Phanes Therapeutics announced that the first patient has been dosed in its clinical study evaluating spevatamig in combination with chemotherapy for the treatment of biliary tract carcinoma (BTC). This milestone represents a significant advancement for the clinical-stage biotech company's first-in-class bispecific antibody program targeting an aggressive malignancy with limited treatment options.
Novel Dual-Target Mechanism
Spevatamig is a native IgG-like bispecific antibody that simultaneously targets claudin 18.2 and CD47. Claudin 18.2 is a protein overexpressed in BTC and gastric cancers, while CD47 functions as a checkpoint inhibitor. This dual targeting approach represents a unique strategy to overcome resistance mechanisms in solid tumors by combining immune activation with direct tumor cell targeting.
The drug has garnered significant regulatory attention, receiving orphan drug designation from the FDA for pancreatic cancer treatment in 2022. In 2024, the FDA granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma, underscoring the potential of spevatamig to address critical gaps in treatment options.
TWINPEAK Clinical Program
The multi-center Phase I/II clinical trial of spevatamig, designated as the TWINPEAK study (NCT05482893), is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of the bispecific antibody in patients with advanced gastric, gastroesophageal junction, pancreatic ductal, or biliary tract adenocarcinomas.
The trial's adaptive design allows for evaluation of spevatamig as both monotherapy and in combination with chemotherapy and pembrolizumab, Merck's anti-PD-1 therapy. This collaboration with Merck, established through a clinical collaboration agreement in 2023, provides access to pembrolizumab for combination studies.
Parallel clinical development is underway in China, with Phase I (CTR20241655) and Phase II (CTR20252758) trials currently recruiting patients, positioning Phanes to capture opportunities in the Asia-Pacific region where BTC incidence rates are rising.
Market Opportunity and Competitive Landscape
The global BTC treatment market is projected to grow at a 5.7% compound annual growth rate to reach $1.28 billion by 2032. Current treatment options for BTC are dominated by chemotherapy and emerging targeted therapies such as FGFR inhibitors, which often provide modest survival benefits with significant toxicity profiles.
The anti-CD47 drugs market, in which spevatamig participates, is projected to experience substantial growth at a 43.1% CAGR through 2032, driven by advancements in bispecific antibody technology. This market dynamic suggests strong potential for Phanes' platform technology.
Broader Pipeline Development
Phanes Therapeutics is currently conducting three Phase I/II clinical trials, including the MORNINGSTAR study with mavrostobart, a best-in-class monoclonal antibody, and the SKYBRIDGE study with peluntamig. Both spevatamig and peluntamig are first-in-class bispecific antibodies that have received orphan drug designations and Fast Track designations from the FDA.
The company has developed its pipeline using proprietary technology platforms: PACbody®, SPECpair®, and ATACCbody® to create novel biologics addressing high unmet medical needs in cancer treatment.
Financial Considerations
Phanes Therapeutics operates with a funding base of $40 million, which raises considerations about the company's ability to fund late-stage trials and commercialization efforts without additional partnerships or capital infusion. The company's recent clinical milestones, including the first BTC patient dosing in combination therapy, signal progress in its development programs.
