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Theseus (THRX) Falls 72% on Decision to Discontinue GIST Study
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Theseus Pharmaceuticals, Inc. announced its decision to discontinue enrollment in its ongoing early-mid-stage study of THE-630 in patients with gastrointestinal stromal tumors (GIST). The company also terminated the development of THE-630 in GIST. The decision to discontinue the development of the candidate was taken after serious adverse events were observed in patients, following treatment with the candidate. The stock of the company plunged 72% on Friday in response to the dismal news.
The dose-escalation portion of the study is evaluating seven dose strengths (3 mg to 27 mg) of THE-630 in seven different cohorts. In May 2023, 23 patients had been dosed through Cohort 6 and two patients had been enrolled in Cohort 7 (27 mg) of the study. These first two patients in Cohort 7 did not experience any adverse events.
However, the third patient enrolled in Cohort 7 experienced grade 3 hand-foot skin reaction (HFSR), which required an expansion of the cohort to six patients. Following this, another patient enrolled in the Cohort 7 expansion group experienced grade 2 HFSR. This triggered a dose interruption of ≥7 days. The adverse reactions to treatment with THE-630 in Cohort 7 were determined to be dose-limiting toxicities according to the study protocol. It was thus concluded that the 27 mg dose exceeds the maximum tolerated dose.
Year to date, shares of Theseus have lost 46.6% compared with the industry’s 10% fall.
Image Source: Zacks Investment Research
As of Jul 10, 2023, six patients were observed to have developed grade 1 to 3 HFSR across all seven cohorts treated with THE-630. Out of these six patients, three patients were from the 27 mg cohort, two patients in the 18 mg cohort and one patient originally from the 9 mg cohort after intra-patient dose escalation to the 18 mg cohort.
Furthermore, THRX reported that it does not believe that lower doses of THE-630 have a differentiated safety profile, despite reporting no HFSR observed at doses of 12 mg or lower. Patients already enrolled in the study will continue to receive THE-630 until a treatment discontinuation criterion is met.
The company plans on analyzing these data to determine the feasibility of developing low-dose THE-630 for KIT-associated mast cell-driven inflammatory indications.
In the same press release, THRX announced having reallocating resources to advance another pipeline candidate, THE-349, into clinical studies. THE-349 is the company’s potentially best-in-class fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor for the treatment of EGFR mutant non-small cell lung cancer. The company remains on track to submit an investigational new drug application (IND) for THE-349 in the fourth quarter of 2023. Subject to IND enabling, Theseus intends to begin clinical development right away.
Moreover, the company plans to nominate development candidates across blood cancer and GIST indications in the first half of 2024.
With the THE-630 development program discontinued, Theseus currently has no clinical-stage candidate in its pipeline.
In the past 90 days, the Zacks Consensus Estimate for ADC Therapeutics’ 2023 loss per share has widened from $2.58 to $2.61. During the same period, the estimate for ADC Therapeutics’ 2024 loss per share narrowed from $2.72 to $2.45. Year to date, shares of ADCT have lost 60.7%.
ADCT beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 10.70%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 43 cents to 39 cents. During the same period, the estimate for Anixa Biosciences’ 2024 loss per share has narrowed from 46 cents to 38 cents. Year to date, shares of ANIX have lost 14.3%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 31.21%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $2.97 to $2.80. During the same period, the estimate for AKRO’s 2024 loss per share narrowed from $3.40 to $3.27. Year to date, shares of AKRO have lost 16.9%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
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Theseus (THRX) Falls 72% on Decision to Discontinue GIST Study
Theseus Pharmaceuticals, Inc. announced its decision to discontinue enrollment in its ongoing early-mid-stage study of THE-630 in patients with gastrointestinal stromal tumors (GIST). The company also terminated the development of THE-630 in GIST. The decision to discontinue the development of the candidate was taken after serious adverse events were observed in patients, following treatment with the candidate. The stock of the company plunged 72% on Friday in response to the dismal news.
The dose-escalation portion of the study is evaluating seven dose strengths (3 mg to 27 mg) of THE-630 in seven different cohorts. In May 2023, 23 patients had been dosed through Cohort 6 and two patients had been enrolled in Cohort 7 (27 mg) of the study. These first two patients in Cohort 7 did not experience any adverse events.
However, the third patient enrolled in Cohort 7 experienced grade 3 hand-foot skin reaction (HFSR), which required an expansion of the cohort to six patients. Following this, another patient enrolled in the Cohort 7 expansion group experienced grade 2 HFSR. This triggered a dose interruption of ≥7 days. The adverse reactions to treatment with THE-630 in Cohort 7 were determined to be dose-limiting toxicities according to the study protocol. It was thus concluded that the 27 mg dose exceeds the maximum tolerated dose.
Year to date, shares of Theseus have lost 46.6% compared with the industry’s 10% fall.
Image Source: Zacks Investment Research
As of Jul 10, 2023, six patients were observed to have developed grade 1 to 3 HFSR across all seven cohorts treated with THE-630. Out of these six patients, three patients were from the 27 mg cohort, two patients in the 18 mg cohort and one patient originally from the 9 mg cohort after intra-patient dose escalation to the 18 mg cohort.
Furthermore, THRX reported that it does not believe that lower doses of THE-630 have a differentiated safety profile, despite reporting no HFSR observed at doses of 12 mg or lower. Patients already enrolled in the study will continue to receive THE-630 until a treatment discontinuation criterion is met.
The company plans on analyzing these data to determine the feasibility of developing low-dose THE-630 for KIT-associated mast cell-driven inflammatory indications.
In the same press release, THRX announced having reallocating resources to advance another pipeline candidate, THE-349, into clinical studies. THE-349 is the company’s potentially best-in-class fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor for the treatment of EGFR mutant non-small cell lung cancer. The company remains on track to submit an investigational new drug application (IND) for THE-349 in the fourth quarter of 2023. Subject to IND enabling, Theseus intends to begin clinical development right away.
Moreover, the company plans to nominate development candidates across blood cancer and GIST indications in the first half of 2024.
With the THE-630 development program discontinued, Theseus currently has no clinical-stage candidate in its pipeline.
Theseus Pharmaceuticals, Inc. Price and Consensus
Theseus Pharmaceuticals, Inc. price-consensus-chart | Theseus Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Theseus currently has a Zacks Rank #3 (hold).
Some better-ranked stocks in the same industry are ADC Therapeutics (ADCT - Free Report) , Anixa Biosciences (ANIX - Free Report) and Akero Therapeutics (AKRO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for ADC Therapeutics’ 2023 loss per share has widened from $2.58 to $2.61. During the same period, the estimate for ADC Therapeutics’ 2024 loss per share narrowed from $2.72 to $2.45. Year to date, shares of ADCT have lost 60.7%.
ADCT beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 10.70%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 43 cents to 39 cents. During the same period, the estimate for Anixa Biosciences’ 2024 loss per share has narrowed from 46 cents to 38 cents. Year to date, shares of ANIX have lost 14.3%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 31.21%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $2.97 to $2.80. During the same period, the estimate for AKRO’s 2024 loss per share narrowed from $3.40 to $3.27. Year to date, shares of AKRO have lost 16.9%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.