About Us | ScientistLVTX LAVA Therapeutics N.V.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
LAVA-051
Chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML)
|
Phase 1/2
Phase 1/2
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
LAVA-206x207
Castration-resistant prostate cancer
|
Phase 1
Phase 1
|
Phase 1/2 trial to commence 2H 2021.
|
Latest News
-
LAVA Therapeutics Announces Appointment of Amy Garabedian as General Counsel and Corporate SecretaryView Full Article Hide Full Article
UTRECHT, The Netherlands and PHILADELPHIA, July 27, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a clinical-stage biotechnology company focused on developing bispecific gamma-delta T cell engagers to transform the treatment of cancer, today announced the appointment of Amy Garabedian as general counsel and corporate secretary. Ms. Garabedian is a seasoned leader with extensive corporate and transactional expertise within the life science industry.
"We are very pleased to welcome Amy to our executive team. Amy's proven experience across a wide range of complex strategic legal and corporate matters in life sciences will be invaluable as our differentiated pipeline of bispecific gamma-delta T cell engagers for both solid and hematological malignancies further advances into the clinic," said Stephen Hurly, president and chief executive officer of LAVA Therapeutics.
Ms. Garabedian stated, "I have spent my career combining my passion for science and law to create innovative business solutions to help improve the lives of patients. LAVA is well-positioned to be a leader in developing selective and transformative cancer treatments and I look forward to helping shape our evolving business, science, development programs and efforts to bring bispecific gamma-delta T cell engagers to patients during this important stage of significant growth and opportunity."
Amy Garabedian has over 15-years of experience advising pharmaceutical and biotechnology companies from early-stage start-ups to multi-national public companies. Most recently, Ms. Garabedian served as associate general counsel of Spark Therapeutics (Roche) where she helped drive the successful U.S. launch of the first gene therapy and led key business development transactions enabling pre-clinical, clinical and commercial product development. She holds a B.S. in genetics and developmental biology from Penn State University, a M.S. in regulatory affairs from Temple University and a J.D. from Widener University Delaware School of Law.
About LAVA
LAVA Therapeutics N.V. is a clinical-stage biotechnology company developing a portfolio of bispecific gamma-delta T cell engagers for the treatment of solid and hematological malignancies. The company's innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells via the triggering of Vγ9Vδ2 T cell antitumor effector functions upon cross-linking to tumor associated antigens. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematological malignancies is enrolling patients. The Company currently estimates to have data from the Phase 1 dose escalation phase of the study in the first half of 2022 with top line clinical data from the Phase 2a expansion cohorts expected in the second half of 2022. The Company plans to initiate a Phase 1/2a clinical study to evaluate LAVA-1207 in patients with prostate cancer in the second half of 2021. For more information, please visit www.lavatherapeutics.com.LAVA's Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including in respect of the company's anticipated growth and clinical developments plans, including the timing of clinical trials. Words such as "anticipate," "believe," "could," "expect," "should," "plan," "intend," "estimate," "potential" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on LAVA's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for LAVA's product candidates, and the potential use of our product candidates to treat various tumor targets. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical trials, changes in expected or existing competition, changes in the regulatory environment, failure of LAVA's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, among others. In addition, the COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity. LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.Investor Contact:
Corey Davis, Ph.D.
LifeSci Advisors
[email protected]
212-915-2577
-
View Full Article Hide Full Article
UTRECHT, The Netherlands and PHILADELPHIA, July 13, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on developing bispecific gamma-delta T cell engagers (bsTCEs) to transform the treatment of cancer, today announced dosing of the first patient in the company's Phase 1/2a clinical trial of LAVA-051 in patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML). LAVA-051, LAVA's lead product candidate, is a humanized bsTCE engineered to selectively target CD1d-expressing hematological cancers through activation of both gamma-delta T cells and type 1 natural killer T (NKT) cells.
"The dosing of the first patient with LAVA-051 is an important step towards harnessing the therapeutic potential of the Vγ9Vδ2 subset of gamma-delta T cells in the clinic," said Benjamin Winograd, M.D., Ph.D., chief medical officer of LAVA. "Our preclinical data demonstrate that LAVA-051 targets CD1d-expressing tumors by activating both Vγ9Vδ2 T cells and type 1 NKT cells, leading to robust antitumor activity. These data make us confident that our dual-targeting approach may lead to important new treatment options for CD1d expressing hematological malignancies like CLL, MM and AML, which are devastating, difficult to treat cancers, for which novel treatments are needed."
The open-label, multi-center, Phase 1/2a clinical trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-051. The Phase 1 dose-escalation portion will determine an optimal Phase 2 dose of LAVA-051. Once a recommended Phase 2 dose has been established, the trial will expand into the Phase 2a portion, which will enroll patients in three disease specific cohorts for relapsed and/or refractory CLL, MM and AML, to confirm safety and evaluate preliminary antitumor activity in each disease cohort.
The Phase 1/2a clinical trial for LAVA-051 will initially be conducted in Europe, where the Company has already received regulatory approval for its Clinical Trial Application (CTA). LAVA expects to file an Investigational New Drug application (IND) with the U.S. Food and Drug Administration, which if accepted, will subsequently expand the trial to include patients in the United States.
Stephen Hurly, president and chief executive officer of LAVA, added, "This important milestone marks LAVA's transition to a clinical stage company. LAVA-051, the most advanced product candidate from our off-the-shelf antibody platform, is designed to utilize bi-specifics to unlock the full anti-cancer potential of a patient's own gamma-delta T cells. We believe our approach overcomes the limitations of first-generation T cell engagers, reducing the risk of off-target toxicity, regulatory T-cell activation and cytokine release syndrome, while also amplifying efficacy through innate and adaptive immune responses. Adding to our momentum in the clinic, our second clinical program, LAVA-1207 in metastatic prostate cancer, is expected to enter the clinic before year end. We look forward to generating important clinical data to support our approach in both hematological malignancies and solid tumors."
About LAVA-051
LAVA-051 is a humanized gamma-delta bsTCE that activates both Vγ9Vδ2 T cells and type 1 NKT cells to kill tumor cells while leveraging their natural ability to distinguish tumor from healthy cells. LAVA-051 consists of two VHH domain antibodies linked via a short, five amino acid glycine-serine linker. One domain recognizes the Vd2 chain of the Vγ9Vδ2 T cell receptor and the other domain is specific for CD1d, a glycoprotein involved in the presentation of lipid antigens to distinct T cell populations including type 1 NKT cells, that are expressed on a wide range of hematological malignancies, including CLL, MM and AML. CD1d is also be expressed by several solid tumors, including prostate, cervical, breast, renal cell and colorectal cancers.About LAVA
LAVA Therapeutics N.V. is a clinical stage biotechnology company developing a portfolio of bispecific gamma-delta T cell engagers (gamma-delta bsTCEs) for the treatment of solid tumors and hematological malignancies. The company's innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells via the triggering of Vγ9Vδ2 T cell antitumor effector functions upon cross-linking to tumor associated antigens. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematological malignancies is enrolling patients. The Company currently estimates to have data from the Phase 1 dose escalation phase of the study in the first half of 2022 with top line clinical data from the Phase 2a expansion cohorts expected in the second half of 2022. The Company plans to initiate a Phase 1/2a clinical study to evaluate LAVA-1207 in patients with prostate cancer in the second half of 2021. For more information, please visit www.lavatherapeutics.com.LAVA's Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including in respect of the company's anticipated growth and clinical developments plans, including the timing of clinical trials. Words such as "anticipate," "believe," "could," "expect," "should," "plan," "intend," "estimate," "potential" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on LAVA's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for LAVA's product candidates, and the potential use of our product candidates to treat various tumor targets. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical trials, changes in expected or existing competition, changes in the regulatory environment, failure of LAVA's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, among others. In addition, the COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity. LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.Investor Contact:
Corey Davis, Ph.D.
LifeSci Advisors
[email protected]
212-915-2577 -
View Full Article Hide Full Article
UTRECHT, The Netherlands and PHILADELPHIA, May 25, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on applying its expertise in bispecific gamma-delta T cell engagers to transform cancer therapy, today announced that Stephen Hurly, chief executive officer, will present at the 2021 Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 11:30 a.m. ET.
The presentation will be webcast and can be accessed from the investor relations section of the company's website at www.lavatherapeutics.com.
About LAVA
LAVA Therapeutics N.V. is a clinical stage biotechnology company developing a portfolio of bispecific gamma-delta T cell engagers (gamma-delta bsTCEs) for the treatment of solid tumors and hematological malignancies based on its proprietary platform. The company's innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells and induce gamma-delta T cell-mediated immunity through activation of Vγ9Vδ2 T cells upon cross-linking to tumor associated antigens. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematologic malignancies is anticipated to generate top line clinical data in the first half of 2022. The Company expects to initiate a Phase 1/2a clinical study to evaluate LAVA-1207 in patients with prostate cancer in the second half of 2021. For more information, please visit www.lavatherapeutics.com.
Contact
Chelcie Lister
THRUST Strategic Communications
[email protected] -
View Full Article Hide Full Article
IPO bolsters balance sheet to $160 million in cash and cash equivalents; expected to fund operations at least into the second half of 2023
Clinical development plans on schedule in both hematological and solid tumor programs
Leadership strengthened through key management and board appointments
UTRECHT, The Netherlands and PHILADELPHIA, May 20, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on applying its expertise in gamma-delta bispecific T cell engagers (bsTCEs) to transform cancer therapy, today reported its business update and first quarter 2021 financial results.
"We continue to make important strides across all aspects of our business as we transition to a clinical stage organization," said Stephen Hurly, chief executive officer of LAVA Therapeutics. "With the recent additions to our leadership team and board and the proceeds from our IPO, we are well-positioned to advance our pipeline as we work toward our mission of transforming cancer therapy for patients."
Recent Business and Pipeline Highlights
Phase 1/2a Clinical Trial of LAVA-051 for Multiple Hematological Malignancies on Track: LAVA is on track to initiate its open-label, multi-center, Phase 1/2a clinical trial of LAVA-051 for the treatment of relapsed and/or refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML) in the first half of 2021. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-051.
Preclinical Data Supporting Anti-Tumor Activity of LAVA-051 Presented at AACR Virtual 2021 Annual Meeting: In April 2021, LAVA presented preclinical data on LAVA-051 at the virtual American Association for Cancer Research (AACR) Annual Meeting. The data demonstrated that LAVA-051 exerted substantial antitumor activity against patient derived CLL, MM and AML cells that express CD1d. In addition, improved survival was observed in in vivo AML and MM mouse xenograft models treated with LAVA-051.
Successful Initial Public Offering Completed: In March 2021, LAVA priced its initial public offering (IPO) at $15.00 per share. In connection with the offering, the Company issued 7,125,712 common shares resulting in gross proceeds, before deducting underwriting discounts and commissions and offering expenses payable by LAVA, of approximately $107 million.
Leadership Team Strengthened by Appointment of Edward Smith as Chief Financial Officer: In March 2021, LAVA further strengthened its management team with the appointment of Edward F. Smith as its chief financial officer. Ed has more than 20 years of executive finance and operational leadership experience in publicly traded biotechnology companies from early stage through commercialization. Ed most recently served as chief financial officer of Marinus Pharmaceuticals and is currently a member of the board of directors of Benitec Biopharma, Inc.
Industry Veterans Appointed to Board of Directors:
- In February 2021, LAVA appointed Dr. Kapil Dhingra as chairman of the board of directors. Kapil is a medical oncologist and physician-scientist and brings more than 30 years of experience in oncology clinical research and drug development within the biotechnology and pharmaceutical industries. Most recently, he served as vice president, head of the oncology disease biology leadership team and head of oncology clinical development at Hoffmann-La Roche, during which he led numerous drug approvals, including Herceptin®, Tarceva® and Avastin®. In addition to LAVA, he is currently a member of the boards of directors of Black Diamond Therapeutics, Inc., Replimune, Inc., Five Prime Therapeutics, Inc., Autolus Therapeutics plc, and Median Technologies.
- In April 2021, LAVA appointed biopharmaceutical finance executive, Karen Wilson, to its board of directors and as chair of its Audit Committee. Karen brings more than 30 years of finance and leadership experience in the life sciences industry, most recently serving as senior vice president of finance at Jazz Pharmaceuticals plc. In addition to LAVA, she currently serves on the board of directors of Angion Biomedica, Connect Biopharma and Vaxart, Inc.
First Quarter Financial Results
- Cash and cash equivalents were €134.7 million as of March 31, 2021, compared to €12.9 million as of December 31, 2020. The increase in cash and cash equivalents was attributable to proceeds from the Series C financing and subsequent IPO during the first quarter of 2021, partially offset by operating expenses.
- Research and license revenue increased to €0.9 million for the three months ended March 31, 2021 compared to no such revenue for the three months ended March 31, 2020. Research and license revenue is solely attributable to the company's collaboration with Janssen Biotech, Inc., which was entered into in May 2020.
- Research and development expenses were €15.7 million for the three months ended March 31, 2021, an increase of €12.8 million, compared to €2.9 million for the three months ended March 31, 2020. The increase was primarily due to license fees of €12.1 million triggered by the IPO, most of which will be paid on the first and second anniversaries of the IPO and may be paid in either cash or common stock of the Company. In addition, personnel-related costs increased €0.5 million due to increased headcount.
- General and administrative expenses were €1.4 million for the three months ended March 31, 2021, an increase of €0.7 million, compared to general administrative expenses of €0.7 million for the three months ended March 31, 2020. The increase is primarily due to the increase in personnel-related costs of €0.3 million and the non-cash share-based compensation expense of €0.3 million due to the increase in headcount.
- Net loss was €16.6 million, or €10.19 per share, for the first quarter of 2021, compared to €3.7 million, or €8.22 per share, for the first quarter of 2020.
About LAVA
LAVA Therapeutics N.V. is a clinical stage biotechnology company developing a portfolio of bispecific gamma-delta T cell engagers (gamma-delta bsTCEs) for the treatment of solid tumors and hematological malignancies based on its proprietary platform. The company's innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells and induce gamma-delta T cell-mediated immunity through activation of Vγ9Vδ2 T cells upon cross-linking to tumor associated antigens. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematologic malignancies is anticipated to generate top line clinical data in the first half of 2022. The Company expects to initiate a Phase 1/2a clinical study to evaluate LAVA-1207 in patients with prostate cancer in the second half of 2021. For more information, please visit www.lavatherapeutics.com.
LAVA's Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including in respect of the company's anticipated growth and clinical developments plans, including the timing of enrollment in and progress of clinical trials and reporting of results thereof. Words such as "anticipate," "believe," "could," "expect," "should," "plan," "intend," "estimate," "potential" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on LAVA's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for LAVA's product candidates, and the potential use of our product candidates to treat various tumor targets. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical trials, changes in expected or existing competition, changes in the regulatory environment, failure of LAVA's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, among others. In addition, the COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity. LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Unaudited Condensed Consolidated Interim Statements of Profit or Loss
EUR (000's)Three Months Ended March 31, Notes 2021 2020 Research and license revenue € 921 € - Operating expenses: Research and development (15,739 ) (2,935 ) General and administrative (1,415 ) (682 ) Total operating expenses (17,154 ) (3,617 ) Operating loss (16,233 ) (3,617 ) Total non-operating expenses (320 ) (58 ) Loss before income tax (16,553 ) (3,675 ) Income tax benefit (expense) (21 ) (3 ) Loss for the period € (16,574 ) € (3,678 ) Loss per share, in Euros Loss per share, basic and diluted € (10.19 ) € (8.22 ) Weighted average common shares outstanding, basic and diluted 1,626,598 447,525 Condensed Consolidated Interim Statements of Financial Position
EUR (000's)March 31, December 31, Notes 2021 2020 (unaudited) Assets Non-current assets € 1,875 € 1,843 Other current assets 1,013 1,959 Cash and cash equivalents 134,745 12,881 Total assets € 137,633 € 16,683 Equity and Liabilities Total Equity € 113,471 € 6,207 Deferred revenue 4,109 5,030 Lease liabilities 384 389 License liabilities 12,073 - Borrowings 3,010 2,935 Trade payables and other 1,464 760 Accrued expenses and other current liabilities 3,122 1,362 Total liabilities 24,162 10,476 Total equity and liabilities € 137,633 € 16,683 Contact
Investors:
Chelcie Lister
THRUST Strategic Communications
[email protected] -
View Full Article Hide Full Article
UTRECHT, The Netherlands and PHILADELPHIA, May 18, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on applying its expertise in bispecific gamma-delta T cell engagers to transform cancer therapy, today announced that Stephen Hurly, chief executive officer, will present at the 2021 UBS Global Healthcare Virtual Conference on Wednesday, May 26, 2021 at 1:00 p.m. ET.
The presentation will be webcast and can be accessed from the investor relations section of the company's website at www.lavatherapeutics.com.
About LAVA
LAVA Therapeutics N.V. is a clinical stage biotechnology company developing a portfolio of bispecific gamma-delta T cell engagers (gamma-delta bsTCEs) for the treatment of solid tumors and hematological malignancies based on its proprietary platform. The company's innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells and induce gamma-delta T cell-mediated immunity through activation of Vγ9Vδ2 T cells upon cross-linking to tumor associated antigens. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematologic malignancies is anticipated to generate top line clinical data in the first half of 2022. The Company expects to initiate a Phase 1/2a clinical study to evaluate LAVA-1207 in patients with prostate cancer in the second half of 2021. For more information, please visit www.lavatherapeutics.com.
Contact
Chelcie Lister
THRUST Strategic Communications
[email protected]