LAVA Announces Clinical Development Milestone Achieved by Pfizer for PF-08046052 (formerly SGN-EGFRd2/LAVA-1223)

2024-03-07

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March 05, 2024 -- LAVA Therapeutics N.V. (NASDAQ: LVTX, “LAVA”), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody® platform of bispecific gamma delta T cell engagers, today announced that Pfizer has achieved a clinical development milestone for PF-08046052 (formerly SGN-EGFRd2 /LAVA-1223), prompting the first milestone payment of $7 Million to LAVA. LAVA granted Seagen (acquired by Pfizer in December 2023) a worldwide, exclusive license to PF-08046052 in September 2022.

“We are very pleased with the initiation of clinical development by Pfizer of PF-08046052, formerly SGN-EGFRd2/LAVA-1223. We have always viewed this molecule with excitement about its potential in oncology. Achievement of this milestone is another important step in realizing the potential of LAVA’s Gammabody® platform. As the Phase 1 study advances, we look forward to continued clinical progress and future data readouts,” said Stephen Hurly, President and Chief Executive Officer of LAVA.

“The initiation of the Phase 1 study for PF-08046052 marks the third asset utilizing LAVA’s Gammabody® platform to enter the clinic and will add further information on safety, clinical pharmacology and potential anti-tumor activity to the growing database for this novel class of molecules,” commented Charles Morris, M.D., Chief Medical Officer, LAVA. “We are especially encouraged by the ongoing progress for PF-08046052 and PSMA-directed LAVA-1207, currently in a Phase 1/2a study. Both programs direct Vγ9Vδ2 T cells to validated targets and have the potential to provide important proof-of-concept for LAVA’s Gammabody® platform.”

About PF-08046052 (formerly LAVA-1223)

PF-08046052 is a potential first-in-class asset utilizing the Gammabody® platform designed to conditionally activate Vγ9Vδ2 (Vgamma9 Vdelta2) T cells, upon crosslinking to epidermal growth factor receptor (EGFR), to trigger the potent and preferential killing of EGFR-positive tumor cells. EGFR is a well-validated target that is over-expressed in multiple solid tumor types, including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC) and pancreatic ductal adenocarcinoma (PDAC). PF-08046052 is being evaluated in an ongoing Phase 1 study (NCT05983133) by Pfizer under an exclusive worldwide license agreement. In accordance with the agreement, LAVA received a $50 million upfront payment and is eligible to receive milestones of up to approximately $650 million upon achievement of development, regulatory and commercial milestones as well as royalties on potential sales.

About LAVA Therapeutics

LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company focused on advancing its proprietary Gammabody® platform to develop a portfolio of bispecific gamma-delta T cell engagers for the potential treatment of solid tumors and hematologic malignancies. The Company utilizes bispecific antibodies engineered to selectively kill cancer cells by triggering Vγ9Vδ2 (Vgamma9 Vdelta2) T cell antitumor effector functions upon cross-linking to tumor-associated antigens.

A Phase 1/2a dose escalation study (NCT05369000) to evaluate the lead program, LAVA-1207, in patients with metastatic castration-resistant prostate cancer (mCRPC) is actively enrolling in Europe and the United States in a study evaluating monotherapy and combination treatment with interleukin-2 (IL-2). The Company is also planning to expand the Phase 1/2a study to include a combination arm with KEYTRUDA®(pembrolizumab), through a clinical collaboration with Merck & Co., Inc., Rahway, NJ, USA. The Company licensed PF-08046052 (formerly SGN-EGFRd2/LAVA-1223) to Pfizer for clinical development and commercialization. For more information, please visit www.lavatherapeutics.com, and follow us on LinkedIn, X, and YouTube.

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