MedPath

Evorpacept

Generic Name
Evorpacept
Drug Type
Biotech
CAS Number
2484949-51-9
Unique Ingredient Identifier
X7K762X1IJ
Background

evorpacept is under investigation in clinical trial NCT04755244 (A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)).

Innate Pharma's Novel NK Cell Engager IPH6501 to Be Presented at EHA 2025 Congress

• Innate Pharma's IPH6501, a tetraspecific NK cell engager targeting CD20 B cells for Non-Hodgkin Lymphoma, will be featured at the European Hematology Association Congress in June 2025. • The ANKET® platform technology represents a new class of cancer immunotherapies that co-engage multiple receptors on NK cells while targeting tumor antigens, potentially offering superior efficacy to existing antibody treatments. • Preclinical data has shown IPH6501 demonstrates better anti-tumor efficacy than approved benchmark antibodies, with the compound currently being evaluated in a Phase 1/2 trial for relapsed/refractory CD20-expressing B-cell lymphomas.

GSK's Linerixibat Shows Significant Improvement in Cholestatic Pruritus for Primary Biliary Cholangitis Patients

• GSK's phase III GLISTEN trial demonstrates linerixibat significantly improves cholestatic pruritus (relentless itch) in patients with primary biliary cholangitis, addressing a major quality of life concern. • The late-breaking results were presented at the European Association for the Study of the Liver (EASL) Congress 2025, highlighting the potential for a new treatment option for this challenging symptom. • Primary biliary cholangitis is a chronic autoimmune liver disease that primarily affects women, with pruritus being one of the most debilitating symptoms impacting daily functioning and quality of life.

Evorpacept-Keytruda Combination Fails to Meet Primary Endpoints in Head and Neck Cancer Trials

• ALX Oncology announced that evorpacept combined with Keytruda (pembrolizumab), with or without chemotherapy, failed to meet primary endpoints in two Phase 2 trials for head and neck squamous cell carcinoma. • Despite showing a manageable safety profile, the company will discontinue pursuing this specific combination for HNSCC treatment, instead focusing on evorpacept's more promising combinations with anti-cancer antibodies in other tumor types. • Evorpacept, a CD47-blocker designed to help the immune system target cancer cells, will continue development in multiple clinical trials for breast cancer, colorectal cancer, non-Hodgkin lymphoma, and multiple myeloma.

Robust Pipeline of 220+ Drugs Advancing for Gastric Cancer Treatment, Led by Major Pharmaceutical Companies

• DelveInsight's comprehensive analysis reveals over 200 companies actively developing 220+ pipeline therapies for gastric cancer treatment, indicating significant industry investment in addressing this disease. • Key players including BeiGene, Bristol-Myers Squibb, and AstraZeneca are advancing promising candidates like tislelizumab, relatlimab-nivolumab combination, and trastuzumab deruxtecan through clinical trials. • Multiple therapeutic approaches are being explored, from monoclonal antibodies to small molecules, with several drugs in late-stage development including Catumaxomab in Phase III and Tivumecirnon in Phase II trials.

EPCORE NHL-2 Trial Shows Promise Combining Chemotherapy and Immunotherapy for DLBCL

• A phase Ib/II clinical trial led by Mount Sinai researchers demonstrates successful outcomes in combining chemotherapy with immunotherapy for diffuse large B-cell lymphoma treatment. • The groundbreaking research, published in Blood journal, was conducted under the leadership of Dr. Joshua Brody, director of the Lymphoma Immunotherapy Program at the Tisch Cancer Institute. • The study represents a significant advancement in lymphoma treatment, supported by the Leukemia & Lymphoma Society's research initiatives, which have invested over $600 million in hematologic oncology research.

Evorpacept Shows Promising Results in Phase 2 Trial for HER2-Positive Gastric Cancer

ALX Oncology's CD47-blocking therapy evorpacept demonstrated significant improvement in overall response rates and progression-free survival in HER2-positive gastric cancer patients. The drug nearly tripled the response rate compared to standard therapy, achieving 48.9% ORR versus 24.5% in the control group, while maintaining a favorable safety profile.

Evorpacept Shows Promise in HER2-Positive Gastric Cancer: Phase 2 ASPEN-06 Trial Results

• The ASPEN-06 Phase 2 trial demonstrated a 41.3% overall response rate (ORR) with evorpacept plus trastuzumab, ramucirumab, and paclitaxel (ETRP) in previously treated HER2-positive gastric cancer patients. • Patients with confirmed HER2-positive tumors via fresh biopsy or ctDNA showed a 48.9% ORR and a median duration of response of 15.7 months with the evorpacept combination. • Evorpacept plus TRP was generally well-tolerated, with adverse events consistent with the control group, suggesting a manageable safety profile in this patient population. • The FDA has granted Fast Track designation to evorpacept for second-line treatment of HER2-positive gastric or gastroesophageal junction carcinoma, highlighting its potential clinical significance.

Evorpacept Shows Promise in HER2-Positive Gastric Cancer: Updated ASPEN-06 Data

• ALX Oncology's ASPEN-06 Phase 2 trial evaluates evorpacept, a CD47-blocker, in HER2-positive advanced gastric cancer patients who have been previously treated. • Updated data from the ASPEN-06 trial were presented at the 2025 ASCO Gastrointestinal Cancers Symposium (ASCO GI). • The virtual event hosted by ALX Oncology on January 23, reviewed the ASPEN-06 data, focusing on evorpacept's potential in immuno-oncology. • The ASPEN-06 trial is a phase 2/3 study of evorpacept in patients with HER2-overexpressing gastric/gastroesophageal cancer.

Gastrointestinal Cancer Symposium 2025: Key Advances in Treatment Strategies

• Nivolumab plus ipilimumab demonstrates superior progression-free survival compared to nivolumab alone in MSI-H/dMMR metastatic colorectal cancer. • Encorafenib combined with cetuximab and chemotherapy shows significant improvement in overall response rate for BRAF V600E-mutated metastatic colorectal cancer. • TACE plus camrelizumab and rivoceranib extends progression-free survival in patients with unresectable hepatocellular carcinoma, offering a manageable safety profile.

Novel HER2-Targeted Therapies Show Promise in Overcoming Treatment Resistance in Advanced Breast Cancer

• New HER2-directed antibody-drug conjugate SHR-A1811 demonstrates impressive 76.3% response rate in HER2-positive breast cancer patients, with potentially improved safety profile compared to existing treatments. • Bispecific antibody zanidatamab combined with evorpacept shows 55.6% response rate in heavily pretreated patients who progressed on T-DXd, offering hope for resistant disease. • Research reveals potential resistance mechanisms to HER2-targeted therapies, including topoisomerase I alterations and HER2 gene loss, helping guide future treatment strategies.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

ALX Oncology Faces Mixed Outcomes in Clinical Trials and Executive Changes

ALX Oncology Holdings Inc. has seen a mix of clinical trial outcomes, including positive results in HER2-positive metastatic breast cancer treatment and a decline in efficacy in a Phase II gastric cancer study. The company also announced the resignation of its Chief Medical Officer and received Fast Track designation from the FDA for evorpacept in treating HER2-positive gastric or GEJ carcinoma.

Zanidatamab and Evorpacept Combination Shows Promise in HER2+ Breast Cancer

• Zanidatamab plus evorpacept demonstrates promising antitumor activity in heavily pretreated HER2-positive metastatic breast cancer patients, even after progression on prior T-DXd. • In HER2-positive metastatic breast cancer, the combination therapy achieved a confirmed overall response rate of 33.3% and a disease control rate of 71.4%. • The combination also showed antitumor activity in heavily pretreated HER2-low metastatic breast cancer, warranting further development of this chemotherapy-free regimen. • Treatment-related adverse events were manageable, with mostly grade 1/2 events, supporting the tolerability of the zanidatamab and evorpacept combination.

ALX Oncology Highlights Evorpacept Data in Metastatic Breast Cancer at SABCS 2024

• ALX Oncology presented initial Phase 1b/2 data on evorpacept combined with zanidatamab for heavily pretreated metastatic breast cancer at SABCS 2024. • The virtual event on December 17 will feature an overview of the data by principal investigator Dr. Alberto J. Montero and ALX Oncology's CMO, Dr. Alan Sandler. • Evorpacept, a CD47 blocker, is being investigated as a potential cornerstone therapy in immuno-oncology across various cancer indications. • The webcast of the virtual event will be available on ALX Oncology's website for those interested in the clinical trial results and company updates.

ALX Oncology's Evorpacept Shows Promise in Multiple Cancer Trials

• ALX Oncology reported a 40% reduction in net loss for Q3 2023, alongside advancements in evorpacept clinical trials. • Phase 2 ASPEN-06 trial showed a 40.3% overall response rate for evorpacept in HER2-positive gastric/GEJ cancer, compared to 26.6% in the control arm. • Interim Phase 1 data from the ASPEN-07 trial indicated a 61% unconfirmed overall response rate for evorpacept in urothelial cancer. • ALX Oncology is expanding evorpacept's development through collaborations and strategic initiatives, including ADC development and trials for HNSCC.

Evorpacept Enters Phase 2 Trial for Platinum-Resistant Ovarian Cancer

• ALX Oncology's evorpacept is being evaluated in a Phase 2 trial for recurrent platinum-resistant ovarian cancer. • The trial combines evorpacept with liposomal doxorubicin and pembrolizumab (KEYTRUDA®). • The study is led by UPMC Hillman Cancer Center, with Merck providing pembrolizumab. • Evorpacept is also being evaluated in combination with zanidatamab for HER2-positive and HER2-low metastatic breast cancer, with results to be presented at SABCS 2024.

Evorpacept Plus Zanidatamab Shows Promise in HER2-Positive and HER2-Low Metastatic Breast Cancer

• Phase 1b/2 trial data of evorpacept with zanidatamab in HER2-positive and HER2-low metastatic breast cancer will be presented at SABCS 2024. • The open-label, multicenter study (NCT05027139) evaluates the combination as a novel treatment for HER2-expressing breast cancer and other cancers. • The presentation will highlight the potential of evorpacept to enhance zanidatamab's efficacy in heavily pretreated breast cancer patients. • ALX Oncology's evorpacept is being investigated across multiple clinical trials for various cancer indications, aiming to improve patient outcomes.

Robust Clinical Trial Pipeline Fuels Hope for Renal and Breast Cancer Advances

• The renal cancer clinical trial pipeline is robust, with over 70 companies developing more than 75 therapies, including novel immunotherapies and targeted agents. • Breast cancer research is also thriving, with over 100 companies exploring 120+ new drugs, such as antibody-drug conjugates and PARP inhibitors, in clinical trials. • Recent FDA actions, including Fast Track and Breakthrough Therapy designations, highlight the potential of emerging therapies for both renal and breast cancer. • Advances in diagnostics, such as PET imaging agents for clear cell renal cell carcinoma, are also contributing to improved management of these diseases.

CD47-Targeted Immunotherapies Show Promise in Cancer Treatment

• CD47-targeted therapies are emerging as a novel cancer immunotherapy approach, inhibiting the "don't eat me" signal that cancer cells use to evade immune surveillance. • Several CD47 inhibitors, like magrolimab and evorpacept, are undergoing clinical trials, showing encouraging results in hematological and solid tumors, often in combination with other treatments. • Regulatory bodies are supportive, granting fast track designations and IND clearances, indicating a rapidly expanding CD47 market driven by the rising incidence of cancer. • Pharmaceutical companies and research institutions are actively involved, with the United States leading the sector, while countries like China are increasing their engagement in clinical studies.
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