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Alpine (ALPN) Down on FDA Partial Clinical Hold on Cancer Study
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Shares of Alpine Immune Sciences, Inc. (ALPN - Free Report) were down 8.9% on Monday after the FDA placed a partial clinical hold on its NEON-2 study, a cancer study evaluating its pipeline candidate, davoceticept (ALPN-202).
The NEON-2 study is evaluating davoceticept in combination with Merck’s (MRK - Free Report) blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), for treating adult patients with advanced malignancies.
Merck’s biggest revenue generator, Keytruda, is approved for treating several types of cancer indications. MRK is also studying the drug for yet more types of cancer indications.
Alpine’s stock has plunged 49.6% so far this year compared with the industry’s decline of 15%.
Image Source: Zacks Investment Research
The FDA issued the partial clinical hold owing to a patient's death, which is categorized as a Grade 5 serious adverse event in the NEON-2 study, as reported by Alpine. The company will not enroll additional patients in the study till the partial clinical hold is resolved.
Per the press release, the participant, who had choroidal melanoma, previously received treatment with Bristol Myers’ cancer drugs, Opdivo (nivolumab) and Yervoy (ipilimumab). The participant had received a single dose each of davoceticept and pembrolizumab. The participant’s death was due to cardiogenic shock related to immune-mediated myocarditis or possible infection, as contemplated by physicians.
However, patients currently enrolled in the NEON-2 study might continue to receive treatment with davoceticept plus pembrolizumab.
Last June, Alpine entered into a collaboration and supply agreement with Merck for conducting the NEON-2 study.
ALPN-202, a conditional CD28 co-stimulator and dual checkpoint inhibitor, has demonstrated superior efficacy in tumor models compared with checkpoint inhibition alone, in preclinical studies.
Alpine is also conducting the phase I NEON-1 study, which is evaluating ALPN-202 as a monotherapy for the treatment of patients with advanced malignancies. Regulatory updates on the study are expected during the first half of 2022.
The above-mentioned partial clinical hold by the FDA does not affect the NEON-1 study.
Apart from ALPN-202, Alpine has another candidate, ALPN-303, which is being developed for autoimmune diseases.
A phase I study on ALPN-303 is expected to begin enrollment shortly, with top-line data expected in the first half of 2022.
Catalyst Pharmaceuticals’ earnings estimates have been revised 42% upward for 2022 over the past 60 days. The stock has rallied 13.9% in the year so far.
Earnings of Catalyst Pharmaceuticals have surpassed estimates in three of the trailing four quarters and met the same once.
Sigilon Therapeutics’ loss per share estimates have narrowed 4.3% for 2022 over the past 60 days.
Earnings of Sigilon Therapeutics have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions.
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Alpine (ALPN) Down on FDA Partial Clinical Hold on Cancer Study
Shares of Alpine Immune Sciences, Inc. (ALPN - Free Report) were down 8.9% on Monday after the FDA placed a partial clinical hold on its NEON-2 study, a cancer study evaluating its pipeline candidate, davoceticept (ALPN-202).
The NEON-2 study is evaluating davoceticept in combination with Merck’s (MRK - Free Report) blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), for treating adult patients with advanced malignancies.
Merck’s biggest revenue generator, Keytruda, is approved for treating several types of cancer indications. MRK is also studying the drug for yet more types of cancer indications.
Alpine’s stock has plunged 49.6% so far this year compared with the industry’s decline of 15%.
Image Source: Zacks Investment Research
The FDA issued the partial clinical hold owing to a patient's death, which is categorized as a Grade 5 serious adverse event in the NEON-2 study, as reported by Alpine. The company will not enroll additional patients in the study till the partial clinical hold is resolved.
Per the press release, the participant, who had choroidal melanoma, previously received treatment with Bristol Myers’ cancer drugs, Opdivo (nivolumab) and Yervoy (ipilimumab). The participant had received a single dose each of davoceticept and pembrolizumab. The participant’s death was due to cardiogenic shock related to immune-mediated myocarditis or possible infection, as contemplated by physicians.
However, patients currently enrolled in the NEON-2 study might continue to receive treatment with davoceticept plus pembrolizumab.
Last June, Alpine entered into a collaboration and supply agreement with Merck for conducting the NEON-2 study.
ALPN-202, a conditional CD28 co-stimulator and dual checkpoint inhibitor, has demonstrated superior efficacy in tumor models compared with checkpoint inhibition alone, in preclinical studies.
Alpine is also conducting the phase I NEON-1 study, which is evaluating ALPN-202 as a monotherapy for the treatment of patients with advanced malignancies. Regulatory updates on the study are expected during the first half of 2022.
The above-mentioned partial clinical hold by the FDA does not affect the NEON-1 study.
Apart from ALPN-202, Alpine has another candidate, ALPN-303, which is being developed for autoimmune diseases.
A phase I study on ALPN-303 is expected to begin enrollment shortly, with top-line data expected in the first half of 2022.
Zacks Rank & Stocks to Consider
Alpine currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) and Sigilon Therapeutics, Inc. , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Catalyst Pharmaceuticals’ earnings estimates have been revised 42% upward for 2022 over the past 60 days. The stock has rallied 13.9% in the year so far.
Earnings of Catalyst Pharmaceuticals have surpassed estimates in three of the trailing four quarters and met the same once.
Sigilon Therapeutics’ loss per share estimates have narrowed 4.3% for 2022 over the past 60 days.
Earnings of Sigilon Therapeutics have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions.