Cusatuzumab

- OncoVerity licenses Cusatuzumab, a first-in-class anti-CD70 antibody, from argenx - Max Colao, MBA appointed as Chief Executive Officer and Dr. Clay Smith as Chief Medical Officer - OncoVerity closes $30M Series A financing AURORA, CO, USA I March 27, 2023 I OncoVerity, a pioneer in applying advanced multiomic, data driven patient stratification to the development of human therapeutics in oncology, has secured worldwide licensing rights to cusatuzumab from argenx and received $30M in funding from argenx and a joint venture of UCHealth and University License Equity Holdings, Inc. on the University of Colorado Anschutz Medical Campus for its continued development. Cusatuzumab is a first-in-class anti-CD70 antibody that has generated promising results in early acute myeloid leukemia (AML) human studies. OncoVerity will optimize cusatuzumab’s continued development in AML and explore its application in other cancers. OncoVerity is also announcing the appointment of Max Colao, MBA as Chief Executive Officer, and Dr. Clay Smith as Chief Medical Officer. "We are thrilled to welcome Max and Clay to the OncoVerity leadership team. Together with Max’s extensive commercial leadership experience and Clay’s proven track record in research and development, we are confident that will drive growth and expansion as we enter the next phase of development,” said Arjen Lemmen, Vice President, Corporate Development and Strategy at argenx, and OncoVerity Board Member. Mr. Colao has over 30 years of biotechnology leadership experience. In his most recent position, he served as the Chief Commercial Officer of Aurinia, where he built out the commercial team through launch. Prior to that, Mr. Colao held senior roles of increasing responsibility at Alexion, where he led the US commercial operations and built out the new business units in launching several rare disease therapies. He also spent over 20 years at Amgen, where he launched multiple therapies in the areas of hematology, oncology, and autoimmune disorders supporting Amgen’s growth from small to large biotech. Dr. Smith joins OncoVerity with more than 30 years of experience in oncology research, clinical care and clinical trials. He was previously Professor and Associate Chief of the Hematology Division at the University of Colorado. He was also the Director at UCHealth Blood Disorders and Cell Therapies Center. With the support of the University of Colorado Anschutz Medical Campus and UCHealth, Dr. Smith and his team pioneered the clinical and single cell multiomics infrastructure necessary to support, de-risk, and accelerate the development of this innovative therapy. Throughout his career, Dr. Smith has published over 150 scientific articles. “I am excited to lead OncoVerity to its next phase of development and believe that the licensing of cusatuzumab and new funding demonstrate our commitment to advance novel cancer therapies in areas of high unmet need,” said Max Colao. “OncoVerity’s differentiated approach and talented team put us in a strong position to answer unresolved disease and therapeutic questions in oncology. I’m grateful for the contributions of the University of Colorado and argenx in establishing OncoVerity and look forward to making significant progress on behalf of cancer patients around the world.” “OncoVerity is an example of a unique partnership that bridges the best in research, healthcare delivery, and the use of advanced multiomic data science-driven drug development to bring cutting edge treatments to patients in the areas of greatest unmet medical need,” said Kimberly Muller, Executive Director, CU Innovations, Anschutz Medical Campus, General Partner, CU Healthcare Innovation Fund, and Board Member of OncoVerity. "This is a very exciting time to be joining OncoVerity as we start this journey to advance cancer research and develop targeted therapies that can make a real difference in the lives of patients," said Dr. Clay Smith. "I am particularly enthusiastic about the potential for our work on cusatuzumab for the treatment of AML, a disease where despite many advances in the treatment paradigm there remains a significant opportunity to develop effective therapies that meaningfully prolong survival.” About Cusatuzumab Cusatuzumab is a monoclonal antibody targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. Cusatuzumab is designed to: block CD70, kill cancer cells expressing CD70 through complement dependent cytotoxicity, enhanced antibody-dependent cell-mediated phagocytosis and enhanced antibody-dependent cell-mediated cytotoxicity, and restore immune surveillance against solid tumors (Silence K. et al. mAbs 2014; 6 (2):523-532) . Cusatuzumab is currently being evaluated in patients with hematologic malignancies, including a Phase 2 trial in combination with azacitidine and a Phase 1b trial in combination with azacitidine and venetoclax in patients with newly diagnosed AML. About Acute Myeloid Leukemia Despite the advancements in medical research, there is still a significant lack of effective therapies to treat Acute Myeloid Leukemia (AML). The five-year survival rate for AML patients remains the lowest of all blood malignancies (5-20%), and relapse is common. AML is a heterogeneous disease, which means that it can differ in its genetic and molecular characteristics from one patient to another. This makes it difficult to develop effective treatments that can target all types of AML. Innovative therapies and targeted treatment approaches that can improve the survival rates, reduce toxicity, and target specific subtypes of AML are urgently needed to address this unmet need. About OncoVerity OncoVerity is pioneering the use of a unique clinical and single cell multiomics database to better the lives of patients battling cancer. OncoVerity’s approach leverages the University of Colorado Anschutz Medical Campus and UCHealth infrastructure of single cell analysis capabilities for multiple types of -omic technologies including genomics, transcriptomics, and proteomics, alongside one of the most comprehensive and highly curated AML patient databases to gain insights to tumor characteristics and therapeutic response Cusatuzumab is expected to be the first of many novel therapeutics that will benefit from the OncoVerity platform and differentiated approach to oncology drug development. In collaboration with world-renowned hematologists specializing in acute myeloid leukemia (AML), OncoVerity aims to develop cusatuzumab by truly understanding and acting upon the heterogeneous characteristics of AML. SOURCE: OncoVerity

Michelle Berrey → Jason Campagna and Sandip Kapadia were two execs who punched their tickets out of Intercept as things went pear-shaped, and the teetering NASH biotech has found their replacements as CMO Michelle Berrey and CFO Andrew Saik take over their positions. Berrey, the ex-president and CEO at Chimerix, was Pharmasset’s CMO from 2007-12. Just before her Pharmasset days, she had been with GlaxoSmithKline as VP, viral diseases, clinical pharmacology & discovery medicine. Berrey will also be Intercept’s president of R&D in addition to CMO. SVP Gail Cawkwell had been pinch-hitting after Campagna’s departure and subsequent move to Q32 Bio. For the last year, Saik was CFO at Vyne Therapeutics and held the same title at PDS Biotech, Vertice Pharma and Auxilium Pharmaceuticals. Chief accounting officer Rocco Venezia had been filling the gap between Kapadia and Saik as interim CFO at Intercept, which also saw CEO Mark Pruzanski exit stage left after the FDA rebuffed its NASH drug — a ruling that seems positively quaint in light of Monday’s highly controversial aducanumab approval. → One of the companies that tried and categorically failed in its Alzheimer’s efforts was Neurotrope. For ex-CEO Charles Ryan, it’s a fresh start at another biotech as he becomes president and CEO of Singapore-based Travecta Therapeutics, which is setting its sights on drugs that can cross the blood-brain barrier. Before leading Neurotrope, Ryan was SVP and chief intellectual property counsel for Forest Laboratories (now AbbVie) and spent a year as general counsel at Cold Spring Harbor Laboratory. Gina Consylman → Mark Mallon decided to walk away as Ironwood’s CEO in March, leaving president Thomas McCourt to pick up the pieces after the trial failures of two drugs last year. McCourt has shaved off the interim label this week and will officially make his CEO duties at Ironwood permanent. Meanwhile, CFO Gina Consylman follows Mallon out the door after seven years at Ironwood, effective July 2. According to the press release, “Ms. Consylman’s resignation is not due to any disagreement with Ironwood on any matter relating to the Company’s financial reporting.” Neha Krishnamohan → Expanding its reach into China with a joint venture that raised $35 million in a Series A, Kinnate has welcomed Neha Krishnamohan as CFO and EVP, corporate development, along with a whole host of other execs. Krishnamohan’s tenure at Goldman Sachs began in 2008 and for the last six years was VP in the Healthcare Investment Banking Group before joining Nima Farzan’s squad. In addition to Krishnamohan, Kinnate has added Ken Kobayashi (SVP, clinical development), Jason Cox (VP, medicinal chemistry), Jason Hampson (VP, head of regulatory affairs), David Madden (VP, finance), Clement Pimor (VP, strategy and portfolio management) and Barbara Warren (VP, human resources) to its burgeoning team. → What was initially sketched out as a $75 million IPO actually ballooned into a $222 million IPO for Emeryville, CA-based 4D Molecular Therapeutics in December. Going full steam ahead with its gene therapies, 4DMT has appointed Carolyne Zimmermann as CBO. Zimmermann starts afresh here after she was VP of transactions at Johnson & Johnson Innovation, and she took on various roles in a 13-year period at Novartis, including head of the global cardio-metabolic franchise’s business development and licensing. Filip Janku → Filip Janku has been given the nod as CMO of ubiquitous Peer Review entrant Monte Rosa, the “molecular glue” biotech that raked in another $95 million worth of Series C funding in March. Since 2009, Janku has filled several roles at The University of Texas MD Anderson Cancer Center, and for the last three years he had been center medical director at the cancer facility’s Clinical and Translational Research Center. Monte Rosa has been adding staffers at a furious pace in the last nine months, also bringing in a CFO, CTO, COO, CSO and other execs in that span to flesh out CEO Markus Warmuth’s team. Jill Howe → DTx Pharma makes another C-suite move as CFO Jill Howe heads over to the RNA-focused biotech. Howe has stayed in the San Diego area for a while now, where she has been controller at Receptos and Amplyx and then rejoined Faheem Hasnain and Sheila Gujrathi from Receptos as Gossamer Bio’s treasurer and VP of finance. Back in January, DTx Pharma promoted Bryan Laffitte to CSO just months after he was named VP, biology. David Fontana → Peer Review frequent flyer Umoja Biopharma has named a CMO and CFO in recent weeks. This time it’s David Fontana’s turn at bat as he becomes chief business and strategy officer at the Seattle oncology player. While at Bristol Myers Squibb, Fontana was VP of the cell therapy franchise, presiding over the development of liso-cel and seeing it through to its approval as Breyanzi. He’s also served as Pfizer’s VP of immuno-oncology with involvement in such drugs as Bavencio. → A year after Li Peng became Palleon Pharmaceuticals’ first chief scientist, David Feltquate has jumped on board at the glycol-immunology biotech as Palleon’s first CMO. Feltquate, recently the global head of hematology development and chair of the precision medicine leadership team for Novartis, had a 13-year journey at Bristol Myers that included work as clinical head for nivolumab, development leader for ipilimumab/nivolumab life cycle management, and head of oncology early clinical development. Angela Wang → Running alongside what they believe are sparkling Phase II data for the inhaled form of flecainide, San Francisco’s InCarda has welcomed Big Pharma vet Angela Wang as CFO. Formerly the CFO at MAIA Biotechnology, Wang devoted 12 years to Novartis in a number of capacities, culminating in her leadership of the ophthalmics business unit, and he’s also held roles at Sanofi and Syngenta. Chris Freeman → Chris Freeman has left Gilead after 10 years to take on the chief commercial officer role at Redwood City, CA liquid biopsy outfit Guardant Health. After being a captain in the US Army, Freeman joined Genentech leading marketing for Rituxan and Xolair. He then rose through the ranks at Gilead, getting promoted to VP of the HIV business unit and leading the Veklury EUA launch for Covid-19 before making the switch here. → Vancouver-based Incisive Genetics has tapped Kevin Chow as president. Chow brings with him experience from his stints at Vitaeris, Gilead and Alder Biopharmaceuticals. During his time at Vitaeris (acquired by CSL Behring), Chow was co-founder, president and CEO. → Newly-launched Aurion Biotech has plucked up Greg Kunst as its CEO. Kunst comes from Glaukos, where he spent 6 years leading worldwide marketing, reimbursement, health economics and outcomes research, government affairs, and business development teams. Before Glaukos, Kunst was global franchise director over the glaucoma surgery and retina pharmaceutical businesses at Alcon. Nora Yang → Nora Yang has been appointed CSO at French hearing loss biotech Sensorion. Yang co-founded and was CSO of Stratify Therapeutics for the last year, and she has lived among the pharma giants, both as a program team leader at Eli Lilly and a global project manager at Amgen developing oncology and metabolic disease therapies. While at the NIH from 2010-19, Yang was director, portfolio management and strategic operations, therapeutics for rare and neglected diseases for NCATS. → Chinook Therapeutics, which merged with the struggling Aduro, has made two promotions in its leadership team: CBO Tom Frohlich is now COO and Andrew King, head of renal discovery and translational medicine, is now CSO. Frohlich joined Chinook in January 2019. Prior to his role with the company, Frohlich was VP of business development at Arbutus Biopharma. Before that, he was with J&J and Merck. Meanwhile, King joined Chinook in May 2019. King previously served as senior director of discovery and translational biology at Ardelyx and held a variety of roles at AbbVie. Iman Barilero → Solid Biosciences is relying on the expertise of new chief regulatory officer and Big Pharma alum Iman Barilero, hoping to turn the corner with its IGNITE-DMD trial after building an entire obstacle course full of safety concerns and clinical holds with its Duchenne muscular dystrophy drug. Barilero has pharmacovigilance and regulatory experience from Sanofi, Roche and J&J and was Lundbeck’s VP, global head, regulatory science & policy from 2007-16. She joins Solid after a run as SVP, global head regulatory affairs at Poxel that began in 2019. Richard Morris → Dosing its first patient with CAR-macrophages (CAR-M) in March, UPenn spinout Carisma Therapeutics (formerly known as Carma) has turned to Richard Morris to be CFO. Morris hails from Passage Bio, where he was CFO since October 2019, and he owned the same title at Context Therapeutics and at Vitae Pharmaceuticals before it was snapped up by Allergan in 2016. → Just as J&J ditched a two-and-a-half-year cusatuzumab collaboration, argenx has locked in Karl Gubitz as CFO, replacing Eric Castaldi when he leaves June 30. Gubitz makes the transition after more than 17 years’ worth of financial posts at Pfizer, capped by his recent gig as VP, finance in the global oncology business. He also served as VP of finance, North America in the pharma giant’s global innovative products business. Kevin D’Amour → Concentrating on cytokine-based cell therapies with IRX-2 for squamous cell cancer of the head and neck, Brooklyn ImmunoTherapeutics has placed Kevin D’Amour in the CSO slot. D’Amour was director of stem cell biology, VP of research and eventually CSO during his 10-plus years at ViaCyte. A couple months ago, Howard Federoff took command as CEO of Brooklyn ImmunoTherapeutics after briefly helming Aspen Neuroscience. → And what about D’Amour’s replacement at ViaCyte? It’s Evert Kroon on an interim basis for the time being. Since starting out as a scientist 18 years ago at the stem cell biotech setting its sights on type 1 diabetes, Kroon has climbed the ladder to his current role of VP, translation research, one that he’ll hold for two more weeks before D’Amour leaves June 25. Ritu Shah → Spinning out Kyma Therapeutics in a collaboration just a couple weeks ago with Alloy Therapeutics, Pyxis Oncology has bolstered the C-suite with Steve Monks as chief technical officer and Ritu Shah as COO. Monks was with Aura Biosciences from 2015-19 — the last three of those years as SVP of development — and spent the previous six years with Agenus as VP, manufacturing, process & analytical technologies and later, VP of technical development. Shah, a Baxter and Shire vet who was chief of staff to the CEO and VP of program management at AveXis, joins the Pyxis family after almost three years as Levo Therapeutics’ VP of business operations and program management. → Eli Lilly vet Jeremy Graff has signed on as CSO of Nova Scotia-based IMV, which is targeting breast and advanced ovarian cancer with its lead drug maveropepimut-S. Graff, the ex-president and CSO of Biothera Pharmaceuticals whose first day on the job is Monday, was recently HiberCell’s chief development officer and SVP of research. He rounded out his 16 years at Eli Lilly by building the translational oncology unit as group leader, cancer biology and patient tailoring. Furthermore, IMV has made former Bristol Myers exec Stanley Frankel a clinical advisor. Thomas Russo → Pushing forward with a slate of vaccine candidates — including for Covid-19 — using VLP technology from Neil King at the University of Washington, Icosavax has recruited Thomas Russo as CFO. Russo pivots to Icosavax, which just raised $100 million a couple months ago in a Series B, after being John McHutchison’s CFO at Assembly Biosciences. They were both at Gilead together, with Russo moving on up to VP, head of commercial finance during his seven years there. → Zimmer Biomet has recruited two new faces to its leadership team: Wilfred van Zuilen as president of Europe, Middle East and Africa, and Nitin Goyal in the newly created role of chief science, technology and innovation officer. Van Zuilen comes to Zimmer from Medtronic, where he was serving as regional VP, North Western Europe (United Kingdom, Ireland, Nordics and Benelux). Prior to his role at Medtronic, van Zuilen was with Covidien, Novartis and Edwards Lifesciences. Meanwhile, Goyal hops aboard from Rally Health, where he was CMO and SVP of innovation and digital care delivery. Additionally, Goyal is the founder and CEO of Pulse Platform. → Securing big-time Series C funding a couple weeks ago while maintaining a bare-bones website, Wilmington, DE-based NiKang Therapeutics has made Robert Xin CMO. Since January 2019, Xin served as SVP, clinical development at Turning Point Therapeutics, and before that he was interim VP of oncology early clinical development at the conclusion of his seven years at Pfizer. Jamie Iudica → With a glioblastoma drug in development, Research Triangle biotech Istari Oncology has selected Jamie Iudica as chief manufacturing officer. Prior to his latest role at Xellia Pharmaceuticals as SVP, global product supply, Iudica was Pfizer’s VP, global biologics operations and brings more Big Pharma experience from Merck, GlaxoSmithKline and Novartis. → Arecor Therapeutics has bagged Lindsey Foulkes as COO. Foulkes started her career with McKinsey & Company in 1995 before jumping aboard med device startup Nexan. Afterward, Foulkes had roles at Acambis, Cangene and Liminal Biosciences. → Strata Oncology has welcomed Mark Szewczyk to the team as CCO. Szewczyk brings with him a variety of experiences from his time spent at Abbott as VP, global commercial operations, molecular diagnostics; Philips Healthcare and Cleveland Clinic Home Care. Brent Dial → Cancer genomics-focused Personal Genome Diagnostics (PGDx) has brought on Brent Dial as CFO. Dial comes aboard after being a principal with Chordata Ventures. Prior to that he was CFO at Anheuser-Busch’s high-end beer business unit. Dial has also led initiatives at JP Morgan Chase, Deutsche Bank Securities and TCOM. → Looking for the FDA’s approval with omidubicel — a stem cell therapy for blood cancer patients— Boston-based Gamida Cell has brought on Vladimir Melnikov as SVP, global operations and manufacturing. Melnikov was recently a general manager at Omrix Biopharmaceuticals, spending nearly a decade at the company J&J bought in 2008. He was also biologic technical operations lead at J&J subsidiary Ethicon Biosurgery. Niels Svenstrup → RA Capital-backed PepGen debuted with a $45 million round in December, then named RA Capital venture partner (and Cydan and Vtesse co-founder) James McArthur president and CEO in February. The neuromuscular disease player is shoring up its staff this week with Niels Svenstrup as SVP, CMC and David Pelissier as VP of finance. A Lundbeck and Bayer vet, Svenstrup pivots to PepGen after his time at Cydan as SVP, development, and he’s also been Ascendis Pharma’s director of project management and CMC. Pelissier’s stay as VP, controller at Avrobio didn’t last a year, but he did spend the previous three years at Ra Pharmaceuticals, where he was promoted to senior director, controller. → Humanigen, which filed an EUA for lenzilumab last week to treat severe Covid-19 cases, has locked in Ken Trbovich as SVP, investor relations. Trbovich was a specialty pharmaceutical analyst with RBC, later becoming managing director, healthcare research at Janney Montgomery Scott. Humanigen revealed data in late March asserting that lenzilumab helped keep Covid-19 patients off ventilation. → Southern California medtech Inogen, specializing in portable oxygen for home use, has waved in Stanislav Glezer as CMO. Since September 2018, Glezer had been Becton Dickinson’s worldwide VP of medical affairs for diabetes care. After 14 years of numerous posts at Sanofi, Glezer then spent a year with Novo Nordisk as VP of global medical affairs and another year as CMO of Adocia. Laura Shawver → Silverback CEO Laura Shawver and BridgeBio COO-in-residence Christine Siu are now board members at Bright Peak Therapeutics. The cytokine immunotherapy biotech just scored a $107 million Series B round this week with RA Capital leading the pack of investors. → Pan-variant kinase inhibitor biotech Theseus Pharmaceuticals, which launched with a $100 million Series B in April, has added Kathy Yi to the board of directors. Yi, the CFO for Tony Coles at Cerevel, held the same post at Sangamo from 2017-19. Sapna Srivastava → Aura Biosciences has pulled in Sapna Srivastava to its board of directors. Srivastava currently serves as chief financial and strategy officer at eGenesis. Prior to that, she held the same role at Abide Therapeutics and Intellia Therapeutics and was a senior biotechnology analyst for Goldman Sachs, Morgan Stanley and ThinkEquity Partners. → Bryan, TX CMO iBio has elected Eef Schimmelpennink to its board of directors. Schimmelpennink, the ex-president and CEO of Pfenex, was an exec at Hospira and after Pfizer bought the company, was fleetingly the pharma’s VP of global sterile injectables. Sue-Jean Lin → Frank Watanabe’s crew at Arcutis is bringing Sue-Jean Lin into the fold as a member of its board of directors, while Jonathan Silverstein exits the board “for personal reasons.” Lin, a 26-year Allergan veteran, is Alcon’s SVP and chief information officer. → Heather Behanna and Deepa Prasad have joined the board of directors at Friedreich’s ataxia biotech Design Therapeutics, now led by ex-Abeona CEO João Siffert. Behanna has been a principal at SR One for two years, and Prasad is managing director at WestRiver Group. Piratip Pratumsuwan → As part of securing $23 million in funding for this week’s launch, Alcyone has added Piratip Pratumsuwan to its board of directors. Pratumsuwan is a managing director at RTW Investments — one of the companies that chipped in with Alcyone’s funding. Pratumsuwan joined RTW in 2014. → San Diego-based onvansertib developer Cardiff Oncology has reserved board seats for Mani Mohindru and Renee Tannenbaum. Mohindru, who joined the board of directors at CytomX in December, is CEO of Novasenta and the ex-CEO of CereXis. Before her current role as VP of global partnering at Halozyme, Tannenbaum was AbbVie’s head of global customer excellence. Mary Smith → PTC Therapeutics has elected Mary Smith to its board of directors. Smith is the current vice chair at the VENG Group. Smith previously served as the principal deputy director and CEO equivalent at the Indian Health Service, an HHS division that provides medical care to Native Americans. → Non-profit n-Lorem Foundation has named Claire Grezemkovsky as director of philanthropy. Grezemkovsky has worked with the Salk Institute for Biological Studies, the Keck Observatory and most recently The Scripps Research Institute. → Atlantic Healthcare has enlisted Robert Dow and Julian Thurston as non-executive directors of its board. Dow comes with experience from his times as head of global drug development at Roche and CMO of PPD. Meanwhile, Thurston has 40 years of experience working with multi-national law firms.