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Ambrx Biopharma Inc. (NASDAQ: AMAM) is a clinical-stage biopharmaceutical company pioneering the development of next-generation antibody drug conjugates (ADCs) and other engineered therapies aimed at modulating the immune system. Utilizing its proprietary expanded genetic code technology platform, Ambrx is at the forefront of creating innovative treatments for multiple cancer indications.
The company's flagship product, ARX517, is a prostate-specific membrane antigen (PSMA)-targeting ADC, specifically developed to treat metastatic castration-resistant prostate cancer (mCRPC). Recently, ARX517 received Fast Track designation from the U.S. Food and Drug Administration (FDA), underscoring its potential as a novel therapy for advanced prostate cancer. The ongoing Phase 1/2 study, APEX-01, has shown promising early efficacy signals with notable PSA reductions and minimal off-target toxicity.
Additionally, Ambrx's portfolio includes ARX788, targeting human epidermal growth factor receptor 2 (HER2) for metastatic breast cancer, and ARX305, targeting CD-70 for renal cell carcinoma. These programs highlight Ambrx's commitment to addressing high unmet medical needs in oncology.
In June 2023, Ambrx successfully closed a $75 million market-priced registered direct offering, bolstering its financial position to $237.4 million in cash, cash equivalents, and marketable debt securities as of May 31, 2023. This funding is primarily allocated to the research and development of its product candidates, working capital, and general corporate purposes.
Ambrx's technology platform, born out of The Scripps Research Institute, enables precise and stable conjugation of synthetic amino acids into proteins, creating homogenous ADCs with enhanced stability and specificity. This technology sets the stage for the development of safer and more effective cancer treatments. Collaborations with multiple partners further amplify the impact of Ambrx's innovations.
Looking ahead, Ambrx's strategic vision and robust pipeline position it as a key player in the biotech landscape. The company is poised to continue its trajectory of growth and innovation, offering hope and improved outcomes for patients with cancer.
Ambrx Biopharma (NASDAQ: AMAM) announced promising preclinical data at the 2023 AACR Annual Meeting. Key highlights include data on ARX517, an anti-PSMA ADC, which showed significant anti-tumor activity in enzalutamide-resistant and sensitive prostate cancer models. In a non-human primate study, ARX517 displayed high stability with a half-life of 11 to 15 days. In a separate study, ARX305 demonstrated strong anti-tumor effects in renal cell carcinoma models, exhibiting a terminal half-life of 16.5 days. The APEX-01 trial for ARX517, targeting advanced prostate cancer, is ongoing, with the latest cohort initiated at 2.9 mg/kg. Ambrx focuses on developing next-generation ADCs, aiming to improve treatment outcomes in various cancers.
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.
Ambrx Biopharma Inc. (NYSE: AMAM) completed net sales of approximately
Ambrx Biopharma Inc. (NYSE: AMAM) announced its voluntary transfer from the New York Stock Exchange to the Nasdaq Stock Market, effective March 16, 2023, after market close. Trading on Nasdaq will begin on March 17, 2023, with the ticker symbol remaining AMAM. CEO Daniel J. O'Connor emphasized that this move is a significant milestone in the company's growth, aimed at enhancing visibility and shareholder value. Ambrx specializes in developing antibody-drug conjugates and other therapies targeting cancer, supported by its proprietary technology.
Ambrx Biopharma Inc. (NYSE: AMAM) announced that its partner, NovoCodex Biopharmaceuticals, completed an interim analysis of the pivotal Phase 3 ACE-Breast-02 trial for ARX788, an anti-HER2 antibody drug conjugate. The study met its pre-specified primary efficacy endpoint, demonstrating significant progression-free survival (PFS) benefits compared to the control treatment. The trial involved 441 HER2 positive breast cancer patients in China. Based on these favorable interim results, NovoCodex plans to submit a marketing approval application to the National Medical Products Administration (NMPA) in China.
Ambrx Biopharma Inc. (NYSE: AMAM) has reported promising initial results from its Phase 1 APEX-01 trial of ARX517, an anti-PSMA antibody-drug conjugate targeting advanced prostate cancer. In Cohort 6, 3 patients at the 2.0 mg/kg dose level showed a >50% reduction in prostate-specific antigen (PSA) levels, with 2 patients demonstrating a >90% decrease. No severe drug-related adverse events were noted. This trial marks a significant step in addressing the high unmet medical need for effective treatments in metastatic prostate cancer, with further data expected on February 24, 2023, during an Analyst and Investor Day.
Ambrx Biopharma Inc. (NYSE: AMAM) will host a virtual Analyst and Investor Day on February 24, 2023, from 12:00 PM to 1:00 PM ET. This event will feature key oncology experts, including Hope S. Rugo and Paula R. Pohlmann, discussing Ambrx's innovative treatments ARX788 and ARX517. Dr. Rugo will highlight ARX788's role in treating HER2-positive metastatic breast cancer, while Dr. Pohlmann will discuss its evaluation in the I-SPY 2.2 trial. A data update on the APEX-01 study for ARX517 in prostate cancer patients will also be provided. Registration is required for attendance, and the event will be available for replay on Ambrx's website.
Ambrx Biopharma, Inc. (NYSE: AMAM) appointed Dr. Sandra Aung as Executive Vice President and Head of Clinical Development, overseeing clinical trials for its antibody-drug conjugates (ADCs). Dr. Aung brings over 20 years of experience in oncology, having led successful projects at Nektar Therapeutics and published extensively in the field. This strategic move comes as Ambrx aims to enhance its ADC technology's efficacy and safety across various trials. The company focuses on developing next-generation ADCs targeting cancer indications, including ARX517 and ARX788, which could have significant market potential.
Ambrx Biopharma Inc. (NYSE: AMAM) announced on November 23, 2022, that it received a notice from the NYSE regarding non-compliance with listing standards due to its American Depositary Shares (ADS) trading below $1.00 for 30 consecutive days. Ambrx has six months to regain compliance by achieving an average closing price above this threshold. As of the press release date, ADSs have closed above the minimum price. The company plans to implement strategies to increase ADS value to maintain its NYSE listing.
Ambrx Biopharma Inc. (NYSE: AMAM) shared preliminary safety and efficacy results from its Phase 2 ACE-Breast-03 study at the 2022 San Antonio Breast Cancer Symposium. The study focused on ARX788, an anti-HER2 antibody drug conjugate, showing a 57.1% confirmed overall response rate (ORR) and a 100% disease control rate (DCR) in heavily pre-treated patients with HER2 positive metastatic breast cancer. No severe adverse events were reported, confirming the treatment was well tolerated. The ongoing trial demonstrates strong potential for ARX788 in addressing drug resistance in this population.
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