Earnings release
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ALX ONCOLOGY ALX Oncology Reports Third Quarter 2021 Financial Results and Provides Clinical Development and Operational Highlights November 11 , 2021 -- SOUTH SAN FRANCISCO , Calif . , Nov. 11 , 2021 ( GLOBE NEWSWIRE ) ALX Oncology Holdings Inc. , ( " ALX Oncology " ) ( Nasdaq : ALXO ) a clinical - stage immuno - oncology company developing therapies that block the CD47 checkpoint pathway , today reported financial results for the third quarter ended September 30 , 2021 and provided clinical development and operational highlights . " The third quarter was marked by substantial progress advancing our lead program , evorpacept ( ALX148 ) through multiple clinical trials , " said Jaume Pons , Ph.D. , Founder , President and Chief Executive Officer of ALX Oncology . " Highlights include reporting new data at the ESMO conference from ASPEN - 01 , our Phase 1b trial testing evorpacept with trastuzumab , ramucirumab and paclitaxel in ≥2nd line HER2 - positive gastric or gastroesophageal junction cancer . We also dosed the first patient in ASPEN - 04 , our Phase 2 trial testing evorpacept in combination with pembrolizumab and chemotherapy for 1st line patients with unresectable or metastatic squamous cell carcinoma of the head and neck . Subsequent to the quarter end , we dosed the first patients in our ASPEN - 05 Phase 1/2 study in acute myeloid leukemia and in our Phase 1/2 collaboration with Zymeworks , which is evaluating the combination of evorpacept and zanidatamab in patients with HER2 - positive breast cancer and other solid tumors . On the business development front , in October , we acquired privately - held ScalmiBio , giving us full access to their proprietary SHIELD platform for conditional activation of antibodies in the tumor microenvironment and proprietary cytotoxic payloads for antibody - drug conjugates . " " Looking ahead , we expect a data - filled fourth quarter , which will include four poster presentations at the upcoming SITC conference , including data from ASPEN - 01 , which we presented on November 9 , the trial designs from both our Phase 2 head and neck cancer studies in collaboration with Merck ( ASPEN - 03 and ASPEN - 04 ) and preclinical data for ALTA - 002 , a first in class SIRPa - directed TLR9 agonist antibody conjugate being developed in collaboration with Tallac Therapeutics , " Dr. Pons continued . " Later this quarter , we expect to report additional Phase 1b data from ASPEN - 02 in myelodysplastic syndromes , and the initiation of ASPEN - 06 , our randomized Phase 2 trial in second line gastric cancer , " Dr. Pons continued . Recent Clinical Developments for Evorpacept ( ALX148 ) • Data for Phase 1b ASPEN - 01 Study Presented at Society for Immunotherapy of Cancer's 36 th Anniversary Annual Meeting o In November 2021 , announced updated results from ASPEN - 01 , the evorpacept phase 1b study , evaluating patients with solid tumor malignancies at the Society for Immunotherapy of Cancer's 36th Anniversary Annual Meeting ( abstract 498 ) . ALX Oncology reported updated results from the gastric / gastroesophageal junction cancer patient cohort receiving evorpacept plus trastuzumab plus chemotherapy , and from the head and neck squamous cell carcinoma patient cohort receiving evorpacept plus pembrolizumab with and without chemotherapy . Data showed robust and durable responses with emerging signs of clinical benefit in survival - based endpoints in patients with advanced solid tumors . All data reflected response evaluable patients as of September 1 , 2021 . • Abstract Data for Phase 1/2 ASPEN - 02 Study in Myelodysplastic Syndromes Released as part of the 63rd American Society of Hematology ( " ASH " ) Annual Meeting o In November 2021 , presented an ASH abstract and updated data evaluating evorpacept in combination with azacitidine for the treatment of myelodysplastic syndromes ( " MDS " ) . Among the 5 newly diagnosed subjects evaluable for response ( all with TP53 mutation ) , there were 2 subjects with cytogenetic response who met criteria for complete response subsequent to the date of this abstract , 1 subject with a best response of marrow complete response with hematologic improvement , and 1 subject each with stable disease and progressive disease . No dose - limiting toxicities were observed in any cohort and no maximum tolerated dose was reached . Additional results will be presented in a poster at the ASH meeting to be held December 11-14 conference ( Session 637 : Poster II ) . • First Patient Dosed in Phase 1/2 ASPEN - 05 Study o In October 2021 , dosed first patient in the Phase 1/2 ASPEN - 05 study evaluating the combination of evorpacept with venetoclax and azacitidine for the treatment of patients with AML . The Phase 1 portion will characterize the dose of evorpacept in combination with venetoclax and azacitidine for the treatment of patients with