Medical
Businesswire | June 29, 2023
Alloy Therapeutics, a biotechnology ecosystem company, announced the launch of its novel AntiClastic™ Antisense Oligonucleotide (AntiClastic ASO) platform, which employs optimally created spatial conformation nucleic acids that further enhance the drug-like properties of antisense. Alloy has exclusively licensed IP underlying the AntiClastic ASO platform from Sudhir Agrawal’s Arnay Sciences LLC.
Antisense therapeutics hold promise for reaching many undruggable intracellular targets at the nucleic acid level but have been limited due to therapeutic index and delivery challenges. Alloy’s AntiClastic ASO platform combines improvements in the primary sequence with a novel spatial conformation of nucleic acid drugs. The resultant AntiClastic ASO candidates have improved potency, promote the delivery of antisense to target RNA, and minimize interactions with unintended RNA targets and the inflammatory responses—for a superior therapeutic index. This platform is broadly applicable to treat diseases by targeting genes expressed in the central nervous system (CNS), liver, muscles, ocular, and more.
“The AntiClastic format has the potential to transform the development of antisense therapeutics,” said Agrawal. “Alloy’s model of making pre-competitive discovery technologies widely available to drug developers through accessible terms and an ecosystem mindset means this technology can reach the widest possible audience of patients—rather than staying locked up under one company and accessible to a limited set of therapeutic programs.”
Drug developers can access the novel AntiClastic ASO format by collaborating on their desired target or by providing existing antisense sequences to be converted into AntiClastic molecules. All collaborative campaigns receive Alloy’s discovery support and preclinical data and leverage Alloy’s flexible research and partnership terms based on a shared success model.
In launching the AntiClastic ASO platform, Alloy is expanding into its third biologic modality, genetic medicines. The company started by making its ATX-Gx™ transgenic humanized mice platform for antibody discovery widely available to the global scientific community through campaigns with Alloy’s Antibody Discovery Services or for use in partner’s respective labs. The platform has since accrued more than 150 partners and has provided the framework for how Alloy makes pre-competitive technologies available to drug developers everywhere. It launched Keyway™ TCR Discovery to democratize technologies and expertise for developing soluble TCR therapeutics and TCR mimics against intracellular targets. Alloy’s genetic medicines group is led by Vinod Vathipadiekal, PhD, who has held research leadership roles across RNA and nucleic acid therapeutics programs at biotech and pharma companies. Over the last year, Alloy has generated promising data on applying the AntiClastic technology to multiple antisense drug candidates against many relevant targets, enabling discovery collaborations with partners.
“Alloy is executing successfully against an ambitious roadmap in applying the AntiClastic platform and has developed a powerful model of collaboration and innovation with premier inventors like Sudhir,” said Alloy President Piotr Bobrowicz, PhD. “In offering an advanced, novel set of discovery capabilities across modalities, we aim to provide the global scientific community with the tools and expertise needed to advance the best drugs, regardless of format.”
In conjunction with the launch of its AntiClastic ASO platform, Alloy is also revealing its genetic medicines scientific advisory board (SAB), a group of leading thinkers across immunology, RNA- and nucleic acid-based therapeutics, rare disease, and bioinformatics who will guide further development of the platform
Douglas Golenbock, MD—Neil and Margery Blacklow Chair in Infectious Diseases and Immunology at UMass Chan Medical School—and a pioneering researcher in innate immunity, Toll-like receptor (TLR) biology, and the inflammasome.
Frank Slack, PhD—Shields Warren Mallinckrodt Professor, Department of Pathology, and Director of the Institute for RNA Medicine at Beth Israel Deaconess Medical Center—who has spent decades researching and re-thinking small RNA gene regulation capabilities.
Malcolm MacCoss, PhD—Visiting Professor of Chemistry for Medicine at Oxford University—with decades of expertise in novel chemistries for nucleoside and nucleic acid-based therapeutic approaches through research roles at Merck and Schering Plough, as well as SAB or consultant positions at Idera, Gilead, UCB, and Sitryx, among others.
Matt Might, PhD—Professor and Director of the Hugh Kaul Precision Medicine Institute at the University of Alabama at Birmingham—whose expertise spans precision medicine leveraging novel bioinformatic techniques and developing therapies for rare diseases.
“We are grateful that the best minds and innovators in genetic and precision medicine and the disease areas that can benefit from it have coalesced around this exciting platform and new modality at Alloy,” said Errik Anderson, Alloy Therapeutics CEO and Founder. “Our model of co-creating pre-competitive technologies and making them as widely available as possible means more patients will be able to benefit from new, potent antisense therapeutics for previously intractable conditions.”
About Alloy Therapeutics
Alloy Therapeutics is a biotechnology ecosystem company empowering the global scientific community to make better medicines together. Through a community of partners across academia, biotech, and the largest biopharma, Alloy democratizes access to pre-competitive tools, technologies, services, and company creation capabilities that are foundational for discovering and developing therapeutic biologics across six modalities: antibodies, TCRs, genetic medicines, peptides, cell therapies, and drug delivery. Partners may access all current and future technologies through a discovery service relationship or for a flat annual fee through Alloy’s Innovation Subscriptions offering. As a reflection of Alloy’s relentless commitment to the scientific community, Alloy reinvests 100% of its revenue in innovation and access to innovation.
About AntiClastic™ Antisense Oligonucleotides
AntiClastic™ Antisense Oligonucleotides (AntiClastic ASOs) are a novel therapeutic format exclusively available through Alloy Therapeutics collaborations that are designed to overcome potency and therapeutic index challenges that have historically limited the promise of antisense drugs. Sudhir Agrawal invented the core IP, which combines improvements in the primary sequence with a novel spatial conformation of nucleic acid drugs to promote the delivery of antisense to target RNA, mitigate the inflammatory response, and improve a drug’s therapeutic index. The resultant drug candidates have shown a significant increase in potency compared to gapmer antisense formats.
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Medical, Industry Outlook
Globenewswire | July 13, 2023
NANOBIOTIX a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced a global licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the investigational, potential first-in-class radioenhancer NBTXR3.
NBTXR3 is currently being evaluated in several studies across solid tumor indications including NANORAY-312, a global Phase 3 pivotal study evaluating NBTXR3 for the treatment of patients with locally advanced head and neck cancer. NBTXR3 is also being evaluated for its potential as a systemic agent in combination with anti-PD-1 immune checkpoint inhibitors for patients with metastatic cancers.
Under the terms of the license agreement, in collaboration with the Interventional Oncology R&D Unit at Johnson & Johnson, Nanobiotix will grant Janssen a worldwide license for the development and commercialization of NBTXR3. The license is exclusive, excepting territories previously licensed to Nanobiotix partner LianBio. Dial-in information for a conference call Nanobiotix will host to discuss the agreement can be found below.
“As pioneers in the field of nanotherapeutics for the past 20 years, we knew that the true impact of our innovation in oncology would be in its potential to reach millions of patients around the world. For that, we needed to find the right partner, at the right time, with proven global development and commercialization capabilities,” said Laurent Levy, Nanobiotix chairman of the executive board. “We are delighted to collaborate with Janssen as we aim to improve the lives of patients with cancer around the world.”
Nanobiotix will receive near term cash and operational support valued up to $60 million. This includes an upfront cash licensing fee of $30 million, and in-kind regulatory and development support for study NANORAY-312 valued at up to $30 million that Janssen may provide at its sole discretion. Nanobiotix will maintain operational control of NANORAY-312 and all other currently ongoing studies, along with NBTXR3 manufacture, clinical supply, and initial commercial supply. Janssen will be fully responsible for an initial Phase 2 study evaluating NBTXR3 for patients with stage three lung cancer and will have the right to assume control of studies currently led by Nanobiotix.
Nanobiotix is eligible for success-based payments of up to $1.8 billion, in the aggregate, relating to potential development, regulatory, and sales milestones. Moreover, the agreement includes a framework for additional success-based potential development and regulatory milestone payments of up to $650 million, in the aggregate, for five new indications that may be developed by Janssen at its sole discretion; and of up to $220 million, in the aggregate, per indication that may be developed by Nanobiotix in alignment with Janssen.
Following commercialization, Nanobiotix will also receive tiered double-digit royalties on net sales of NBTXR3.
“We expect this agreement, and the collaboration it enables, to further drive the expansion of NBTXR3 development and accelerate the realization of its promise for patients in need,” said Bart van Rhijn, Nanobiotix chief financial officer. “We look forward to maximizing the value of NBTXR3 for our global stakeholders.”
Separately, Nanobiotix is eligible to receive up to $30 million in equity investments from Johnson & Johnson Innovation – JJDC, Inc. (“JJDC”) including, as part of capital increases without preferential subscription rights: (1) an initial tranche equal to the lower of 5% of the Company and $5 million; and (2) a second tranche of $25 million subject to certain maximum ownership caps in connection with a future financing.
The price of the initial tranche will be equal to $5.21 per American Depositary Share (“ADS”) if that price (1) is approved by Nanobiotix shareholders or (2) exceeds 85% of the volume-weighted average price (“VWAP”) of Nanobiotix ordinary shares on Euronext: Paris for three consecutive trading days, starting with the fourth trading day after the date of agreement, in each case if occurring within the ninety trading days following the date f the agreement. Also, JJDC may elect any time during that ninety-trading day period to instead consummate the initial tranche at a price per ADS equal to 85% of the VWAP of Nanobiotix ordinary shares on Euronext for three consecutive trading days starting with the fourth trading day after the date of the agreement. The second, $25 million tranche is conditioned upon, and at the same price as, a concurrent Nanobiotix financing with gross proceeds of at least $25 million (excluding the potential investment by JJDC) occurring prior to certain long-term development milestones or December 31, 2027, at the latest.
For illustrative purposes only1, in the event that the initial tranche is implemented at $5.21 per ADS, the dilutive impact for shareholders resulting from this capital increase would be 0.97% and JJDC group would own 2.65% of the Company’s share capital.
The transaction is subject to customary closing conditions and regulatory clearances including clearance by US antitrust authorities under the Hart-Scott-Rodino Act, and will become effective as soon as these conditions have been met.
As of the date the license agreement becomes effective, prior to utilizing the second tranche of equity investment outlined above and excluding near term development milestones, Nanobiotix expects to extend its cash runway into the first quarter of 2024.
About NANOBIOTIX
Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.
Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The Company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.
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Industry Outlook
Businesswire | June 26, 2023
Enveda Biosciences, a biotechnology company discovering new medicines from natural sources, released the details of one of its foundational AI models, MS2Mol, in a pre-print posted on ChemRxiv. MS2Mol is designed to predict the structure of metabolites, which are the building blocks and breakdown products of the cell. Despite their essential role in all cell processes, it is estimated that less than 1% of all naturally-occurring metabolites are known to science. The ability of MS2Mol to rapidly predict the structure of previously uncharacterized metabolites without lengthy laboratory experimentation enables their prioritization as potential drug candidates and expands our knowledge of the natural world.
“Metabolites have a long and successful history as the basis for impactful drugs including aspirin, taxol, metformin, artemisinin, and statins. This is particularly impressive given that we, as scientists, have barely scratched the surface of natural metabolite diversity. With MS2Mol integrated into our platform, we can tap evolutionary chemical intelligence for the next generation of powerful medicines at scale,” said Viswa Colluru, Ph.D., founder and CEO of Enveda.
Enveda’s proprietary platform solves the long-standing obstacles in natural product drug development including active molecule identification, property and structure prioritization, amenability to medicinal chemistry, and large-scale material access. The company recently closed its Series B1 round and will progress multiple platform-derived molecules to the clinic in 2023 and 2024 across inflammation, fibrosis, and neurosensory indications.
“Metabolite identification used to be a process that was time-consuming, prone to failure, and required highly specialized expertise. MS2Mol takes the most easily accessible – but extremely cryptic – form of data on metabolites, the mass spectrum, and translates it into a language that scientists can use: the chemical structure. Solving this translation problem with AI puts the most useful information in the hands of drug hunters at massive scale,” said David Healey, Ph.D., VP of Data Science at Enveda and senior author of the pre-print.
“While other companies use AI to predict what you want to buy, we use AI to discover what humanity needs to know,” said Tom Butler, Ph.D., VP of Machine Learning at Enveda and first author of pre-print.
“Unlocking bioactive chemistry honed by billions of years of evolution for modern drug discovery has led us to discover a slate of exciting candidate medicines at a remarkable pace,” said Sotirios Karathanasis, Ph.D., CSO at Enveda. “We look forward to modification of disease pathophysiology by our medicines in the clinic and redefinition of the concept of target undruggability with the Enveda platform.”
With the creation of MS2Mol, Enveda continues to deliver field-changing technology for the discovery and utilization of natural metabolites to drive novel therapeutic development.
About Enveda Biosciences
Enveda Biosciences is a biotechnology company building the first high-resolution chemical map of the natural world to tackle the toughest problems in drug discovery. Enveda’s platform is the world’s most advanced drug discovery search engine from the expanse of nature’s unknown chemistry, building on years of cutting-edge advancements at the intersection of metabolomics and machine learning. Complementing its breakthrough technology, Enveda’s team includes seasoned drug hunters with decades of experience in the pharmaceutical industry working with preeminent data scientists.
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