PF-08046052 / LAVA Therap, Pfizer - LARVOL DELTA

SGNEGFRd2-001: A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=290 | Recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | Trial completion date: Jul 2029 ➔ Jan 2030 | Trial primary completion date: Jul 2028 ➔ Jan 2029

Trial completion date • Trial primary completion date • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • MSI

LAVA Reports First Quarter 2025 Financial Results, Provides Business Update (GlobeNewswire) - "Enrollment in LAVA-1266 Phase 1 continues to progress...J&J is enrolling patients in a Phase 1, open label, multi-center study, underway in Canada and Spain. The study includes a dose escalation and dose expansion segment to evaluate JNJ-89853413 in approximately 100 adults with relapsed/refractory (R/R) AML or R/R higher risk of MDS; Pfizer is enrolling patients in a Phase 1 open label, multi-center study, underway in the U.S. and UK. The study is intended to evaluate PF08046052 in approximately 275 subjects...Research and development expenses were $4.2 million and $5.6 million for the quarters ended March 31, 2025 and 2024, respectively. The decrease in the quarter ended March 31, 2025 was primarily due to lower clinical costs associated with the discontinuation of LAVA-1207, announced in December 2024, slightly offset by accruals related to restructuring activities and startup activities for LAVA-1266."

Commercial • Enrollment status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Solid Tumor

Pfizer Partnered Program (PF08046052) (GlobeNewswire) - "Milestone: Clinical development milestone of $7 million received from Pfizer in Q1 2024."

Commercial • Solid Tumor

SGNEGFRd2-001: A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=275 | Recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | Trial completion date: Sep 2028 ➔ Jul 2029 | Trial primary completion date: Jul 2027 ➔ Jul 2028

Trial completion date • Trial primary completion date • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • MSI

LAVA Reports Third Quarter 2024 Financial Results and Announces Pipeline Reprioritization and Cash Runway Extension into 2027 (GlobeNewswire) - "Pfizer Partnered Program –(PF08046052) – In Phase 1 Trial (NCT05983133)...Key Indications: Include colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and pancreatic ductal adenocarcinoma (PDAC); Current Status: Monotherapy Phase 1 dose escalation study underway to evaluate the safety and tolerability in advanced EGFR-expressing solid tumors; Milestone: Clinical development milestone of $7 million received from Pfizer in Q1 2024."

Financing • Trial status • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Squamous Cell Carcinoma of Head and Neck

LAVA…Announces Pipeline Reprioritization and Cash Runway Extension into 2027 (GlobeNewswire) - "Reprioritized pipeline to focus on LAVA-1266, with continued support for partnered programs with Pfizer (PF-08046052) and Johnson and Johnson (JNJ-89853413)....'LAVA is well capitalized, with approximately $79 million in cash, and with this pipeline reprioritization, we expect our cash balance to fund the Company into 2027.'"

Financing • Pipeline update • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Solid Tumor

Phase 1 study of SGN-EGFRd2 in solid tumors (SGNEGFRd2-001) (AACR 2024) - P1 | "Accrual is ongoing in the US. Additional sites in Europe and Canada are planned."

IO biomarker • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • BRAF • KRAS

SGN-EGFRd2 binding and activity are agnostic to common EGFR extracellular resistance mutations acquired in response to anti-EGFR targeted antibody therapies (AACR 2024) - "Two antibodies are currently approved for the treatment of EGFR-expressing, KRAS wild-type metastatic colorectal cancer (mCRC): cetuximab (CET) and panitumumab (PAN). SGN-EGFRd2 binding to EGFR ECD mutant cell lines induced the production of interferon gamma and expression of cell surface CD107a on gamma delta T cells, confirming functional engagement.In contrast to current anti-EGFR therapeutic antibodies, SGN-EGFRd2 binding and activity was unaffected by commonly identified EGFR ECD mutations. These findings highlight SGN-EGFRd2 as a novel molecule targeting wild-type EGFR and common EGFR ECD mutations identified in the mCRC setting."

Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • IFNG • KRAS • LAMP1

LAVA Announces Clinical Development Milestone Achieved by Pfizer for PF-08046052 (formerly SGN-EGFRd2/LAVA-1223) (GlobeNewswire) - "LAVA Therapeutics...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....'As the Phase 1 study advances, we look forward to continued clinical progress and future data readouts'....Milestone triggered by clinical progress in Phase 1 study, initiated in Q4 2023."

Financing • Trial status • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Seagen Third Quarter 2023 Financial Results Reflect Strong Product Sales Growth, and Significant Portfolio and Pipeline Progress (Seagen Press Release) - "The Company expects to initiate a phase 3 trial for SGN-B6A, a novel, vedotin ADC targeting integrin beta-6, as a monotherapy in previously treated patients with NSCLC before the end of 2023....The Company initiated a phase 1 trial for SGN-EGFRd2, a gamma delta bispecific T-cell engager for EGFR-expressing solid tumors. Year to date, the Company has submitted INDs for three novel targeted cancer therapies, including SGN-EGFRd2, SGN-35T and SGN-CEACAM5C, with the goal of submitting one additional IND before year end."

IND • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of SGN-EGFRd2 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=275 | Recruiting | Sponsor: Seagen Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • MSI

LAVA Therapeutics Provides Business Update and Reports Second Quarter 2023 Financial Results (GlobeNewswire) - "LAVA-1207...Recruitment is on track and dose escalation continues across 10 sites in a globalized trial in Europe and the United States. Currently recruiting dose level 8 for monotherapy treatment. Currently recruiting dose level 7 with low-dose interleukin-2. The Company expects to report additional safety and efficacy data for the dose escalation phase of the trial in the next twelve months, which may inform the design of a future pivotal trial....An investigational new drug application clearance for SGN-EGFRd2 (LAVA-1223) in advanced solid tumors was received from the U.S. Food and Drug Administration. Seagen plans to initiate the Phase 1 trial in 2023 (NCT05983133)."

IND • P1/2 data • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of SGN-EGFRd2 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=275 | Not yet recruiting | Sponsor: Seagen Inc.

Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • MSI

"Interesting that LAVA-1223 isn't even $LVTX's lead asset. $SGEN sending a message that it's business as usual and it isn't up for sale? $MRK" (@JacobPlieth)

Seagen and LAVA Therapeutics Announce Exclusive Worldwide License Agreement to Advance LAVA-1223, a Preclinical Gamma Delta Bispecific T Cell Engager for EGFR-Expressing Solid Tumors (GlobeNewswire) - "Seagen Inc...and LAVA Therapeutics N.V...announced an exclusive license agreement in which Seagen will work to develop, manufacture and commercialize LAVA-1223. LAVA-1223 is an advanced preclinical asset that utilizes LAVA’s proprietary Gammabody™ technology to target epidermal growth factor receptor (EGFR)-expressing solid tumors....Under the terms of the agreement, Seagen will receive an exclusive global license for LAVA-1223 and pay LAVA $50 million upfront; up to approximately $650 million in potential development, regulatory and commercial milestones; and royalties ranging from the single digits to the mid-teens on future sales. The agreement also provides Seagen with the opportunity to exclusively negotiate rights to apply LAVA's proprietary Gammabody™ platform on up to two additional tumor targets."

Licensing / partnership • Oncology • Solid Tumor

"Not entirely clear whether $LAVA LAVA-1223 uses a full MAb format or the one without an Fc region" (@JacobPlieth)

LAVA Therapeutics Provides Business Update and Reports Fourth Quarter and Year End 2021 Financial Results (GlobeNewswire) - "Early-Stage Pipeline Development: In addition to LAVA’s two lead programs, the Company is developing a portfolio of earlier stage Gammabody™ programs including LAVA-1223, a Gammabody™ directed at the epidermal growth factor receptor (EGFR) for the treatment of solid tumors, for which a clinical trial application (CTA) is planned for late 2022....LAVA today announces the addition of LAVA-1266, a CD123 Gammabody™, to its pipeline for the treatment of hematological malignancies. A CTA is planned for late 2023."

Non-US regulatory • Oncology • Solid Tumor

LAVA Therapeutics Presents Preclinical Data on its Gammabody T Cell Engager Platform at the 21st Annual PepTalk Conference (GlobeNewswire) - "The presentation will also include new non-human primate data with a fully cross-reactive gamma delta bsTCE utilizing a surrogate Fc-containing Gammabody™ format to assess the safety of its most advanced solid tumor programs, LAVA-1207 and LAVA-1223....In preclinical experiments, LAVA-1207 has shown the ability to activate Vγ9Vδ2 (Vgamma9 Vdelta2) T cells to exert cytotoxicity toward PSMA (prostate specific membrane antigen)-expressing tumor cells at picomolar concentrations. Using prostate cancer patient samples, LAVA-1207 activated autologous Vγ9Vδ2 T cells and triggered lysis of tumor cells, while sparing normal prostate tissue....A first-in-human Phase 1/2a open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and antitumor activity of LAVA-1207 in patients with therapy refractory metastatic castration-resistant prostate cancer (mCRPC) is currently recruiting."

Enrollment status • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor