ALX Oncology Announces New Data for ASPEN-01, Phase 1b
– 72% ORR observed in patients with >2L HER2 Positive Cancer of the gastric or gastroesophageal junction
– OS estimated at 12 months of 76%
– ALX Oncology to host a conference call on July 6e at 8:30 a.m. ET
BURLINGAME, Calif., July 03, 2021 (GLOBE NEWSWIRE) – ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies to block the stitch mechanism CD47 Control, today 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 ”). The new results, shared during an oral presentation at the 23rd World Congress on Gastrointestinal Cancer, show that ALX148 in combination with trastuzumab and chemotherapy is very active and well tolerated in second-line or higher patients (“>2L ”) HER2 positive GC [abstract SO-31].
“The data that continue to emerge from this clinical trial is extremely encouraging, suggesting that the combination of ALX148 with trastuzumab, ramucirumab and paclitaxel may offer an important breakthrough for patients who have progressed on or after previous treatment with trastuzumab and chemotherapy, ”said Hyun Cheol Chung, MD, Yonsei Cancer Center, South Korea, researcher for ASPEN-01. “It is important to note that these results also support the safety profile of ALX148, further differentiating it as a unique CD47 blocker that can be used in combination with a range of anti-cancer drugs, including chemotherapy. “
As of the data cut-off date of May 3, 2021, 18 patients had been treated with 10 mg / kg or 15 mg / kg of ALX148 once weekly with standard regimens of trastuzumab, ramucirumab and paclitaxel.
- In patients with >GC 2L HER2 positive, whose tumors progressed during previous treatment with trastuzumab, ALX148 demonstrates a promising initial confirmed objective response rate (“ORR”) of 72% and an estimated overall survival (“OS” at 12 months of age. 76%).
- These results compare favorably with historical randomized control studies; RAINBOW reported an ORR of 28% and a 12-month OS of 40%, and DESTINY-01 reported an ORP of 41% and a 12-month OS of 52%.
- Preliminary data suggest that ALX148 can be combined with trastuzumab, ramucirumab and paclitaxel without a maximum tolerated dose having been reached. The maximum dose of ALX148 administered in combination was 15 mg / kg once weekly.
July 6 conference calle at 8:30 a.m. ET
ALX Oncology will host a conference call on Tuesday, July 6, 2021 at 8:30 a.m. ET to further discuss new GC data from ASPEN-01, the Phase 1b study of ALX148 that was presented at ESMO 23rd World Congress on Gastrointestinal Cancer.
To access the conference call, please dial (844) 467-7655 (local) or (409) 983-9840 (international) at least 10 minutes before the start time and refer to Conference ID 4117088 The presentation slides will be available for download under “News & Events” (see “Events”) in the Investors section of the ALX Oncology website at www.alxoncology.com.
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company that aims to help patients fight cancer by developing therapies that block the CD47 checkpoint pathway and connect the innate and adaptive immune system. ALX Oncology’s flagship product candidate, ALX148, is a next generation CD47 blocking drug that combines a high affinity CD47 binding domain with a proprietary and inactivated Fc domain. ALX148 has demonstrated promising clinical responses in a range of hematologic and solid malignancies in combination with a number of leading anticancer agents. ALX Oncology intends to continue the clinical development of ALX148 for the treatment of multiple indications of solid tumors and hematologic malignancies, including AML and myelodysplastic syndromes.
Caution regarding forward-looking statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial condition, business strategy, product candidates, preclinical studies and planned clinical trials, results of clinical trials, research and development costs, approvals regulations, timing and likelihood of success, management plans and objects for future operations, as well as statements regarding industry trends. These forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it as of the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that could cause actual results, performance or achievements of ALX Oncology to differ materially from those expressed or implied by the forward-looking statements. These and other risks are described in more detail in documents filed by ALX Oncology with the Securities and Exchange Commission (“SEC”), including ALX Oncology’s annual reports on Form 10-K, quarterly reports on Form 10-Q and other documents filed by ALX Oncology with the SEC from time to time. Except to the extent required by law, ALX Oncology does not undertake to update these statements to reflect events that occur or circumstances that exist after the date on which they were made.