Interim Data from Ambrx's Study of ARX788 selected for Spotlight Poster Discussion at the 2022 San Antonio Breast Cancer Symposium

Interim Data from Ambrx's Study of ARX788 selected for Spotlight Poster Discussion at the 2022 San Antonio Breast Cancer Symposium

ARX788 is an anti-HER2 antibody drug conjugate currently being studied in several registrational trials in breast cancer and gastric/GEJ cancer by Ambrx's partner, NovoCodex Biopharmaceuticals, in China. Pursuant to its recently announced strategic reprioritization, Ambrx has paused the internal development of ARX788 and is seeking to partner ARX788 outside of China.

Details for the Spotlight Poster Discussion poster presentation are shown below:

Date: Friday December 9, 2022
Time: 7:00 AM - 8:15 AM
Title: ACE-Breast-03: Efficacy and safety of ARX788 in patients with HER2+ metastatic breast cancer previously treated with T-DM1
Poster Number: PD18-09
Presenter: Sarah Hurvitz, M.D.

About Ambrx Biopharma Inc. (Ambrx)
Ambrx is a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop Engineered Precision Biologics. These include 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 its lead product candidate ARX517, a prostate-specific membrane antigen (PSMA) targeting ADC. In addition, Ambrx has clinical collaborations with multiple partners on drug candidates generated using Ambrx technology. For more information, please visit www.ambrx.com .

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 "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "may," "will," "could," "should," "seek," "potential" and similar expressions, and include, without limitation, express or implied statements regarding Ambrx's beliefs and expectations regarding the advancement and potential benefits of its product candidates, clinical development and strategic plans, the timing of program updates and milestones related to its product candidates. 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 of novel therapeutics, including potential delays in clinical trials and regulatory submissions and the fact that future clinical trial results may not be consistent with preliminary results or results 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 United States Securities and Exchange Commission (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
mtattory@lifescicomms.com

Source: Ambrx


Primary Logo

News Provided by GlobeNewswire via QuoteMedia

AMAM
The Conversation (0)
Ambrx Biopharma Inc. Announces Receipt of NYSE Non-Compliance Letter Regarding ADS Trading Price

Ambrx Biopharma Inc. Announces Receipt of NYSE Non-Compliance Letter Regarding ADS Trading Price

Ambrx Biopharma Inc. (Ambrx) (NYSE: AMAM), a clinical stage biopharmaceutical company using its proprietary Engineered Precision Biologics platform to create antibody drug conjugates, announced today that it received a notice (the Notice) on November 23, 2022 from the New York Stock Exchange (NYSE) that it was not in compliance with the NYSE's continued listing standards because the average closing price of Ambrx's American Depositary Shares (ADS), each representing seven ordinary shares, had fallen below $1.00 per ADS (Minimum Stock Price) over a period of 30 consecutive trading days, which is the minimum average closing price per ADS required to maintain continued listing on the NYSE.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Ambrx Announces Encouraging Preliminary Safety and Efficacy Data Evaluating ARX788 in HER2 Positive Metastatic Breast Cancer Patients Who Progressed Following T-DM1 Treatment

Ambrx Announces Encouraging Preliminary Safety and Efficacy Data Evaluating ARX788 in HER2 Positive Metastatic Breast Cancer Patients Who Progressed Following T-DM1 Treatment

  • Data to be discussed in a Spotlight Poster Presentation at the 2022 San Antonio Breast Cancer Symposium
  • Preliminary Phase 2 results from ACE-Breast-03 study demonstrate 57.1% confirmed overall response rate (ORR) by RECIST v1.1 and 100% disease control rate (DCR) in heavily pre-treated patients with HER2 positive metastatic breast cancer (mBC) following treatment with Ambrx's ARX788 anti-HER2 Antibody Drug Conjugate
  • No drug-related severe adverse events (SAEs) were observed

Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using its proprietary Engineered Precision Biologics (EPBs) platform to create antibody drug conjugates (ADCs), today announced preliminary safety and efficacy data from its Phase 2 ACE‑Breast-03 study during a Spotlight Poster Presentation at the 2022 San Antonio Breast Cancer Symposium (SABCS). The data presented by the investigator demonstrated 51.7% overall response rate (ORR) by RECIST v1.1 and 100% disease control rate (DCR) after treatment with ARX788 in HER2 positive mBC patients who are resistant or refractory to T-DM1.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Ambrx Announces NovoCodex's Dosing of First Patient with ARX305, Ambrx's Investigational Antibody Drug Conjugate Targeting CD70

Ambrx Announces NovoCodex's Dosing of First Patient with ARX305, Ambrx's Investigational Antibody Drug Conjugate Targeting CD70

- ARX305 is being evaluated by Ambrx's partner, NovoCodex, in a Phase 1 clinical trial in various advanced tumors -

- First patient dosing triggers milestone payment to Ambrx -

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Ambrx Biopharma Inc. Appoints Daniel O'Connor as Chief Executive Officer

Ambrx Biopharma Inc. Appoints Daniel O'Connor as Chief Executive Officer

Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics (EPBs), today announced the appointment of Daniel O'Connor as Chief Executive Officer.

"On behalf of the board of directors and management team, I would like to welcome Dan to Ambrx. I very much look forward to working with him to execute on Ambrx's new strategic direction," said Katrin Rupalla, Chair of Ambrx's Board of Directors. "Dan is the ideal candidate for the role of CEO, given his extensive leadership experience in oncology drug development, strategic partnership formation, and streamlining operations within the biotech industry. I would also like to thank Kate Hermans, our interim CEO and board member, for her hard work, dedication, and leadership over the past several months to reprioritize Ambrx's development pipeline."

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Ambrx Biopharma Inc. Announces Strategic Reprioritization and Provides Corporate Update

Ambrx Biopharma Inc. Announces Strategic Reprioritization and Provides Corporate Update

- Company now focused on earlier stage engineered antibody drugs for cancer therapies, including new lead asset ARX517 –

- Revised focus and projected cost-reductions expected to extend cash runway into 2025 –

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
AbbVie Announces New Data Demonstrating Atogepant  Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention

AbbVie Announces New Data Demonstrating Atogepant Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention

  • TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month   1
  • Atogepant met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority versus topiramate, demonstrating clinical efficacy   1
  • Full results from the TEMPLE study will be presented at an upcoming medical meeting

AbbVie (NYSE: ABBV) today announced positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (QULIPTA ®  AQUIPTA ® 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mgday) in adult patients with a history of four or more migraine days per month. 1

The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention. Over the 24-week double-blind treatment period, discontinuation due to AEs was significantly lower with atogepant (12.1%) compared to topiramate (29.6%), representing a relative risk of 0.41 (95% CI: 0.28, 0.59; p 1

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Emyria Limited

Medibank to Fund Emyria’s PTSD Program at Perth Clinic

Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”) a leader in developing and delivering innovative mental health treatments, is pleased to announce that Medibank Private Limited (“Medibank”), Australia’s largest private health insurer, has commenced funding for eligible customers to access Emyria’s Empax PTSD care program delivered in association with Perth Clinic.

Keep reading...Show less
AbbVie Provides Update on VERONA Trial for Newly Diagnosed Higher-Risk Myelodysplastic Syndromes

AbbVie Provides Update on VERONA Trial for Newly Diagnosed Higher-Risk Myelodysplastic Syndromes

AbbVie (NYSE: ABBV) announced the global Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) did not meet the primary endpoint of overall survival (OS) with a hazard ratio (HR) of 0.908; stratified log-rank, p=0.3772. No new safety signals were observed. 1 Results from the VERONA trial will be available in a future medical congress andor publication. Any patients who received venetoclax in combination with azacitidine through participation in the MDS clinical trials will be informed by their treating physician.

These data do not impact any current approved indications for venetoclax.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
ASX:HIQ

HITIQ Announces Exclusive Global Agreement with Shock Doctor for PROTEQT Instrumented Mouthguard

Common Shareholder Questions – Entitlement Offer

HITIQ Limited (ASX: HIQ) (HITIQ or the Company), a pioneer in concussion management, proudly announces an exclusive global agreement with Shock Doctor, the world’s leading mouthguard innovator. This landmark agreement marks Shock Doctor’s two-year effort to design a mouthguard that will integrate HITIQ’s PROTEQT technology. The result is a fully developed, market-ready solution that merges HITIQ’s smart sensor technology with Shock Doctor’s unmatched global production partner capabilities.

Keep reading...Show less
U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET®  as First and Only Treatment for People with Acute Hepatitis C Virus

U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET® as First and Only Treatment for People with Acute Hepatitis C Virus

  • MAVYRET ® (glecaprevir/pibrentasvir) is the first and only oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV)*
  • With this approval, providers can now treat HCV patients immediately at the time of diagnosis
  • HCV is a curable condition, but patients can often go undiagnosed. 1 If left untreated, people with acute HCV   could progress to chronic disease, including liver-related complications, such as cirrhosis or liver cancer 1
  • The approval supports global clinical guidelines to advance testing and treatment for people with HCV regardless of chronicity, and supports public health goals for disease elimination

AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for MAVYRET ® (glecaprevirpibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, MAVYRET is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate. 2,†

HCV is a highly infectious blood-borne disease affecting the liver. 1 People recently infected, or those with acute HCV, may not have symptoms. 1 If left untreated, HCV could lead to liver-related complications, such as cirrhosis or liver cancer. 1 The United States is expected to incur ~$120 billion in total medical costs over the next 10 years through 2035 linked to chronic liver disease and other related conditions caused by untreated HCV. 3

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
HeartSciences Inc

HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis

Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed for Seamless Integration with Hospital EHR Systems

Keep reading...Show less

Latest Press Releases

Related News

×