RESEARCH, PHARMA TECH
Biocytogen | March 09, 2023
On March 8, 2023, Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen) announced a non-exclusive license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The deal was facilitated by Johnson & Johnson Innovation LLC.
Under the agreement, Janssen and its affiliates have been granted a global, non-exclusive license to utilize Biocytogen's RenLite® platform and its underlying intellectual property to research, discover, develop, manufacture and commercialize fully human antibody therapeutics, as well as other biological therapeutics, for unlimited drug targets and indications.
RenLite® is a part of Biocytogen's RenMiceTM family of completely human antibodies. RenLite® mice can produce fully human antibody candidates with high affinity, specificity, variety, and druggability, as well as a common light chain for further assembly of multispecific and bispecific antibodies with minimal mismatch and high success rate. In addition, the multispecific and bispecific antibodies assembled following the discovery of RenLite® feature a conventional antibody structure and good physiochemical characteristics that are beneficial for downstream CMC development.
About Biocytogen
Biocytogen is a leading biotech company that offers comprehensive solutions to the global biomedical community for developing next-generation antibody drugs. It has created a streamlined platform for efficient antibody drug discovery and validation using advanced gene editing technology and modern animal facilities. This includes animal model creation, therapeutic antibody discovery through their RenMab™ mice, and preclinical validation studies in vivo and in vitro. Biocytogen partners with over 70% of the leading biotech and pharmaceutical companies worldwide to develop innovative medicines for a healthier world. The company is a leading figure in the field of biomedical research, pushing the boundaries of what is possible in this critical area of study.
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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.
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BUSINESS INSIGHTS, PHARMA TECH
Koneksa | January 18, 2023
On January 17, 2023, Koneksa, a healthcare technology company that develops evidence-based validated digital biomarkers, announced the beginning of a clinical study that will compare the treatment effect of at-home mobile spirometry using digital biomarkers versus in-clinic spirometry in patients who have moderate asthma and are receiving long-acting beta-agonist (LABA) treatment.
The LEARN study is a single-arm interventional trial that compares the identification of treatment effects in people with moderate asthma using at-home mobile spirometry by utilizing an ultrasonic spirometer and a smartphone compared to in-clinic spirometry. Up to 60 people with mild, uncontrolled asthma who already use inhaled corticosteroids (ICS) will take part in the study. Besides, it will also cover those who need to take LABA medication for a six-week treatment period.
In-clinic spirometry can be performed at home with the same or higher accuracy compared to in-clinic and potentially less strain on the patient. The study will analyze the LABA treatment impact in clinic and mobile spirometry along with assessing the association between different readouts of mobile spirometry, in addition to evaluating asthma control as determined by the ACQ-6, a patient-reported outcome questionnaire. Other goals include assessing patient and site-specific satisfaction with mobile spirometry technology.
Chris Benko, CEO & Founder, Koneksa, stated, “This study builds on Koneksa's prior work demonstrating that mobile spirometry has the potential to detect clinically meaningful changes in very small cohorts of asthma patients on standard of care.” He further added, “The LEARN study will evaluate whether at-home mobile spirometry can detect treatment effects of a known positive control (LABA) in a significantly smaller population than would traditionally be assumed for an in-clinic proof-of-concept study.”
(Source – Business Wire)
About Koneksa
Based out of New York, Koneksa is a patient-centric digital biomarker firm that develops end-to-end solutions for remotely obtained clinical data to expedite clinical research and guide decision-making in drug development and market strategy for the pharmaceutical and biotechnology industries. It seeks to revolutionize effect detection in clinical research by providing integrated solutions for efficient trial designs that yield more meaningful data. Its evidence-based biomarker solutions allow for more efficient clinical trial designs, allowing novel medicines to reach patients sooner.
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