AMAM AMBRX BIOPHARMA INC

Ambrx Appoints Renu Vaish, M.Sc., as Chief Regulatory Officer to Lead Regulatory Affairs

Ambrx Appoints Renu Vaish, M.Sc., as Chief Regulatory Officer to Lead Regulatory Affairs

SAN DIEGO, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc. (“Ambrx” or the “Company”) (NASDAQ: AMAM), today announced the appointment of Renu Vaish, M.Sc., as Chief Regulatory Officer. Ms. Vaish will be responsible for overseeing and designing the Company’s global regulatory strategy and will report to the Company’s President and Chief Executive Officer, Daniel J. O’Connor.

Ms. Vaish is an experienced leader in U.S. and global regulatory affairs with extensive experience in oncology drug development ranging from pre-clinical to commercial products in many fields, including prostate and breast cancer. She has held senior regulatory leadership positions at Celgene, Merck and Kite Pharma, as well as other biopharma companies. Most recently, she served as the Senior Vice President, Regulatory Affairs at SpringWorks Therapeutics.

Ms. Vaish brings a strong business acumen and technical ability that will be used to leverage strategic thinking into innovative regulatory solutions at Ambrx. She has a demonstrated ability to adapt quickly in challenging and dynamic environments while leading through periods of organizational growth. Her successful track record of achieving results in a variety of diverse, global regulatory and quality settings will be a significant asset to Ambrx.

Ms. Vaish has a Master of Science in Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and Health Sciences and a Bachelor of Science in Cell and Molecular Biology, from Concordia University.

“Renu’s extensive regulatory background and her experience in designing global regulatory strategy for multiple biopharma companies will be an important asset to Ambrx as we progress our core ADC product candidates, ARX788 and ARX517, through the clinical trial process,” said Mr. O’Connor.

Renu Vaish, M.Sc., added: “I am excited and honored to be joining Ambrx at this time and very much look forward to working with my colleagues on the continued development of potentially transformative medicines for patients.”

In connection with her appointment, Renu Vaish received a one-time inducement award of 2,600,000 ordinary share options, or the equivalent of 371,428 American Depository Shares, which vest over three years. The Company approved the award as an inducement material to Ms. Vaish entering into employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).

About Ambrx Biopharma Inc.

Ambrx is a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop next generation antibody drug conjugates (ADCs) and other engineered therapies to modulate the immune system. Ambrx is advancing a focused portfolio of clinical and preclinical programs designed to optimize efficacy and safety in multiple cancer indications, including ARX517, its proprietary antibody-drug conjugate (ADC) targeting the prostate-specific membrane antigen (PSMA) and ARX788, its proprietary ADC targeting HER2. In addition, Ambrx has preclinical and clinical collaborations with multiple partners on drug candidates generated using Ambrx technology. Ambrx spun out of The Scripps Research Institute in 2003 and has several other product candidates involving ADCs and other aspects of Ambrx’s protein engineering technology. For more information, please visit Ambrx routinely posts information that may be important to investors on its website.

Forward-Looking Statements

This press release includes certain “forward-looking statements” intended to qualify for the “safe harbor” from liability established by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements may be identified by the words “intend,” “plan,” and similar expressions. Forward-looking statements are based on Ambrx’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, those risks and uncertainties associated with: the continuing impact of the COVID-19 pandemic and other public health-related risks and events on Ambrx’s business, operations, strategy, goals and anticipated milestones; Ambrx’s ability to execute on its strategy including with respect to the timing of its R&D efforts, initiation of clinical trials and other anticipated milestones; risks associated with development and marketing approval of novel therapeutics, including potential delays in clinical trials and regulatory submissions and the fact that future clinical trial results/data may not be consistent with interim, initial or preliminary results/data or results/data from prior preclinical studies or clinical trials; Ambrx’s ability to fund operations as anticipated; and the additional risks and uncertainties set forth more fully under the caption “Risk Factors” in Ambrx’s Quarterly Report on Form 10-Q filed with the SEC on May 11, 2023, and elsewhere in Ambrx’s filings and reports with the SEC, including the prospectus supplement to be filed in connection with the Offering. Forward-looking statements contained in this press release are made as of this date, and Ambrx undertakes no duty to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law.

Contacts

INVESTORS

Mike Moyer

LifeSci Advisors

617-308-4306

 

MEDIA

Mike Tattory

Account Supervisor

LifeSci Communications

 

Source: Ambrx Biopharma Inc.



EN
01/08/2023

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on AMBRX BIOPHARMA INC

 PRESS RELEASE

Ambrx Shareholders Approve Acquisition by Johnson & Johnson

Ambrx Shareholders Approve Acquisition by Johnson & Johnson SAN DIEGO, March 06, 2024 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., (“Ambrx” or the “Company”) (NASDAQ: AMAM), today announced that its shareholders approved a proposal to adopt the merger agreement entered into between the Company and Johnson & Johnson at its Special Meeting of Shareholders. As previously announced, under the terms of the transaction, Ambrx shareholders will receive $28.00 per share in cash in connection with the closing of the transaction. Daniel J. O’Connor, Chief Executive Officer of Ambrx, said, “We want t...

 PRESS RELEASE

Ambrx Announces Sale to Johnson & Johnson

Ambrx Announces Sale to Johnson & Johnson SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., or Ambrx (NASDAQ: AMAM), today announced that it has entered into a definitive agreement pursuant to which Johnson & Johnson will acquire all of the outstanding shares of Ambrx for $28.00 per share in cash, representing an approximately 105% premium to Ambrx’s closing stock price on January 5, 2024, for a total equity value of approximately $2.0 billion. “We are excited to reach this agreement with Johnson & Johnson for advancing scientific research to treat cancers with high unm...

 PRESS RELEASE

Ambrx to be Added to the NASDAQ Biotechnology Index (NBI)

Ambrx to be Added to the NASDAQ Biotechnology Index (NBI) SAN DIEGO, Dec. 14, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., or Ambrx, (NASDAQ: AMAM), today announced that the Company will be added to the NASDAQ Biotechnology Index (NASDAQ: NBI), effective prior to the market open on Monday, December 18, 2023. “2023 has been a transformational year for Ambrx, especially for our publicly held securities. We voluntarily transferred to Nasdaq from the New York Stock Exchange, we changed our parent company domicile to Delaware from the Cayman Islands and we terminated our ADS program, resul...

 PRESS RELEASE

Ambrx Provides Update On APEX-01, an On-Going Phase 1 / 2 Dose Escalat...

Ambrx Provides Update On APEX-01, an On-Going Phase 1 / 2 Dose Escalation Study Evaluating ARX517, a Proprietary PSMA-Targeting ADC, in Metastatic Castration-Resistant Prostate Cancer Cohort 9 Following completion of the 21-day observation period at 3.4 mg/kg (Cohort 9), no dose limiting toxicities (DLTs) or serious adverse events (SAEs) were observed Two patients in Cohort 9 experienced rapid PSA reduction at three weeks post-treatment following the first ARX517 dose Cohort 8 The cohort (2.88 mg/kg) is now fully enrolled with 20 patients Recommended phase 2 dose expected by early nex...

 PRESS RELEASE

Ambrx Announces ARX517, a PSMA-Targeted ADC, Demonstrates a Promising ...

Ambrx Announces ARX517, a PSMA-Targeted ADC, Demonstrates a Promising 52% PSA50 (≥50% Reduction) and a Highly Differentiated Safety and PK Profile in Patients with mCRPC, who Progressed on Multiple FDA-Approved Treatments Newly published data from the Phase 1 portion of the on-goingPhase 1 / 2 APEX-01 trial provide the following key points: Multiple efficacy endpoints demonstrate consistent and promising anti-cancer activity at therapeutic doses of 2.0 – 2.88 mg/kg (Cohorts 6-8) in heavily pretreated patients (median of 4 and maximum of 13 prior lines of therapy): 52% (12/23) of patient...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch