INDUSTRIAL IMPACT, MEDICAL
Molecular Assemblies, Inc. | March 15, 2023
On March 14, 2023, Molecular Assemblies, Inc., a leading life sciences company, made a significant announcement regarding its enzymatic DNA synthesis technology. The company has successfully shipped the first enzymatically synthesized oligonucleotides to leading researchers in biotechnology, academic, and synthetic biology. The capacity to synthesize lengthy, extremely pure DNA promptly utilizing a proprietary Fully Enzymatic Synthesis (FES) technology solves critical unmet demands in DNA synthesis, thus allowing demanding and high-value applications such as CRISPR gene editing.
Long, highly pure single-stranded oligonucleotides are critical in various applications, such as CRISPR gene editing tools used in therapeutic development, research discovery and protein engineering. However, the availability of desired sequences required to make advanced edits has been a significant bottleneck.
Molecular Assemblies' Key Client Program gives chosen researchers priority access to lengthy and customized oligonucleotides synthesized utilizing the company's FES technology. Thanks to this initiative, customers are expected to speed up their research in CRISPR gene editing and other applications needing long oligonucleotides. In addition, key customers can give input to shape the future of enzymatic DNA synthesis. Molecular Assemblies plans to present more details about the technology at the SynBioBeta 2023 conference in Oakland, California, from May 23-25.
Molecular Assemblies' President and CEO Michael J. Kamdar commented, "With the achievement of this significant commercial milestone, we are proving that fully enzymatic synthesis can deliver the DNA that customers want today, without compromise," He further emphasized, "Customers want application-ready DNA, unrestricted by length and sequence-complexity, which we know is essential to power new breakthroughs in scientific research and accelerate innovation for many industries, including next generation medicines and technologies."
(Source – PR Newswire)
About Molecular Assemblies, Inc.
Molecular Assemblies, Inc. is a leading company dedicated to developing enzymatic DNA synthesis technology to address key challenges in DNA synthesis. Its proprietary Fully Enzymatic Synthesis (FES) technology aims to provide an innovative solution to produce long, pure DNA quickly, efficiently, and sustainably. As a result, molecular Assemblies' FES technology has the potential to transform the field of DNA synthesis by enabling the production of high-quality, long oligonucleotides. This development has significant implications for research discovery, therapeutic development, and protein engineering, particularly in the context of CRISPR gene editing. The company was founded in 2013 and is headquartered in San Diego, California. It has received significant funding from various sources, including venture capital firms, angel investors, and government agencies.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Axcella | February 16, 2023
On February 15, 2023, Axcella Therapeutics, a clinical-stage biotechnology firm that develops innovative approaches to complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a phase 2b/3 trial in the United States for AXA1125 for the treatment of Long COVID Fatigue.
The company stated that it has obtained FDA regulatory guidance in favor of a trial that would serve as the registration trial for patients with Long COVID Fatigue. The trial now has acceptance from both the U.K. and U.S. regulatory authorities.
Last month, the company also announced a regulatory path to registration for the treatment of Long COVID Fatigue with AXA1125, having received regulatory guidance from the U.K.'s regulatory agency, The Medicines and Healthcare products Regulatory Agency (MHRA), supporting a single trial that can serve as the registration trial for patients suffering from Long COVID Fatigue.
The guidance follows the company's submission of data to both regulatory agencies, including results from the Phase 2a randomized, double-blind, placebo-controlled study, which showed that patients who received AXA1125 experienced statistically and clinically significant improvements in both physical (p=0.0097) and mental fatigue (p=0.0097) scores compared to those on the placebo.
Consistent with the Ph2a trial, the trial for phase 2b/3 will register patients with fatigue lasting at least 12 weeks post-COVID-19 infection. The primary endpoint will use the same patient reported outcome tool, the Chalder Fatigue Questionnaire (CFQ-11), to measure fatigue improvements alongside physical function, quality of life, and ability to return to work as additional endpoints. The trial participants will receive AXA1125 or a placebo for three months.
Long COVID is a persistent long-term effect of the pandemic, which affects a large number of patients worldwide, estimated to be around one hundred million. Fatigue is the most frequently reported symptom, with recent estimates indicating that 15-20% of Americans with COVID suffer from ongoing health problems, and up to four million Americans are unable to work because of Long COVID symptoms. In addition, Long COVID has caused approximately $1 trillion in lost earnings and $544 billion in increased medical expenses.
Founded in 2010, Axcella is a clinical-stage biotechnology firm dedicated to introducing a novel approach to treating complex diseases using endogenous metabolic modulator (EMM) compositions. Its product candidates contain EMMs and derivatives that are engineered in distinct ratios and combinations to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. The company's pipeline includes lead therapeutic candidates undergoing Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH).
MEDTECH, INDUSTRIAL IMPACT
BioNTech and InstaDeep | January 12, 2023
BioNTech and InstaDeep Ltd. recently signed an agreement wherein the former is set to acquire InstaDeep, a worldwide leader in AI and ML technologies.
The acquisition involves a total upfront payment of about £362 million in cash, while BioNTech shares will be used to buy the remaining 100% of InstaDeep shares, excluding those currently held by BioNTech.
The acquisition strengthens BioNTech's aim to establish world-leading abilities in AI-driven drug discovery and develop vaccines as well as next-generation immunotherapies to treat diseases with significant unmet medical needs. In addition, the company will enhance its network of worldwide research collaborators and expand its presence in many talent hubs throughout the United States, the Middle East, Africa, and Europe due to the acquisition.
With the acquisition of InstaDeep, BioNTech's proven and new AI- and ML-based models will be added to all of its discovery platforms and linked to an automated lab infrastructure through InstaDeep's DeepChainTM platform.
MD, CEO and Co-Founder of BioNTech, Prof. Ugur Sahin, said, "Since the inception of BioNTech, we have focused on leveraging computational solutions to create personalized immunotherapies that can reach a wide patient population."
(Source: Globe Newswire)
Adding to this, CEO and Co-Founder of InstaDeep, Karim Beguir, stated, "AI is progressing exponentially and our mission at InstaDeep has always been to make sure it benefits everyone. We are very excited to join forces and become one team with BioNTech, with whom we share the same culture of deep tech innovation and focus on positive human impact."
(Source: Globe Newswire)
BioNTech is a fully-integrated and worldwide leader in immunotherapy. It has been focusing on automating and digitizing processes and developing capacities for the specialized production of individual vaccinations and large-scale goods, such as the COVID-19 vaccine. As immunotherapy pioneers, the company believes that science and innovation can make a difference for humankind. Therefore, since the beginning, it has focused on harnessing the immune system's total capacity to combat cancer and infectious diseases.