Medical, Industry Outlook
PRNewswire | July 14, 2023
Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Limited, committed to cutting-edge antibody technology innovation and provider of integrated solutions from "Idea to IND" (I to ITM) announced that, DualityBio, a collaborator of Nona Biosciences, and BeiGene entered into an agreement for BeiGene to acquire an exclusive option for a global clinical and commercial license to an investigational, preclinical ADC program for patients with select solid tumors. This program was developed under the collaboration agreement commenced between Nona Biosciences and DualityBio.
Nona Biosciences entered into a collaboration agreement with DualityBio in 2022, pursuant to which Nona Biosciences granted the exclusive rights of its monoclonal antibodies for specific tumors to DualityBio to develop the world's first-in-class ADC. The collaboration between Nona Biosciences and DualityBio will continue in accordance with the terms of the collaboration agreement.
Nona Biosciences has established considerable experience and expertise in ADC field. While continuously optimizing its advanced platform technology, Nona Biosciences has actively established an ADC cooperation ecosystem and closely cooperated with multiple innovation pioneers, to fully unleash its innovation capability and accelerate the innovations of novel ADC therapeutics globally. Nona Biosciences will further expand its networks in ADC innovation as one of its core strategies, continue to enhance the value of innovation, and fulfill global medical needs.
About Nona Biosciences
Nona Biosciences is a global biotechnology company committed to cutting edge technology innovation, and providing a total solution from "Idea to IND" (I to ITM), ranging from target validation and antibody discovery through preclinical research. The integrated antibody and antibody-related discovery services with multiple modalities range from antigen preparation, animal immunization, single B cell screening, to antibody lead generation and engineering, developability assessment and pharmacological evaluation, leveraging advantages of Harbour Mice® platforms and the experienced therapeutic antibody discovery team.
Harbour Mice® generates fully human monoclonal antibodies in classical two light and two heavy chain (H2L2) format, and heavy chain only (HCAb) formats. Integrating Harbour Mice® and a single B cell cloning platform, Nona Biosciences is focused on driving global inventions of transformative next-generation drugs.
DualityBio is a clinical-stage company focusing on the discovery and development of the next generation ADC therapeutics for patients with cancer and autoimmune diseases. DualityBio has successfully established a number of next-generation ADC technology platforms with global intellectual property rights. Building upon deep understanding of disease biology and translational capability, DualityBio has advanced four assets into global clinical studies, and developed more than 10 innovative product candidates that are currently in preclinical stage. Additionally, DualityBio is continuing to evolve its novel protein engineering and ADC technology platforms for the next wave of "super ADC" molecules including diverse payload classes, bispecific ADCs and dual-payload ADCs.
prnewswire | September 01, 2023
Exacta Bioscience, a biotech company that harnesses the power of nature and its microorganisms for crop protection, and Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, today announced that Exacta is leveraging Ginkgo's end-to-end agricultural R&D services to run a fermentation optimization and scale-up program to enhance one of its crop protection products, FitoRoot®, paving the way for large-scale commercialization.
FitoRoot, a biostimulant product composed of three Bacillus strains, is designed to help crops better absorb water, nutrients and strengthen their defenses against abiotic stress. This can lead to overall better crop health, improved yield and increased resistance to stress conditions such as drought or extreme temperatures. Through this partnership, Exacta will use Ginkgo's fermentation and formulation optimization services to reduce the cost of goods to make its FitoRoot technology more competitive. Accordingly, FitoRoot is currently marketed in Chile and is expected to expand to other Latin American markets, with a planned launch in 2023 by Adama Chile, who is driving biological adoption in the region. Adama Ltd is one of the world's leading crop protection companies.
"We chose Ginkgo because their deep expertise in agricultural product development and optimization positions us to make one of our key crop protection products, FitoRoot, more accessible," said José Bustos, CEO at Exacta Bioscience. "We're proud of the progress Exacta has made, and this partnership marks a vital step toward accelerating our efforts to assure the quality and availability of one of our products and creating a stable and safer ecosystem."
"Exacta Bioscience's emphasis on microbial solutions in crop health brings more sustainable and differentiated solutions to farmers throughout the Americas," said Magalie Guilhabert, Head of Ag Biologicals, Ginkgo Bioworks. "Together, we can continue to push the boundaries of agricultural innovation through biotechnological solutions that promote a more sustainable future for our food systems."
Ginkgo's end-to-end agricultural services can help R&D teams develop more effective biological products across a variety of applications. Find out more.
About Ginkgo Bioworks
Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect, and respond to a wide variety of biological threats.
About Exacta Bioscience
Exacta Bioscience is a pioneering biotech company that uses microorganisms to create innovative bioproducts for agriculture. Their nature-inspired solutions support a future without chemical pesticides and antibiotics. With extensive knowledge of microorganisms and their effects on crops and soil, Exacta tackles modern farming challenges. Their expertise is in formulating microorganism mixtures, providing a wide range of bioproducts, specifically for crop protection. They are dedicated to delivering effective, stable, and safe crop protection and soil-enhancing products. They invite everyone to join in advancing sustainable practices for a healthier future.
Globenewswire | August 10, 2023
Regeneron Pharmaceuticals, Inc. and Decibel Therapeutics, Inc. a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced a definitive agreement for the acquisition of Decibel by Regeneron at a price of $4.00 per share of Decibel common stock payable in cash at closing, with an additional non-tradeable contingent value right (CVR) to receive up to $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for Decibel’s lead investigational candidate, DB-OTO, within specified time periods. The proposed acquisition values Decibel at a total equity value of approximately $109 million based on the amount payable at closing, and a total equity value of up to approximately $213 million if the CVR milestones are achieved.
“We at Decibel are deeply committed to discovering and advancing innovative new therapies with the potential to be transformative for people with severe forms of hearing loss. We have built a pipeline of gene therapy product candidates for the ear that we believe have such potential. After full consideration, the Decibel Board has determined that this transaction is the best way to maximize shareholder value and ultimately benefit patients,” said Laurence E. Reid, Ph.D., President and Chief Executive Officer of Decibel. “We have collaborated with our colleagues at Regeneron for the past six years and have huge respect for their research and development capabilities. We have full confidence that with Regeneron’s expertise and resources the Decibel pipeline can be optimally developed, and our team is committed to enabling that long-term success.”
Decibel and Regeneron established their initial collaboration in 2017, with an extension announced in 2021, and are developing three gene therapy programs targeting different forms of congenital, monogenic hearing loss. DB-OTO, which is currently in the global Phase 1/2 CHORDTM clinical trial, is an investigational cell-selective, adeno-associated virus (AAV) gene therapy designed to provide durable, physiological hearing to individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene. Preclinical programs include AAV.103 for people with GJB2-related hearing loss and AAV.104 for people with stereocilin (STRC)-related hearing loss.
“We are delighted to announce the planned acquisition of Decibel, who have been long-standing collaborators, notable for their deep scientific knowledge and commitment to people with hearing loss,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, Chief Scientific Officer and President of Regeneron. “DB-OTO, our shared lead investigational gene therapy, will soon reach patients in its first clinical trial, offering new promise to children with this rare form of congenital hearing loss, as well as potential proof-of-concept for future gene therapies addressing more common forms of genetic hearing loss. We believe that Decibel’s assets and specialized team will further strengthen our genetic medicines portfolio, enabling Regeneron to accelerate the development of innovative genetic therapies and a rich pipeline of hearing loss treatments.”
Congenital hearing loss is a significant unmet medical need with no approved medical therapies that affects approximately 1.7 out of every 1,000 children born in the United States. While hearing loss caused by mutations of the otoferlin gene is rare, the majority of permanent, congenital hearing loss cases diagnosed in developed countries are sensorineural and result from a single gene defect, making them appealing targets for gene therapy. Hearing aids and cochlear implants may offer benefits, but they fall short of replicating normal hearing function.
The merger agreement provides for Regeneron, through its wholly owned subsidiary Symphony Acquisition Sub, Inc., to initiate a tender offer to acquire all outstanding shares of Decibel at a price of $4.00 per share of Decibel common stock payable in cash at closing plus one CVR payable in cash subject to the terms and conditions contained in a contingent value rights agreement (“CVR Agreement”). CVR holders would become entitled to receive contingent payments as follows: (i) $2.00 in cash, upon the fifth participant being administered with DB-OTO in a clinical trial on or prior to December 31, 2024 (the DB-OTO Milestone); and (ii) $1.50 in cash, upon (a) the first participant being administered with DB-OTO in a registration enabling trial (as defined in the CVR Agreement) or (b) acceptance for review of a Biologics License Application by the U.S. Food and Drug Administration, a Marketing Authorization Application by the European Medicines Agency or the U.K. Medicines and Healthcare Products Regulatory Agency, or an equivalent application by the applicable national regulatory authority in any of Germany, France, Italy or Spain for DB-OTO, whichever occurs first, on or prior to December 31, 2028; provided the DB-OTO Milestone is achieved on or prior to December 31, 2024. There can be no assurance that any payments will be made with respect to the CVR. The closing of the tender offer will be subject to certain conditions, including the tender of at least a majority of the outstanding shares of Decibel common stock and other customary closing conditions. Upon the successful completion of the tender offer, Regeneron will acquire all shares not acquired in the tender through a second-step merger for the same consideration per share paid in the tender offer. The transaction is expected to close in the third quarter of 2023.
Regeneron’s legal advisor for the transaction is Wachtell, Lipton, Rosen & Katz. Centerview Partners LLC and Leerink Partners LLC are serving as Decibel’s financial advisors and Wilmer Cutler Pickering Hale and Dorr LLP is serving as Decibel’s legal advisor.
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
About Decibel Therapeutics
Decibel Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, one of the largest areas of unmet need in medicine. Decibel has built a proprietary platform that integrates single-cell genomics and bioinformatic analyses, precision gene therapy technologies and expertise in inner ear biology. Decibel is leveraging its platform to advance gene therapies designed to selectively replace genes for the treatment of congenital, monogenic hearing loss and to regenerate inner ear hair cells for the treatment of acquired hearing and balance disorders. Decibel’s pipeline, including its lead gene therapy product candidate, DB-OTO, to treat congenital, monogenic hearing loss, is designed to deliver on our vision of creating a world of connection for people with hearing and balance disorders.