ALX Oncology Holdings Inc. ALXO announced that the FDA has granted Orphan Drug designation to its lead product candidate, evorpacept, for the treatment of patients with gastric cancer and gastroesophageal junction cancer (collectively known as GC).
The Orphan Drug designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes one that affects fewer than 200,000 individuals in the United States. The designation also includes incentives, including financial aid for clinical testing and seven-year marketing exclusivity upon regulatory approval.
Shares of ALX Oncology were up 4.5% in after-hours trading on Thursday following the announcement of the news. However, the stock has plunged 81.9% in the past year compared with the industry’s decline of 39.3%.
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The phase Ib ASPEN-01 study is evaluating evorpacept in combination with Roche’s RHHBY Herceptin (trastuzumab) plus ramucirumab and paclitaxel for treating patients with >2L HER2 positive GC. Data from the study showed that treatment with the evorpacept combo led to an initial objective response rate of 72.2%, with a median duration of response of 14.8 months and a median overall survival of 17.1 months in the given patient population.
Roche has a strong presence in the oncology market. Herceptin is one of Roche’s legacy cancer drugs. RHHBY is facing stiff competition from biosimilars for Herceptin, which is negatively affecting the drug’s sales.
ALX Oncology is looking to initiate a phase II/III study — ASPEN-06 — which will evaluate evorpacept for the treatment of patients with advanced HER2 positive GC.
Evorpacept, a next-generation CD47 blocker, is being developed for treating multiple cancer indications.
ALX Oncology has also initiated several early-to-mid-stage studies for evaluating evorpacept in combination with a number of leading anti-cancer agents for treating unresectable or metastatic squamous cell carcinoma of the head and neck, acute myeloid leukemia, myelodysplastic syndromes, non-hodgkin lymphoma, HER2-positive breast cancer, and other solid tumors.
If successfully developed and upon potential approval, evorpacept can tap into a market with significant potential and drive growth for ALX Oncology as it will be able to generate revenues from evorpacept’s sales.
Zacks Rank & Stock to Consider
ALX Oncology currently carries a Zacks Rank #4 (Sell).
Top-ranked stocks in the biotech sector include Cara Therapeutics, Inc. CARA and Alkermes plc ALKS, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Cara Therapeutics’ loss per share estimates have narrowed 1.3% for 2022, over the past 60 days.
Cara Therapeutics’ earnings surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Alkermes’ earnings estimates have been revised 1.4% upward for 2022 over the past 60 days. The stock has increased 17% in the past year.
Alkermes’ earnings have surpassed estimates in each of the trailing four quarters.
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