MEDICAL, INDUSTRY OUTLOOK
Businesswire | May 11, 2023
Bayer and Bicycle Therapeutics plc a biotechnology company pioneering a new and differentiated class of therapeutics by utilizing proprietary bicyclic peptides technology (Bicycle®), announced that they have entered into a strategic collaboration agreement to discover, develop, manufacture, and commercialize Bicycle radioconjugates for multiple agreed upon oncology targets.
Bicyclic peptides are peptides consisting of 9-20 amino acids that can be synthetically manufactured and bind to targets with high affinity and selectivity, affording high tumor penetration and fast excretion from healthy organs. They are chemically synthesizable, featuring a low molecular weight and tunable pharmacokinetics, with a large surface-area for molecular interactions that allows protein-protein interactions to be targeted. The two companies will jointly use Bicycle’s peptide technology to develop bicyclic peptides for several undisclosed oncology targets. Targeted radiotherapies are an innovative class of cancer therapies. Due to their unique mode of action, they have the potential to unlock a broad opportunity space and serve patients in high-unmet medical need indications.
“At Bayer, we enter strategic collaborations to expand our access to innovation,” said Christian Rommel, Ph.D., Global Head of Research and Development and Member of the Executive Committee, Pharmaceuticals Division, Bayer. “With Bicycle’s proprietary peptide-based technology, we continue to strengthen our oncology development pipeline by adding next-generation targeted radiotherapeutics to address high unmet medical needs of cancer patients.”
“Bayer is a pioneer in the radiopharmaceuticals space and provides new and additional validation of our unique technology,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “We believe our bicyclic peptide platform, coupled with Bayer’s scale and expertise in developing radiopharmaceuticals, has the potential to deliver improved clinical outcomes for patients with cancer. We look forward to collaborating with Bayer to bring forth new potential first-in-class radiopharmaceutical treatments based on Bicycles.”
Under the terms of the agreement, Bayer and Bicycle will collaborate on the development of bicyclic peptides for multiple oncology targets. Bicycle will utilize its proprietary phage platform to discover and develop bicyclic peptides and Bayer will be responsible for, and fully fund, all further preclinical and clinical development, manufacturing, and commercialization activities. Bicycle will receive a $45 million upfront payment and with potential development and commercial-based milestone fees, payments to Bicycle could total up to $1.7 billion. Bicycle will also be eligible to receive mid-single to double-digit tiered royalties on Bicycle-based medicines commercialized by Bayer. The closing of the transaction is subject to clearance of the transaction under the U.K. National Security and Investment Act 2021.
About Bicycle Therapeutics
Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate (BTC™) targeting EphA2; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA™ targeting Nectin-4 and agonizing CD137, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
The Center for Breakthrough Medicines | March 13, 2023
Nucleus Biologics and Stoic Bio have teamed up to form a supply agreement with the Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization that aims to accelerate the development and manufacture of advanced therapies. Under the agreement, Nucleus Biologics will become CBM's selected supplier of cell culture media and other biological solutions, ensuring a consistent supply of this critical material with tighter quality control measures.
Nucleus Biologics' approach to cell culture media, which sees it as a critical raw material that can drive desired attributes of cells crucial to the success of cell and gene therapy research, is complementary to CBM's focus on transparency, technology, and end-to-end solutions. By working together, they hope to expedite cell and gene therapy breakthroughs.
In addition, CBM will be an early adopter of Stoic Bio's innovative family of point-of-use media makers, Krakatoa™, which allows scientists to manufacture their own media with 65% fewer CO2 emissions than conventional media. By demonstrating that developing and manufacturing lifesaving therapies doesn't have to come with a high environmental cost, CBM hopes to set an example for the industry.
With over 2,200 cell and gene therapies in development, collaborations like this one are needed to speed up the process of getting these therapies to the clinic and ultimately approved. The CBM, Stoic Bio and Nucleus Biologics collaboration aim to create a unique service offering that introduces a paradigm shift in development and manufacturing, showing how technology and sustainability can converge to make better therapies sustainably.
About The Center for Breakthrough Medicines
The Center for Breakthrough Medicines (CBM) is a CDMO focused on accelerating the development and manufacture of advanced therapies to save lives. It offers end-to-end solutions such as process development, manufacturing, and quality control for cell and gene therapies, gene editing, and immunotherapies. In addition, CBM collaborates with pharmaceutical companies, academic institutions, and healthcare providers to make advanced therapies more accessible while ensuring compliance with regulatory standards. The company also prioritizes sustainability by implementing green initiatives and sustainable technology and strives to positively impact the communities it operates in.
Globenewswire | May 04, 2023
Magenta Therapeutics, Inc. and Dianthus Therapeutics, Inc. a privately-held, clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics, announced today that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on advancing Dianthus’ pipeline of next-generation complement inhibitors, including DNTH103 currently in a Phase 1 clinical trial. Upon completion of the merger, the combined company is expected to operate under the name Dianthus Therapeutics, Inc. and trade on the Nasdaq under the ticker symbol “DNTH”.
In support of the merger, Dianthus has secured commitments for a $70 million private investment in its common stock and pre-funded warrants from a syndicate of healthcare investors led by Fidelity Management & Research Company, Catalio Capital Management, 5AM Ventures, Avidity Partners, Wedbush Healthcare Partners and founding investors Fairmount, Tellus BioVentures and Venrock Healthcare Capital Partners, that is expected to close immediately prior to completion of the merger. With the cash expected from both companies at closing and the proceeds of the concurrent private financing, the combined company is expected to have approximately $180 million of cash or cash equivalents immediately post-closing. The cash resources are intended to be used to advance Dianthus’ pipeline through multiple clinical data catalysts and is expected to fund operations into mid-2026. The merger and related financing are expected to close in the third quarter of 2023.
“I’m delighted to announce this planned merger with Magenta, which comes at a pivotal moment in the evolution of our company as we advance our pipeline of next-generation complement therapeutics for people living with severe autoimmune diseases,” said Marino Garcia, President and Chief Executive Officer of Dianthus Therapeutics. “Gaining access to the public capital markets can enhance our financial strength and fuel our growth strategy, enabling us to unlock the full potential of our pipeline, including our plans to address multiple autoimmune disorders with our clinical-stage active C1s inhibitor, DNTH103.”
“After a thorough exploration of our strategic alternatives, management and our Board of Directors believe the transaction with Dianthus Therapeutics will culminate in a successful outcome for our stockholders,” said Steve Mahoney, President, Chief Financial and Operating Officer of Magenta. “Dianthus has made rapid progress in developing and advancing DNTH103 into the clinic where it has the potential to be a transformative classical pathway inhibitor for severe autoimmune diseases. We are extremely grateful to our current and former employees who contributed to Magenta’s efforts to develop its programs and we now look forward to the combined company’s advancement on opportunities for value creation for patients.”
Magenta previously announced a comprehensive review of strategic alternatives in February 2023 and has since completed winding down a majority of its activities and costs associated with its research and development initiatives, including the termination of its lease and the sale of key assets.
erving as co-financial adviser and Goodwin Procter LLP is serving as legal counsel to Magenta Therapeutics. Jefferies, Evercore ISI, Guggenheim Securities and Raymond James are serving as the placement agents to Dianthus Therapeutics, and Gibson, Dunn & Crutcher LLP is serving as legal counsel to Dianthus Therapeutics.
About Magenta Therapeutics
Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of stem cell transplant to more patients with blood cancers, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant community to revolutionize immune reset for more patients.