Clinical-stage immuno-oncology company ALX Oncology Holdings Inc. (ALXO:NASDAQ), which is focused on addressing cancer by developing therapies aimed to block the CD47 checkpoint mechanism and bridge the innate and adaptive immune system, announced "the presentation of updated clinical data from its ongoing ASPEN-01 trial evaluating ALX148 in combination with trastuzumab and chemotherapy for the treatment of gastric or gastroesophageal junction cancer (GC)."
ALX Oncology stated that "the new results, shared in an oral presentation at the 23rd World Congress on Gastrointestinal Cancer, show that ALX148 in combination with trastuzumab and chemotherapy is highly active and well-tolerated in patients with second-line or greater (">2L") HER2 positive GC [abstract SO-31]."
Hyun Cheol Chung, M.D., an investigator in the ASPEN-01 study from the Yonsei Cancer Center in South Korea, commented, "The data that continue to emerge from this clinical trial are tremendously encouraging, suggesting that the combination of ALX148 with trastuzumab, ramucirumab and paclitaxel may offer an important advancement for patients who have progressed on or after prior trastuzumab and chemotherapy…Importantly, these results also support ALX148's tolerability profile, further differentiating it as a unique CD47 blocker that may be used in combination with an array of anti-cancer drugs, including chemotherapy."
The company advised that a total of 18 patients in the Phase 1b ASPEN-01 trial had been treated with either 10 mg/kg or 15 mg/kg of ALX148 once weekly with standard dosing regimens of trastuzumab, ramucirumab and paclitaxel through the data cut-off date of May 3, 2021.
The firm indicated that the data obtained in the study showed that "in patients with >2L HER2 positive GC, whose tumors have progressed upon prior trastuzumab therapy, ALX148 demonstrates a promising initial confirmed objective response rate (ORR) of 72% and estimated overall survival (OS) at 12 months of 76%."
ALX Oncology noted that the recent results were highly favorable and far superior to those observed in prior randomized studies. The company pointed out that the historic controlled RAINBOW study reported an ORR of only 28% and 12-month OS of just 40% and that the DESTINY-01 trial results measured ORR of 41% and 12-month OS of 52%.
The company stated that the maximum administered dose of ALX148 in combination was 15 mg/kg once weekly and that it believes that "the preliminary data suggests that ALX148 can be combined with trastuzumab, ramucirumab and paclitaxel with no maximum tolerated dose reached."
ALX Oncology a clinical-stage immuno-oncology company based in Burlingame, Calif. The firm is engaged in the fight against cancer by creating and developing therapies that are designed to block the CD47 checkpoint pathway to mobilize the patient's innate and adaptive immune system. The company indicated that its lead product candidate ALX148, which combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain, has displayed promising responses in in both hematologic and solid malignancies clinical studies when used in combination with other anti-cancer agents. ALX Oncology said it plans to initiate further clinical studies of ALX148 to evaluate its potential use in treating AML and myelodysplastic syndromes.
ALX Oncology has a market cap of around $2.2 billion with approximately 40.23 million shares outstanding and a short interest of about 5.0%. ALXO shares opened greater than 20% higher today at $67.50 (+$11.60, +20.75%) over Friday's $55.90 closing price. The stock has traded today between $61.03 and $70.00 per share and is currently trading at $61.78 (+$5.88, +10.52%).[NLINSERT]
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