Alladapt Immunotherapeutics, Inc.

A scrappy team of drug developers has come together to create new medicines for patients with autoimmune diseases and allergies. They’re going after the bustling subfield of Graves’ disease and also aiming to take on Xolair, the blockbuster allergy medication from Roche and Novartis. The group, Merida Biosciences, gave Endpoints News an exclusive peek as the Cambridge, MA-based biotech emerged with $121 million in Series A funding on Tuesday. Blue-chip investor Third Rock Ventures created the biotech in 2022, but it remained in stealth for multiple years. Bain Capital Life Sciences, BVF Partners and Third Rock co-led the Series A. Alphabet’s GV and Perceptive Advisors also took part. The Reid Huber-chaired biotech also named former Apellis Pharmaceuticals chief operating officer Adam Townsend as its CEO. He joined Merida last month after taking a one-week break between industry jobs to fix tables, chairs and plumbing at home. Townsend said he’s better suited for running a team of scientists and drug developers than being a handyman. “I was lucky enough to have been offered multiple CEO roles of small biotechs. This one was the absolute pinnacle in my mind,” Townsend said in an interview. Merida will enter the clinic this year with an experimental medicine for the autoimmune thyroid condition known as Graves’ disease (with potential for the drug also in the related condition called thyroid eye disease). The biotech will quickly follow that with programs in food allergy and primary membranous nephropathy, an autoimmune kidney disease. The goal is to target the pathogenic antibodies behind multiple diseases beyond just those three initial indications, Townsend and Merida’s C-suite said in an exclusive interview last week. Merida derived from a personal experience. CSO Dario Gutierrez co-founded the company after seeing a family member go through a difficult treatment period for an auto-antibody-driven disease known as immune thrombocytopenic purpura, or ITP. The family member was given high-dose steroids and went through a surgical operation known as a splenectomy. That treatment regimen “did not match the knowledge that we had of the disease,” Gutierrez said. Researchers knew the pathogenic antibodies involved. There could be more targeted medicines, he reasoned. “Why are we not doing anything about this that’s more specific?” Gutierrez thought. So he and the team started making molecules that could trap patients’ autoantibodies and neutralize and degrade them. Gutierrez, an avid marathoner who’s hoping his leadership team will become fellow runners, quickly went to work with the help of seed funding from Third Rock, and applied methods like cryo-electron microscopy. Merida wants to upend the current treatment landscape and give the autoimmune field its precision medicine moment, just as the oncology world has experienced in recent years. “Steroids, B cell therapies, you’re basically wiping out the whole field to just take out a couple of weeds,” chief medical officer Matthew Leoni said. “To be able to not have to do that, to have laser scalpel-like precision, instead of using a sledgehammer, to remove completely the causative agent without damaging any of the surrounding systems, or the immune system or anything else — that’s revolutionary.” The biotech’s name hints at the precision medicine approach. The name can be traced to the capital of the Yucatán state in Mexico, but also a Disney princess. “There’s something special about that princess. She was an archer, a very accurate archer, and we’re a precision medicine company,” Gutierrez said. Gutierrez and team are making treatment candidates that can be delivered subcutaneously. They’re not calling them biologics, but they have a similar half-life, the CSO said. They’re produced like other antibodies, he added. “It’s an Fc-based fusion protein. It is actually an asymmetric protein,” Gutierrez said. “The antigen that traps the antibodies is only expressed in one of the Fc chains; the other one is empty. That is to increase the safety profile of the molecules so that we’re not creating large immune complexes.” Leoni said the ambition is to get to quarterly or six-month dosing “in an ideal world.” “Those [dosing schedules] are achievable with the types of molecules that Dario is producing both from the standpoint of kinetics,” Leoni said, “because you’re removing all the antibodies that are there in a matter of hours, and you clean the system, and then it’s just basically dosing above what you need to do that to have a sustained effect over time.” The biotech is starting with Graves’ disease, where other companies are making headway, including Immunovant and Biohaven . Graves was selected as the first indication, in part because of the efficacy signals that can be gleaned quite early in clinical trials. With thyroid function tests and other objective measures, Merida will be able to see whether its experimental treatment candidate is performing well. The depth of depletion of the auto-antibody is a “direct correlative” and can be predictive of larger registrational-type studies, Leoni said. Merida also wants to take on Xolair, an allergy medication that racked up $4.4 billion in sales between partners Novartis and Roche last year. The startup has engineered antibodies that are able to recognize immunoglobulin E, or IgE, like Xolair does. “But, rather than just binding it, can actually drive degradation,” Merida operating chief Dodzie Sogah said. “The whole team and the board are very supportive of going into this big, aggressive market,” Townsend said. “And for a small, lean, nimble biotech, yes, hell yes we should chase that.” The food allergy field has been quite difficult to crack into. Alladapt Immunotherapeutics, a well-funded biotech that was constructing its own manufacturing facility, shut down last year after discussing Phase 3 plans for an oral food allergy treatment with the FDA. “If you can beat Xolair when it comes to efficacy, imagine the unlocked potential that you have across multiple allergic diseases,” Townsend said. “Food allergy is our gateway into showing our science and how it works there.”

Alladapt Immunotherapeutics, a well-financed biotech working in the food allergy field, shut down following talks with the FDA, according to a source familiar with the company. After claiming success in a Phase 1/2 trial in June 2023, Alladapt prepared for a Phase 3 of its experimental food allergy drug. Codenamed ADP101, the oral candidate had received the FDA fast track tag for mono- and multi-food allergies. But a late-stage trial proved too financially daunting. The “FDA guidance for the Phase 3 trial made it economically unviable,” according to the source, who confirmed the company closure to Endpoints News on the condition of anonymity. Investors got a “partial recovery on their investment,” the source added. The Menlo Park, CA-based startup was co-founded in 2018 by CEO Ashley Dombkowski and Kari Nadeau, a former Stanford allergist and now chair of the Department of Environmental Health at Harvard School of Public Health. Dombkowski didn’t respond to an Endpoints inquiry. Alladapt disclosed a $119 million funding round in June 2022 and a $50 million loan with Hercules Capital two months later. The biotech disclosed construction of a manufacturing facility on the outskirts of Philadelphia the year prior. The facility was expected to be completed in “late 2024,” according to architecture and engineering firm Genesis. The company’s investors included Patient Square Capital’s Enavate Sciences, Gurnet Point Capital, AllerFund, Red Tree Venture Capital, Novartis and others. Its equipment was listed for auction in July. Rock Creek Advisors, a firm that works on liquidations and restructurings, lists Alladapt as a client on its website. Some of its top executives left this year for posts at Eccogene and Navigator Medicines . The food allergy space has been through a series of ups and downs in recent years. Nestlé’s attempt to market a peanut allergy drug — known as Palforzia, from its $2.6 billion Aimmune acquisition — had failed commercially. There was a major win in February with the FDA approval of Novartis and Genentech’s Xolair for children and adults with one or more food allergies. Novartis had also axed a peanut allergy Phase 3 trial earlier this year, but said it expected to start a new study of the anti-inflammatory, dubbed ligelizumab, later in 2024. With its ADP101 candidate, Alladapt aimed to deliver small bits of protein from the “big nine” food allergies — milk, eggs, wheat, fish, shellfish, peanuts, tree nuts, soy and sesame — so that patients wouldn’t be as sensitized to the allergens. The startup also terminated an open-label extension study this year. Also in the food allergy space are Leaps by Bayer-backed Ukko and Regeneron, which is testing Dupixent combined with its hematology drug linvoseltamab in Phase 1 .

→ Kristen Mulholland will take over for the retiring Peter Fasolo as chief human resources officer at J&J on Oct. 1. “Peter has led J&J’s talent strategy for the past 16 years including remarkable leadership through the global pandemic and the separation of our consumer health business,” CEO Joaquin Duato said in a statement . “He leaves a legacy of strong leaders, deep bench strength and an inclusive, caring and patient-focused culture.” Fasolo is a Bristol Myers Squibb HR vet who left J&J to become chief talent officer for KKR , only to return in 2010. Mulholland started at J&J in 2005 and has spent nearly five years as head of human resources, global total rewards & enterprise HR functions. → Just do it: Amgen technology chief David Reese said in a LinkedIn post that the pharma giant has appointed Sean Bruich as SVP of artificial intelligence and data. Bruich moves into the pharma world after an 11-year run with Nike , where he vaulted to global VP, insights, data science & analytics. This is the second high-level AI hire by a major pharma in as many weeks — Pfizer just welcomed Berta Rodriguez-Hervas as its new chief AI and analytics officer. → In its biggest personnel news since Doug Williams ’ resignation , Sana Biotechnology has poached Dhaval Patel from UCB as the Seattle biotech awaits data readouts for its CD19-targeted allogeneic CAR-T therapy in a host of indications. Patel had a 10-year career with Novartis before he held the CSO post at UCB for nearly seven years, and he’ll have the same responsibilities at Sana under CEO Steve Harr . Sana said in its second-quarter update that the goal is to reveal data for SC291 in B cell malignancies — and such autoimmune diseases as lupus nephritis, extrarenal lupus and ANCA-associated vasculitis — sometime this year. “His expertise in immunology and autoimmune diseases make[s] him ideally suited to help advance our clinical pipeline,” Harr said in a statement . → Brian Di Donato , the CFO and head of strategy at Immunocore since May 2020 , is stepping down “at the end of the year” to take the CEO job at an unnamed San Diego biotech. Di Donato was the finance leader for Achillion when Alexion scooped it up for $930 million, and he’s also a board member at Jim Wilson joint iECURE , where ex-Achillion chief Joseph Truitt is CEO. → Telix Pharmaceuticals has separated its business into four separate entities: Telix Therapeutics , Telix Precision Medicine (diagnostics), Telix Lightpoint (medtech, from its acquisition of Lightpoint Medical ) and Telix Manufacturing Solutions . With these changes in place, Telix has tapped Richard Valeix as CEO of Telix Therapeutics, Kevin Richardson as Telix Precision Medicine’s chief executive, and Raphael Ortiz as CEO of Telix International . Christian Behrenbruch ’s title has been slightly modified to group CEO. Telix had hoped to join the Nasdaq in June with an IPO around the $200 million mark, but the Melbourne biotech made a gametime decision to pull those plans . → Cambridge, MA-based neuro player Cognito Therapeutics has promoted Christian Howell to CEO. Brent Vaughan had been running Cognito since 2020 after co-founding and leading the autism diagnostic specialist Cognoa , and he hired Howell as his chief commercial officer last October. Howell had a long career with Medtronic and then joined Aetion , where he was elevated to SVP and general manager of the emerging channels group (medical device, diagnostics, digital health, and government) in April 2023. → Elsewhere, Endo is also losing its president and CEO Blaise Coleman . Board member Scott Hirsch will serve in the interim as the company searches for a permanent successor. Hirsch joined Endo’s board in April, around the same time that the company sued the FDA over its approval of a generic version of Endo’s drug Adrenalin . Hirsch is the former CEO of Solta Medical and also held the roles of president of Ortho Dermatologics and CBO of Bausch Health / Bausch + Lomb . → Thomas Bock has handed in his resignation as CEO of Notable Labs , and CSO Joseph Wagner will take over the top spot on an interim basis. This isn’t uncharted territory for Wagner: He’s the former CEO of Oncocyte (2011-15) and Canadian I/O biotech BriaCell Therapeutics (2015-16). Notable Labs merged with VBL Therapeutics in February 2023 and will start enrolling patients in its Phase 2 study of the ex- Boehringer Ingelheim drug volasertib for acute myeloid leukemia “in the coming months,” the company said in July. → Delfi Diagnostics marked the beginning of the year with a new CEO it hired away from Illumina . Now, the competitor to Grail has brought on Thomas Russo as finance chief. Russo served in the same role at Icosavax and Assembly Biosciences . During his time at Icosavax, Russo helped with the company’s growth until its $838 million upfront acquisition by AstraZeneca . → Marea Therapeutics , the Third Rock upstart led by ex- Graphite Bio CEO Josh Lehrer , has selected Ian Clements as CFO. Clements resigned from the same post at Livmarli maker Mirum Pharmaceuticals in May 2023 after four years overall with the company, and he’s the ex-VP of investor relations for Dermira . Marea launched in June with $190 million in “combined Series A and B” funding, testing an ex-Novartis monoclonal antibody that targets ANGPTL4 in adults with metabolic dysfunction. → With ex- Synlogic CEO Aoife Brennan at the controls, a seemingly rejuvenated Eliem Therapeutics has named Brett Kaplan as COO and Nishi Rampal as SVP, clinical development. Kaplan had been president and chief financial & corporate development officer for epigenetic editing upstart Chroma Medicine , and he was also the finance chief at Prevail until Eli Lilly bought the gene therapy biotech for $1 billion. An Alexion vet, Rampal also handled the role of global development and strategy lead for the neuromyelitis optica spectrum disorder (NMOSD) treatment Uplizna as an executive director with Horizon /Amgen. Eliem’s hunt for strategic alternatives ended with the acquisition of Tenet Medicines and its anti-CD19 antibody budoprutug , once known as TNT119 . → Backed by RA Capital and Forbion , Navigator Medicines disclosed its $100 million Series A this week and the recruitment of Dana McClintock as CMO. McClintock spent six years in the same position at Alladapt Immunotherapeutics and was global head of the Office of I2O Innovation for Genentech . Navigator also said that Forbion general partner Wouter Joustra and RA Capital managing director Andrew Levin have made their way to the board of directors. → Alex Bastian has been named VP, commercial strategy at Swiss-based Memo Therapeutics , reuniting with CEO Erik van den Berg . Toward the end of van den Berg’s tenure as CEO of AM-Pharma , Bastian was the Dutch biotech’s VP, commercial & patient access. He also worked for Galapagos as VP, head of value & market access. → Structure Therapeutics , one of many biotechs developing a GLP-1 drug for obesity, has elected ex- Shire CEO Angus Russell to the board of directors. The 68-year-old Russell has chaired the board at Daxxify maker Revance Therapeutics since 2014 and has a board seat at Lineage Cell Therapeutics . → Ex- Vividion CEO Jeff Hatfield has joined the board of directors at Gate Bioscience , a California drug developer that launched last November with a $60 million Series A from several blue-chip investors. Hatfield chairs the board at Vividion and Rome Therapeutics . → Opna Bio has made room for Inozyme co-founder and former CEO Axel Bolte on the board of directors. The South San Francisco biotech also announced that it had dosed the first patient in a Phase 1 trial of its multiple myeloma candidate OPN-6602 and appointed Myeloma Investment Fund managing director Stephanie Oestreich as a board observer.