Philadelphia-based biotech Context Therapeutics has terminated the development programme for one of its pipeline bispecific T-cell engagers (BiTEs) as the company looks to cut costs amid a dwindling cash runway.
In a Q2 earnings call, Context announced it would be discontinuing CT-95, a mesothelin (MSLN) and CD3-targeting TCE, to home in on its development efforts for the two other assets in its pipeline.
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Context largely made this decision due to the data generated on CT-95 to date, which did not meet the company’s internal bar for advancement.
In a research note, William Blair analyst Matt Phipps noted that, though positive initial data for CT-95 “could have driven significant upside” to Context’s share price, the financial services firm had always taken the stance that MSLN was a high-risk target for TCEs, due to its expression in healthy lung tissues.
Context originally acquired CT-95 from Link Immunotherapeutics for $3.75m in 2024, which had progressed the asset to the Phase I-ready stage. Once the drug was in Context’s hands, the biotech began an early-stage study (NCT06756035) looking into its role in treating advanced cancers associated with mesothelin expression, with the Phase Ia dose escalation portion of the study focusing on CT-95 in various forms of gynaecological, lung, gastric and colorectal cancers.
The biotech originally planned to share an interim data readout for this study in September.
Reallocating focus
Context drops CT-95’s clinical development programme as the company looks to reallocate its dwindling capital reserves to higher-priority areas – instead opting to focus on the development of its other two bispecific TCE assets.
One of these is Claudin 6 (CLDN6) and CD3-targeting therapy, CTIM-76, which Context is currently evaluating in a Phase Ia trial in platinum-resistant ovarian cancer, with the initial safety, tolerability and efficacy data expected in the second quarter of 2027. The Phase Ib dose expansion trial is set to initiate in Q1 2027. Context originally secured the rights to CTIM-76 through a research collaboration and licensing agreement with Integral Molecular.
Another is CT-202, which targets Nectin-4 and CD3. Context will soon enter the drug into a Phase I trial evaluating its potential in urothelial, colorectal and triple-negative breast cancer (TNBC). The company expects to dose the first patient in this trial during the third quarter of 2026. Context plans to debut initial safety data from the Phase Ia in the second quarter of 2027, and hopes to begin the Phase Ib dose expansion portion of the study in Q1 2027.
BiTE market picks up
GlobalData forecasts that the BiTE market will experience growth in the coming years, reaching over $20bn by 2030. Analysts predict that Johnson & Johnson will lead the commercial space, driven by Tecvayli (teclistamab) and Talvey (talquetamab), while R&D expands from late-line blood cancers into solid tumours and earlier treatment lines.
Amgen’s Blincyto, which received FDA approval for B-cell lymphoblastic leukaemia in 2014, was the highest-selling BiTE in 2023, with $897m in sales. In 2023, BiTEs collectively generated $1.45bn in global sales.
Analysts predict that Roche will be the runner-up company sales-wise in the 2030 BiTE market, as they say three of its products will $2.9bn. The Swiss pharma giant’s top product, Columnvi, is forecast to generate $1.7bn, becoming the third top-selling BiTE behind Tecvayli and Talvey.
GlobalData is the parent company of Clinical Trials Arena.
