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LONDON and MONTREAL, Oct. 24, 2024 /PRNewswire/ -- Cancer Research UK, one of the world's largest funders of cancer research, and KisoJi Biotechnology Inc., a company focussed on the discovery and development of antibody therapeutics, have signed a landmark agreement to bring KisoJi's lead asset, KJ-103, into a first-in-human clinical trial. KJ-103 is a naked anti-TROP2 antibody that has been created by KisoJi using its proprietary antibody technology. Continue Reading Cancer Research UK Logo Under the agreement, Cancer Research UK's Centre for Drug Development (CDD) will sponsor, design and deliver a Phase 1/2a clinical trial of KJ-103, in selected TROP2 expressing solid tumours. KisoJi will supply the antibody for the clinical trial and work with CDD to complete the preclinical package. Cancer Research Horizons, Cancer Research UK's innovation arm, will manage the commercial relationship. Unlike antibody drug conjugates (ADCs), KJ-103 does not require a cytotoxic payload but instead functions by recruiting immune cells to kill tumour cells. KJ-103 binds to TROP2 in a location distinct from where current TROP2 ADCs bind. It uses TROP2 as a way of directing macrophage activation and phagocytosis of the tumour cells expressing it, leading to tumour cell death. KJ-103 may provide an alternative treatment option for TROP2-expressing cancers in which TROP2 ADCs have proven ineffective or are not suitable due to their toxicity profile. Tumour types expressing TROP2 include: colorectal, head and neck, ovarian, breast, bladder and lung cancers. Lars Erwig, Director of the CDD, said: "We are excited to collaborate with KisoJi to bring KJ-103 into clinical development. This partnership aligns with our mission to explore innovative therapeutic approaches for hard-to-treat cancers. With KJ-103's unique mechanism of action, which harnesses the body's immune system without the potential toxicity of a drug conjugate, we hope to offer new treatment options for patients with TROP2-expressing solid tumours." David Young, co-founder and CEO of KisoJi said: "We are thrilled to be advancing KJ-103 into the clinic in partnership with Cancer Research UK. As the first naked antibody to target TROP2 cancers, KJ-103 is the first of a new wave of antibodies to come from our modernised technology platform that leverages AI grounded in biology to create transformative antibody therapeutics." About Cancer Research UK's Centre for Drug Development Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 30 years, taking over 160 potential new anti-cancer agents into clinical trials in patients. Six of these new agents have made it to market, including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase 3 trials. Thirteen agents remain in active development with the potential to reach the market. It currently has a portfolio of 16 projects in preclinical development, Phase 1 or early Phase 2 clinical trials. About KisoJi Biotechnology KisoJi is a Canadian biotechnology company that deploys the latest scientific and AI tools to conduct therapeutic antibody discovery in a fundamentally new way. KisoJi has developed a multi-species transgenic mouse to generate highly diverse single domain antibodies, as well as a modular multi-specific antibody scaffold with high stability and productivity. Most recently, KisoJi has used advanced AI tools to visualise the universe of all antibodies against a target in order to uncover novel biology and new therapeutic antibody capabilities for its partners and its own pipeline. About KJ-103 KJ-103 is a single domain antibody that binds to a unique epitope on TROP2. It acts via effector cell mechanisms, including the activation of macrophages, to kill tumour cells. KJ-103 has been shown to have significant anti-tumour potency with no evidence of toxicity or resistance across a number of preclinical solid tumor models. KJ-103 was humanised by LifeArc. Cancer Research UK Contact: Tim Bodicoat [email protected] +44 203 469 8300 +44 203 469 8301 (out of hours) KisoJi Biotechnology Contact: Investors and Media Argot Partners Sam Martin/Cameron Willis [email protected] +1 212 600 1902 SOURCE KisoJi Biotechnology Inc.; Cancer Research UK WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Techbio is a field where the computational expertise of the tech sector and the biological know-how of the biotech sector converge. This leads to applications including the use of clinical and genomic data as well as sophisticated artificial intelligence (AI) algorithms to cut healthcare costs, deliver personalized medicine, and speed up drug discovery. “If you're not leveraging tech, you're not competitive,” said Leigh Brody, investment manager at the UK firm AlbionVC, on the panel Investment for TechBio companies. “There is no way back anymore.” Chris Baker, investment principal at the charity LifeArc Ventures, acknowledged that techbio is in the industry spotlight, with AI-based computational tools for drug discovery developed by Google DeepMind winning part of this year’s Nobel Prize in Chemistry. Even with the biotech market being slow to invest in companies at present, techbio companies that are “on trend” will get capital, he said. And while big pharma companies waited and watched the space for a time, the giants have begun to share their resources with techbio players in mounting partnership and licensing deals, Brody said. "We are finally seeing everyone jump in at different levels,” she added. From struggling startup to big pharma acquisition The panel saw Eli Lilly’s acquisition of the UK-based company Aparito earlier this year as a sign of how big pharma has come around to the promise of techbio. Aparito has developed an app platform that lets patients measure their clinical progress using their own devices, letting healthcare professionals monitor them remotely in clinical trials. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Back when Aparito’s CEO and founder Elin Haf Davies set up the company, however, techbio companies found it harder to attract backers. "None of the tech investors got us and none of the life science investors got us,” Haf Davies explained. She later said she “pitched to all these funds and was rejected time and time again." While Aparito raised less funding than its techbio peers, the Wrexham-based business carved out its own niche by focusing on academic and patient group partnerships in addition to other collaborations. It also focused on having a revenue model from the start, with constant feedback from clients, which have different metrics to those of investors. With the Lilly acquisition in the bag, Haf Davies sees things turning around for techbio startups nowadays. "These things take time to mature, and I'm sure that the pace of change will be much quicker now," she said. Business models and investors Specialist tech and biotech investors were reluctant to take the plunge in the past but they are beginning to bridge the techbio “gray area” between the two spaces, Brody said. However, there is plenty of room for generalists such as angel investors to come in and support techbio companies, she noted. On the other hand, generalists are sometimes unprepared for the inevitable nuances of a techbio business, and this can complicate efforts to move the company forward, said Baker. For example, techbio companies have a diverse array of business models, including offering a software as a service (SaaS) or using their technology to develop a pipeline of products. A company evolving its business model when times are difficult can lead investors with different theses to disagree on the destination of the company, Baker said. There are other inevitable headwinds for investors and founders, with one being that sealing a collaboration or licensing deal with pharma companies can take 12 to 18 months, Brody said. This can be “very burdensome on companies, especially when they're raising money,” she explained, adding that many companies seek bridge funding rounds until they can close revenue-generating deals, which can be a challenge for investors to navigate. Tips for techbio success One of the main tips for techbio investors is that they should look outside their usual horizons and consider non-traditional founders and locations, Haf Davies said. One spectacular example of this was social impact investors in Aparito, which received a greater than 10 times return on their investment, she noted. On the other side of the coin, founders should be enthusiastic about their technology but, given limited time and capital, channel the enthusiasm properly with real deliverables and objectives ironed out, the panellists said. Meanwhile, they should keep in mind that there are different ways of succeeding in techbio other than the traditional investment and exit focus, Haf Davies emphasized. “I can assure every single founder out there that the highs and the lows are particularly extreme, and that's why you have to make sure that you're enjoying the journey of building the company,” Haf Davies noted.

Astellas receives an exclusive option to license AVB-101, an investigational, AAV-based gene therapy in Phase 1/2 development AviadoBio receives $20 million equity investment, up to $30 million in upfront payments and is eligible to receive up to $2.18 billion in license fees and milestone payments plus royalties if Astellas exercises its option LONDON, UK and TOKYO, Japan I October 8, 2024 I AviadoBio Ltd. (“AviadoBio”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced an exclusive option and license agreement for AVB-101, an investigational, AAV-based gene therapy in Phase 1/2 development for patients with frontotemporal dementia with progranulin mutations (FTD-GRN). FTD is a devastating form of early-onset dementia that typically leads to death within three to 13 years from diagnosis.  People with FTD commonly experience a rapid decline in executive function (attention control, working memory, problem-solving etc.), uncharacteristic behaviors, loss of language, apathy, and reduced mobility. It is an important cause of dementia in those under the age of 65 and is often underrecognized, and misdiagnosed. 1,2,3,4 Under the terms of the agreement, Astellas will have the option to receive a worldwide exclusive license for the development and commercialization rights to AVB-101 in FTD-GRN and other potential indications. Astellas will make a $20 million equity investment and up to $30 million in upfront payments for the option to license AVB-101. AviadoBio is also eligible to receive up to $2.18 billion in license fees and milestone payments plus royalties if Astellas exercises its option. Lisa Deschamps, CEO, AviadoBio “As we complete dosing of the first cohort of patients in our Phase 1/2 ASPIRE-FTD trial of AVB-101, we are excited about the potential of this collaboration to help address the unmet need that exists today in frontotemporal dementia. This strategic collaboration will combine our promising gene therapy candidate for FTD-GRN and delivery expertise with Astellas’ global capabilities in development and commercialization of gene therapies. Together, we can further accelerate delivering this investigational medicine to families around the world who so desperately need treatment options for FTD-GRN and other neurological diseases.” Adam Pearson, Chief Strategy Officer, Astellas “We look forward to collaborating with the team at AviadoBio as we expand our gene therapy pipeline to help a broader range of people living with debilitating, neurodegenerative diseases. AVB-101 represents a truly innovative approach to the treatment of FTD-GRN and has the potential to be part of the next generation of gene therapy products through the creation of this agreement. Genetic regulation remains a cornerstone of our primary focus strategy at Astellas and this agreement helps us to continue to provide potential solutions for patients in need.” About AviadoBio At AviadoBio, we are relentlessly chasing cures by translating groundbreaking science and precision delivery into life-changing medicines for people living with neurological conditions. With our deep understanding of the brain and suite of proprietary gene therapy platforms and delivery technologies, AviadoBio is working to overcome the challenges of delivering the right drug to the right place. Its innovative, neuroanatomy-led approach is designed to maximize the therapeutic potential of gene therapy to halt or potentially reverse neurodegenerative diseases. AviadoBio was founded on pioneering research from King’s College London and the UK Dementia Research Institute and has a leadership team with extensive gene therapy development, delivery, and commercialization experience which uniquely positions the company for success in bringing transformative medicines to patients. AviadoBio’s investors include New Enterprise Associates (NEA), Monograph Capital, F-Prime Capital, Johnson & Johnson Innovation – JJDC, Inc. (JJDC), SV Health Investor’s Dementia Discovery Fund (DDF), Advent Life Sciences, EQT Life Sciences (Dementia Fund), and LifeArc Ventures. For more information, please visit www.aviadobio.com and follow us on X @AviadoBio and LinkedIn at AviadoBio . About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ ® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en . About Astellas Gene Therapies Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines with the potential to deliver transformative value for patients. Our gene therapy drug discovery engine is built around innovative science, a validated AAV platform, and industry leading internal manufacturing capability with a particular focus on rare diseases of the eye, CNS and neuromuscular system. Astellas Gene Therapies will also be advancing additional Astellas gene therapy programs toward clinical investigation. Astellas Gene Therapies is based in South San Francisco, with manufacturing and laboratory facilities in South San Francisco, Calif., Sanford, N.C. and Tsukuba, Japan. SOURCE: Astellas Pharma