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])

On January 9, 2026 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, reported that members of its management team will meet one-on-one with existing shareholders and hold meetings with other institutional specialist investors during the 44th Annual J.P. Morgan Healthcare Conference, January 12-14, 2026, in San Francisco.

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Valneva’s CEO Thomas Lingelbach and CFO Peter Bühler will discuss upcoming catalysts from its clinical development pipeline, including the pivotal data readout for its Lyme disease vaccine in the first half of this year, as well as the Company’s commercial portfolio of vaccines.
To schedule a 1on1 investor meeting with Valneva, institutional investors and analysts can contact Valneva’s investor relations department at [email protected].

(Press release, Valneva, JAN 9, 2026, View Source [SID1234661904])

On January 9, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that the Company has submitted a protocol amendment to the U.S. Food & Drug Administration ("FDA") for its Phase 3 VERSATILE-003 clinical trial. The proposed amendment to the VERSATILE-003 Phase 3 trial changes the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power, potentially providing the basis for accelerated approval of PDS0101. Median overall survival (mOS) remains the primary endpoint for full approval as originally recommended by FDA.

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The submission follows a constructive Type C meeting held with the FDA in December 2025 to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer. The amendment is supported by positive final results from the Company’s VERSATILE-002 trial, which showed promising mOS and durable PFS.

"Submission of the amended protocol is an exciting next step in our mission to make this promising treatment available to patients in need," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We believe that including PFS as a primary endpoint offers an important opportunity to shorten the duration of VERSATILE-003. The amendment retains mOS and safety as requirements for full FDA approval, and based on the dialogue we had with the agency in December, we are confident that we have a pathway to potentially accelerate our regulatory submission."

(Press release, PDS Biotechnology, JAN 9, 2026, View Source [SID1234661901])

On January 9, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported the completion of a Series F financing round in December 2025 led by Lightspeed Venture Partners. With $250M in new equity capital from its two most recent financing rounds, along with a 2025 amendment to its Silicon Valley Bank credit facility providing up to $100M in additional liquidity, Orca Bio possesses the financial strength to scale its commercial operations and advance its clinical pipeline.

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The proceeds will be used to ensure commercial readiness as the company approaches the April 6, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Orca-T, Orca Bio’s lead investigational allogeneic T-cell immunotherapy. The funding will help strengthen the company’s infrastructure to support future commercial scale, including the addition of East Coast manufacturing capacity to complement its Sacramento, CA operations. The capital will also support the accelerated advancement of Orca Bio’s pipeline across multiple clinical programs designed to expand treatment to more patients in need.

"Our financial position is a powerful validation of Orca-T’s transformative potential and reflects our commitment to pioneering a new standard in cell therapy," said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. "With the resources and infrastructure now in place, we are uniquely positioned to bring our first high-precision therapy to leukemia patients in the U.S. This milestone not only solidifies our anticipated commercial launch but also provides the runway to advance our promising pipeline as we seek to redefine treatment across multiple life-threatening blood cancer and autoimmune diseases."

In parallel to commercialization efforts, Orca Bio remains focused on advancing its pipeline of high-precision cell therapies. The company progressed two clinical programs designed to evaluate Orca-T and Orca-Q in both the reduced intensity conditioning (RIC) and nonmyeloablative (NMA) settings for patients who may not be candidates to receive a traditional myeloablative conditioning (MAC) regimen.

"While myeloablative conditioning offers the best chance to eradicate disease with a traditional allogeneic stem cell transplant, the high toxicity levels carry significant risks, particularly for older patients or those with co-morbidities," said Scott McClellan, M.D., Ph.D., chief medical officer at Orca Bio. "Less intensive conditioning regimens are safer for patients who are not candidates for myeloablative conditioning. Through these new studies, we aim to evaluate if Orca-T and Orca-Q can bring safer, curative interventions to a broader population of blood cancer patients."

SERENE-T Phase 2 Study: SERENE-T (NCT07216443) is a new multicenter, open-label Phase 2 trial evaluating the safety, tolerability and efficacy of Orca-T in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing RIC or NMA. The overall survival (OS), another secondary endpoint, was 93.7% (95% CI: 86%, 97%) in the Orca-T arm and 83.2% (95% CI: 73%, 90%) in the alloHSCT arm (HR 0.49; p=0.11823).
Expanded Phase 1b Study of Orca-Q: The first patients have been treated in the expanded Phase 1b study (NCT03802695​) which now includes three additional cohorts of patients receiving RIC or NMA with either matched related or unrelated, 7/8 mismatched unrelated or haploidentical related donors. Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy for patients with AML, MDS or mixed phenotype acute leukemia (MPAL). The cumulative incidence of non-relapse mortality (NRM) was 3.4% (95% CI: 0.9%, 8.8%) for Orca-T versus 13.2% (95% CI: 6.8%, 21.6%) for alloHSCT (HR 0.27 [95% CI: 0.08, 0.93]; p=0.03 in a post hoc analysis).

Both studies are now enrolling with plans to open at additional centers across the U.S. For more information, visit ClinicalTrials.gov.

(Press release, Orca Bio, JAN 9, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-announces-250m-in-aggregate-financing-in-preparation-for-potential-commercialization [SID1234661900])