RESEARCH, PHARMA TECH
Ambrx | February 21, 2023
Ambrx Biopharma Inc., recently released positive preliminary results from its current Phase 1 trial, APEX-01 (NCT04662580), which is examining ARX517, Ambrx's patented anti-PSMA ADC, in patients with prostate cancer.
Patients with advanced prostate cancer who have progressed on at least two prior FDA-approved treatments are enrolled in the Phase 1, first-in-human, open label dose escalation and dose expansion experiment known as APEX-01. In the US, APEX-01 is the only clinical trial that uses an ADC to treat PSMA. The trials revealed
• No grade ≥3 treatment-related adverse events (AEs) or drug-related serious adverse events (SAEs) have been reported in the 22 individuals who were evaluable for safety. ARX517 was well-tolerated otherwise with grade 1 or 2 treatment-related adverse events were observed. It is yet to reach the maximum tolerated dose (MTD) • Starting with the second to lowest dose of 0.64 mg/kg, PSA reductions of > 30% have been seen in Cohorts 2-5 • 3 (100%) patients in Cohort 6 (2.0 mg/kg dosage) had a PSA level reduction of at least 50%. PSA levels were reduced by more than 90% in 2 out of 3 patients. At the initial on-treatment scan, soft tissue measurable disease was found in 1 of the 3 patients, and showed a partial RECIST v1.1 response • In Cohort 7, three patients received doses with no DLTs
Daniel J. O’Connor, CEO of Ambrx, said, “While recent advances have considerably reduced the number of men who die from prostate cancer, it remains the second-most common form of death from cancer in the United States. Approximately 1 man in 41 will die of prostate cancer. Thus, there remains an urgent need for better treatments, in particular for men with advanced prostate cancer.” He further added, “We are very pleased to see a significant reduction of greater than 50% in PSA levels in the first three patients at 2.0 mg/kg, two of which went on to see a greater than 90% PSA level reduction, without any serious drug-related adverse events.”
(Source – Business Wire)
About Ambrx
Ambrx Inc., is a clinical-stage biopharmaceutical company. It develops precision biologics using an extended genetic code. Synthetic amino acids are incorporated into proteins using Ambrx technology, which is carried out entirely within a living cell. Precision Biologics, a novel therapeutic class with significant potential uses these synthesized amino acids.
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BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | March 24, 2023
Curia, a leading contract research, development and manufacturing organization, today announced a collaboration with Corning Incorporated to expand and accelerate continuous-flow development and manufacturing programs for the chemical and biopharmaceutical industries globally. The collaboration with Corning’s Advanced-Flow™ Reactor (AFR) team includes the first installation of Corning’s G1 production system, designed for the continuous industrial production of active pharmaceutical ingredients (API).
Continuous flow chemistry is critical for the development and manufacture of pharmaceutical intermediates and APIs, and provides advantages compared with traditional batch processing. It is an inherently safer technology that delivers faster and more robust material production with a higher selectivity of desired products.
“Innovation in drug development and production calls for safety at high speed,” said Christopher Conway, president, Research & Development, Curia. “The implementation of Corning’s G1 Production Reactor at our Albany facility expands our capability to provide scalable solutions that address complex development and manufacturing requirements facing the pharmaceutical industry. Using advanced technology and standardized workflows, Curia offers continuous flow chemistry from targeted development to commercial scale globally.”
The G1 production reactor includes an updated set of dosing lines and controls that enable continuous operations and compliance to cGMP standards.
“Collaborating with an innovation-focused company like Curia will help drive advancements in the chemical-processing industry,” said Alessandra Vizza, business director, Corning Advanced-Flow Reactors. “The implementation of Corning’s G1 production system can deliver a host of benefits. The system is an inherently safer technology that will help Curia reduce time to market with higher-quality chemical and API processing, increased efficiency of chemical and API synthesis, and lower production costs.”
“Additionally, the space-saving, energy-conserving, and waste-reducing benefits of Corning’s AFR Technology may help customers reduce the environmental impact of their manufacturing business – a key attribute as the field continues to gain momentum in the U.S. and around the world,” said Vizza.
Curia’s expertise and global network of facilities, combined with Corning’s continuous flow technology, can help drive business efficiencies and, ultimately, improve patients’ lives.
About Curia
Curia is a leading contract research, development, and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s nearly 4,000 employees at 29 locations across the U.S., Europe, and Asia help its customers advance from curiosity to cure.
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BUSINESS INSIGHTS, PHARMA TECH
Hovione | March 21, 2023
Hovione, the specialist integrated CDMO, leader in spray drying and particle engineering, and Ripple Therapeutics, a leading ophthalmic sustained drug delivery company, have entered a strategic partnership to expand the use of Ripple's Epidel® platform beyond ophthalmic applications.
The core feature of Ripple's Epidel® technology is the ability to deliver sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. This enables higher drug loading, smaller size implants, defined and predictable biocompatible degradation products with straightforward and scalable manufacturing processes. Surface erosion-based drug release provides a highly effective way to control dose and duration. By incorporating Ripple's Epidel® platform into its toolbox, Hovione can expand its portfolio of novel drug delivery solutions to the pharmaceutical industry.
"The combination of technology synergy, innovative vision and cultural fit makes collaborating with Hovione an exciting next step in the advancement of the Epidel® platform beyond the ophthalmic field," stated Dr. Wendy Naimark, Ripple co-founder and Chief Technology Officer. "Hovione's expertise in controlled, sustained drug delivery, along with their experience in chemical synthesis and pharmaceutical manufacturing, makes for a great partnership."
"We are thrilled to partner with Ripple, who developed a state-of-the-art platform for sustained release," says Dr. Jean-Luc Herbeaux, Hovione's CEO. " Our shared goal is to accelerate and broaden the access to this highly innovative and enabling technology for the benefit of our pharmaceutical customers and their patients worldwide."
By extending the use of the Epidel® platform beyond ocular applications, this partnership will enable the development of a diverse range of new products with optimal sustained release profiles.
About Hovione
Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione's culture is based on innovation, quality and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.
About Ripple Therapeutics
Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple's Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. Ripple's novel therapeutics provide for better outcomes for patients, easier management of care for physicians and lower costs for payors. Ripple has a full product pipeline in development.
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