Ambrx to Present Preclinical Data on ARX517 and ARX305 at the 2023 AACR Annual Meeting

Rhea-AI Summary

Ambrx Biopharma Inc. (NASDAQ: AMAM) announced three poster presentations at the AACR Annual Meeting 2023 in Orlando, featuring preclinical data on ARX517 and ARX305, along with ongoing clinical trial details for APEX-01, a Phase 1 trial for advanced prostate cancer. ARX517, the only anti-PSMA ADC in active clinical development, aims to treat patients whose tumors have progressed after prior FDA-approved therapies. The conference runs from April 14-19, 2023, and Ambrx's abstracts will be available on its website.

Positive

• Presentation of preclinical data for ARX517 and ARX305 at a major oncology conference.
• ARX517 is the only anti-PSMA ADC in active clinical development.
• Ongoing Phase 1 clinical trial (APEX-01) targeting advanced prostate cancer.

Negative

• None.

Three posters will be presented at AACR and include data from preclinical studies of ARX517 and ARX305 and Trial in Progress Poster on APEX-01

SAN DIEGO, March 27, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., or Ambrx (NASDAQ: AMAM), announced the presentation of three posters featuring preclinical data at the upcoming 2023 American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida, from April 14 to 19, 2023. The two preclinical posters will provide data from Ambrx’s preclinical studies of ARX517 (anti-PSMA ADC) and ARX305 (anti-CD70 ADC). Further, a clinical trial in progress poster will be presented from APEX-01 (NCT04662580), the Company’s Phase 1, first-in-human, open label dose escalation and dose expansion trial of ARX517 enrolling patients with advanced prostate cancer whose tumors have progressed on at least two prior FDA-approved treatments. ARX517 is the only anti-PSMA ADC in active clinical development.

Ambrx’s abstracts are posted on the AACR Annual Meeting website. The posters will be posted on the Ambrx website during the conference.

Presentation details:

Poster Title: ARX517, a Next-Generation anti-PSMA Antibody Drug Conjugate for the Treatment of Metastatic Castration-Resistant Prostate Cancer, Demonstrates Anti-Tumor Activity in Enzalutamide-Resistant and Enzalutamide-Sensitive Models and a Clear Therapeutic Index in a Non-Human Primate Model

Session Date and Time: Tuesday Apr 18, 2023, 9:00 AM - 12:30 PM
Session Category: Experimental and Molecular Therapeutics
Session Title: Oncogenes and Tumor Suppressor Genes as Targets for Therapy 3
Location: Poster Section 19
Poster Board Number: 20
Published Abstract Number: 3997

Poster title: ARX517, an anti-PSMA ADC targeting mCRPC resistant or refractory to standard therapies: A phase 1 dose escalation and dose expansion study (APEX-01 NCT04662580)
Session Date and Time: Monday Apr 17, 2023, 1:30 PM - 5:00 PM
Session Title: Phase I Clinical Trials in Progress
Location: Poster Section 46
Poster Board Number: 9
Abstract Presentation Number: CT121

Poster Title: Preclinical characterization of ARX305, a next-generation anti-CD70 antibody drug conjugate for the treatment of CD70-expressing cancers
Session Date and Time: Wednesday Apr 19, 2023, 9:00 AM - 12:30 PM
Session Category: Experimental and Molecular Therapeutics
Session Title: Growth Factor Receptors as Therapeutic Targets
Location: Poster Section 21
Poster Board Number: 25
Published Abstract Number: 6318

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 www.ambrx.com. 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, and include, without limitation, express or implied statements regarding Ambrx’s preliminary estimates of cash, cash equivalents and marketable debt securities, available-for-sale, as of December 31, 2022, Ambrx’s estimated cash runway and Ambrx’s clinical trial and product candidate plans and strategy. 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 Annual Report on Form 20-F filed with the SEC on April 26, 2022, and elsewhere in Ambrx’s filings and reports with the SEC. 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
mmoyer@lifesciadvisors.com

MEDIA
Mike Tattory
Account Supervisor
LifeSci Communications
media@ambrx.com

Source: Ambrx Biopharma Inc.

FAQ

What will be presented at AACR 2023 regarding AMAM?

Ambrx will present three posters on preclinical data for ARX517 and ARX305, and a clinical trial in progress poster for APEX-01.

What is the purpose of the APEX-01 trial?

The APEX-01 trial is a Phase 1 study evaluating ARX517 in patients with advanced prostate cancer whose tumors have progressed after prior treatments.

When are the presentations scheduled during AACR 2023?

Presentations will occur between April 17 and April 19, 2023, at various times throughout the conference.

What is ARX517 targeting?

ARX517 targets the prostate-specific membrane antigen (PSMA) in advanced prostate cancer.

How is Ambrx advancing its drug development?

Ambrx is utilizing an expanded genetic code technology platform to develop next-generation antibody-drug conjugates and other therapies.