BUSINESS INSIGHTS, PHARMA TECH
Epredia | January 19, 2023
On January 18, 2023, PHC Group, a healthcare company renowned in diagnostics and life sciences, announced that it would join the RegeneratOR Innovation Accelerator to grow its presence in regenerative medicine. The Wake Forest Institute for Regenerative Medicine (WFIRM) and the RegenMed Development Organization (ReMDO) are the two institutions expediting the discovery and translation of regenerative medicine therapeutics located in the Innovation Quarter.
PHC Group, being an early partner of ReMDO's RegeneratOR Test Bed, offered advanced tissue processing technologies as well as support to researchers for prototype and product development. In addition, another ReMDO program, the Innovation Accelerator, was formed to give space and support to companies with innovative or emerging regenerative medicine technologies.
PHC Group is now opening a local office within the Innovation Accelerator. Its holding companies and partners include Epredia, a precision cancer diagnostics company whose products are used by researchers and pathologists worldwide, and Aiforia, a medical software company that develops artificial intelligence software for image analysis in pathology. Aiforia's collection of preclinical and clinical pathology instruments is distributed globally by Epredia.
The firms work together to deliver slide imaging and AI-based solutions that enable researchers to investigate and extract information beyond the scope of human visual perception. Thus, clinical research, drug discovery, and translational studies with the goal of better understanding disease states are all linked together through diagnostic microscopic imaging and artificial intelligence.
PHC Group's presence, along with Epredia and Aiforia's superior technology assistance at the Innovation Accelerator, will also pave the path for RegeneratOR's newest initiative, the RegenMed Clinical Trials Catalyst.
As a part of Wake Forest University School of Medicine and the academic core of the newly merged Advocate Aurora Health and Atrium Health, the Catalyst will have access to 5.5 million patients, serving 67 hospitals in North Carolina, Wisconsin, South Carolina, Georgia, Alabama, and Illinois.
Epredia is a leading comprehensive laboratory solutions provider for instruments and consumables in anatomic pathology, histology, and cytology. It was established through an acquisition by PHC Group from Thermo Fisher Scientific. The company provides solutions for cancer diagnostics through its renowned brands: Richard Allen Scientific, Erie Scientific, Microm, Shandon, and Menzel-Glaser. Epredia is committed to realizing its aim of advancing cancer diagnostics for patients worldwide in order to save lives.
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)
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.
BUSINESS INSIGHTS, PHARMACY MARKET
Accord Healthcare | March 14, 2023
On March 13, 2023, Accord Healthcare informed that it has expanded its portfolio with Teriflunomide, a film-coated tablet equivalent to Sanofi Genzyme's Aubagio. The drug treats relapsing forms of MS in adults, including clinically-isolated syndrome and active secondary progressive disease. The company offers Teriflunomide in 14 mg and 7 mg tablets, now available for shipping.
Teriflunomide has been granted FDA approval as an immunomodulatory agent for patients aged 18 and above. Its purpose is to reduce the frequency and severity of relapses, which can lead to new or worsening neurological symptoms associated with the disease.
Accord Healthcare US Vice President of Sales Jim Brown stated, "We're proud to add Teriflunomide to our portfolio. This is an important oral therapy for the millions of patients living with relapsing MS." He added, "Generic medicine allows broad access to effective therapy, to help improve disease course and potentially slow progression of MS."
(Source – Cision PR newswire)
Teriflunomide is an immunomodulatory medication that inhibits an enzyme critical to a metabolic pathway that supports lymphocyte proliferation. This results in fewer activated lymphocytes, which minimizes inflammation and immunological reactivity, resulting in lower recurrence rates and protection of brain volume against inflammatory nerve cell attacks.
Around 2.8 million people globally have multiple sclerosis, with the majority diagnosed with relapsing-remitting MS that typically begins in their twenties or thirties. Diagnosis involves experiencing two or more attacks or relapses while maintaining stability. New or exacerbated symptoms characterize relapses, and the immune system attacks the myelin sheath surrounding nerve fibers, ultimately causing long-term damage. Symptoms include numbness, fatigue, double vision, and balance problems. Besides, relapsing-remitting MS can also progress to active secondary progressive disease.
About Accord Healthcare
Accord Healthcare, a subsidiary of Intas Pharmaceuticals, is recognized as a prominent player in the generic pharmaceutical industry. The company's vision is to enhance patient access to medicines and revolutionize the pharmaceutical experience for healthcare providers and patients. With an emphasis on advanced manufacturing technology and in-house research, Accord Healthcare delivers a wide range of affordable, complex, and essential medicines. The company's dedication to forward-thinking and innovative solutions remains at the core of its mission. Headquartered in Durham (North Carolina), its products are marketed in 80 countries through the Intas network.