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Corvus Stock Up on Initiation of Phase III Lymphoma Study on Lead Drug
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Shares of Corvus Pharmaceuticals (CRVS - Free Report) gained 13.9% on Sept. 10 after the company announced the initiation of a phase III registrational study of its lead product candidate, soquelitinib, to treat patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).
Corvus’ soquelitinib is an investigational, oral, small-molecule drug that selectively inhibits interleukin-2 inducible T-cell kinase (ITK), a protein tyrosine kinase that plays a role in T-cell development and differentiation. The company believes that the candidate’s unique mechanism of action of ITK inhibition offers significant potential for treating lymphomas, solid tumors and autoimmune/allergic diseases.
Corvus’ Registrational Phase III Lymphoma Study Design
The phase III registrational study of soquelitinib will enroll approximately 150 patients with relapsed/refractory PTCL who have failed one to three prior lines of therapy. The enrolled patients will then be randomized equally into two groups to receive either a twice-daily, 200mg dose of soquelitinib or standard-of-care chemotherapy with either belinostat or pralatrexate.
The primary endpoint of the late-stage study is the progression-free survival (PFS) of the patients treated with the candidate. The secondary endpoints will include overall survival, objective response rate and duration of response.
Year to date, shares of Corvus have skyrocketed 163.4% against the industry’s 1.6% decline.
Image Source: Zacks Investment Research
PTCL is a rare and aggressive form of non-Hodgkin lymphoma that originates from mature T-cells in the peripheral lymphoid tissues, such as the lymph nodes, spleen or other organs. Standard-of-care treatment involves combination chemotherapy, but most patients either fail to respond or experience a relapse within the first two years. For those who relapse, different chemotherapy agents are used, though the outcomes remain poor. Median PFS is typically three to four months, with an overall median survival of six to 12 months. Currently, there are no approved drugs for relapsed PTCL.
Soquelitinib, on the other hand, has been well-tolerated while demonstrating durable anti-tumor activity in patients with very advanced, refractory, difficult-to-treat T-cell malignancies in earlier-stage studies. The candidate’s novel mechanism of action enhances the host’s anti-tumor response.
Corvus’ soquelitinib currently enjoys Orphan Drug designation and Fast Track designation in the United States for treating relapsed/refractory PTCL.
Corvus’ Other Clinical-Stage Pipeline Programs
Apart from the lymphoma indication, Corvus is also currently evaluating soquelitinib in an early-stage study to treat patients with moderate to severe atopic dermatitis.
Corvus and partner, Kidney Cancer Research Consortium, are evaluating its second product candidate, ciforadenant, in combination with Bristol Myers’ (BMY - Free Report) Yervoy (a CTLA-4 inhibitor) and Opdivo (a PD-1 inhibitor) in a phase Ib/II study, as a potential first-line therapy for metastatic renal cell cancer.
Bristol Myer’s Opdivo, in combination with Yervoy, is indicated in the United States for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar. This indication is approved under accelerated approval based on the overall response rate and duration of response. BMY is currently looking to expand the combo’s label to include first-line treatment of adult patients with HCC in the United States and the EU. Opdivo is also approved both as a monotherapy and in combination with Yervoy to treat several other cancer indications in many countries, including the United States and the EU.
Corvus, in partnership with China-based Angel Pharmaceuticals, is also developing a third product candidate, mupadolimab, in a separate early-stage study, as a monotherapy or in combination with Merck’s (MRK - Free Report) blockbuster oncology drug, Keytruda, to treat patients with non-small cell lung and head and neck squamous cell cancers.
Like Bristol Myers’ Opdivo, Merck’s Keytruda is also an anti-PD-1 therapy. It is currently marketed as the standard of care in the frontline treatment of metastatic non-small cell lung cancer patients. Merck’s Keytruda is approved for several types of cancer, accounting alone for 47% of the company’s pharmaceutical sales in 2023. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 24.9%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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Corvus Stock Up on Initiation of Phase III Lymphoma Study on Lead Drug
Shares of Corvus Pharmaceuticals (CRVS - Free Report) gained 13.9% on Sept. 10 after the company announced the initiation of a phase III registrational study of its lead product candidate, soquelitinib, to treat patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).
Corvus’ soquelitinib is an investigational, oral, small-molecule drug that selectively inhibits interleukin-2 inducible T-cell kinase (ITK), a protein tyrosine kinase that plays a role in T-cell development and differentiation. The company believes that the candidate’s unique mechanism of action of ITK inhibition offers significant potential for treating lymphomas, solid tumors and autoimmune/allergic diseases.
Corvus’ Registrational Phase III Lymphoma Study Design
The phase III registrational study of soquelitinib will enroll approximately 150 patients with relapsed/refractory PTCL who have failed one to three prior lines of therapy. The enrolled patients will then be randomized equally into two groups to receive either a twice-daily, 200mg dose of soquelitinib or standard-of-care chemotherapy with either belinostat or pralatrexate.
The primary endpoint of the late-stage study is the progression-free survival (PFS) of the patients treated with the candidate. The secondary endpoints will include overall survival, objective response rate and duration of response.
Year to date, shares of Corvus have skyrocketed 163.4% against the industry’s 1.6% decline.
Image Source: Zacks Investment Research
PTCL is a rare and aggressive form of non-Hodgkin lymphoma that originates from mature T-cells in the peripheral lymphoid tissues, such as the lymph nodes, spleen or other organs. Standard-of-care treatment involves combination chemotherapy, but most patients either fail to respond or experience a relapse within the first two years. For those who relapse, different chemotherapy agents are used, though the outcomes remain poor. Median PFS is typically three to four months, with an overall median survival of six to 12 months. Currently, there are no approved drugs for relapsed PTCL.
Soquelitinib, on the other hand, has been well-tolerated while demonstrating durable anti-tumor activity in patients with very advanced, refractory, difficult-to-treat T-cell malignancies in earlier-stage studies. The candidate’s novel mechanism of action enhances the host’s anti-tumor response.
Corvus’ soquelitinib currently enjoys Orphan Drug designation and Fast Track designation in the United States for treating relapsed/refractory PTCL.
Corvus’ Other Clinical-Stage Pipeline Programs
Apart from the lymphoma indication, Corvus is also currently evaluating soquelitinib in an early-stage study to treat patients with moderate to severe atopic dermatitis.
Corvus and partner, Kidney Cancer Research Consortium, are evaluating its second product candidate, ciforadenant, in combination with Bristol Myers’ (BMY - Free Report) Yervoy (a CTLA-4 inhibitor) and Opdivo (a PD-1 inhibitor) in a phase Ib/II study, as a potential first-line therapy for metastatic renal cell cancer.
Bristol Myer’s Opdivo, in combination with Yervoy, is indicated in the United States for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar. This indication is approved under accelerated approval based on the overall response rate and duration of response. BMY is currently looking to expand the combo’s label to include first-line treatment of adult patients with HCC in the United States and the EU. Opdivo is also approved both as a monotherapy and in combination with Yervoy to treat several other cancer indications in many countries, including the United States and the EU.
Corvus, in partnership with China-based Angel Pharmaceuticals, is also developing a third product candidate, mupadolimab, in a separate early-stage study, as a monotherapy or in combination with Merck’s (MRK - Free Report) blockbuster oncology drug, Keytruda, to treat patients with non-small cell lung and head and neck squamous cell cancers.
Like Bristol Myers’ Opdivo, Merck’s Keytruda is also an anti-PD-1 therapy. It is currently marketed as the standard of care in the frontline treatment of metastatic non-small cell lung cancer patients. Merck’s Keytruda is approved for several types of cancer, accounting alone for 47% of the company’s pharmaceutical sales in 2023. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market.
Corvus Pharmaceuticals, Inc. Price and Consensus
Corvus Pharmaceuticals, Inc. price-consensus-chart | Corvus Pharmaceuticals, Inc. Quote
Zacks Rank & Stock to Consider
Corvus currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Fulcrum Therapeutics, Inc. (FULC - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 24.9%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.