GV20 Therapeutics

BOSTON, Sept. 16, 2024 /PRNewswire/ -- GV20 Therapeutics, a clinical-stage AI-based next generation biotherapeutics company, today announced presentation of clinical results from its Phase 1/2 study of GV20-0251 at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. Dr. Kristopher Wentzel from The Angeles Clinic and Research Institute gave an oral presentation on the clinical data from the monotherapy dose escalation portion of the ongoing study of GV20-0251, a first-in-class antibody targeting the novel immune checkpoint IGSF8, in patients with advanced solid tumors (NCT05669430). Key highlights from the presentation include: Patient Population: The study enrolled 38 heavily pre-treated patients across six dose levels and two dosing schedules. The median age was 62 years, with a median of 4 prior lines of treatment. Safety: GV20-0251 was well-tolerated across all dose levels (0.5 to 20 mg/kg) with no dose-limiting toxicities observed. Most of treatment-related adverse events were grade 1/2, with only one case of grade 3 pneumonitis reported. Efficacy: Two confirmed partial responses were observed in 12 efficacy-evaluable metastatic cutaneous melanoma patients. Additionally, 14 of 29 efficacy-evaluable patients showed stable disease, including 4 with tumor shrinkage. Pharmacokinetics: Dose-proportional pharmacokinetics with half-life around 25.6 days and full target occupancy on circulating T cells were observed at doses ≥ 3 mg/kg. Click here to access the ESMO presentation. "We are excited by these encouraging results for GV20-0251, which represent a significant milestone as the first clinical data for an AI-designed antibody against an AI-predicted target," said Dr. Shirley Liu, Co-founder and Chief Executive Officer of GV20 Therapeutics. "The favorable safety profile and preliminary efficacy signals, particularly in melanoma patients, support the potential of IGSF8 as a novel immune checkpoint target." GV20-0251 is designed to enhance NK cell killing of malignant cells, upregulate dendritic cell antigen presentation, and increase T cell signaling. This mechanism of action may be particularly relevant for patients with antigen presentation-deficient tumors, which are often resistant to current immune checkpoint inhibitors. The company is currently recruiting anti-PD1-relapsed and refractory cancer patients to be treated by GV20-0251 in combination with pembrolizumab to further evaluate the drug safety, pharmacokinetics, pharmacodynamics, and efficacy. ABOUT GV20 THERAPEUTICS GV20 Therapeutics is developing a differentiated pipeline of next generation biotherapeutics integrating AI, genomics, & disease biology. Its lead program, GV20-0251, a first-in-class, fully human, Fc-attenuated IgG1 monoclonal antibody targeting a novel immune checkpoint IGSF8 to activate innate and adaptive immunity, is in a multi-center Phase 1/2 clinical trial in patients with advanced solid tumors (NCT05669430). Its discovery pipeline includes best-in-class and first-in-class ADCs and degraders. To learn more about GV20, please visit and follow the company on LinkedIn. Business Contact Ying Gong, Ph.D., CBO [email protected] SOURCE GV20 Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CAMBRIDGE, Mass., Aug. 21, 2024 /PRNewswire/ -- GV20 Therapeutics, a clinical-stage AI and genomics-based next generation biotherapeutics company announced today that Dr. Kristopher Wentzel from The Angeles Clinic and Research Institute will present the clinical data on GV20-0251 monotherapy dose escalation at the ESMO Congress 2024, taking place in Barcelona on Sept 13-17, 2024. GV20-251 is the first clinical stage, AI-designed antibody therapeutic against an AI-predicted target in the clinic. The monotherapy dose escalation study started on Mar 27, 2023, and has enrolled across six dose cohorts and two schedules. GV20-0251 has shown favorable safety profile and promising monotherapy clinical efficacy. Details of the oral presentation are below: Title: "A phase 1/2, open-label study of the novel checkpoint IGSF8 inhibitor GV20-0251 in patients with advanced solid tumors" Session Type: Mini oral session Session Title: Investigational Immunotherapy Session Date/Time: Monday Sep 16, 2024, 10:15-11:45AM Session Room: Granada Auditorium - Hall 6 Presentation Number: 1000MO ABOUT GV20 THERAPEUTICS GV20 Therapeutics is developing a differentiated pipeline of next generation biotherapeutics integrating AI, genomics, & disease biology. Our lead program, GV20-0251, a first-in-class, fully human, Fc-attenuated IgG1 monoclonal antibody targeting a novel immune checkpoint IGSF8 to activate innate and adaptive immunity, is in a multi-center Phase 1/2 clinical trial in patients with advanced solid tumors (NCT05669430). Our discovery pipeline includes best-in-class and first-in-class ADCs and degraders. GV20 is headquartered in Cambridge, MA. To learn more about GV20, please visit and follow the company on LinkedIn. Business Contact Ying Gong, Ph.D., CBO [email protected] SOURCE GV20 Therapeutics

Less than 12 months into her job leading the commercial rollout of one of the world’s biggest-selling biotech products, Moderna ’s Covid-19 vaccine, Corinne Le Goff departed the household name in December 2021, but her future in the industry is just now coming into clear view. The more than 30-year industry veteran — whose posts have run the gamut across Pfizer , Sanofi , Merck , Roche and Amgen — is now CEO and president of Celsion , which itself is potentially looking to get into the SARS-CoV-2 vaccine landscape, albeit way later than her previous employer. Le Goff kicked off her stint at the New Jersey biotech on July 18, replacing Michael Tardugno , who held the top post for the past 15 years. He remains in his role as executive chair. “She adds tremendous depth of knowledge and joins us at a key inflection point in our evolution, as we work to rapidly advance our GEN-1 program for the treatment of advanced-stage ovarian cancer and build a proprietary vaccine platform based on our PLACCINE technology,” the outgoing CEO said in a statement. The 37-year-old company has for decades been working on cancer drugs and has been working through a Phase III trial of its lead asset, dubbed ThermoDox , since the second half of 2014. Celsion also has clinical-stage work in ovarian cancer, and is in the preclinical stages with glioblastoma and bladder cancer assets. Another potential avenue going forward is developing a vaccine candidate for the pandemic. The new chief executive steps into a biotech with relatively small cash reserves of $47.3 million, which is about three times its market cap. Celsion said that amount, as of March 31, is good enough to fund operations into the second quarter of 2025. — Kyle LaHucik → Severin Schwan is the latest Big Pharma CEO to plan his exit, handing the keys to Roche Diagnostics chief Thomas Schinecker on March 15, 2023. Roche will nominate Schwan, who has guided the Swiss multinational since 2008, as chairman to replace Christoph Franz . A board member for 11 years, Franz has been chairman since 2014 and won’t seek re-election. Under Schwan’s watch, a number of drugs achieved blockbuster status at Roche, including Ocrevus , Kadcyla , Actemra and Tecentriq . Analysts project that its spinal muscular atrophy drug Evrysdi — approved in August 2020 — is headed down the same blockbuster path, giving Zolgensma and Spinraza a run for their money. Schwan follows the recent transitions of Merck’s Ken Frazier and J&J ’s Alex Gorsky in the land of pharma giants, and Biogen is on the hunt for Michel Vounatsos ’ successor. Both Frazier and Gorsky have served as executive chairman of their respective companies after their CEO days ended. → Compass Pathways is pointing in the direction of a new CEO, as Kabir Nath takes over for George Goldsmith at the London psychedelics biotech on Aug. 1. From there, Goldsmith will be executive chairman until Dec. 31, when he’ll settle into his role as chairman. Nath is currently senior managing director of Otsuka ’s global pharmaceutical business, and earlier he was president and CEO of the Otsuka North America pharmaceutical business. Nath also held several posts at Bristol Myers Squibb , including president of BMS China and SVP, virology, transplant & optimized brands. → Feng Ren vaulted to co-CEO with Alex Zhavoronkov at Insilico Medicine last month just after a $60 million cash infusion , and the AI outfit’s team has grown with Sujata Rao overseeing global clinical development. At Eli Lilly , Rao was associate VP of global clinical development for such drugs as sintilimab , which has famously been struck down by the FDA for its reliance on China-only data. Rao has further Big Pharma ties as immuno-oncology medical lead and oncology scientific advisor at Bristol Myers for nivolumab ( Opdivo ). → Not only has Editas Medicine seen volatility at the top with multiple CEOs in short order, the CMO position had been vacant since Lisa Michaels ’ sudden and unexplained ouster in February. Baisong Mei was named as her successor early this week, leaving Sanofi behind after his tenure as senior global project head, rare diseases and rare blood disorders. Following 10 years at Bayer , he then moved on to Biogen in 2010, first as director, discovery research and then as therapeutic area head for hematology clinical development. Editas is on its fourth chief executive in three years after Katrine Bosley ’s departure in early 2019. In April, ex- Sarepta CMO Gilmore O’Neill replaced Jim Mullen , who took control when Cynthia Collins left in February 2021. → Kunwar Shailubhai has turned in his resignation as CEO, CSO and member of the board at Tiziana Life Sciences , and on Aug. 1, executive chairman Gabriele Cerrone will take charge as interim CEO. Shailubhai’s decision “is not related to any disagreement with the Company on any matter relating to the Company’s operations, policies or practices,” the statement reads. Tiziana has two candidates in early-stage trials: foralumab , an anti-CD3 monoclonal antibody; and milciclib , a pan-CDK inhibitor. → J&J general counsel Michael Ullmann is calling it a career after 33 years at the pharma giant, retiring “at the end of this year” and assisting with the transition as Elizabeth Forminard takes the wheel on Oct. 17. Ullmann started out as an M&A attorney for J&J in 1989 and has spent the last 11 years as general counsel, while Forminard joined from Pfizer in 2006 and was elevated to worldwide VP, general counsel for the pharmaceutical sector three years ago. → Life after Intercept is coming into clearer focus for Mark Pruzanski , taking another CEO gig at Versanis Bio , Joe Jimenez and Mark Fishman ’s obesity play from the Aditum Bio family of companies. “There were a number of other opportunities that I was looking at, but Versanis just became utterly compelling to me,” Pruzanski told Endpoints News this week. “And the reason for that starts with the fact that we’re looking at addressing what I consider to be the chronic disease epidemic of our age.” And at this point, where isn’t John Maraganore grabbing a board seat or an advisory post? The Maraganore Meter is up and running again, and ex-Intercept CFO Barbara Duncan joins him on Versanis’ board. → Stephen Dilly is making a quick comeback to the biotech scene as the new CEO of enzyme engineer Codexis . Dilly makes the jump not long after selling Sierra Oncology to GSK in February. Dilly is taking over the reins from John Nicols , who is retiring after a decade of service to focus on family and to devote his time to Solve ME/CFS — the nonprofit he chairs that is dedicated to myalgic encephalomyelitis/chronic fatigue syndrome. Dilly has worn the CEO hat not only at Sierra, but at Aimmune Therapeutics as well, which was sold to Nestlé Health Science after securing the first FDA nod for a peanut allergy treatment. → Max Colao is out as chief commercial officer of Aurinia “to tend to personal matters” as CEO Peter Greenleaf lines up Scott Habig as his replacement. The revolving door is getting a workout at the Lupkynis maker , which has also welcomed Volker Knappertz as EVP of R&D and DeDe Sheel as VP of investor relations. Habig just ended a 10-year run at UCB as head of global SLE (systemic lupus erythematosus) and he’s also held sales and marketing posts at Centocor . Knappertz spent nearly five years as CMO and EVP of R&D at GW Pharmaceuticals , now in the hands of Jazz Pharmaceuticals after a $7.2 billion buyout in 2021. Sheel owned the same title at Sierra Oncology and Aimmune , and she also had investor relations roles at Exelixis and Myovant . → Fab Five: Notching a $115 million Series B in January for its gene therapy 3.0 ambitions, SalioGen is brimming with new hires under CEO Ray Tabibiazar . First up is Cathryn Clary (SVP of clinical Development and CMO), an ex-Pfizer and Ipsen exec who was CSO and head of US medical affairs and clinical development in the general medicines division at Novartis. Also, Pat Sacco (SVP of manufacturing, quality, and operations) was SVP of technical operations at Translate Bio from 2019-20 after a 16-year run at Shire ; Joe Senn (SVP of nonclinical development) comes to SalioGen from Moderna, where he finished up eight years at the Covid-19 vaccine titan as VP, nonclinical sciences; Feng Yao (VP of research — molecular switch and gene regulation) invented the T-REx technology used by Thermo Fisher and also taught at Brigham and Women’s Hospital and Harvard Medical School; and Oleg Iartchouk (VP of genomics and biomarkers) was global head of genomics during his eight years at NIBR . → The HBV drug vebicorvir will ride the pine at Assembly Biosciences , and as a result of the discontinued studies , 30% of John McHutchison ’s workforce will be shown the door, prompting a game of musical chairs in the C-suite. CMO Luisa Stamm and CFO Michael Samar are out in the coming weeks, but a couple of colleagues have been promoted : Michele Anderson , Assembly Bio’s SVP of development operations, will move up to chief development officer, and COO Jason Okazaki will add the role of president to his business card on Aug. 1. In dueling statements, McHutchison didn’t see a way forward with vebicorvir combos, while its HBV partner Arbutus Biopharma begged to differ. → Tim Springer and Andrew Kruse ’s GPCR play Tectonic Therapeutic , one of the Endpoints 11 winners last year and under the leadership of ex-Merck R&D vet Alise Reicin , has promoted Peter McNamara to CSO after bringing him on board from the Genomics Institute of the Novartis Research Foundation as head of research in May 2021. Tectonic has also introduced Barry Rubenstein as SVP, people and culture and Washington Alves as VP, biologics manufacturing. Rubenstein makes a change here after three years as VP, human resources at Kala Pharmaceuticals , and he also took on a series of HR positions at AMAG Pharmaceuticals from 2010-19. A Pfizer and Merrimack vet, Alves had previously been senior director, CMC operations for Gemini Therapeutics . → You may have read last week that Chris Morabito left Fulcrum Therapeutics , and it hasn’t taken him long to turn up at another biotech . Astria Therapeutics , the company once named Catabasis Pharmaceuticals until September 2021, has put down the welcome mat for Morabito as CMO after a year in the same position at Fulcrum. The ex- Cardurion CMO has also held a number of R&D posts at Takeda , Sanofi and Merck. Astria’s lead program STAR-0215 is in a Phase Ia trial for hereditary angioedema. → While Evelo Biosciences ’ $79.2 million direct offering in May has done little for its fading stock price, Marella Thorell will seek to put the Flagship inflammatory disease biotech on solid footing as CFO on Sept. 1. After her dual role as CFO and COO of Realm Therapeutics , Thorell became finance chief of Palladio Biosciences , now a Centessa subsidiary. She was then named head of finance at Centessa and had served as chief accounting officer since April 2021. → Chinese CAR-T player Gracell has selected Samuel Zhang as CBO. His Big Pharma experience runs the gamut, to wit: global launch lead for blockbuster drug Alimta at Eli Lilly; medical director/global medical head, immuno-oncology with Pfizer; head of prostate tumor strategy for Bristol Myers; and head of immuno-oncology product and portfolio strategy at Novartis . Most recently, Zhang was the business chief at NeoImmuneTech . → European venture capital firm Forbion , which made an initial close of $504 million for its second growth fund last month, has tapped Peter Høngaard Andersen as operating partner and Matt Cooper as venture partner. Andersen hails from Lundbeck and Novo Nordisk and comes aboard with quite a few other stints under his belt, including co-founding Acadia Pharmaceuticals , Zealand Pharmaceuticals , Glycom and Epitherapeutics . Meanwhile, Cooper has founded or co-founded companies such as Sitala and Inflazome and was the founder of the Center for superbug solutions, community for open access antibiotic discovery & center for drug discovery and design at the University of Queensland. → Trying to scrape itself off the canvas after getting knocked down by a partial clinical hold with its CDK inhibitor NUV-422 , David Hung ’s Nuvation Bio has installed David Liu as CMO and Kerry Wentworth as chief regulatory officer. Liu worked on Opdivo and Yervoy for Bristol Myers in China as group director, oncology global clinical research and was recently the medical chief for Shanghai-based 3D Medicines . Wentworth was chief regulatory officer for Flexion before Pacira Biosciences bought it for a song last year, and she also spent a decade with Agenus , where she was VP, clinical, regulatory, and quality. → More execs are pouring into Opus Genetics , the new gene therapy biotech for eye diseases based in the Research Triangle founded by Jean Bennett . Vikram Arora (VP of non-clinical development) spent 11 years at Grifols and was director of pharmacology & toxicology at Talecris Biotherapeutics ; Erin O’Neil (VP of clinical development) is a Google marketing specialist-turned-ophthalmologist at the Children’s Hospital of Philadelphia; and Sarah Tuller (VP of regulatory and medical writing) is an Astellas regulatory alum who comes to Opus after a year as VP of regulatory affairs at Disc Medicine . → With its Endosomal Escape Vehicles (EEVs) going after Duchenne muscular dystrophy and myotonic dystrophy type 1 (DM1) first, Boston’s Entrada Therapeutics has promoted Karla MacDonald to chief corporate affairs officer. MacDonald, formerly VP of corporate communications and investor relations, was Ipsen’s VP, communications and patient advocacy following an 11-year run at Merck, where she rose to head of international communications. → Back in May 2020, Robert Foerster and Bill Erhardt joined New York neuro biotech Oligomerix as CFO and CMO, respectively. Foerster has now tacked on the role of COO, while Erhardt has been named president, head of development & operations to accommodate Oligomerix’s shift to two business units. CEO James Moe will be head of research & strategy and handle Discovery Group duties, while Erhardt leads the Development Group. Foerster and Erhardt both worked for Pfizer at the same time and have more than 35 years of combined experience at the pharma giant. → San Diego-based Replicate Bioscience has welcomed Zelanna Goldberg as CMO and Mohit Trikha as a member of its board of directors. Goldberg joins the company after a stint as CMO at Alpine Immune Sciences . Prior to that, Goldberg was SVP of clinical development at Iovance and a 9-year gig at Pfizer. Meanwhile, Trikha is a venture partner at Apple Tree Partners and is the former VP and head of oncology early development at AbbVie . → Kate Surdez has signed on to be chief human resources officer of regenerative medicine biotech MiMedx . She was global HR director during her eight-year run at AstraZeneca , then led HR at the pharma giant’s spinoff Viela Bio until it was sold to Horizon for $3 billion last year. Since then, Surdez had been head of HR for Vaxxinity . → RenovoRx has named James Ahlers as CFO, succeeding Christopher Lehman , who is heading for greener pastures. Ahlers most recently served as CFO of Intarcia Therapeutics and served in finance roles at Titan Pharmaceuticals and Ansan Pharmaceuticals . In addition, the company has recruited Ronald Kocak as VP and controller. Kocak hops aboard from Sensei Biotherapeutics , where he was controller and senior director of finance. → Backed in part by Oxford Science Enterprises , which started its week off with a bang by raising $300 million (£250 million), OMass Therapeutics has plugged in Jon Roffery as VP, head of medicinal chemistry. Roffery had led drug discovery at Nanna Therapeutics since February 2021, and he’s also been director of chemistry at Azeria Therapeutics . Oxford Science Enterprises contributed to OMass’ $100 million Series B in April alongside such investors as Syncona and GV . → Now that Eagle Pharmaceuticals plunked down $103 million for Acacia Pharma and its approved meds Barhemsys and Byfavo in late March, Debra Hussain will help with the relaunch of both products as SVP, head of commercial. Hussain was Acacia’s chief commercial officer until the deal was made, and she held a string of roles during a 22-year tenure at Eli Lilly that concluded in 2021 as senior director of marketing. → Based in the small Canadian border town of Baudette, MN — touted as the walleye capital of the world — ANI Pharmaceuticals has reeled in Meredith Cook as SVP, general counsel and corporate secretary. Cook spent the last two years as VP and associate general counsel for Amneal Pharmaceuticals after joining the company in 2019 as VP, transactions. → Swiss-based Relief Therapeutics is bringing on Serene Forte as SVP, head of genetic medicine. Forte hails from RCP Bio , where she served as CSO. Prior to that, she was VP, medical affairs — gene therapy at Krystal Biotech . Earlier in her career, Forte had gigs at PTC Therapeutics , Sarepta and Medimmune . → Relmada Therapeutics is reeling in John Hixon as head of commercial. Hixon had a 31-year stint at Eli Lilly, most recently serving as senior director for global new product planning — biomedicines. → Corvus Pharmaceuticals has appointed James Rosenbaum as SVP of research. Rosenbaum is a rheumatologist and immunologist and is a former professor of ophthalmology, medicine and cell biology at Oregon Health & Science University. → Vividion CEO Jeff Hatfield has been named chairman of the board of directors at repeatome-focused ROME Therapeutics , which features ARCH ’s Kristina Burow , Nimbus CEO Jeb Keiper and ROME CEO Rosana Kapeller . Hatfield, a Bristol Myers vet and board member at George Scangos ’ Vir Biotechnology , replaced Diego Miralles as Vividion chief in November 2020. → Cambridge, MA-based GV20 Therapeutics is picking up a trio of advisors with the appointments of Alessandra Cesano (CMO of ESSA Pharmaceuticals ), Julie Cherrington (former CEO and president of ARCH Oncology ) and Mike Varney (former head of Genentech Research and Early Development and life sciences senior advisor at Frazier Healthcare Partners ). → Picking up the pieces after disastrous animal studies for its hemophilia A gene therapy program , Generation Bio has elected Novartis vet Dannielle Appelhans to the board of directors. Appelhans surfaced on Peer Review a year ago around this time when she took the COO job at Rubius . → We’re not done with Rubius execs getting board gigs, as Jose Carmona joins the board at allosteric drug developer HotSpot Therapeutics . Carmona, the CFO at Rubius for nearly two years, is also on the board of directors at Senda Biosciences . → Belgian biotech Apaxen , whose lead program is an NLRP3 inflammasome inhibitor for pulmonary arterial hypertension, has pegged Graham Dixon as chairman of the board. The AstraZeneca alum has also been CSO of Galapagos , where CAR-T is now a part of ex-J&J star Paul Stoffels ’ turnaround project. → After picking up GSK vet Amol Ketkar as chief development officer at the start of the month, London-based Resolution Therapeutics has now brought Bill Symonds onto its board of directors. Symonds currently serves as the CEO of Sumitovant subsidiaries Altavant Sciences and Enzyvant Sciences . Symonds is also the former chief development officer of Roivant Sciences . → Mitch Gold has reserved space at Alpine Immune Sciences for Viela Bio co-founder Jörn Drappa on the board of directors. Drappa, an Amgen and Genentech vet, recently left Ventyx Biosciences just eight months after taking the CMO job. → Carlos Albán is headed to the board of directors at Pfizer spinoff SpringWorks Therapeutics . After 26 years at Abbott , Albán became AbbVie’s EVP, commercial operations in 2018 and retired as chief commercial officer in March 2021. → Eiger BioPharmaceuticals — the company that received an FDA OK back in 2020 in Progeria for a drug Merck licensed to them at no cost — has made the addition of Lisa Kelly-Croswell to its board of directors. Kelly-Croswell currently serves as SVP and chief human resources officer at Boston Medical Center Health System and is the former human resources lead at Vertex . → Back in 2021, iOmx Therapeutics bagged $75.3 million in a Series B to search for immune checkpoint targets on tumor cells, now the German company is adding three new members to its advisory board: Matthias Kromayer (managing partner at MIG Capital ), Michael Burgess (head of R&D at SpringWorks Therapeutics ) and Rainer Kramer (CBO at Immatics ). The trio are joining Gerald Moeller (former CEO of Boehringer Mannheim Group ), Henrijette Richter (managing parter at Sofinnova Partners ) and Rainer Strohmenger (managing partner at Wellington Partners ).