UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
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Item 8.01 |
Other Events. |
On October 16, 2023, Ambrx Biopharma, Inc. ("Ambrx") announced that two abstracts detailing updated safety and efficacy data from the ongoing Phase 1 / 2 trial, APEX‑01 (NCT04662580), evaluating ARX517 for metastatic castration-resistant prostate cancer ("mCRPC") was made available as part of the 2023 European Society of Medical Oncology (ESMO) Congress 2023 meeting, taking place in Madrid, Spain, October 20‑24, 2023.
APEX‑01 opened for enrollment in July 2021, and is the only ongoing clinical trial in the United States targeting PSMA with an antibody-drug conjugate (ADC). APEX-01 is a first-in-human, open-label, dose escalation and dose expansion study enrolling patients with mCRPC whose tumors have progressed on at least two prior FDA-approved treatments, including at least one second-generation androgen receptor pathway inhibitor. The inclusion criteria included one of the following: PSA progression defined by a minimum of two rising PSA values, radiographic progression by RECIST v1.1 or disease progression by the presence of new bone lesions.
The two clinical abstracts submitted to ESMO regarding the APEX‑01 trial used a cutoff date of May 3, 2023. Ambrx will provide more mature data, including a significantly greater number of patients from the dose expansion portion of APEX‑01 in the ESMO posters and in its associated press release.
Highlights from abstract titled “First-in-human Phase 1 / 2 study of ARX517, an anti-prostate-specific membrane antigen (PSMA) antibody-drug conjugate (ADC), in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)”:
Highlights from abstract titled “ARX517, a next generation anti-PSMA antibody drug conjugate (ADC), demonstrates notable stability and pharmacokinetic (PK) profile in the ARX517 Phase 1 / 2 clinical trial (APEX-01)”:
Forward-Looking Statements
This Current Report on Form 8‑K 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: 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 Current Report on Form 8‑K filed with the SEC on October 12, 2023, 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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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AMBRX BIOPHARMA, INC. |
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(Registrant) |
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Date: October 16, 2023 |
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By: |
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/s/ Sonja Nelson |
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Sonja Nelson |
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Chief Financial Officer |
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