Generate:Biomedicines

All year, the question around #AI in drug development has been whether it’s still mostly talk, or finally becoming real. In a new piece for the Boston Business Journal, reporter Hannah Baratham-Green explores that question through GB-0895, our AI-engineered antibody for #SevereAsthma that is advancing into late-stage trials. She reports that we will soon kick off two global Phase 3 studies of GB-0895 in about 1,600 people with severe asthma whose disease isn’t adequately managed on current medicines, and notes our CEO, Michael Nally’s view that this is “an important moment for the broader AI/ML field.” For us, the heart of the story is how she connects the technology to what it delivers in practice: Our CMO I&I Laurie A. Lee's observation that “our Phase 1 data showed that the molecule performed as we intended it to perform and as it was designed,” the fact that work on the asthma program started just four years ago, and the potential to lessen treatment burden with a subcutaneous injection given every six months. It’s a thoughtful look at what this Phase 3 program could mean for patients and for the role of AI in biotech. Read Hannah's full article in the BBJ → https://lnkd.in/ehFFe95a Learn more about SOLAIRIA → https://lnkd.in/evbvv5fy #ClinicalTrials | #GenerativeAI

Our plan to initiate the SOLAIRIA Studies marks a major step: the first global Phase 3 studies of a long-acting anti-TSLP antibody for severe asthma. In Andrew Dunn's coverage yesterday for Endpoints News, he underscored the significance of this milestone. His reporting emphasizes the importance of preparing to launch these first studies and also noted, “It appears set to be the first Phase 3 start for an AI-focused biotech.” For us, the SOLAIRIA Studies (www.solairia.com) reflects how intentional design can advance into large-scale clinical studies. In the article, Andy spoke with our CEO, Michael Nally and our CMO I&I, Laurie A. Lee about the design goals behind GB-0895, the long-acting profile under evaluation, and what this step means as #GenerativeBiology advances into its next phase. For a deeper dive, read Andrew Dunn's full article: https://lnkd.in/eZSEisDJ #ClinicalTrials | #RespiratoryHealth

Progress in #GenerativeBiology becomes real when a molecule performs exactly as it was designed. Today, we announced the initiation of SOLAIRIA, the first global Phase 3 studies of a long-acting anti-TSLP antibody for #SevereAsthma. These studies will evaluate GB-0895, which blocks TSLP — an upstream driver of the inflammatory response in #asthma. Using our generative optimization technology stack, GB-0895 was computationally designed to improve potency and half-life while retaining specificity, supporting a potential every-six-month dosing schedule. This move into #Phase3 demonstrates what programmable biology can enable — design translating into development. Learn more about SOLAIRIA → https://lnkd.in/eMTCZpXC Read our full announcement → https://lnkd.in/e2Q9K7-Y #ClinicalTrials | #RespiratoryHealth

How can a small moment of appreciation reinforce how a team operates at scale? Ahead of #Thanksgiving, colleagues at our Andover and Boynton Yards locations gathered for potlucks that created a brief pause in the usual pace of the day. Taking that moment together underscored something simple but important: connection isn’t separate from how we work — it influences how teams coordinate, communicate, and move. We believe appreciation strengthens the systems behind high performance. When people have space to connect, teams operate with clearer intent and faster alignment. These are the same principles that drive how we build and deliver. If this is the kind of environment you want to grow in, explore roles here → https://lnkd.in/gKaKkEGJ Happy Thanksgiving from all of us. #ThisIsGenerate | #TranscendTogether

Biotech doesn’t move forward by accident. It moves forward when leaders rethink how we design, develop, and deliver medicines—and then do the work to make that real. That’s what Flagship Pioneering recognized in our CEO, Michael Nally, with this year’s "Bigger Leaps Award" at their 2025 Annual General Meeting. The award honors leaders who pair scientific vision with operational discipline and help build cultures that turn aspiration into achievement. Under Mike’s leadership, we’ve brought together a team who builds powerful models, run sophisticated experiments, and navigate drug development—so we can ensure our medicines truly help patients. To hear directly from Mike and learn more about our science, visit our YouTube channel → https://lnkd.in/e6h4rcXd Congratulations, Michael Nally, on this well-deserved recognition. #ProgrammingBiology | #NowWeCan

On #WorldCOPDDay, we’re recognizing the impact of COPD and the need for more effective options for people living with this condition. According to the Global Initiative for Chronic Obstructive Lung Disease, COPD is one of the leading causes of death worldwide and affects an estimated 391 million people. A single exacerbation can increase the risk of hospitalization or death — a reminder of the significant unmet need for new therapeutics. GB-0895, our anti-TSLP monoclonal antibody, is currently in a Phase 1 clinical trial in adults with #COPD. This study represents the second indication for GB-0895 and builds on our ongoing work in severe asthma. It reflects our hope that a TSLP-targeted antibody with broader anti-inflammatory effects and an extended dosing interval could help address important needs in management of this disease. Learn more about our #AI-engineered pipeline: https://lnkd.in/eEpPjrTF #ProgrammingBiology | #LungHealth

What if designing an antibody could be as systematic as writing code? On November 19 at the AI Drug Discovery & Development Summit, our co-founder and CTO, Gevorg Grigoryan, joins Eli Bixby of Cradle and Claudette L. F. of Genmab for “AI-Driven Antibody Discovery and Optimization: Unlocking New Therapeutics,” moderated by Petar Pop-Damkov of AstraZeneca. Together, they will explore how #generativeAI is transforming antibody discovery – shifting drug discovery from trial-and-error to intentional design. They will dive into how #AI is optimizing antibody stability, immunogenicity, and target binding to create optimal protein therapeutics. This is the foundation of a new discipline— #GenerativeBiology—and ultimately, the platform driving our work today: using #ML and large-scale experimentation to program biology. Learn more about the summit: https://lnkd.in/gid5t8vr #ProgrammingBiology | #ProteinEngineering 

“Patients can’t wait” isn’t just something we say — it’s one of our values, and it sets the standard for how we work. Yesterday, we welcomed Kathy Giusti — founder of the Multiple Myeloma Research Foundation - MMRF, two-time cancer survivor, and author of Fatal to Fearless — for a conversation with our Chief Corporate Affairs Officer, Kym White. She showed how urgency becomes action when the right pieces align: “In a world where we now have #AI, where we have amazing science, and if you have a patient focus, you’ve got a triple whammy that is going to drive really good things to the market.” Kathy reminded us that urgency means staying focused on the people behind every discovery — and never losing sight of the promise our work represents. We’re now preparing to file two #oncology INDs: one for our MMAE payload neutralizer and another for our CAR-T therapy. Both are designed to make a difference for people living with cancer.  Want to learn more about our work in oncology? Watch our payload neutralizer in action: https://lnkd.in/eDMA5Twu #PatientsCantWait | #NowWeCan 

As #AI redefines how medicines are discovered, it’s also testing what investors believe about value, risk, and what it takes to build a company that lasts. At McDermott Will & Schulte’s upcoming panel, “From data to deals: AI’s impact on life sciences investing”, our CFO, Jason Silvers, will join Eric Converse of PreciseDx, Jonathan Gilbert, PhD., of Eli Lilly and Company, Wasim Malik, of Iaso Ventures, and Jennifer Geetter of McDermott Will & Schulte to explore how the investment landscape is shifting. As AI-native biotechs push the boundaries of science, the conversation will focus on what it takes to earn trust — from how data is used and protected to how companies show they can deliver lasting value on their own. We believe durability starts with design. We’re building a system that doesn’t just accelerate drug discovery — it generates optimal molecular solutions with the intentionality to last. Don’t miss this conversation: https://lnkd.in/ekNVMHDt #GenerativeAI | #ProgrammingBiology  

Protein design isn’t just an application of #AI — it’s the test case for whether AI can meet the full complexity of biology. Yesterday at Genetic Engineering & Biotechnology News’s “The State of AI in Drug Discovery 2025”, moderated by Fay Lin, PhD, our VP of Platform Strategy and Operations, Tharindi Hapuarachchi, PhD, joined Surge Biswas of Nabla Bio and Oliver Vince of Basecamp Research for a panel exploring where protein design is headed — and whether today’s tools are up to the task. From data scarcity to model limitations, the conversation surfaced what it will take to move from theoretical potential to therapeutic precision. That difference defines the work ahead. Our platform is built to generate optimal molecular solutions — not faster by default, but better by design — and built to close the gap between what AI can create and what patients actually need. Don’t miss this replay: https://lnkd.in/e5Z7WiZc #GenerativeAI | #ProgrammingBiology