Gammadelta Therapeutics Ltd.

Board strengthened with appointments of Tim Haines (Abingworth) as Non-executive Chair and Dr Oliver Nussbaumer (co-founder of GammaDelta Therapeutics and Adaptate Biotherapeutics) and Dr Inga Deakin (Molten Ventures) as Non-executive Directors London, UK, 24 January 2024 — IMU Biosciences (or “the Company”), a techbio company revolutionising immune powered precision medicine, today announces the close of a £11.5 million Series A financing round. The round was led by European tech VC Molten Ventures and included LifeX Ventures and other individuals. IMU Biosciences is coupling deep, systems-level immune profiling with a proprietary AI platform to build a uniquely detailed immune atlas spanning the breadth of human health and disease. Its CytAtlas® platform is fuelling a new understanding of the immune system to power the future of translational research and clinical practice, from diagnostics to drug development and treatment response, and with application across multiple high-growth areas, including immune-oncology, cell therapy, autoimmune disorders and transplantation. In immuno-oncology, IMU’s unique approach enables rapid immunophenotyping from liquid biopsy (blood) samples to enable patients to be matched with therapy that is most likely to be effective, while also providing ongoing and real-time immune monitoring along the entire patient journey to maximise therapeutic impact and safety. Furthermore in cell therapy, IMU’s platform is being applied to identify immune signatures in donors that predict for efficient and consistent cell therapy expansion thereby significantly improving manufacturing efficiency – a major challenge in this nascent field. "With our technology, we’re building the world's largest immune data assets across health and disease, which allows us to perform analyses with a level of depth and granularity that was previously unthinkable," said Dr Adam Laing, CEO and Co-founder of IMU Biosciences. “This systems-level approach to understanding immune function enables us to look at the bigger picture rather than just focusing on individual disease-associated parameters. Our goal is to revolutionise precision medicine, improving its effectiveness, reducing failure rates in clinical trials, and making these therapies more viable in the long run.” "Our technology could fundamentally change how we approach patient stratification for advanced therapies, disease monitoring and diagnostics," explained Dr Tom Hayday, CSO and Co-founder of IMU Biosciences. "We're talking about better patient outcomes, more effective therapies, and even cost reductions in healthcare over the long term. This potential is already being recognised by pharma and biotech companies as well as leading academic institutions, offering us multiple opportunities to create significant value from strategic collaborations that leverage our unique approach." The new capital raised through the Series A round will be deployed to supercharge IMU Biosciences' expansive roadmap, including advancing its novel CytAtlas® platform, fostering new strategic partnerships and projects, conducting cutting-edge, large-scale immune research, and expanding its operations into the Boston/Cambridge, MA area. Dr Inga Deakin, Principal, Molten Ventures said:“IMU's technology has the potential to transform our understanding of the immune system. Its advanced AI platform – combined with deep immune data profiling – enables unique insights into the immune system, which plays a critical role in virtually every disease. We are thrilled to lead this investment round and support IMU in their journey towards groundbreaking discoveries in healthcare.” In conjunction with the fundraising, Tim Haines was appointed to the IMU Biosciences board of directors as Non-executive Chair and Dr Oliver Nussbaumer and Dr Inga Deakin were appointed as Non-executive Directors. Tim is Executive Partner at Abingworth, a leading international life sciences investment group, and brings more than 30 years of international investor and management experience in the life sciences industry. Oliver is a leading immunologist specialising on innate immune cells and their use in immuno-oncology, early research and development to IND. He was R&D Distinguished Fellow (Executive Scientific Director), Cell Therapy Innovations at Takeda and a co-founder of GammaDelta Therapeutics and Adaptate Biotherapeutics (both acquired by Takeda in 2022). Inga is a Principal at Molten Ventures with over 10 years’ experience building and investing in life science and digital health companies. She spent three years in the US, gaining international industry and healthcare experience, as Chief of Staff in a commercial stage molecular diagnostics company and as Entrepreneur in Residence at Duke University. IMU Biosciences was founded in 2021 by Dr Adam Laing (Chief Executive Officer), Dr Tom Hayday (Chief Scientific Officer) and Mario Cantero (Chief Operating Officer), based on ten years of research out of the laboratory of Professor Adrian Hayday at King’s College London. Applying AI-driven data analytics to immunology research crystalised further when COVID-19 emerged, and the team leveraged its technology to understand the human immune response to the virus. IMU Biosciences has further validated and fine-tuned its unique approach in partnership with leading pharmaceutical and biotech companies. The Company was initially seed funded by the European technology investor Kfund and other angel investors. Ends About Molten Ventures Molten Ventures plc is one of the most active venture capital firms in Europe, developing and investing in disruptive, high growth technology companies. We believe it is our role to support the visionary entrepreneurs who will invent the future. We fuel their growth with our ‘energy’ in the form of truly patient capital, access to international networks and decades of experience building businesses. Currently, Molten Ventures is a shareholder in a diverse portfolio of companies including Revolut, Trustpilot, Ledger and Thought Machine. For more information please visit: About LifeX Ventures LifeX Ventures is a New York-based venture capital firm investing in global visionary entrepreneurs using software and AI to develop transformational solutions that will extend the life of humans and the planet. With its $100M debut fund, LifeX is targeting the two largest sectors in the world: People (bio/health) and Planet (climate), where Software and AI suddenly matter. To learn more, please visit About Kfund Kfund is a family of funds supporting the best tech entrepreneurs in all their stages (multistage) while covering all their needs (multiproduct), across Southern Europe and Latam. With more than €500M in AUM, we invest from pre-seed to Series B and can write cheques between €100K to €15M. Contacts Adam Laing, CEO and Co-founder, IMU Biosciences media@imubiosciences.com Mark Swallow, Frazer Hall, Leila Adlam, MEDiSTRAVA Consulting IMUBiosciences@medistrava.com Oliver Pink, Head of Communications, Molten Ventures Oliver.pink@molten.vc

Five years ago this month, Takeda Pharmaceuticals completed a $62 billion acquisition of Shire one of the largest deals in pharmaceutical industry history. The anniversary has resurfaced scrutiny over the buyouts value and mixed results.The addition of Shire grew the footprint of Japans largest pharma, helping it expand into European and U.S. markets. It also bolstered Takedas pipeline and funneled more R&D investment toward vaccines and plasma-derived therapies. And while the company took on about $60 billion in debt to complete the acquisition, Takeda used divestitures to lower its debt burden and exceeded its predicted cost savings a year ahead of schedule.Yet, for all those benefits, Reuters reported in December how the megadeal hasnt delivered value to Takedas shareholders and showcases the risk of high-profile megamergers. And when PharmaVoice sat down with Chris Arendt, the companys chief scientific officer, at the J.P. Morgan Healthcare Conference this month, Takeda was emerging from a fresh cycle of up-and-down news.In October, the company said it was pulling Exkivity, a lung cancer drug, from the market after the treatment failed a confirmatory trial.As challenging and heartbreaking as that is, its kind of how drug development plays out, Arendt said. Thats the reality there will be ups and downs.Weeks later, the company reduced its full-year profit forecast by 36% in the face of pipeline setbacks and patent expirations for major drugs like the ADHD medicine Vyvanse.Yet in November, Takeda won Food and Drug Administration approval of fruquintinib for patients with metastatic colorectal cancer that has been previously treated. Fruquintinib is one of the key drug the companys CEO said would help it rebound in the coming years. At JPM, Arendt was upbeat about the future of Takedas pipeline.Takeda is in a really good place, he said. We are where we want to be this far out from the Shire deal in terms of capabilities and R&D strategies.Living on the edgeArendt came to Takeda from Sanofi in 2015, first as head of immunology, before later leading the oncology cell therapy and therapeutic area unit. As he kicked off his career at Takeda, Arendt, who took over as CSO in October, said the company was embarking in earnest to reshape its therapeutic pipeline and focus on three core areas: neuroscience, gastrointestinal disorders and oncology.In recent years, the company has also leaned into vaccine and PDT development while branching out into new modalities and pursuing partnerships that support those efforts.In particular, Arendt pointed to its $4 billion purchase of Nimbus Therapeutics TYK2 drug in 2022, which delivered positive topline results from a Phase 2b study for psoriatic arthritis in September. The selective TYK2 inhibitor could target multiple immune-mediated inflammatory conditions and, if approved, would go head-to-head with Bristol Myers Squibbs TYK2 inhibitor, Sotyktu.Thats a program were really excited about, Arendt said.On the oncology front, Takeda bought Maverick Therapeutics in 2021 to take hold of its T cell engager pipeline, which involves treatments that use a patients cells to attack solid tumors.We brought in Mavericks T cell focus and married in with our incredible talents and capabilities to further its potential, Arendt said. We love this model of trying to complement what pharma can do at scale with what biotechs do really well.Two other acquisitions in the last few years of GammaDelta Therapeutics and Adaptate Biotherapeutics have also targeted T cell technologies and fit into Takedas strategy of reinventing its oncology pipeline and investing in immunotherapy and antibody-based treatments, Arendt said.Takeda continues to eye other partnerships. Were looking at where pioneering science is emerging, he said. You can look at what other companies are doing and follow the latest press releases into the latest biological space, but we look at the next step changes, and try to advance whats cutting edge.Takedas outlookNone of these changes are to suggest that Takeda is straying completely from its roots in small molecules.Any good investment portfolio needs to be balanced to level the risk and were always considering that, Arendt said. You can look at some of the cutting-edge modalities in cell therapies, but were also still interested in small molecules [to create] a balanced portfolio strategy.What will all of this amount to in 2024?Our transformation was about planting the seeds, Arendt said. A lot of our R&D was seeding and now its maturing 2024 is about bearing fruit in terms of clinical readouts.This year will also mark an overall shift in Takedas pipeline from being historically weighted toward earlier-stage programs to having more in later-stage development, Arendt said.With the launch of newly approved drugs underway, the TYK2 drug moving into Phase 3 trials, a drug development engine thats churning hard the company recorded $4.8 billion in R&D investments in 2022 and an eye out for new partnership opportunities, Takeda isnt done with its latest reinvention.Well surprise you with more deals you may not have seen coming, Arendt said. '

Across two major conferences in June, attendees mockingly referred to the Inflation Reduction Act as the “Innovation Reduction Act.” The biotech industry split off into two conference camps in early June: Oncology researchers headed to Chicago for the American Society of Clinical Oncology (ASCO) meeting, while business development folks gathered in Boston for the BIO International Convention. But one theme loomed large over both events: the Inflation Reduction Act (IRA).  The most significant drug pricing reform in decades, smaller biotechs are crying foul that the legislation could severely trim partnership interest and reduce innovation in the sector. That’s putting increased pressure on biotech companies to prove their value, Rachel King, interim CEO of the Biotechnology Innovation Organization, said in an interview on the sidelines of this year’s conference. “And if the incentives change and the risk equation balances in a different way, we just won't be able to raise money,” she said. Across the conferences, attendees mockingly referred to the legislation as the “Innovation Reduction Act.” Many biotech executives are concerned that today’s pharmaceutical cost savings will stymie the development of tomorrow’s medicines.  The IRA is a sweeping piece of federal legislation signed by President Joe Biden last year that caps out-of-pocket prescription drug costs for Medicare patients at $2,000 a year—a provision the industry is just fine with. But the drug pricing reforms, which give the federal government the ability to negotiate prices of dozens of drugs for Medicare part D and part B beginning in 2026, is what has rankled the biotech executives.  BIO representatives contend that "negotiation" is a lax description. Merck recently referred to the legislation as “extortion” in a lawsuit against the Department of Health and Human Services. Similar lawsuits have also been filed by Bristol Myers Squibb, the U.S. Chamber of Commerce and Pharmaceutical Research and Manufacturers of America (PhRMA), while Biogen CEO Chris Viehbacher has threatened to join. Other pieces of the new law that biotechs object to are new distinctions between small molecules and biologics that will impact when each could be subject to pricing reforms. Specifically, small molecules have nine years from FDA approval before they'd be subject to negotiations, compared to 13 years for biologics. Executives say that this places an inexplicable incentive on the kinds of medicines that are developed for the sake of avoiding negotiations for a few more years.  Pharma spells out IRA's anticipated impact   The legislation has already spurred some pharmaceutical companies to rearrange priorities and cut projects. Alnylam in October 2022 halted plans to expand the development of Amvuttra into Stargardt disease because of an IRA provision that opens drugs to negotiations that have more than one orphan-drug designation from the FDA. Amvuttra had already received the designation for ATTR amyloidosis. A month later, Lilly cut a Fosun Pharma-partnered cancer med, citing the small molecule provisions. Astellas also teased potential future divestments that might occur due to the IRA at ASCO, highlighting the nine-year EMBARK study as clinical development that may have been rendered impossible if the legislation had been in effect when the study launched in 2014. The phase 3 trial of Xtandi and Leuprorelin recruited more than 1,000 patients with nonmetastatic prostate cancer, with the study finding statistically significant improvement in metastasis-free survival compared to Leuprorelin plus placebo, according to an announcement from Astellas and Pfizer.  “I think in a post-IRA world, it would be very difficult to contemplate that type of study and that type of investment,” Phil Tennant, Astellas Pharma's senior vice president of U.S. oncology, told Fierce Biotech at the conference. “The risk is you lose that innovation; you lose that benefit.”  Almost 60% of cancer medicines approved more than 10 years ago have later received label expansions as a result of post-approval clinical trials, according to PhRMA data (PDF) cited by Astellas' U.S. president Mark Reisenauer. He previously warned in a May 31 editorial that hard-to-treat cancers could be particularly vulnerable to the price-setting measures.  What is a biotech?   The legislation has placed a microscope on the differences between larger pharmaceutical companies and biotechs—even though the two industries are intrinsically intertwined. Mathai Mammen, M.D., Ph.D., the newly minted CEO of FogPharma and a former top R&D executive at Johnson & Johnson, described a “mindset difference." At a pharmaceutical company, R&D is focused on establishing new revenue streams to offset existing ones that will eventually be impacted by a loss of exclusivity. At a biotech, the focus is on nabbing a coveted FDA approval and making any revenue at all. Affini-T Chief Operating Officer Kathy Yi said biotech’s focus on speed is what distinguishes it from pharma. She’s worked in executive roles at biotech companies since 2017 after three years at Novartis.  “What Big Pharma gets trapped under is life cycle management,” she said. “The public thinks that you’re just milking. You're just squeezing the lemon to the last degree instead of really, truly innovating.”  That results in a slower pace of new advances, according to Yi, with true breakthroughs coming “every 10 years instead of every few years.”  Teresa Bitetti, Takeda’s president of global oncology, believes pharma will always look to biotech for external sources of innovation, citing the company's recent acquisitions of Adaptate Biotherapeutics, GammaDelta Therapeutics and Maverick Therapeutics. “It might be a fair bit of hubris to think we can do all this on our own by ourselves,” Bitetti said in an interview at ASCO, though she noted that there’s already been more rigor added to assessing partnership value in light of the rocky markets facing biotechs. The IRA entering the scene almost ensures that Big Pharma won’t be dropping those elevated standards any time soon. “As the regulatory environment tightens, you will need to do more work, even during—phase 1, phase 2—to be able to demonstrate the benefits [of the science],” Takeda’s head of global medical affairs oncology Awny Farajallah, M.D., told Fierce Biotech at ASCO.  The legislation certainly did not impact the business development fervor at this year’s BIO conference, with more than 57,000 partnering meetings—a record-high for the conference. Uwe Schoenbeck, Ph.D., senior vice president and chief scientific officer of Pfizer’s emerging science and innovation team, said that so far his group's evaluation efforts have continued apace: “I think we have to see how it plays out."  Lobbyists wage new battles    Given the key differences between the industries, the lobbying approaches for BIO and PhRMA have historically differed: The former has appealed to Democrats while the latter targeted Republicans. But with such a divided Congress, both have now narrowed in on moderate politicians on either side of the aisle. “We really need to keep folks—and mostly in the middle—focused on rationale and the science and the common sense that comes out of the science,” said outgoing BIO Chairman Paul Hastings, who formally handed the reins to Ted Love, M.D., at the conference. The political strategy is also due to the organization feeling burned by the Democrat-controlled Congress as the IRA neared passage last year.  “What we were told was, ‘Let's get this through for us and we can work with you on the other side,’” he said. “And I knew there was no way that they were going to work with us on the other side. We all did.”  King says that the most “draconian” aspects of the legislation, such as the distinctions between small molecules and biologics, will have to be tackled with a “legislative fix.” Hastings said that BIO’s board has an invite from politicians in Washington to talk and that at an executive meeting during the convention, both a Democrat and Republican politician (each unnamed) solicited input from the board.  BIO and PhRMA have also been waging a campaign against pharmacy benefit managers, middlemen that negotiate drug prices on behalf of insurance companies, Medicare plans and large companies, among others. The drug companies contend that PBMs gobble up rebates and drive up drug prices. “My child needed lifesaving medicine and pharmacy benefit managers got in the way,” Katie McKoy, a woman from Moreland, Georgia, said in a recent PhRMA ad.  This is where biotech can help out pharma, Hastings says, even though PhRMA and some major companies have taken a public-facing role in the criticism. He noted it's difficult for companies with an approved drug to chastise PBMs since they stand between them and consumers; it's the healthcare equivalent of “don’t bite the hand that feeds you.” But biotech companies can more easily out PBMs since they’re years away from the market.  The PBM argument seems to have made headway, as members of the U.S. Senate Finance Committee, including Sen. Bob Menendez, D-New Jersey, and Sen. Martha Blackburn, R-Tennessee, released legislation aimed at curtailing the industry. The proposal would restrict their income under Medicare part D utilization to service fees that can’t be passed onto another party—the consumer.  The reality for leaders of the biotech world is that the IRA and drug pricing reform is finally here after years of talk and little congressional action. King is confident in the industry as a whole, so long as it can regain political prowess.  “I have enough confidence in where the science could lead us that I'm optimistic about the longer term for the industry,” she said. “At the same time, I would say that it is critical that we get the policy right, to ensure that the industry can do what it needs to do to deliver.”