BUSINESS INSIGHTS

Cullinan Oncology Forms Strategic Collaboration Agreement with Mount Sinai to Advance Oral HPK1 Protein Degrader for Cancer Treatment

Cullinan Oncology, Inc. | January 10, 2022

Cullinan Oncology, Inc. a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for cancer patients, today announced the Company has entered into a collaboration agreement with the Icahn School of Medicine at Mount Sinai to develop novel small molecule immune modulators.​

This exclusive option and multi-year collaboration agreement will be focused on the optimization and development of oral protein degraders targeting hematopoietic progenitor kinase 1 (HPK1), a key regulator of immune cell activation and a high-priority target in immune-oncology. The collaboration aims to accelerate the development of novel, best-in-class HPK1 degraders that stimulate robust anti-tumor immunity. The research will be conducted by leading scientists at both Cullinan and Icahn Mount Sinai. Cullinan will fund the collaboration and has an exclusive option to license the intellectual property for further development and commercialization.

The Icahn Mount Sinai team will be co-led by Steven J. Burakoff, M.D., Lillian and Henry M. Stratton Professor of Cancer Medicine, Dean for Cancer Innovation, and Chief, Pediatric Oncology at Icahn Mount Sinai, and Jian Jin, Ph.D., Mount Sinai Professor in Therapeutics Discovery and Director, Mount Sinai Center for Therapeutics Discovery, at Icahn Mount Sinai.

Our team is excited to work with the talented and experienced cancer drug developers at Cullinan. Our research has already demonstrated that a degrader approach to targeting HPK1 may control tumor growth more effectively compared to simply inhibiting HPK1 kinase activity. We believe this collaboration will help us identify novel, differentiated oral HPK1 degraders and can bring future benefit to cancer patients worldwide.”

 Dr. Jin

“We are proud to partner with Icahn Mount Sinai, which is at the forefront of cancer research and patient care,” said Leigh Zawel, Chief Scientific Officer, Small Molecules, of Cullinan Oncology. “We are very excited to build on the synergy between the deep scientific expertise of the Icahn Mount Sinai team and the strong drug development capabilities at Cullinan to advance therapies that have the potential to significantly improve the lives of patients with cancer. We look forward to a fruitful collaboration in this novel area of science.”

About Cullinan Oncology
Cullinan Oncology is a biopharmaceutical company that is developing a diversified pipeline of targeted therapeutic candidates across multiple modalities in order to bring important medicines to cancer patients. The Company’s strategy is to source innovation through both internal discovery efforts and external collaborations, focusing on advanced stage assets with novel technology platforms and differentiated mechanisms. 

Spotlight

Metabolomics is an emerging field of “omics” concerned with measuring and interpreting the metabolic state (i.e. metabolome) and is an essential technology for defining the key functional attributes of tumors or cancer cells.


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BUSINESS INSIGHTS

Suvoda and N-SIDE Announce Agreement to Deliver Integrated Clinical Trial Optimization and IRT Solutions for Real-Time Demand Planning

Suvoda LLC | May 13, 2022

Suvoda LLC, a global clinical trial technology company that specializes in complex studies in therapeutic areas such as oncology, central nervous system, and rare disease, today announced they have entered into an agreement to partner with N-SIDE — a deeptech company that empowers organizations in the clinical trials industry to make better decisions and optimize the use of critical resources.  To date, the two companies have successfully partnered on more than 100 clinical trials in drug development, activating machine learning based on real-time data and increased efficiency in trial supply. Suvoda's IRT enables the implementation of optimized resupply strategies with adapted IRT algorithms that seamlessly integrate N-SIDE's forecasting and mathematical optimization recommendations. This results in significant cost savings through reduced drug wastage and accelerated trial timelines. Partnership Delivers Faster Start and Flexible Supply Strategy The most successful forecasting and optimization strategies consider the end-to-end supply chain, including impact assessments of trial design decisions. Efficient strategies — like the ones jointly deployed by N-SIDE and Suvoda — must be carefully evaluated and implemented, and have the flexibility to adapt in real-time to the unknowns that come with clinical trials. "As global clinical trials grow more complex, clinical trial professionals need the right partners and tools to help them gain control and account for the 'what ifs' as quickly as possible. N-SIDE has a history of excellence in clinical supply optimization that is unrivaled in the industry, and Suvoda is known for delivering clinical trial technology solutions that are built to manage change quickly. Our seamless integration and deep expertise will enable study teams to focus on other day-to-day decisions, while giving them peace of mind in their drug supply strategy." Anthony Encarnacao, Vice President, Global Partnerships for Suvoda This partnership allows for the inclusion of a flexible IRT solution during the development of the trial protocol, giving Suvoda greater visibility into the supply chain parameters based on the protocol discussions and finalization. Moving IRT more upstream in the startup process helps mitigate the risks and time constraints associated with last minute IRT implementations. Clients also gain access to N-SIDE's real-time monitoring of recruitments, demands, and inventories, supported by Suvoda's data. Coupled with N-SIDE's optimization, sponsors and CROs will experience an expedited IRT contracting, set-up, and build process, with greater optimization after study go-live. "In a world where decisions are made every day by different teams, with different objectives, it is easy to forget the impact that decisions have outside of one's team," explains Amaury Jeandrain, head of BD engineering at N-SIDE. "We connect clinical operations, supply chain, manufacturing, and IRT to ensure a global optimum that reduces drug waste while increasing patient centricity and accelerating trial timelines. And, working with partners like Suvoda, who understand this challenge and are able to bring flexibility and efficiency within their solutions, is a big step towards this objective." About Suvoda Suvoda is a global clinical trial technology company that specializes in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest, Romania and Tokyo, Japan. The company consistently boasts a Net Promoter Score (NPS) of close to 70, far exceeding the technology industry average of 50, and has been selected by trial sponsors and CROs to support more than 1000 trials across 65 countries. About N-SIDE N-SIDE is a deeptech company that empowers organizations in the life sciences to make better decisions and optimize the use of critical resources. We're doing so by combining deep industry expertise with applied mathematics and artificial intelligence into easy to use and cutting-edge software that transforms uncertainty and complexity into clear decisions. We have been an active player in clinical trial supply chain management for over 20 years and work with the majority of the top 20 pharmaceutical companies. With our software solution, the N-SIDE Suite, and expert services, we streamline the clinical supply of pharmaceutical and biotech companies by accelerating clinical plans, mitigating risks and curbing drug waste. We empower clinical leaders to make better, faster, and safer decisions for patients waiting for life-changing medications. Our successes on over 10,000 trials include an average of 20%-60% of drug waste and cost reduction, with no delays due to drug shortages and an acceleration of 2-6 months of clinical trial timelines.

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BUSINESS INSIGHTS

Telix Granted FDA Orphan Drug Designation for Bone Marrow Conditioning Treatment

Telix Pharmaceuticals Limited | March 29, 2022

Telix Pharmaceuticals Limited announces that the United States Food and Drug Administration has granted Orphan Drug Designation for TLX66 for conditioning treatment prior to hematopoietic stem cell transplant. The granting of an ODD for TLX66 qualifies Telix for various drug development incentives, which may include FDA administered market exclusivity for seven years, waived FDA prescription drug user fees, and tax credits for R&D and clinical development costs. Bone marrow conditioning is performed prior to HSCT, a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells (cells that can develop into different types of cells), to encourage production of new bone marrow that produces healthy blood cells. Traditional conditioning regimens are associated with morbidity and mortality from chemotherapy, limiting their use particularly in pediatric and rare diseases.[1] TLX66 has the potential to add to the depth of conditioning, thereby removing additional disease-causing cells. In addition, TLX66's potential to reduce the toxicity of existing conditioning regimens could increase the number of patients that are eligible for transplant. HSCT is being used increasingly in malignant hematological conditions, such as multiple myeloma and acute myeloid leukemia, and in non-hematological malignancies and rare / immune-mediated diseases.[2] In 2018, 22,729 HSCTs were performed in the United States.[3] During 2021, the Company reported initial results for safety and tolerability for the Targeted Radiotherapy for AL-amyloidosis, a Phase I trial conducted at the University of Southampton, United Kingdom.[4] The study found that TLX66 was well-tolerated in patients with systemic amyloid light chain amyloidosis, enabling successful engraftment of the patients' own transplanted stem cells without the need for toxic chemotherapy in this rare immune condition with a poor prognosis. "The granting of an Orphan Drug Designation by the FDA for TLX66, combined with recent encouraging data from prior studies in hematological malignancies and autoimmune disease provides a strong impetus to advance our development plans for TLX66. This treatment has potential application in a number of hematological cancers and rare diseases and potentially also in the future for conditioning for cell and gene therapies." Telix Chief Medical Officer, Dr Colin Hayward TLX66 has also previously been granted ODD status by the European Medicines Agency in Europe for treatment in hematopoietic stem cell transplantation. TLX66 has not received a marketing authorisation approval in any jurisdiction. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.

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SiO2 Materials Science and Doosan Corporation Enter Into Strategic Partnership to Accelerate Market Development in Asia

SiO2 Materials Science | December 27, 2021

Doosan Corporation, founded in 1896, one of South Korea's largest diversified conglomerates, and SiO2 Materials Science, a privately-owned U.S. advanced materials science corporation introducing breakthrough disruptive technology for packaging biological pharmaceuticals and vaccines, announced an exclusive partnership to sell, market, and distribute SIO2's vial, syringes and blood collection tubes in Asia/Oceania. The partnership will focus initially on the pharmaceutical and diagnostics markets but will extend to other markets through the joint development of new technologies. As part of the strategic partnership, Doosan will invest $100 million into SiO2 and will additionally invest in substantial infrastructure and human resources for the acceleration of the business in Asia/Oceania. The partners have defined key volume milestones over a 15 year period. "The Asia and Oceania region represents a significant market opportunity for vials and syringes specifically designed for biologic drugs and vaccines. South Korea has become a world leader in biological drug manufacturing, so it makes sense to establish a strong presence with a respected partners in the market," says Lawrence Ganti, President of SiO2 Materials Sciences The SiO2 Materials Sciences technology platform combines the benefits of glass and plastic while eliminating the drawbacks of both. The technology has been commercially validated through the packaging of hundreds of millions of COVID-19 vaccine doses around the world and is working with more than 100 active projects with leading pharmaceutical and diagnostic companies to bring their products to market in a safer container. The company was a key collaborator and part of the US Government's COVID-19 Response (formerly known as Operation Warp Speed) and has expanded its manufacturing footprint in Auburn, Alabama, more than 12-fold in the last 18 months. "South Korea is a strategic hub for biologic drug manufacturing. Doosan believes that the SiO2 technology would greatly support the packaging of these new drugs and vaccines and are proud to exclusively represent the technology in Asia," says Han Lee, Vice President of Doosan. "There is so much potential in the SiO2 technology, and we will also jointly develop new technologies and products by bringing our existing technologies and engineering minds together," says Chief Business Officer of Doosan Corporation. About SiO2 Materials Science SiO2 Materials Science is an advanced materials science corporation introducing breakthrough disruptive technology serving the biopharma, molecular diagnostic, and consumer healthcare industries. The company is located in Auburn, Alabama. The company has deep partnerships with leading professors at the foremost research universities such as University of California - Santa Barbara, University of Chicago, and MIT / Harvard. About Doosan Doosan Corporation is Korea's oldest conglomerate, founded in 1896. The company operates across multiple divisions such as: Electro-Materials, Industrial Vehicles, Fuel Cell Power, Retail, and Digital Innovation. The company is always developing innovative new business in support of materials science.

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PHARMACY MARKET

IAMA Therapeutics Partners with the Italian Institute of Technology to Embark on Landmark Research on Neuroscience Drug Discovery

IAMA Therapeutics | March 31, 2022

IAMA Therapeutics, a Series A preclinical-stage pharmaceutical company focused on the discovery, development, and commercialization of novel medicines to make a difference in the lives of individuals suffering from brain disorders, today announced a strategic collaboration with the IIT-Istituto Italiano di Tecnologia where they will design and profile new classes of compounds targeting cation cotransporters in the CNS area. This partnership consolidates a scientific collaboration between IAMA Therapeutics and IIT, which signed, together with the Telethon Foundation earlier in 2021, a license agreement, granting IAMA therapeutics an exclusive, worldwide license to research, develop, manufacture, and commercialize a novel class of modulators of intracellular chloride concentration. "We are pleased with and excited by this partnering opportunity with IAMA Therapeutics, a clear example of IIT technology transfer approach. We are setting the Italian way of producing science and tech-based innovation, where the collaboration among brilliant researchers, important founding agencies like Fondazione Telethon, and investors creates the right ecosystem enabling new businesses to emerge." Dr. Matteo Bonfanti, Director of Technology Transfer at Istituto Italiano di Tecnologia "We are very happy for the partnership between IAMA Therapeutics and IIT," said Francesca Pasinelli, General Manager of Fondazione Telethon. "This collaboration is based on innovative science, which was selected and nurtured earlier on by Fondazione Telethon. As part of our focus on fostering development, we funded the project and supported researchers through the technology transfer process together with IIT. Now, this promising research avenue is accessing the resources and competencies necessary to take and accelerate the long and expensive path to patients. It shows what can be accomplished through a timely and coordinated effort to maximize research impact". About IAMA Therapeutics IAMA Therapeutics is a pharmaceutical company that couples emerging advances in drug discovery and neurobiology to build a leading, next-generation neuroscience pipeline. We have developed a platform to identify and advance diverse classes of small molecules to selectively inhibit the sodium potassium chloride cotransporter and other therapeutic targets relevant to treating central nervous system disorders characterized by neuronal imbalance, including primary and secondary autism, epilepsy, and movement disorders. About Istituto Italiano di Tecnologia Istituto Italiano di Tecnologia is a foundation established jointly by the Italian Ministry of Education, Universities, Research, and the Ministry of Economic and Finance to promote excellence in basic and applied research and contribute to Italy's economic development. The primary goals of the IIT are the creation and dissemination of scientific knowledge and the strengthening of Italy's technological competitiveness. To achieve these two goals, the IIT cooperates with academic institutions and private organizations, fostering scientific development, technological advances, and training in high technology. About Fondazione Telethon Fondazione Telethon is a major biomedical charity in Italy whose mission is to advance biomedical research to cure rare genetic diseases. Throughout its 32 years of activity, Fondazione Telethon has invested almost €600 million in funding over 2,700 projects to study 580 diseases, involving more than 1,600 researchers in Italy. As part of its goal to foster development and maximize the therapeutic impact of research, Fondazione Telethon further pursues cooperation with academia, industry, and venture capital through the creation of partnerships and start-ups.

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