LAVA-1207 / LAVA Therap - LARVOL DELTA

KEYNOTE F73: Trial of LAVA-1207 in Patients with Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=180 | Active, not recruiting | Sponsor: Lava Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

LAVA Reports Third Quarter 2024 Financial Results and Announces Pipeline Reprioritization and Cash Runway Extension into 2027 (GlobeNewswire) - P1/2a | N=180 | KEYNOTE-F73 (NCT05369000) | Sponsor: Lava Therapeutics | "LAVA-1207 – Discontinued....The Phase 1 study of LAVA-1207 did not reach LAVA’s internal benchmarks and the program and drug will be made available for patients currently receiving LAVA-1207 for as long as considered necessary by their treating physician. The decision to discontinue LAVA-1207 is not due to safety concerns. Clinical signals recorded in several patients, including PSA reductions and extended time on study for patients with higher baseline circulating Vd2 T cells, as well as the encouraging safety and tolerability profile, are consistent with the intended mechanism of action and support further investigation of the platform."

Discontinued • P1 data • Castration-Resistant Prostate Cancer

LAVA Reports Second Quarter 2024 Financial Results and Business Update (GlobeNewswire) - "LAVA-1207: Monotherapy Arm: Enrolling in dose level 12 with no ≥ Grade 2 Cytokine Release Syndrome (CRS) since the implementation of step-dosing in Q1 2024; KEYTRUDA (pembrolizumab) Combination: Initiated dosing in the LAVA-1207 + pembrolizumab dose-escalation arm (KEYNOTE-F73) to potentially enhance the anti-tumor activity of LAVA-1207; We expect to release the next data for LAVA-1207 at a medical meeting later this year."

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

Phase I/II trial of LAVA-1207, a novel bispecific gamma-delta T-cell engager alone, or with low dose IL-2 or pembrolizumab, in metastatic castration resistant prostate cancer (mCRPC). (ASCO 2024) - P1/2 | "Dose escalation is ongoing. Expansion arm(s) will be included based on available data from part 1 of the study and may include one or more of LAVA-1207, LAVA-1207 with low dose IL-2, or LAVA-1207 in combination with pembrolizumab."

Metastases • P1/2 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

LAVA Provides Business Updates and Reports First Quarter 2024 Financial Results (GlobeNewswire) - "LAVA-1207 – In Phase 1/2a (NCT05369000) – Next update H2 2024: Monotherapy: Enrolling patients at dose level 10. No ≥ Grade 2 Cytokine Release Syndrome (CRS) since the implementation of step dosing in Q1 2024; KEYTRUDA (pembrolizumab) Combination: Expecting to enroll the first patient in Q2 2024 in the LAVA-1207 + pembrolizumab dose-escalation arm (KEYNOTE-F73)....Research and development expenses were $6.0 million and $9.9 million for the quarters ended March 31, 2024 and 2023, respectively. The decrease was primarily due to lower pre-clinical and clinical trial expenses due to the discontinuation of LAVA-051, announced in June 2023, and reduced personnel-related expenses due to a reduction in research and development headcount in the second half of 2023."

Commercial • Trial status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Lava Therapeutics | N=66 ➔ 180 | Trial completion date: Mar 2024 ➔ Apr 2027 | Trial primary completion date: Sep 2023 ➔ Apr 2027

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

LAVA-1207: Expiry of patents related to composition-of-matter and methods of treating diseases in US/ex-US between 2041 and 2044 (Lava Therapeutics) - Annual Report 2023

Patent • Oncology • Solid Tumor

LAVA Provides Business Updates and Reports Fourth Quarter and Year-End Financial Results (GlobeNewswire) - "LAVA 1207 – In Phase 1/2a -- Next update expected H2 2024 targeting a medical conference....The first-in-human Phase 1/2a clinical trial is enrolling patients in monotherapy and combination arms; Completed enrollment in dose level 9 monotherapy arm. Expect to begin enrolling in the dose escalation and dose expansion arm, in combination with KEYTRUDA (pembrolizumab) in the coming months....LAVA-1266 – IND Submission Expected in Q2 2024."

IND • P1/2 data • Trial status • Acute Myelogenous Leukemia • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Malignancies • Leukemia • Metastatic Castration-Resistant Prostate Cancer • Myelodysplastic Syndrome • Oncology • Prostate Cancer • Solid Tumor

LAVA-1207: Data from P1/2a trial (NCT05369000) for mCRPC in Q3 2024 (Lava Therapeutics) - Corporate Presentation

P1/2 data • Oncology • Prostate Cancer

LAVA Therapeutics Announces Collaboration with Merck & Co., Inc., Rahway, NJ, USA to Evaluate LAVA-1207 in Combination with KEYTRUDA (GlobeNewswire) - "LAVA Therapeutics N.V...today announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Rahway, NJ, USA to evaluate its anti-PD-1 therapy KEYTRUDA (pembrolizumab) in combination with LAVA-1207, a Gammabody designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells, in patients with therapy refractory metastatic castration-resistant prostate cancer (mCRPC)...Under the terms of the agreement, Merck & Co., Inc., Rahway, NJ, USA will provide pembrolizumab for the dose escalation and expansion phases of LAVA’s ongoing Phase 1/2a study of LAVA-1207 (NCT05369000), with the combination arm expected to be initiated in the first half of 2024. Enrollment and dose escalation will also continue in the LAVA-1207 monotherapy and interleukin-2 arms of the study."

Licensing / partnership • Trial status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

LAVA-1207: “LAVA-1207 reached a dose of 120 mg (starting dose 1.5 mg) without the occurrence of high-grade (>2) CRS or DLTs in therapy refractory mCRPC patients”; Metastatic castration-resistant prostate cancer (Lava Therapeutics) - Corporate Presentation: “Preliminary signs of clinical activity observed with disease stabilization and PSA reduction during dose escalation”

P1/2 data • Oncology • Prostate Cancer

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

LAVA Therapeutics Provides Updates on Clinical Programs and Extends the Cash Runway (GlobeNewswire) - "LAVA Therapeutics N.V...announced its decision to rationalize its pipeline and prioritize its lead solid tumor program. The Company will continue to advance LAVA-1207, its Gammabody program designed to target the prostate-specific membrane antigen (PSMA) as well as earlier stage programs. The ongoing clinical trial of LAVA-051 targeting CD1d expressing hematological tumors, including multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and acute myeloid leukemia (AML) will be discontinued (NCT04887259)....The Company expects that the discontinuation of this LAVA-051 trial and its focus on the LAVA-1207 program will result in cost savings that will extend its cash runway further into 2026."

Financing • Trial termination • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology

LAVA Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2022 Financial Results (GlobeNewswire) - "Research and development expenses were $10.5 million and $6.6 million for the quarters ended December 31, 2022 and 2021, respectively, and $40.1 million and $36.9 million for the years ended December 31, 2022 and 2021, respectively. The higher quarterly and full-year expense was due to ongoing activities of the clinical trials for LAVA-051 and LAVA-1207, which were offset by a one-time license fee of $14.4 million triggered in the first quarter of 2021 by the IPO."

Commercial • Oncology

Early dose escalation of LAVA-1207, a novel bispecific gamma-delta T-cell engager (Gammabody), in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2023) - P1/2 | "LAVA-1207 has been well tolerated early in dose escalation; further clinical activity including PSA results, response assessment, and pharmacodynamic data will clarify determination of an optimal biological active dose. Clinical trial information: NCT05369000."

Clinical • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

LAVA-1207: Additional data from P1/2a trial (NCT05369000) for mCRPC in H2 2023 (Lava Therapeutics) - SVB Securities Global Biopharma Conference

P1/2 data • Oncology • Prostate Cancer • Solid Tumor

LAVA Therapeutics Announces Initial Data from the Ongoing Phase 1/2a Clinical Trial of LAVA-1207 in Therapy Refractory mCRPC at the 2023 ASCO GU Symposium (GlobeNewswire) - P1/2a | N=66 | NCT05369000 | Sponsor: Lava Therapeutics | "LAVA Therapeutics N.V...announced initial clinical data from its ongoing Phase 1/2a study of LAVA-1207 in patients with therapy refractory metastatic castration resistant prostate cancer (mCRPC)....The safety profile is favorable to date, without occurrence of high grade (>2) cytokine release syndrome or dose-limiting toxicities. LAVA-1207 showed predictable and linear pharmacokinetics and on-mechanism pharmacodynamics including Vγ9Vδ2-T cell activation. Preliminary signs of anti-tumor activity were observed at week 8, with iRECIST stable disease (iSD) in 8 out of 14 evaluable patients and PSA levels stabilizing or decreasing. The largest overall decrease in PSA was 61% (46% vs baseline)."

P1/2 data • PK/PD data • Genito-urinary Cancer • Oncology • Prostate Cancer

"Conferences #GU23 - 16-18 Feb $LVTX is presenting LAVA-1207 phase 1/2 data in mCRPC Roadshows Analyst roadshow: New York, Boston, San Francisco - 13-17 Feb (3/3)" (@KempenLS)

P1/2 data • Genito-urinary Cancer • Prostate Cancer

LAVA Therapeutics to Present LAVA-1207 Clinical Data at the 2023 ASCO GU Symposium (GlobeNewswire) - "LAVA Therapeutics N.V....announced that clinical data from a Phase 1/2a study in patients with therapy refractory metastatic castration resistant prostate cancer will be presented at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco from February 16-18, 2023."

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

Analyst Says This Small Cap Stock Might Be ’Game Changer’ In Bispecific T Cell Engagers Space (Yahoo Finance) - "The lead candidate, LAVA-051, is being evaluated in a Phase 1/2a study in multiple blood cancer settings; Initial Phase 1 data showed a favorable safety profile and early signs of clinical activity; Additional dose-escalation data is expected in 2H22, and initial Phase 2a data from the expansion cohorts in 1H23....LAVA is also evaluating LAVA-1207 in a Phase 1/2a study in metastatic castration-resistant prostate cancer (mCRPC) therapy, with initial data expected in 4Q22/1Q23; 'We believe Gammabody could be a game changer in the bispecific T cell engagers space. We currently project LAVA to generate risk-adjusted peak revenues of $391 million in 2032, growing from $4 million in 2026,' the analyst writes."

Commercial • P1 data • P1/2 data • P2a data • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Genito-urinary Cancer • Hematological Malignancies • Multiple Myeloma • Oncology • Prostate Cancer

LAVA Therapeutics Provides Business Update and Reports Second Quarter Financial Results (GlobeNewswire) - "Recent Pipeline and Business Highlights: (i) LAVA-051: Additional clinical data are expected in the fourth quarter of 2022; (ii) LAVA-1207: Initial Phase 1 data readout is expected in the fourth quarter of 2022; (iii) LAVA-1266, a CD123 Gammabody for the treatment of hematologic malignancies: A CTA and/or IND is planned for late 2023."

IND • P1 data • Genito-urinary Cancer • Hematological Malignancies • Oncology • Prostate Cancer • Solid Tumor

Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=66 | Recruiting | Sponsor: Lava Therapeutics

New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

LAVA Therapeutics Presents Initial LAVA-051 Clinical Data at the ESMO Targeted Anticancer Therapies Congress 2022 (GlobeNewswire) - P1/2a | N=55 | NCT04887259 | Sponsor: Lava Therapeutics | "LAVA Therapeutics N.V...announced initial data from its first clinical study with LAVA-051...The presentation will include data from the first three cohorts of the LAVA-051 Phase 1/2a clinical trial along with preclinical data on its two lead programs, LAVA-051 and LAVA-1207, that illustrate characteristics of its Gammabody™ platform...The first three dose-escalation cohorts showed LAVA-051 to be safe and well tolerated with no dose limiting toxicities or cytokine release syndrome (CRS) observed...Drug exposure and Vγ9Vδ2 T cell receptor occupancy of LAVA-051 increased with LAVA-051 dose increases and peripheral blood Vγ9Vδ2 T cells also expressed higher levels of activation markers after LAVA-051 dosing....Additional data from the dose escalation phase of the trial is expected in the second quarter of 2022 and from the disease-specific expansion cohorts in the second half of 2022."

P1/2 data • Preclinical • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology

LAVA Therapeutics Presents Initial LAVA-051 Clinical Data at the ESMO Targeted Anticancer Therapies Congress 2022 (GlobeNewswire) - "A Phase 1/2a clinical study to evaluate LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC) is enrolling with data from the Phase 1 dose escalation phase of the trial expected in the second half of 2022 and data from the Phase 2a expansion cohort expected in the first half of 2023."

Enrollment status • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

LAVA Therapeutics Announces Treatment of First Patient in Phase 1/2a Clinical Trial of LAVA-1207 for Metastatic Castration-Resistant Prostate Cancer (GlobeNewswire) - "LAVA Therapeutics N.V...announced dosing of the first patient in the company’s Phase 1/2a clinical trial of LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC). LAVA-1207 is a Gammabody™ that targets the prostate-specific membrane antigen (PSMA) and has demonstrated preclinical proof-of-concept driving antitumor responses in a variety of prostate cancer models...The Phase 1/2a clinical trial for LAVA-1207 was initiated in Europe and will subsequently expand to enroll patients in the United States."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer