Triumvira Immunologics, Inc.

TORL BioTherapeutics , the antibody-drug conjugate startup led by former Celgene chief Mark Alles , has brought aboard a chief medical officer with big pharma chops. Aran Maree will be overseeing clinical development at the Los Angeles biotech, born out of Herceptin founder Dennis Slamon ’s lab at UCLA. Maree departs a nearly 20-year career at Johnson & Johnson , where he was chief medical officer of the medtech unit before stepping into the same post at the pharmaceuticals division, which was recently renamed J&J Innovative Medicine . The J&J veteran’s move over to TORL comes as the biotech is just weeks into its first potentially registrational trial in CLDN6 positive platinum-resistant ovarian cancer. The well-funded startup is testing an ADC called TORL-1-23. The pipeline also contains early-stage ADCs against CLDN18.2, CDH17 and DLK1. Other immunotherapies are also in the works. Alles and crew raised a $158 million round in April 2023 . Almost a year to the day, they raised another round of the exact same size. They’ve kept a low profile the entire time, wishing not to speak with the news media. — Kyle LaHucik → Samsung Bioepis has promoted Kyung-Ah Kim to president and CEO, becoming the first female exec in the Samsung universe to hold this title that isn’t part of the founding family. Kim has worked at the biosimilar maker since 2015 and had been development division leader for the past three years. Her predecessor, Christopher Hansung Ko , was CEO since its founding in February 2012 and will be the new leader of Samsung’s Future Business Division. The FDA approved Samsung Bioepis’ Soliris biosimilar Epysqli in July, and the company will soon launch its Stelara biosimilar in the US. → Iskra Reic will lead AstraZeneca ’s China business as EVP of international. She’ll take over for detained exec Leon Wang while he is still under investigation in China, a market that CEO Pascal Soriot called “an important part of innovation in the industry” last month. Reic is a 23-year AstraZeneca vet who ran the vaccines and immune therapies unit after a stint as EVP for Europe and Canada. → On the same day President-elect Donald Trump nominated Marty Makary to lead the FDA, a commish from his first administration picked up a board seat. Stephen Hahn — the current CEO of Flagship company Harbinger Health — has joined the board at Faeth Therapeutics , a cancer startup that lists Sid Mukherjee and Lewis Cantley as founders. Faeth has also appointed Rivus Pharmaceuticals CEO and ex- Aimmune boss Jayson Dallas to the board. “Faeth’s approach of leveraging metabolic research in combination with AI has opened up metabolism as a new pillar in the treatment of cancer,” Hahn said in a statement . → Franklin Biolabs , a contract research organization that Jim Wilson founded after leaving his leadership post at the University of Pennsylvania’s Gene Therapy Program, has installed a CEO. Vatsala Naageshwaran got promoted to head of business development for US CGT & lab services for Pharmaron and had a long career with Absorption Systems before it was sold to Pharmaron in late 2020. Brazilian health research institute Fiocruz made a commitment of up to $100 million for Wilson’s other venture, GEMMABio , in an effort to make gene therapies more accessible globally. → Scott Wolchko will retire as president and CEO of Fate Therapeutics on Jan. 1, and R&D chief Bob Valamehr will take over, according to a Black Friday release . Wolchko was the San Diego biotech’s first CFO and vaulted to the top spot in 2015, succeeding former Escient Pharmaceuticals chief Christian Weyer . Valamehr has led R&D since 2018 and his promotion will coincide with his 15th anniversary at the company. You may recall that Fate, which has several CAR-T and CAR NK candidates in its pipeline, ended its development deal with J&J in January 2023 and subsequently laid off nearly half of its employees. → Paragon Therapeutics continues to churn out public biotechs — and now has a CEO at the mother ship. Susanna High is the former COO of bluebird bio and, more recently, Dyne Therapeutics . She also had several roles that spanned more than nine years at Alnylam , including SVP, strategy and business integration. Two Paragon companies — Jade Biosciences and Crescent Biopharma — reverse merged their way onto the Nasdaq in October, and Oruka Therapeutics did the same in April. → Volker Herrmann is out as CEO of Flagship’s Sonata Therapeutics , and about 20 other staffers have also been let go, Fierce Biotech reported. Flagship brought two of its companies together, Inzen Therapeutics and Cygnal Therapeutics , to form Sonata two years ago. Herrmann had led Inzen, while Cygnal chief Pearl Huang eventually took the CEO job at Dunad Therapeutics . Herrmann spent more than 15 years at Pfizer and joined Flagship from SQZ Biotechnologies , where he was COO for nearly two years. → Arcutis Biotherapeutics medical chief Patrick Burnett and chief commercial officer Todd Edwards have both been promoted to EVP, and Kent Taylor has been elevated to SVP of sales. Burnett is a Novartis vet who left Verrica Pharmaceuticals to take the CMO job at Arcutis in August 2020; Peer Review informed you about Edwards’ appointment in September 2023, when he took over for Ken Lock after three years with Incyte ; and Taylor — an Incyte vet in his own right — followed Edwards two months later as VP of sales. → OSE Immunotherapeutics co-founder Dominique Costantini is retiring at the end of the year. The French I/O and I&I player has selected Fiona Olivier as chief corporate affairs and investor relations officer, and research head Aurore Morello earns a spot on the executive committee. Costantini, the former CEO who also chaired the board at OSE, had been director of development and strategy. “Many of us have benefited from Dominique’s mentorship and guidance over the years and we have grown stronger as a result,” CEO Nicolas Poirier said in a statement . Olivier spent more than three years with Sanofi as global head of corporate affairs for the General Medicines division. She had several job titles over an eight-year period at AbbVie , including head of global patient relations and international public affairs. → CAR-T cell therapy developer AffyImmune has recruited Deyaa Adib as CMO. Adib just had a very short stay at FibroGen and has also held this position at Triumvira Immunologics . AffyImmune, a company in ORI Capital ’s portfolio, is under new management for the second time this year — in July, Daniel Janse took over for Matt Britz as CEO. Britz had been elevated to the top spot in March after two years as operating chief. → At another CAR-T shop, ex- Bellicum and Artiva Biotherapeutics CEO Tom Farrell has been named president of Shanghai-based Oricell . “Tom is a transformative leader who has consistently delivered results. We believe he will undoubtedly accelerate our clinical development momentum in the US,” CEO Helen Yang said in a statement . Oricell raised a $45 million Series B1 in February 2023 on top of a $120 million haul. → Merck ’s macrocyclic peptide partner Unnatural Products has tapped Simon Bailey as COO and president of R&D. Bailey left protein degradation biotech Plexium in March after more than four years as head of drug discovery and was SVP of research for Intercept from 2016-19. His 20-year career with Pfizer culminated in his role as senior director for worldwide medicinal chemistry in oncology. → Iovance Biotherapeutics has promoted Raj Puri to chief regulatory officer. Puri spent two decades as a director at CBER in the Office of Tissues and Advanced Therapies before coming to Iovance in March 2022 as EVP, regulatory strategy and translational medicine. Iovance fought through multiple delays to receive the first-ever FDA approval for a tumor-infiltrating lymphocyte with its cell therapy Amtagvi . → Synthetic cell specialist Slingshot Biosciences has welcomed Nimisha Srivastava as COO. Srivastava held a number of roles over a decade at Twist Bioscience , where she was VP of engineering and eventually head of R&D. Slingshot also said last month that it had named Tiffany Salas-Morris as chief commercial officer. → Sapience Therapeutics , which is testing its beta-catenin antagonist ST316 in colorectal cancer patients, has recruited Augustine Bourne as VP, business development. He previously worked for Mirati as its business development and corporate strategy leader when Bristol Myers Squibb purchased the Krazati maker for $4.8 billion. In other Sapience news, ex- Replimune CBO Pamela Esposito now has a seat on its board of directors. → Swiss cancer vaccine developer Nouscom has recruited Grünenthal and MorphoSys alum Eckhard Niemeier as CBO. Niemeier just ended a three-year run as business chief at Danish biotech Union Therapeutics , and he was head of business development & portfolio management for Pieris Pharmaceuticals . “Cancer vaccines are, let’s say, back in fashion,” Nouscom CEO Marina Udier told Endpoints News in November 2023, when the biotech announced its Series C funding. → Incendia Therapeutics has appointed Bradford Smith as its first finance chief. Smith has previously been CFO for a number of companies, including Homology Medicines , Ocular Therapeutix , OmniGuide , NeuroMetrix and Synarc . Smith also sits on the boards of Lyra Therapeutics and eGenesis . → Massachusetts-based ITF Therapeutics has recruited Erica Monaco as COO. Monaco joins with previous COO experience from Medicus Pharma and Biofrontera , where she also served as CEO and CFO). Earlier in her career, Monaco was with Sun Pharmaceuticals and Deloitte . → Portuguese CRO FairJourney Biologics has brought aboard Marc van Dijk as CSO, responsible for the company’s antibody discovery and engineering divisions. Dijk also served in the role at MiNK Therapeutics , and earlier in his career, Dijk was with Genmab as VP of antibody technology and chief technology officer at 4-Antibody and Agenus . → CRISPR Therapeutics veteran Chris Gemmiti has landed at Cellino as SVP of therapeutics development. Gemmiti was in charge of CMC for Casgevy , CRISPR and Vertex ’s sickle cell gene therapy, and became VP of technical operations in April 2022. Cellino recently caught our attention by appointing Recursion CEO Chris Gibson to its board of directors. → Looking for the next breakthrough in psychedelic therapy, MindMed has hired yet another exec, bringing in Javier Muniz as VP of research and development strategy. He just finished up a 10-year career with the FDA, where he was associate director for therapeutic review in the agency’s Division of Psychiatry within the Office of Neuroscience. This is MindMed’s third notable leadership move in the past few months, following the additions of chief regulatory and quality assurance officer Gregg Pratt and corporate affairs chief Stephanie Fagan . → Former Bristol Myers exec Kristen Hege leads a new crop of clinical advisory board members at Gilead ’s cancer partner Cartography Biosciences . Kevin Parker ’s crew has also welcomed Affini-T Therapeutics CMO Dirk Nagorsen , UCSF’s Bridget Keenan and Josep Tabernero from the Vall d´Hebron University Hospital in Barcelona. → Beam Therapeutics has added Chirfi Guindo to the board of directors. Guindo had a 27-year career with Merck before joining Biogen in 2017, then returned to Merck in July 2022 as chief marketing officer for the Human Health division. Click here for Andrew Dunn’s Slack interview from February with CEO John Evans , who also spoke to Endpoints for an early look at Beam’s gene-edited sickle cell data. → Ex- Decibel Therapeutics CEO Laurence Reid has sewn up a spot on the board of directors at hereditary angioedema biotech KalVista Pharmaceuticals . Reid sold Decibel to Regeneron for $109 million in August 2023 and chairs the board at Broken String Biosciences . The FDA has assigned a June 17 decision date for KalVista’s HAE drug sebetralstat . → Backed by The Column Group , 8VC and others, California ADC developer Hexagon Bio has elected Ideaya Biosciences CEO Yujiro Hata to its board of directors. This was Hexagon’s first press release of any kind since its $77 million Series B in February 2023. → Longtime EY vet Fran Schulz has joined the board of directors at Tim Lu ’s Senti Bio , as Seer chief Omid Farokhzad exits. Shares $SNTI went through the roof on Monday, rising more than 600% and settling on a 363% jump after Senti Bio disclosed Phase 1 data for its CAR-NK cell therapy SENTI-202 . → Day One Biopharmaceuticals co-founder and R&D leader Sam Blackman is headed to the board of directors at Bonum Therapeutics , the Seattle-based I/O biotech that sprouted from Good Therapeutics and nabbed a $93 million Series A two years ago. Blackman will retire from Day One at the end of the year. → Rare disease AI company Healx has named Abcam founder Jonathan Milner as non-executive chairman, taking over from co-founder David Brown , who will remain on the board. Despite Milner’s opposition , Abcam completed its acquisition of Danaher exactly one year ago.

TAC01-CLDN18.2 was well tolerated, with no dose-limiting toxicities and a favorable safety profile in the first two cohorts of the ongoing trial A pancreatic cancer patient treated with the lowest dose has demonstrated clinical benefit for nearly eight months and achieved a confirmed partial response in the target lesion as well as an unconfirmed complete response in the non-target lesion HOUSTON and SAN DIEGO, Nov. 11, 2024 /PRNewswire/ -- Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, today announced that preliminary results from its Phase I/II clinical trial TACTIC-3 (NCT05862324) investigating the safety and efficacy of autologous TAC01-CLDN18.2 in subjects with Claudin 18.2 positive solid tumors, were presented in a poster and an oral presentation at the 39th Society for Immunotherapy of Cancer Annual Meeting, held November 6-10 in Houston. Ecaterina E. Dumbrava, MD, Assistant Professor in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, presented promising preliminary clinical data from TACTIC-3 showing the positive safety profile and encouraging therapeutic potential of TAC01-CLDN18.2 at lower dosages, even among patients who have undergone multiple prior treatments. Dr. Dumbrava's late-breaking abstract was selected for an oral presentation during the " Biotech Breakthroughs - Solid Tumor IO at the Tipping Point" session on Friday, November 8, and displayed during a Poster session on Saturday, November 9. "As an emerging biomarker, Claudin 18.2 offers a promising target for cellular therapies due to its selective expression in certain advanced solid tumors, including, but not limited to, gastric and pancreatic cancers," said Dr. Dumbrava. "These initial data on TAC01-CLDN18.2, a new T-cell therapy approach designed to address the needs of patients with solid tumors expressing Claudin 18.2 are promising. Because this is a patient population with limited treatment choices, I look forward to the full results of the clinical trial TAC01-CLDN18.2's potential to improve patient outcomes." Key Preliminary Findings The first two dose cohorts of Phase I have been completed, with no reported dose-limiting toxicities (DLT), showing a favorable safety profile. All TAC-related adverse events were low-grade, and no cytokine release syndrome was reported. One subject in cohort 2 experienced a grade 1 neurotoxicity, which resolved the same day without intervention. Six subjects reported a total of 6 serious adverse events, none related to TAC01-CLDN18.2. An 83% disease control rate was observed at first tumor assessment in the six eligible subjects for efficacy assessment. One subject in cohort 1 with heavily pre-treated pancreatic adenocarcinoma with high Claudin 18.2 expression has an ongoing, confirmed partial response in the target lesion. The subject received a second dose approximately five months after the initial dose and has remained on treatment for nearly eight months with ongoing therapy. An efficacy assessment was conducted in early November 2024, three months after the second dose was administered, and in addition to an ongoing partial response in the target lesion, revealed a complete response in the patient's non-target lesion. The incremental response observed following the administration of a second dose highlights the potential benefits of re-treating patients with Claudin 18.2 positive solid tumors with TAC01-CLDN18.2. Oral Presentation Details: Title: A phase 1/2 study evaluating the safety and efficacy of autologous TAC T cells in subjects with claudin 18.2+ advanced solid tumors Authors: Ecaterina E. Dumbrava, Syma Iqbal, Simon Turcotte, Gregory Botta, Benjamin Schlechter, Geoffrey Ku, Peter Hosein, Sam Saibil, Miriam Gavriliuc, Maria Apostolopoulou, Mobolaji Giwa, Kara Moss, Swaminathan Murugappan, Davendra Sohal Session: Biotech Breakthroughs - Solid Tumor IO at the Tipping Point Oral Presentation Date: Friday, November 8, 2024, between 1:45 p.m. and 3:20 p.m. CDT Abstract Number: 1472 Abstract Type: Late-Breaking Abstract Abstracts are currently available on the SITC website. About Triumvira Immunologics Triumvira Immunologics, Inc. ("Triumvira") is a leading clinical-stage solid tumor cell therapy company developing unique, non-gene edited, first-in-class targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors. The company's proprietary T cell Antigen Coupler (TAC) technology platform activates natural T cell functions differently from other cell therapies such as CAR-T and engineered T cell receptor (TCR) therapies, resulting in clinically safe, effective, and re-dosable cell therapies. Triumvira is developing a pipeline targeting promising tumor-associated antigens such as Claudin 18.2, HER2, GUCY2C and GPC3. Triumvira has operations in San Diego, CA, Austin, Texas, and Hamilton, Ontario. For more information, visit us at or follow us on LinkedIn and X. Media Contact David Schull or Ignacio Guerrero-Ros, Ph.D. Russo Partners 858-717-2310 646-942-5604 [email protected] [email protected] SOURCE Triumvira Immunologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HOUSTON and SAN DIEGO – Nov. 11, 2024 /PRNewswire/ — Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, today announced that preliminary results from its Phase I/II clinical trial TACTIC-3 (NCT05862324) investigating the safety and efficacy of autologous TAC01-CLDN18.2 in subjects with Claudin 18.2 positive solid tumors, were presented in a poster and an oral presentation at the 39th Society for Immunotherapy of Cancer Annual Meeting, held November 6-10 in Houston. Ecaterina E. Dumbrava, MD, Assistant Professor in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, presented promising preliminary clinical data from TACTIC-3 showing the positive safety profile and encouraging therapeutic potential of TAC01-CLDN18.2 at lower dosages, even among patients who have undergone multiple prior treatments. Dr. Dumbrava’s late-breaking abstract was selected for an oral presentation during the “Biotech Breakthroughs – Solid Tumor IO at the Tipping Point” session on Friday, November 8, and displayed during a Poster session on Saturday, November 9.