Evorpacept

This year’s San Antonio Breast Cancer Conference yielded major clinical updates on some of the hottest areas of oncology, from VEGF bispecifics that hope to challenge Merck’s Keytruda on efficacy to oral protein degraders that may offer patients more convenience. There were also a handful of early-stage readouts from drugmakers big and small advancing new and improved takes on established mechanisms or sticking it out with approaches that others have left by the wayside. We’ve rounded up data from these presentations here. BeiGene reported early safety data for its CDK4 selective inhibitor on Thursday. CDK4/6 inhibitors work by inhibiting cell cycling, head of solid tumors Mark Lanasa told Endpoints News in an interview. Most of that inhibition is driven by the CDK4 component, while the CDK6 component can add hematologic toxicity, so selective targeting could help minimize side effects, he said. The Phase 1a trial comprises three cohorts testing BeiGene’s BGB-43395 alone and in doublets with fulvestrant and letrozole in people with advanced or metastatic solid tumors, including HR-positive/HER2-negative breast cancer. The most common side effects were gastrointestinal. Blood-related events like neutropenia (4.6%) and anemia (12.3%) were less common and mostly low-grade. Pfizer is also pursuing CDK4 selective inhibition with an asset called atirmociclib. Back in February, the pharma company told investors the drug is a potential successor to its CDK4/6 inhibitor Ibrance, with benefits including more “complete and continuous” target coverage. On Friday, Pfizer presented preliminary data showing atirmociclib plus letrozole attained a 61% confirmed objective response rate in 33 front-line HR-positive/HER2-negative metastatic breast cancer patients in a Phase 1/2a solid tumor study. There were two instances of grade 2 neutropenia and one case of grade 3 neutropenia. ALX Oncology is advancing an approach that drugmakers like Gilead Sciences have given up on due to safety concerns — targeting CD47. The South San Francisco-based biotech has a broad-ranging clinical program for its candidate, evorpacept, which covers non-Hodgkin lymphoma, multiple myeloma and urothelial cancers. On Tuesday, ALX unveiled results from a Phase 1/2b test of evorpacept plus Jazz Pharmaceuticals’ HER2-targeted bispecific antibody Ziihera in solid tumors, including metastatic breast cancer. In 21 patients with HER2-positive disease, the regimen reached a 33.3% confirmed ORR and 3.6 months of median progression-free survival. The response rates (20%) and PFS (1.9 months) were lower in 15 patients with HER2-low disease. Common side effects included fatigue, nausea and diarrhea, but there were no treatment-related deaths or non-infectious lung side effects, the company said.

Webcast on December 17 at 8:00 AM EST to feature ALX Oncology leadership and study principal investigator Alberto J. Montero, MD, MBA SOUTH SAN FRANCISCO, Calif., Dec. 12, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, announced that the company will host a virtual event on Tuesday, December 17, at 5:00 AM PST / 8:00 AM EST to discuss the first data from a Phase 1b/2 clinical trial evaluating the company’s investigational CD47-blocker evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab in heavily pretreated patients with metastatic breast cancer. The data were featured today in a spotlight poster presentation at the 2024 San Antonio Breast Cancer Symposium (SABCS). The poster is now available on the ALX Oncology site under Publications. During the virtual company event, Alberto J. Montero, MD, MBA, Clinical Director, Breast Cancer Medical Oncology Program, Diana Hyland Endowed Chair for Breast Cancer, and Professor of Medicine at University Hospitals Seidman Cancer Center, Case Western Reserve University, and the study’s principal investigator, will provide an overview of the data presented at SABCS 2024 and participate in a fireside chat with Alan Sandler, MD, ALX Oncology’s Chief Medical Officer. Jason Lettmann, Chief Executive Officer at ALX Oncology, will provide opening and closing remarks, highlighting progress and upcoming milestones for the company’s evorpacept clinical program. The event will be webcast live and can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com and selecting Events under News and Events. To participate in the live event, please register using this link: https://edge.media-server.com/mmc/p/8cce2ndq. An archived webcast will be available following the event. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.