Fusion Pharmaceuticals Targeted Alpha Therapies for Cancer

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the opening of its state-of-the-art radiopharmaceutical manufacturing facility. The 27,000 square foot good manufacturing practice (GMP) compliant facility, which is located adjacent to the Company's research and development labs, has clinical and commercial manufacturing scale capabilities designed to support the Company's growing pipeline of targeted alpha therapies (TATs).

"Manufacturing and supply chain are critical components of radiopharmaceutical development and commercialization. Having spun out of a radiopharmaceutical manufacturer, this is a core competency for Fusion, and we believe we are well-positioned to scale production in support of our pipeline of TATs, which now includes five clinical-stage programs," said Fusion Chief Executive Officer John Valliant, Ph.D. "The location of the facility, adjacent to both our internal research organization and McMaster University, a world-class institution that specializes in medical isotope research and training, enables us to efficiently advance new TATs and hire experienced talent to execute on our clinical and future commercial plans."

The new manufacturing facility, part of a 15-year lease agreement with Hamilton, Ontario-based McMaster University, was built by McMaster and equipped and validated by Fusion. At full capacity, it is expected to produce more than 100,000 doses of TATs per year.

Fusion Pharmaceuticals is a spin out company of the Centre for Probe Development and Commercialization (CPDC) hosted at McMaster and founded by Dr. Valliant, who is also a McMaster chemistry professor.

"McMaster University is a pioneer in medical isotope research and the McMaster Innovation Park is the ideal location to produce the next generation radiopharmaceuticals for cancer therapy," said David Farrar, president of McMaster University. "We're proud to expand on our partnership with Fusion –– and to grow our region's biotechnology and biomanufacturing sector."

To ensure scalability and redundancy, Fusion plans to continue to leverage existing contract development and manufacturing organization (CDMO) relationships with Cardinal Health, SpectronRx, Radiomedix and AtomVie.

"With the complexity of just-in-time manufacturing for radiopharmaceuticals, diversification in supply chain and redundancy in production is vital to ensuring reliable patient access to therapy," said Fusion Chief Technology Officer Eric Burak, Ph.D. "Coupled with our previous investments in actinium supply, this new facility provides further control for our entire supply chain to meet the growing patient demand for targeted alpha therapies."

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Response Inhibitors (DDRis) and immuno-oncology agents. The Company recently received IND clearance for the first novel TAT under the collaboration, which targets EGFR-cMET. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion's growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, Inc. and BWXT Medical.

SofySense Testing with AI and No-Code Automation

Today, Sofy, a testing platform for software developers which accelerates product release times by 95 percent, is launching SofySense — the world’s first mobile app testing solution that integrates AI and no-code automation. SofySense enhances Sofy’s existing platform with GPT-integrated intelligent software testing AI technology. SofySense removes the burdensome, cumbersome, and mundane processes and tasks in writing test cases, freeing up testers for more strategic efforts and greatly accelerating product release times. It is also a significant step towards true self-healing software.

Software developers currently spend 20 - 50 percent of their overall time on testing, figuring out the order of operations and the right tests to identify errors in code. This testing is expensive, accounting for 23 - 35 percent of overall IT spend. And while test automation generally reduces development time and associated costs, with SofySense, the benefits of automation increase exponentially. SofySense intelligently looks at the technical documentation and generates testing operations so software testers can modify them to suit their needs and focus on more impactful tasks.

“SofySense is not just a mobile app testing solution, it's the future of intelligent test automation. With years in the making, SofySense builds upon the team's 20 plus years of experience and shared knowledge to integrate AI and no-code automation seamlessly,” said Syed Hamid, founder and CEO, Sofy. “Similar to how ChatGPT can generate human-like text in a matter of moments, with SofySense we’ve enabled AI technology in a useful way, helping testers author and execute tests in seconds.”

SofySense leverages the power of OpenAI's large language models to provide advanced insights, analysis, and assistance for all of an organization's QA needs. This allows users to quickly identify patterns and trends in their test results and generate test cases that can be used to make informed decisions about their overall testing strategy.

The integrated solution is an intelligent resource providing answers to specific test questions, giving users knowledge about their test cases and results, empowering them to test earlier and more often with greater confidence.

With SofySense, organizations can streamline their testing processes while ensuring high-quality releases. It provides a modern way to quickly gather test results, augment test creations, and find answers to questions in one place.

For more information on Sofy, please visit sofy.ai.

NWEA to Explore New Science Experiences

NWEA – a not-for-profit, research and educational services organization serving K-12 students – announced today its new initiative focused on collaborative and immersive education opportunities on Roblox – a global platform bringing millions of people together through shared experiences. Utilizing a Roblox Community Fund grant, the organization will explore innovative ways to use 3D immersive experiences to engage students in the study of science and assess their achievements in the subject.

While assessments are vital in traditional coursework, the results only demonstrate one small piece of a larger puzzle of what students know and are capable of achieving. Current assessments often leave out non-academic skills like student-decision making or progress toward reaching a goal. This is especially true when exploring Next Generation Science Standards.

"This collaboration allows us to explore science as a verb by looking at how students engage in solving science instead of science as a noun," said Dr. Abby Andres, Vice President of the Future Impact and Growth team at NWEA. "We're excited to create high quality science experiences that can lead to new (and richer) data, new measurement opportunities that are both academic and non-academic, and ultimately better insights for teachers."

As part of the Roblox Community Fund, Roblox has provided a grant to NWEA to work with Filament Games, an educational game developer known for such projects as the Mission: Mars designed for the Museum of Science, Boston and launched on the Roblox platform. Filament will build the unique science experience for NWEA to be launched on the Roblox platform.

NWEA Science content and measurement experts are providing the vision, direction, assessment, and research expertise for the project, which is set to begin this spring with the potential of a prototype available to Roblox participants in late 2023.

NWEA® (formerly known as Northwest Evaluation Association) is a mission-driven, not-for-profit organization that supports students and educators in more than 146 countries through research, assessment solutions, policy and advocacy services, professional learning and school improvement services that fight for equity, drive classroom impact and push for systemic change in our educational communities. Visit NWEA.org to learn more about how we're partnering with educators to help all kids learn.

TVM Capital Life Science see Up-and-Coming Leaders

TVM Capital Life Science, a leading international venture capital firm focused on investments in life sciences innovation, today announced the promotion of Dr. Valentina Agostoni and Catello Somma to Senior Associate and Philipp Lechner to Senior Associate Corporate Finance.

“I congratulate our three talented Senior Associates. We are delighted to recognize the contributions Valentina, Catello and Philipp have made to the Company as well as their achievements with these well-deserved promotions. It is gratifying to see each of them expand their roles in our team and take on increased responsibilities,“ said Dr. Luc Marengère, Managing Partner at TVM Capital Life Science.

Dr. Hubert Birner, Managing Partner at TVM Capital Life Science, added: “These promotions underscore TVM’s commitment to professional development and talent recognition. Growing the next generation of leaders is an integral part of our strategy to position TVM for continued success. Each of these individuals brings different backgrounds, views and strengths to the team, which is essential to creating value for both our portfolio companies and investors.”

Valentina Agostoni, PhD joined TVM in December 2019, supporting the team in all stages of the investment process, particularly in deal flow screening and due diligence. Before joining TVM, she worked in preclinical development at Versantis AG and Mperia Therapeutics Inc, where she was involved in the clinical translation, from lead optimization to IND-enabling studies, of novel therapeutics across different disease areas. Valentina holds a Master’s degree in medical biotechnology from the University of Milano Bicocca and a PhD in biopharmacy and pharmaceutical technologies from the University of Paris-Saclay. She was the recipient of a Marie Curie ITN scholarship and conducted postdoctoral research in drug delivery and formulation at the Swiss Federal Institute of Technology Zurich (ETH-Zurich). She has co-authored several scientific articles and is co-inventor of 2 patents.

Catello Somma joined TVM in January 2020 and has played an integral role in deal flow generation and investment due diligence, as well as deal and exit transactions. Catello is a biotech start-up founder with more than ten years of clinical development and corporate development experience. Prior to this role, Catello worked for a mid-cap biotech where he supported the development of immuno-oncology assets, both internal and in partnership with big pharma, including the preparatory work for a successful licensing opportunity. Catello holds an MSc in molecular biology from the Università degli Studi di Napoli Federico II and an MBA with a major in finance, from MIP Politecnico di Milano.

Philipp Lechner joined TVM in July 2020. He is active in investment due diligence, deal and exit transactions as well as corporate finance and fund administration aspects of the fund. Prior to joining TVM, Philipp worked for the Global Healthcare Team at Société Générale Corporate & Investment Banking. In this role, he was involved in several cross-border M&A transactions in different healthcare industries. He holds a Master’s degree in international finance and economics from the Nuremberg Institute of Technology, with a focus on financial markets and corporate finance, and did additional business and finance studies in London, UK and Nuertingen, Germany.

TVM Capital Life Science (“TVM”) is a leading international venture capital firm focused on investing in life science innovations. The company has a highly experienced transatlantic investment team and approximately $900 million under management. TVM’s portfolio focuses on therapeutics and medical technologies from North America and the EU that represent differentiated first-in-class or best-in-class assets with the potential to transform standard of care. TVM pursues a unique two-pronged strategy, financing innovative early-stage therapeutics through a single asset company approach (Project-Focused Company, PFC) that leverages the firm’s strategic relationship with global pharmaceutical firm, Eli Lilly and Company. TVM also invests in differentiated commercial-stage medical technologies and late clinical-stage therapeutics.

The TVM investment team has worked together for over a decade to effectively utilize this innovative approach to maximize returns for investors and finance new therapies and technologies to meaningfully improve patient lives.