER WaM Phase 2 study of iopofosine I 131
Prepare actinium-based CLR 225 for first-in-human trials in pancreatic cancer
Pipeline Expansion:
Progress additional PDC-based radiotherapeutics into preclinical and IND-enabling studies
Partnerships:
Evaluate strategic collaborations for commercialization of iopofosine I 131
Financial Strategy:
Continue disciplined capital management and explore non-dilutive funding opportunities

"Looking ahead, we are focused on receiving a conditional marketing approval in 2027 from the EMA impacting approximately thirty countries, which collectively possess a larger WM population than the U.S. In parallel, we remain committed to advancing our regulatory strategy with the FDA fully understanding the tremendous incremental value it potentially represents for all Cellectar stakeholders. The FDA-recommended post-BTKi indication positions iopofosine I 131 as a treatment option as early as the second line, substantially expanding the available patients in the U.S. market. Additionally, we are actively recruiting patients for our Phase 1b study evaluating CLR 125, our Auger-based radiotherapeutic for the treatment of TNBC, which builds on strong preclinical data showing growth inhibition and tumor volume reduction in this challenging-to-treat cancer," concluded Mr. Caruso.

Mr. Caruso’s Biotech Showcase presentation will be live webcast and can be accessed HERE. A replay of the presentation will be available on the Events section of the company’s Investor Relations website.

(Press release, Cellectar Biosciences, JAN 9, 2026, View Source [SID1234661890])

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 Mabqi reported that Syndivia had exercised an option with Mabqi on a jointly discovered antibody-drug conjugate (ADC) acquired by a Pharma company.

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This option was exercised as part of a research collaboration launched in 2023 between Mabqi and Syndivia to discover and develop a new ADC drug candidate with indications in Prostate Cancer.

This step marked a major milestone in the collaboration between the two companies, combining their complementary strengths: Mabqi’s LiteMab Antibody Discovery Studio and Syndivia’s GeminiMab ADC platform. The antibody was discovered through the LiteMab discovery studio, tailored to meet the precise functional requirements of the final drug candidate, including affinity, developability, and pharmacological properties. Syndivia subsequently designed the final ADC candidate and carried out the full preclinical characterization.

"We are delighted that Syndivia has exercised this option and successfully demonstrated the potency of this candidate within such a short timeframe", said Sylvain Yon, CEO of Mabqi. "The combination of our LiteMab Antibody Discovery Studio with Syndivia’s cutting-edge conjugation platform has proven to be a highly effective approach, enabling the rapid discovery of a drug candidate with strong clinical potential. Through this collaboration, Mabqi reinforces its focus on advancing research in areas of significant medical need by joining forces with partners who contribute complementary expertise and technologies, creating synergies that accelerate the discovery of new treatments for patients."

(Press release, Mabqi, JAN 9, 2026, View Source [SID1234661841])

On January 9, 2026 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported the closing of its previously announced private placement (the "PIPE financing") for gross proceeds of up to $80.8 million to the Company, including initial gross proceeds to the Company of approximately $20.2 million, in each case before placement agent fees and offering expenses.

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In addition to the healthcare-focused institutional investors listed above, the private placement included participation from other new and existing institutional investors, as well as members of the Company’s management team and board of directors.

Laidlaw & Company (UK) Ltd. acted as sole placement agent for the PIPE financing.

(Press release, Curis, JAN 9, 2026, View Source [SID1234661891])