Affyimmune Therapeutics, 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.

DUBLIN--( BUSINESS WIRE )--The "CAR T-cell Therapy - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. The global market for CAR T-cell Therapy was estimated at US$2.7 Billion in 2023 and is projected to reach US$10.8 Billion by 2030, growing at a CAGR of 21.9% from 2023 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The growth in the CAR T-cell therapy market is driven by several factors, including technological advancements, expanding clinical indications, and the increasing demand for personalized cancer treatments. One of the primary drivers is the expanding body of clinical evidence demonstrating the efficacy of CAR T-cell therapy in treating various types of cancer, especially hematologic malignancies such as lymphoma, leukemia, and multiple myeloma. The potential for CAR T-cell therapy to move into the treatment of solid tumors represents another key growth opportunity, as ongoing research continues to investigate new therapeutic targets and applications in cancers like lung, breast, and pancreatic cancer. Technological improvements in gene-editing tools and cell manufacturing processes are also contributing to the market's growth, allowing for faster and more cost-effective production of CAR T-cells. The increasing demand for personalized medicine is another crucial factor driving market expansion, as patients and healthcare providers look for treatments tailored to the unique genetic and molecular profile of individual cancers. This is especially important in cases where traditional therapies have failed, making CAR T-cell therapy a vital option for those with few alternatives. Additionally, the global rise in cancer prevalence is fueling demand for more innovative treatments, particularly in regions where regulatory approvals for CAR T-cell therapies are expanding, such as in Europe and Asia. The development of allogeneic CAR T-cell therapies, which could provide more affordable and widely available treatment options, further accelerates market growth. With continuous advancements in AI, which are improving treatment precision and monitoring, and the growing focus on enhancing patient outcomes, the CAR T-cell therapy market is positioned for robust growth in the years to come. What Are the Current Trends and Challenges in CAR T-Cell Therapy? Several important trends are shaping the future of CAR T-cell therapy, reflecting both its promise and the challenges that must be addressed to maximize its potential. One of the most exciting trends is the expansion of CAR T-cell therapy beyond blood cancers to solid tumors. Historically, treating solid tumors has been more complex due to the protective environment these tumors create around themselves, making it difficult for immune cells to penetrate and attack. However, research is actively exploring ways to enhance T-cell infiltration into solid tumors and sustain their activity in the hostile tumor microenvironment. Another significant trend is the development of allogeneic, or 'off-the-shelf,' CAR T-cell therapies. Unlike the traditional approach that requires extracting and modifying a patient's own cells (autologous therapy), allogeneic CAR T-cell therapy uses T-cells from healthy donors. This approach promises to significantly reduce the time and cost associated with the therapy, potentially making it more widely accessible. Despite these advancements, several challenges remain. Managing severe side effects, such as cytokine release syndrome (CRS) and neurotoxicity, remains a critical concern. These side effects occur when the immune system is over-activated by the therapy, causing inflammation and potentially dangerous complications. Research is focused on mitigating these risks, and several safety mechanisms, including built-in 'suicide switches' that deactivate the CAR T-cells in emergencies, are being developed. Additionally, the high cost of manufacturing CAR T-cell therapy, often exceeding several hundred thousand dollars per patient, is a major barrier to broader adoption. This cost reflects the complexity of producing a personalized, living cell therapy, but efforts to streamline production and develop more efficient manufacturing techniques are underway to reduce costs. Key Insights: Market Growth: Understand the significant growth trajectory of the DLBCL Indication segment, which is expected to reach US$5.1 Billion by 2030 with a CAGR of a 18.6%. The ALL Indication segment is also set to grow at 25.5% CAGR over the analysis period. Regional Analysis: Gain insights into the U.S. market, which was estimated at $761.0 Million in 2023, and China, forecasted to grow at an impressive 21.4% CAGR to reach $1.7 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific. Report Features: Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2023 to 2030. In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa. Company Profiles: Coverage of major players such as A2 Biotherapeutics, Inc., Adaptive Biotechnologies Corporation, Advanced Cell & Gene Therapy, and more. Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments. Key Attributes: Report Attribute Details No. of Pages 179 Forecast Period 2023 - 2030 Estimated Market Value (USD) in 2023 $2.7 Billion Forecasted Market Value (USD) by 2030 $10.8 Billion Compound Annual Growth Rate 21.9% Regions Covered Global Key Topics Covered: MARKET OVERVIEW Influencer Market Insights World Market Trajectories CAR T-cell Therapy - Global Key Competitors Percentage Market Share in 2024 (E) Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2024 (E) MARKET TRENDS & DRIVERS Rising Incidence of Cancer Throws the Spotlight on CAR T-Cell Therapy as a Key Treatment Option Technological Advancements in Gene Editing Propel Growth in CAR T-Cell Therapy Efficacy and Safety Expanding Clinical Applications Beyond Blood Cancers Expands Addressable Market Opportunity Here`s How Personalized Medicine Strengthens the Business Case for CAR T-Cell Therapy Increased Research on Solid Tumor Applications Spurs Growth in CAR T-Cell Therapy Development Allogeneic `Off-the-Shelf` CAR T-Cell Therapies Generate New Opportunities in Manufacturing Emerging Strategies to Combat Cytokine Release Syndrome Expands the Safety Profile of CAR T-Cell Therapy Global Focus on Precision Oncology Expands the Market for CAR T-Cell Therapies FOCUS ON SELECT PLAYERS: (Total 12 Featured) A2 Biotherapeutics, Inc. Adaptive Biotechnologies Corporation Advanced Cell & Gene Therapy AffyImmune Therapeutics Allogene Therapeutics Beam Therapeutics CARsgen Therapeutics Celgene Corporation Cellular Biomedicine Group, Inc. Innovacell For more information about this report visit https://www.researchandmarkets.com/r/qghbj6 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

NATICK, Mass.--( BUSINESS WIRE )-- AffyImmune Therapeutics , a clinical-stage biotechnology company committed to developing its novel, first-in-class ICAM-1 targeting chimeric antigen receptor (CAR) T cell therapy for solid tumors, today announced the appointment of Rick Rutter, Ph.D., and Jorge Nieva, M.D., to its Board of Directors. The addition of these distinguished leaders in clinical development and manufacturing strengthens AffyImmune’s commitment to advancing its AIC100 program in advanced thyroid cancers and non-small cell lung cancer (NSCLC). “AffyImmune is nearing completion of our Phase 1 trial and advancing toward determining the recommended Phase 2 dose in thyroid cancers, while defining the path for NSCLC. Expanding the board to include Rick and Jorge cannot be timelier. Not only will they bring decades of experience in their respective domains, they will also strengthen the board’s ability to steer and govern strategic matters. The management team and board will work closely together to deliver lifesaving cancer therapeutics for patients who currently have no effective treatments,” said Simone Song, Chairwoman, AffyImmune. “We are thrilled to welcome Rick and Jorge to our board at such an important time for AffyImmune, as we advance our CAR T cell product candidate AIC100 towards registrational studies for advanced thyroid cancers, and plan for our Phase 1 trial for non-small cell lung cancer,” said Daniel Janse, CEO, AffyImmune. “Their insight and counsel as members of our board will be invaluable as we validate a commercially robust CAR T cell manufacturing process and focus our NSCLC clinical strategy on patients that will receive the greatest benefit from AIC100.” Rick Rutter, Ph.D., brings over 40 years of experience in the pharmaceutical and biotech industries, with a deep expertise in CMC regulatory strategy and drug product manufacturing. Dr. Rutter has held several key positions, including Executive Vice President of Biotherapeutics Pharmaceutical Sciences at Pfizer. He currently serves as an expert consultant and advises both public and private companies on CMC and supply chain management. Jorge Nieva, M.D., is Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and Section Head of Lung and Head/Neck Tumors at the Norris Comprehensive Cancer Center. He served as a standing member of the U.S. Food and Drug Administration’s Oncology Drug Advisory Committee from 2021-2024. Dr. Nieva’s clinical research teams have been recognized for excellence in the conduct of clinical trials from the National Cancer Institute and the American Association of Oncology Research. “I am delighted to join AffyImmune’s Board and to work with the management team to bring industry-best CMC and supply chain practices, and ready AIC100 for registrational trials and commercial launch,” said Dr. Rutter. “I look forward to sharing my insights and supporting the company as it delivers timely and high-quality autologous CAR T cell products to advanced thyroid cancer and NSCLC patients with significant unmet medical need.” “Joining AffyImmune’s Board of Directors is an exciting opportunity to contribute to the expansion of AIC100 beyond advanced thyroid cancers, into larger indications such as NSCLC,” said Dr. Nieva. “I look forward to working alongside such a dedicated team to drive forward their innovative CAR T therapies. AffyImmune’s technology has the unique potential to broadly revolutionize treatment for patients with solid tumors.” About AffyImmune Therapeutics AffyImmune is a clinical-stage biopharmaceutical company committed to developing a first-in-class, ICAM-1 targeting and affinity-tuned LFA-1 binder CAR T therapy to transform the lives of patients with advanced solid cancers. The Company’s proprietary technology utilizing ICAM-1/LFA-1 interaction can potentially address the critical CAR T challenges such as toxicity, antigen loss, T-cell trafficking and exhaustion, while also allowing in vivo tracking of the CAR T cells. Its lead candidate, AIC100, is currently in a Phase 1 study to treat patients with advanced thyroid cancers, including advanced differentiated thyroid cancer and anaplastic thyroid cancer. AffyImmune is developing a focused pipeline in ICAM-1-positive cancers with high unmet medical need. AffyImmune is based in Natick, MA. For more information, visit www.affyimmune.com .