Affini-T 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.

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )-- Cartography Biosciences, Inc. , an oncology company advancing a pipeline of antibody therapeutics that more precisely target tumors, today announced the appointment of four new members to its Clinical Advisory Board (CAB). The new members include Kristen Hege M.D., Former SVP, Early Clinical Development, Hematology/Oncology & Cell Therapy at Bristol-Myers Squibb (BMS); Bridget Keenan M.D., Ph.D., Assistant Professor at University of California, San Francisco, Dirk Nagorsen, M.D., Chief Medical Officer at Affini-T Therapeutics and, Josep Tabernero, M.D., Ph.D., Head of the Medical Oncology Department at the Vall d´Hebron University Hospital in Barcelona. “Our newly appointed advisors bring world-class academic, scientific and multi-disciplinary biopharma expertise to the advancement and delivery of novel cancer therapies to patients,” said Kevin Parker, Ph.D., CEO of Cartography Biosciences. “Our platform has identified several novel targets and target pairs that we have rapidly engineered new T-cell engagers and ADCs against. As these programs prepare to enter the clinic, we determined the need to assemble the very best minds to help guide our efforts and provide real-world inputs to our plans. We are grateful for the commitment of these prominent experts and look forward to their contributions, beginning with our lead asset CB21 in colorectal cancer, which is on track for an investigational new drug (IND) application next year.” Dr. Hege retired from BMS in 2023 where she served as SVP Early Clinical Development, Hematology/Oncology & Cell Therapy. While there she led the advancement of small molecules, biologics and cell therapies from first-in-human through clinical proof-of-concept studies. Additionally, she led the BCMA CART cell program (Abecma) in multiple myeloma from target selection through FDA approval. Prior to BMS, she served a similar role at Celgene as Vice President, Translational Development. Dr. Hege has also held an active faculty position at the University of California, San Francisco Medical Center since 1996, most recently as Clinical Professor of Medicine, Hematology/Oncology, serving in that role as a volunteer since 2008. Dr. Hege currently serves on the boards of directors at Mersana, Adaptimmune, and Kelonia Therapeutics. She received her M.D. from UCSF and hematology/oncology subspecialty training at Harvard and UCSF. Dr. Keenan is an oncologist and physician-scientist focused on promising new treatments for digestive system cancers. Her research investigates various immunotherapy approaches to fighting cancer, including checkpoint inhibitors, cellular therapies, bispecific antibodies and other new treatments. Dr. Keenan’s current clinical practice is in the Cancer Immunotherapy Clinic at UCSF, where she works with patients with solid tumors who are being treated in early immunotherapy clinical trials. She is the co-director of the UCSF Cancer Immunotherapy Program. Dr. Keenan earned her medical degree and a doctorate in immunology at the Johns Hopkins University School of Medicine. She completed a residency in internal medicine and a fellowship in hematology and oncology at UCSF. Dr. Nagorsen has more than 20 years of experience in hematology and oncology, both in academia and industry. He joined Affini-T Therapeutics as CMO in 2022 after more than 10 years at Amgen, where he was Vice President Early Development and Therapeutic Area Head, Hematology & Oncology Early Development, overseeing more than 30 oncology programs spanning IND filings through Phase 1/2, including the recently approved IMDELLTRA™ (TARLATAMAB-DLLE) a first-in-class DLL3-targeted bispecific T-cell engager for recurrent small-cell lung cancer. His groundbreaking research has resulted in over 60 peer-reviewed manuscripts, including papers published in New England Journal of Medicine and Lancet Oncology. He earned his medical doctorate and his habilitation (equivalent of a PhD) in experimental medicine and tumor immunology from Charité University Medicine Berlin. Dr. Tabernero has spent his career providing care at the forefront of oncology treatment paradigms. He is the Head of the Medical Oncology Department at the Vall d’Hebron University Hospital, a Director of the Vall d’Hebron Institute of Oncology and Professor of Medicine at Universitat de Vic in Barcelona, Spain. Dr. Tabernero has been the Principal Investigator of several clinical studies and translational projects with targeted immune-based therapies. His research focuses on potentiating molecular therapies and targeting specific oncoproteins for personalized care. Dr. Tabernero serves on the Editorial Boards of various top-tier journals including Annals of Oncology, ESMO Open, Cancer Discovery and Clinical Cancer Research. Dr. Tabernero earned his M.D., and Ph.D., degrees from the Universitat Autonoma de Barcelona, Spain. About Cartography Biosciences Cartography Biosciences is building a differentiated oncology pipeline of antibody-based therapies designed to target tumors more precisely than existing therapeutics. Cartography’s ATLAS and SUMMIT drug discovery platforms are powered by an industry-leading, fully integrated dataset spanning over a thousand cell types across the healthy body and large-scale profiling of individual cells from patient tumors. By leveraging petabytes of proprietary data, along with insights from machine learning and AI, Cartography is identifying and developing therapeutics against highly specific targets and target pairs to build a pipeline of molecules with the greatest patient impact. Cartography’s lead program in preclinical development, CB21, is a T-cell engager being advanced for colorectal cancer (CRC). To learn more about Cartography and our mission to treat every patient with cancer, visit cartography.bio and follow us on LinkedIn and X @cartographybio.

ST. PAUL, Minn., Oct. 7, 2024 /PRNewswire/ -- ScaleReady™, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH) and CellReady™, today announced that Christopher A. Klebanoff, MD, a physician-scientist at Memorial Sloan Kettering Cancer Center (MSK) has been awarded a G-Rex® Grant. Dr. Klebanoff's $300,000 G-Rex® Grant will provide enabling reagents to facilitate process development, IND-enabling studies, and support clinical manufacturing of a novel CD8α/β-armored TCR-T cell therapy targeting an HLA-A*11:01-restricted RAS (G12D) public neoantigen in a Phase 1 clinical trial. "Dr. Klebanoff is a leader in the field with over 20 years of experience, and we are fortunate to be able to support his novel approach to cancer treatment. We are confident that this G-Rex Grant will significantly accelerate the path to clinical results and simultaneously set the stage for highly efficient closed system scale out. We are also hopeful that patients will receive significant benefit from treatment with armored TCR-T drug products," said John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex. "Our armored TCR-T therapy is designed to recognize antigen targets that are specific to every cancer cell. We are diligently working to bring this public neoantigen cellular immunotherapy into the clinic to assess its safety and potential efficacy against common solid cancers with significant unmet medical need. The G-Rex Grant will expedite development and accelerate our entrance into human clinical trials," said Dr. Klebanoff, who serves as an Attending Physician, Laboratory Head, Human Oncology & Pathogenesis Program, and Member Investigator, Center for Cell Engineering at MSK. Dr. Klebanoff is also a Scientific Co-Founder of Affini-T Therapeutics, and a member of the Parker Institute for Cancer Immunotherapy (PICI). As part of the G-Rex Grant, Dr. Klebanoff and Dr. Chandran at MSK plan to complete their pre-clinical process development which will include the incorporation of Wilson Wolf's fully closed-system G-Rex bioreactors and the GatheRex for semi-automated volume reduction, cell concentration, and harvest. Additionally, Dr. Klebanoff expects to perform a technology transfer to MSK's cGMP facility, which will perform engineering runs in support of an Investigational New Drug (IND) application to be filed with the FDA with the hope of initiating a Phase 1 clinical trial. "Our goal is to thoughtfully develop and expeditiously transfer a robust manufacturing framework that will reliably and reproducibly enable the generation of infusion products for cancer patients by our cGMP facility. Our hope is that this public-neoantigen specific TCR-T therapy will benefit a patient population that currently does not have many treatment options available. We also recognize this as an invaluable opportunity to holistically learn from this bench-to-bedside experience as we continue to discover and innovate in the lab.", said Smita S. Chandran, PhD, a Scientific Research Lead in the Klebanoff Lab at MSK, who led the discovery and development of the HLA-A*11/RAS(G12D) TCR-T therapeutic. The G-Rex Grant will also support clinical manufacturing runs of their autologous TCR-T cell therapy. Expedited patient enrollment is expected to occur because of MSK's unique IMPACT Program, that prescreens (via next generation sequencing) all incoming patients for commonly mutated genes. MSK will also get early access to a new line of closed system GMP reagents from Bio-Techne that are tailor-made for use with fully-closed system G-Rex bioreactors. The G-Rex ProPak™ CAR-TCR Cytokine Kits, estimated to be commercially available later this year, are weldable bags of liquid cytokines and are designed to streamline reagent preparation and administration in a GMP manufacturing setting without the use of a biosafety cabinet (BSC). ScaleReady's G-Rex Grant Program is a $20M initiative to advance the state of cell and gene-modified cell therapy (CGT) development and manufacturing by awarding individual Grant Awards worth up to $300,000. G-Rex Grant Recipients also gain access to exclusive support from ScaleReady's growing consortium of G-Rex Grant Partners who bring best-in-class tools and technologies as well as unparalleled knowledge and expertise in the areas of cGMP manufacturing, quality and regulatory affairs, CGT business operations, and more. About ScaleReady ScaleReady provides the field of cell and gene-modified cell therapy (CGT) with a G-Rex centric manufacturing platform that enables the world's most practical, flexible, scalable, and affordable CGT drug product development and manufacturing. The G-Rex manufacturing platform is currently used by a rapidly growing list of over 800 organizations and is producing drug products for approximately 50% of CGT clinical trials as well as 5 commercially approved CGT drugs. CGT entities relying on the breadth and scope of ScaleReady's expertise can expect to save years of time and millions of dollars on the path to CGT commercialization. For more information about the ScaleReady G-Rex® Grant Program, please contact [email protected]. About Wilson Wolf Manufacturing Wilson Wolf () is dedicated to simplifying cell and gene-modified cell (CGT) therapy research, process development, and manufacturing. This is being accomplished through its scalable G-Rex® technology, which is used throughout the world in CGT applications ranging from basic research to commercial drug production. Wilson Wolf's mission is to create hope for cancer patients, one G-Rex device at a time. About Bio-Techne Corporation Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing. For more information on Bio-Techne and its brands, please visit or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube. Contact: David Clair, Vice President, Investor Relations & Corporate Development [email protected] 612-656-4416 About CellReady LLC CellReady is the world's first and only G-Rex centric contract development and manufacturing organization (CDMO) specializing in G-Rex based cell and gene-modified cell therapy development and manufacturing. The company offers a wide range of services to support the development and commercialization of these therapies. CellReady's mission is to create hope for cancer patients, one G-Rex process at a time. SOURCE Bio-Techne Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED