Spotlight Therapeutics, Inc.

Walking Fish Therapeutics has closed despite being on the precipice of entering the clinic. (Getty/zoom-zoom) Walking Fish Therapeutics has closed after a lead investor backed out of a critical series B round.  CEO Rusty Williams, M.D., Ph.D., said in an interview with Fierce Biotech that the company was on the precipice of securing fresh capital to enter the clinic when an unnamed top investor backed out, citing concerns about the cost of a multiyear lease. The decision, which came after Walking Fish secured two federal ARPA-H grants to help take the pressure off internal financiers, stunned Williams. “It was a shock,” the CEO said. “T​​his investor just pulled out abruptly and said they wanted to shut down the company.” As a result, 35 employees were laid off, which followed two other layoff rounds to help dwindle costs.  Endpoints News first reported Walking Fish’s closure.  Walking Fish was more than two years removed from a $73 million series A co-led by Northpond Ventures and First Spark Ventures. The biotech previously received funding from Illumina’s venture arm, Quan Capital and the Emerson Collective.  Less than a year ago, the company was adding to its leadership team, hiring Julie Kim as chief business officer and Nallakkan Arvindan, Ph.D., as chief technology officer. Kim joined from Quan after stints at Genentech and Roche, while Arvindan was the former CTO at Spotlight Therapeutics.  The financing and new hires were meant to help advance a three-asset portfolio of B-cell-based therapies, with a lead candidate designed to treat Fabry disease. That asset, WFX-001, was most recently in IND-enabling studies, according to Walking Fish’s website. The biotech intended to reconfigure B cells to help build proteins, including a deficient enzyme in patients with Fabry disease. The biotech also had two additional preclinical assets aimed at undisclosed targets. There’s “a fair amount of interest” in those assets, according to Williams, and conversations are ongoing to find a buyer.  Previously, Williams served as Five Prime Therapeutics' CEO for more than 15 years before its acquisition by Amgen. Before that, he was the chief scientific officer at Chiron, which ultimately was bought by Novartis for $5.1 billion. Now, he’s helming a new venture, Ten30 Bio, which is working on oral molecules.  Reflecting on Walking Fish’s work, Williams concedes that the cost of cell therapy manufacturing and associated clinical trial costs were difficult to overcome. It’s a painful conclusion that many others in cell therapy have realized as they pivot to treat autoimmune conditions.  “I think that B-cell therapy is likely to have its day; I think that what we were doing would have worked,” he said. “But it was just too expensive to get the phase 1 done in that financing environment.” 

DUBLIN, March 2, 2023 /PRNewswire/ -- The "Growth Opportunities In Gene Editing Technologies, Advanced RNA Therapeutics, Antibody Drug Conjugates and Biomanufacturing" report has been added to ResearchAndMarkets.com's offering. This edition of the Life Science, Health & Wellness Technology Opportunity Engine (TOE) highlights some of the recent innovations in gene editing technologies, which aim to make them more targeted and efficient. It also covers few innovations around ADCs (antibody drug conjugates) and its different components which are paving the way for development of safer and longer acting ADCs. In addition, advances in RNA therapeutics including small activating RNA and circular RNA based therapeutics and targeted delivery carriers have been covered. A PoC diagnostic to diagnose psoriasis and automation platform for egg and embryo management are also a part of this issue. The Life Science, Health & Wellness TOE will feature disruptive technology advances in the global life sciences industry. The technologies and innovations profiled will encompass developments across genetic engineering, drug discovery and development, biomarkers, tissue engineering, synthetic biology, microbiome, disease management, as well as health and wellness among several other platforms. The Health & Wellness cluster tracks developments in a myriad of areas including genetic engineering, regenerative medicine, drug discovery and development, nanomedicine, nutrition, cosmetic procedures, pain and disease management and therapies, drug delivery, personalized medicine, and smart healthcare. Key Topics Covered: Innovations in Gene Editing Technologies, Advanced RNA Therapeutics, Antibody Drug Conjugates and Biomanufacturing Exploring the Potential of Circular Ribonucleic Acid (RNA) Therapeutics To Treat Rare Diseases Value Proposition of ORNA Therapeutics ORNA Therapeutics-Investor Dashboard Accelerated Clinical Development of Small Active RNAs to Treat Difficult to Target Diseases Value Proposition Mina Therapeutics Mina Therapeutics-Investor Dashboard Artificial Intelligence (AI)-based Platform Developing Biocompatible RNA Delivery System to Target Multiple Organs Value Proposition of Sixfold Bioscience Sixfold Bioscience-Investor Dashboard Engineered Ribonucleoprotein (RNP) for Delivery of Gene Editing Molecule Value Proposition of Spotlight Therapeutics Spotlight Therapeutics-Investor Dashboard Advanced Analytical Tools to for Cell Line Optimization and Development Valitacell-Value Proposition ValitaCell-Investor Dashboard AI Powered, Integrated Supply Chain Management Platform for Cell and Gene Therapies Trakcel's Proposition Trakcel-Investor Dashboard Novel Class of Site-Specific Nuclease for Development of Allogeneic CAR-T Cells Value Proposition of Poseida Therapeutics Poseida Therapeutics-Investor Dashboard Synthetic Enzyme based on Meganucleases For Developing Innovative Therapies Value Proposition of Precision Biosciences, Precision Biosciences-Investor Dashboard RNA Interference & TCR Inhibition technology for Generating Allogeneic CAR-T Cells Value Proposition of Celyad Oncology Celyad Oncology-Investor Dashboard Targeted Gene-editing Technology Using Short Guide RNA for the Development of Transformative Medicines Value Proposition of Editas Medicine Editas Medicine-Investor Dashboard Engineered Zinc Finger Nuclease Based Targeted Gene Editing Sangamo Therapeutics-Value Proposition Sangamo Therapeutics-Investor Dashboard Therapeutics Targeting Growth Factor Pathways to Treat Fibrotic Indications AgomAb Therapeutics-Value Proposition AgomAb Therapeutics-Investor Dashboard Microfluidics-based Platform for Differential Diagnosis of Psoriasis and Eczema Dermagnostix GmbH-Value Proposition Dermagnostix-Investor Dashboard Toolbox Approach to Developing ADC Technologies for Various Types of Oncologic Targets Iksuda Therapeutics' Value Proposition Iksuda Therapeutics-Investor Dashboard Plug-and-play Engineered Antibodies for Targeted Cancer and Viral Disease Therapeutics Xencor's Value Proposition Xencor-Investor Dashboard Streamlined and Automated Cryospecimen Management Platform for Frozen Eggs and Embryos for Infertility Treatment TMRW Life Sciences' Value Proposition TMRW Life Sciences-Investor Dashboard Digital Biomarkers for Drug Development Trials in the Pharmaceutical Industry VivoSense's Value Proposition VivoSense-Investor Dashboard Flexible, Scalable and Cost-efficient Peptide Based Linker Platform, Offering Highly Stable Antibody Drug Conjugates Value Proposition of Araris Biotech Araris biotech-Investor Dashboard Key Contacts 2. Appendix Criteria for Rating of Innovations--Explanation A selection of companies mentioned in this report includes AgomAb Therapeutics Araris biotech Celyad Oncology Dermagnostix Editas Medicine Iksuda Therapeutics Mina Therapeutics ORNA Therapeutics Poseida Therapeutics Precision Biosciences Sangamo Therapeutics Sixfold Bioscience Spotlight Therapeutics TMRW Life Sciences Trakcel ValitaCell VivoSense Xencor For more information about this report visit 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. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Upon taking the helm at precision oncology-focused Scorpion Therapeutics last summer, Axel Hoo s told Endpoints News that he had a clear vision of the type of leaders he wanted to hire. It appears that former Sanofi project head Michael Streit , one of Hoos’ old colleagues from GSK , fits the bill. Streit has been tapped to lead Scorpion’s first two experimental drugs into the clinic, the company announced on Monday. When Hoos approached him about the open CMO position, Streit said he was “keen about the opportunity” to work together again. “It was the unique combination of a focused strategy and the right people to execute this strategy that attracted me to Scorpion,” he said in an email to Endpoints News. He was most recently at Sanofi, where he served as VP and senior global project head on SAR444245 , the company’s PEGylated, not-alpha interleukin-2 candidate. His resume also includes stops at GSK, where he rose to VP of development, and Janssen , where he led early development for the company’s prostate cancer and hematology programs. When it comes to Scorpion, Streit’s first priority is steering STX-478 and STX-721 into the clinic. The former is designed to inhibit mutant forms of phosphoinositide 3-kinase alpha (PI3Kα), one of the most common drivers across solid tumors, Streit said, while the latter targets the Exon 20 insertion mutation in epidermal growth factor receptor (EGFR) in patients with non-small cell lung cancer. IND filings are expected next year, according to Hoos, though Scorpion has more than 15 other less-advanced programs. “Critical for me as a CEO is that you’re decisive, you’re a good listener so you get all the information you need to make decisions and then you carry that forward with conviction,” Hoos told Endpoints last July. “Conviction is a big thing, especially in biotech. You cannot be successful if you don’t believe in what you’re doing.” — Nicole DeFeudis → The PDUFA date is upon us for eli-cel , and with its gene therapy Zynteglo now approved by the FDA and steeply priced , bluebird bio is looking for its third CFO this year, as chief strategy and financial officer Jason Cole walks out the door Oct. 14 “to pursue new career opportunities.” Cole originally rolled into bluebird eight and a half years ago as general counsel, then became chief legal officer, chief operating & legal officer and chief business officer. He replaced Gina Consylman as finance chief in March when she bolted for Vedere Bio II after eight months, and the job is open again in short order as Danforth Advisors exec Katherine Breedis pinch-hits on an interim basis. This marks the latest departure from bluebird after chief regulatory officer Anne-Virginie Eggimann left for the same post at Flagship ’s Tessera Therapeutics in August. → It may be too early to listen to “Dance of the Sugar Plum Fairy” or “Waltz of the Flowers,” but RNA drug developer Nutcracker Therapeutics is ready to bring in Rob Schott as CMO. Previously the head of therapeutics at Sangamo , Schott is an Eli Lilly alum who was medical chief at the Indianapolis pharma’s subsidiary Chorus . ARCH -backed Nutcracker pulled in a substantial chunk of change in March with a $167 million Series C , and the California biotech fleshed out its leadership this summer with COO John Stubenrauch , CBO Geoff Nosrat i and general counsel Ian Wiener . → Pearl Huang ’s protein degradation upstart Dunad Therapeutics has pegged Ruben Tommasi as chief R&D officer. Tommasi logged 17 years at Novartis and left NIBR to become head of infectious disease chemistry at AstraZeneca in 2011. Since 2015, he had been CSO of AstraZeneca spinout Entasis Therapeutics , the $113 million antibody developer that was sold to Innoviva in May. Flagship stitched together Inzen and Huang’s old company Cygnal to form Sonata Therapeutics that same month, and then Huang took the helm at Cambridge, UK-based Dunad in late June. → Cellics Therapeutics , a San Diego biotech that got the go-ahead on an IND application for its red blood cell nanosponge CTI-005 , has tapped Bristol Myers Squibb veteran Paul Daruwala as president and CEO. Daruwala split his eight years at Cidara Therapeutics between serving as chief commercial officer (2014-18) and COO (since 2018), and at Bristol Myers he was VP of US marketing for the hepatology franchise. Earlier, he spent 18 years at Merck and then pivoted to Vertex in 2010 as VP, commercial & strategic management. → On Sept. 19, Pfizer and Novartis vet Gail Farfel will take over for Gene Williams as CEO of Toronto-headquartered ProMIS Neurosciences , which is going after such diseases as Alzheimer’s, ALS and multiple system atrophy. Farfel just had a seven-year run as chief development officer of Zogenix and is a board member at Avrobio and Durect Corporation . → Nallakkan Arvindan has signed on as chief technology officer of Spotlight Therapeutics , a San Francisco CRISPR gene editing shop that chalked up a $36.5 million Series B in March and added Enhertu whisperer Antoine Yver as a board member in July. In his long career at Five Prime before the $2 billion Amgen buyout of March 2021 , Arvindan was VP, strategic technology operations and would get promoted to SVP in 2018. → Beset by a flailing stock price $TXMD and an M&A move that was called off in July by potential buyer EW Healthcare Partners , former Novartis exec Hugh O’Dowd ’s tenure at Boca Raton, FL women’s health biotech TherapeuticsMD hasn’t panned out, so co-founder Brian Bernick and ex- Esperion chief commercial officer Mark Glickman have thus been named interim co-CEOs. Bernick had filled the role of chief scientific and medical officer, while Glickman had been CBO since June 2021 at TherapeuticsMD, chaired by former HHS Secretary Tommy Thompson . → BioCryst has handed out two promotions as enrollment picks up again on clinical trials for BCX9930 , its lead drug that had received a partial hold from the FDA in May. Bill Sheridan has been elevated to chief development officer, and Ryan Arnold has succeeded Sheridan as CMO of the rare disease biotech. In 2008, Sheridan moved on to BioCryst from Amgen, where he capped off his 14 years with the pharma giant as VP, North American medical affairs. Arnold was brought on board six months ago as SVP of global medical affairs, a position that the Sanofi/ Genzyme alum also held at Sage Therapeutics and Annexon Biosciences . → While looking to broaden the horizons for its FDA-approved pruritus drug Korsuva with an oral formulation in Phase II, Cara Therapeutics has enlisted Ryan Maynard as chief commercial officer. Maynard, the CFO for 10 of his 16 years with Rigel Pharmaceuticals , would later hold the same title at Blade Therapeutics and healthcare solutions outfit LetsGetChecked . He’s also on the board of directors at Iovance alongside such members as chairman Iain Dukes and Athena Countouriotis , the new chairperson at Recludix Pharma who ran Turning Point until Bristol Myers snapped it up for $4.1 billion last year. → While we’re thinking of it, Turning Point’s former interim CSO Gavin Hirst has a new gig as chief scientist at Atomwise , part of Sanofi’s AI full-court press that also includes Exscientia . Before the Takeda vet was with Turning Point, Hirst was Janssen’s senior director and head of immmunology medicinal chemistry. In a deal centered on small molecules, Sanofi paid Atomwise $20 million upfront in August with milestones in the neighborhood of $1 billion. → There’s movement on the Maraganore Meter again as ex- Alnylam chief John Maraganore tacks on another strategic advisory role with Xilio Therapeutics . The I/O biotech has bolstered its board of directors with Tom Heyman , who retired in 2019 after 37 years at J&J , and has plugged in Myles Clouston as VP of investor relations. Clouston worked at Nasdaq for more than eight years and had led US investor relations at MorphoSys . → Science 37 pulled off a $235 million SPAC deal last year, then trimmed its workforce by “just under 25” people this summer as the bear market put many other companies in a similar bind. The decentralized clinical trials provider out of the Research Triangle in North Carolina has since recruited Quintiles vet Michael Shipton as chief commercial officer. Shipton took on the role of SVP, customer solutions & strategy to conclude his four years with Syneos Health . → It hasn’t been all peaches and cream between the FDA and Agenus with its BLA for balstilimab getting pulled last year, and the biotech hopes to get back on track with Patricia Carlos as chief regulatory, quality, and safety officer. Carlos jumps to Agenus from Arcus , where she was SVP of regulatory and quality. Agenus has also welcomed Todd Yancey as senior global clinical development, medical affairs and commercial advisor after his time as BeiGene ’s SVP, global medical affairs and new market development. Carlos also has BeiGene ties from her days as director (and then senior director) of regulatory affairs. → Since its $111 million Series B in January, CAR-T developer ImmPACT Bio has methodically formed its leadership team with a new chief technology officer, COO, CFO and the arrival of Jonathan Benjamin this week as CMO. The ex-medical director at Amgen was SVP for clinical research with Atreca , which had to give itself some breathing room by scaling back the workforce in June. → Pummeled by a drastic 75% staff reduction and a CRL with its cUTI drug tebipenem HBr , Spero Therapeutics has selected Kamal Hamed as CMO. Hamed, a former medical director with Bayer , Bristol Myers and Novartis, just had a six-month run as the medical chief at Lysovant ; he’s also led clinical development and medical affairs for Basilea Pharmaceutica . → Effective Oct. 3, Ronald Herbst will get started as CSO at Biolojic Design , the AI-based antibody shop that started Aulos Bioscience with ATP ’s Michael Ehlers in January 2021. A former MedImmune R&D exec, Herbst was chief scientist at Pyxis Oncology , which pulled the plug on PYX-202 and paused development on PYX-203 and PYX-102 in an August pipeline shakeup. → Going after IL-15 with SOT101 and inking a Keytruda combo deal with Merck after raising more than $300 million in December 2021, Czech cancer player Sotio Biotech has appointed Robyn Hunter as CFO and Martin Steegmaier as CSO . Hunter had been with Fortress Biotech since its Coronado Biosciences days, first as VP & corporate controller and later as CFO, and she’s on the board of directors at Tenax Therapeutics . Steegmaier, the former head of discovery for large molecule research at Roche, wraps up his two years as head of research at MorphoSys. → Swiss I/O biotech Nouscom has promoted Novartis cancer vet Sven Gogov to CMO and picked up Maria Arce-Tomas as VP, head of regulatory affairs. Gogov joined the Janssen partner as VP, clinical development last October after his stint as Incyte ’s executive director, global immuno-oncology. Arce-Tomas has held regulatory positions at GSK, Abbott , Takeda and Novo Nordisk , and since 2019 she had been global head of regulatory affairs with PharmaMar . → Radiopharmaceuticals are a hot commodity, and Jacob Hesterman is entering that world with Ratio Therapeutics as chief data officer. Hesterman was chief technology officer at Realm IDx and Invicro before this newly-created post at Ratio, a Bayer and Lantheus partner that launched from stealth in June with a $20+ million seed round and will be located in the Seaport District in Boston. → Julie Daves has made her way to Minneapolis-based DiaMedica Therapeutics has SVP, clinical development operations. Daves had been global head of clinical operations for Sanifit , a Spanish biotech that was bought by Vifor Pharma , which was bought by CSL in a Matryoshka doll M&A scenario. The FDA issued a clinical hold on DiaMedica’s acute ischemic stroke and chronic kidney disease drug, DM199 , in July. → Global CRO Parexel has a pair of promotions on its leadership team with Peyton Howell being elevated to the newly-created role of chief operating and growth officer and Amy McKee moving up to CMO and global head, Oncology Center of Excellence. Howell joined the company in May 2018 as its chief commercial and strategy officer. Before making her way to Parexel, Howell was president for health systems and specialty care solutions at AmerisourceBergen . Meanwhile, McKee has been with Parexel since 2019, where she started as SVP and head of regulatory consulting services. McKee formerly held an 11-year stint at the FDA, culminating in her role as deputy center director, Oncology Center of Excellence (OCE) and supervisory associate director, OHOP, CDER. → Endpoint Health , not affiliated with Endpoints News , has plucked up Ransi Somaratne as CMO. This isn’t Somaratne’s first time wearing the CMO hat, having served in the same role previously at Spring Discovery . Somaratne also brings with him experience from his times at BioMarin and Amgen. → Not long after Diamyd Medical kicked off its Phase III trial of its drug in an HLA-defined genetic subpopulation of type 1 diabetes patients, the Swedish company has promoted Christoph Nowak to the position of CMO. Nowak joined the autoimmune diabetes biotech last March after a five-year stint as an assistant professor at the Karolinska Institutet . → Phosplatin Therapeutics changed its name to Promontory Therapeutics in May, but not its focus on developing small molecule cancer drugs. This week, the biotech has welcomed Helene Shea as VP of CMC and Kate Hogg Call as VP of clinical operations. Shea was previously the head of CMC at Saniona and also held CMC posts at AMAG Pharmaceuticals and Ariad Pharmaceuticals , while Hogg Call had been the senior director of clinical operations at Checkmate Pharmaceuticals for nearly two years. Promontory is partnering with Pfizer and Merck KGaA on a combo therapy involving Bavencio and its lead asset, PT-112 . → NervGen has named Matvey Lukashev as its VP, research and preclinical development. Lukashev most recently served as VP, translational sciences at the ALS Development Institute . Prior to that, Lukashev held a variety of roles at Biogen . → Adri Osman is joining Azur Group as VP of corporate quality and compliance. Osman comes from Teva Pharmaceuticals , where he served as head of quality strategy and portfolio management. → Ex-Pfizer Oncology president Garry Nicholson has been named chairman of the board at Day One Biopharmaceuticals , which did the positive data-to-public offering two-step in June. Nicholson chairs the board at G1 Therapeutics and had a 28-year run at Eli Lilly before joining Pfizer in 2008. → South San Francisco neuro biotech Nine Square Therapeutics has elected Samumed co-founder and ex- Impact Biomedicines chief John Hood to the board of directors. Hood’s new company, Endeavor Biomedicines , raised $101 million in a Series B round back in February. → Long non-coding RNA (lncRNA) upstart Haya Therapeutics has locked in Brian Thomas as chairman of the board. Thomas holds the top spot at Metagenomi , a gene editing player that inked a CRISPR deal with Moderna last November. → Under the new leadership of CEO Kim Blackwell , Zentalis Pharmaceuticals has reserved space for Jan Skvarka on the board of directors. The CEO of Trillium until it was sold to Pfizer for $2.22 billion last year , Skvarka chairs the boards of GentiBio and Longwood ’s DEM BioPharma , the just-launched CD47 player that scored a $70 million Series A . → Regular CNN contributor Leana Wen , who has been under the microscope for her about-face on Covid mandates , has joined the board of directors at UroGen . The George Washington University professor is also a board member at Glaukos . → The number of board members at 1910 Genetics has grown to four with the selection of Desney Tan . The 18-year Microsoft vet and managing director of Microsoft Health Futures is joining CEO Jen Nwankwo , the NIBR’s Jennifer Leeds and Playground Global venture partner Phyllis Whiteley on the board. → Merit Cudkowicz is taking her talents to South Beach as a member of the scientific advisory board at Miami-based neuro biotech Pasithea Therapeutics . Cudkowicz, the chief of neurology at Massachusetts General Hospital, is a frequent resource for Endpoints’ ALS coverage. → Oxford Biotherapeutics chairman Bernd Seizinger , the acting CEO of CryptoMedix , is headed to the board of directors at Aptose . In the 1990s, Seizinger was VP for oncology drug discovery and VP for corporate and academic alliances with Bristol Myers. → Pliant Therapeutics , another biotech that raised a truckload of cash after positive data, has appointed Agilent Technologies CMO and longtime GSK exec Katharine Knobil to the board of directors. She’s also been CMO and head of R&D at the now-defunct Kaleido Biosciences . → The folks at hC Bioscience just gained a CSO and chief data science officer last week, and now the tRNA player has waved in Brad Margus to the board of directors. The ex-CEO of Cerevance and Envoy Therapeutics also has board seats at Arvinas , Neurona Therapeutics and the A-T Children’s Project. → Prostate cancer biotech ESSA Pharma has added Philip Kantoff to the board of directors. The former chairman of the Department of Medicine at Memorial Sloan Kettering, Kantoff co-founded and is CEO of another biotech that’s targeting prostate cancer, Convergent Therapeutics . → Tel Aviv-based Ukko has welcomed aboard Tim Garnett to its advisory board. Garnett is the former CMO of Eli Lilly, having served in the role from 2008 to 2021. Garnett also previously served as the chair of the R&D leadership forum for PhRMA . → Neogen is pulling out two new seats on its board of directors for Jeff Capello and Aashima Gupta — who come along after a merger agreement with 3M . Capello — currently managing member at Monomoy Advisors — has had a busy career, serving as CFO at a number of places including PerkinElmer , Boston Scientific and Biogen. Meanwhile, Gupta has held a variety of roles, including stints at JP Morgan Chase , Google Cloud , Apigee and Kaiser Permanente .