This single-arm phase II study will assess the impact of tetanus pre-conditioning and adjuvant Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) on overall survival of patients newly diagnosed with World Health Organization (WHO) Grade IV glioblastoma who have undergone definitive tumor resection, are cytomegalovirus (CMV) positive and unmethylated, and completed standard temozolomide (TMZ) and radiation treatment. After completion of the standard of care radiotherapy with concurrent TMZ, patients will receive 1 cycle of dose-intensified TMZ followed by pp65-loaded dendritic cell (DC) vaccination beginning on day 23.

Start Date30 Sep 2019

Sponsor / Collaborator

Duke University

NCT03615404

/ CompletedPhase 1IIT

A Phase 1 Trial of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma

The purpose of this study is to determine the feasibility and safety of administering CMV RNA-pulsed dendritic cells (DCs), also known as CMV-DCs, to children and young adults up to 35 years old with nWHO Grade IV glioma, recurrent malignant glioma, or recurrent medulloblastoma. Evidence for efficacy will also be sought. This will be a phase 1 study evaluating CMV-DC administration with tetanus toxoid (Td) preconditioning and Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) adjuvant in children and young adults up to 35 years old with WHO grade IV glioma, recurrent malignant glioma, or recurrent medulloblastoma. This safety study will enroll a maximum of 10 patients.

Start Date05 Oct 2018

Sponsor / Collaborator

Duke University

NCT02465268

/ CompletedPhase 2IIT

ATTAC-II: A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Patients With Newly-Diagnosed Glioblastoma

The purpose of this research study is to determine if an investigational dendritic cell vaccine, called pp65 DC, is effective for the treatment of a specific type of brain tumor called glioblastoma (GBM) when given with stronger doses of routine chemotherapy.

Start Date09 Aug 2016

Sponsor / Collaborator

University of Florida

[+1]

100 Clinical Results associated with Umitrelimorgene Autodencel

100 Translational Medicine associated with Umitrelimorgene Autodencel

100 Patents (Medical) associated with Umitrelimorgene Autodencel

News (Medical) associated with Umitrelimorgene Autodencel

01 May 2023

·www.prnewswire.com

Significant Positive Shift in the Glioma Market with 13% CAGR During the Study Period (2019-2032) Expected by Analysts at DelveInsight

The dynamics of the glioma market are anticipated to change in the coming years owing to the positive outcomes of the emerging pipeline candidates during the developmental stage by key players, such as Bayer, VBL Therapeutics, Candel Therapeutics, AstraZeneca, DNAtrix, DelMar Pharmaceuticals, Chimerix, KaryoPharma, VBI Vaccines, Kazia Therapeutics, and others LAS VEGAS, May 1, 2023 /PRNewswire/ -- DelveInsight's Glioma Market Insights report includes a comprehensive understanding of current treatment practices, glioma emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Glioma Market Report As per DelveInsight analysis, the glioma market size in the 7MM was approximately USD 1 billion in 2022. According to the assessment done by DelveInsight, the estimated total incident glioma cases in the 7MM were approximately 47K in 2022. Leading glioma companies such as Bayer, Chimerix, Aivita Biomedical, Denovo Biopharma, Northwest Therapeutics, VBL Therapeutics, Laminar Pharmaceuticals, MedImmune, DNAtrix, Immunomic Therapeutics, Imvax, MimiVax, CNS Pharmaceuticals, Epitopoietic Research Corporation (ERC), Istari Oncology, SonALAsense, Kintara Therapeutics, Bristol Myers Squibb, Medicenna Therapeutics, BioMimetix, Eisai and Merck Sharp & Dohme, Kazia Therapeutics, Oblato, Genenta Science, Enterome, Inovio Pharmaceuticals, Karyopharm Therapeutics, VBI Vaccines, TME Pharma, Day One Biopharmaceuticals, Servier, Orbus Therapeutics, TVAX Biomedical, AnHeart Therapeutics, Beigene, SpringWorks Therapeutics, Forma Therapeutics, Hoffmann-La Roche, Incyte Corporation, Eli Lilly, and others are developing novel glioma drugs that can be available in the glioma market in the coming years. The promising glioma therapies in the pipeline include Regorafenib, ONC201, AV-GBM-1, Enzastaurin (DB-102), DCVax-L, Ofranergene Obadenovec (VB-111), LAM561 (2-OHOA), MEDI4736 (durvalumab), Tasadenoturev (DNX-2401), ITI-1000 (pp65 DC Vaccine), IGV-001, SurVaxM, Berubicin, GLIOVAC (Sitoiganap), Lerapolturev + Pembrolizumab, SONALA-001 + Exablate 2.0 Device, VAL-083 (dianhydrogalactitol), Pomalidomide, MDNA55, BMX-001, Lenvatinib ± Pembrolizumab, Paxalisib (GDC-0084), OKN-007, Temferon, EO2401, INO-5401+ INO-9012+ LIBTAYO (cemiplimab), Selinexor (KPT-330), Olutasidenib (FT-2102), VBI-1901, NOX-A12 (Olaptesed Pegol), Tovorafenib (DAY101), Vorasidenib (AG-881), Eflornithine, TVI-Brain-1, AB-218, BGB-290, Mirdametinib, FT-2102 (Olutasidenib), Vinblastine + Bevacizumab, Cobimetinib, PEMAZYRE (Pemigatinib), VERZENIO (abemaciclib) , and others. In December 2022, Chimerix announced the successful launch of the ONC201 Phase III ACTION study in patients with H3 K27M-mutant glioma. In June 2022, Day One Biopharmaceuticals announced positive initial data from its pivotal Phase II (FIREFLY-1) study with tovorafenib (DAY101) in relapsed pediatric low-grade glioma (pLGG). Discover which therapies are expected to grab the major glioma market share @ Glioma Market Report Glioma Overview Glioma is the most common kind of glial cell tumor in the central nervous system (CNS). Gliomas are infiltrative tumors that affect the brain tissue surrounding them. Glioblastoma is the most hazardous type of brain tumor, whereas pilocytic astrocytomas are the least dangerous. Previously, diffuse gliomas were classified into subgroups and grades depending on histopathologies, such as diffuse astrocytomas, oligodendrogliomas, or mixed gliomas/oligoastrocytomas. The specific etiology of glioma, like other primary brain tumors, remains unknown. However, certain variables may increase the risk of getting a brain tumor. Glioma symptoms vary depending on tumor type, size, location, and growth rate. Some common glioma symptoms include headache, nausea or vomiting, memory loss, urine incontinence, speech problems, and others. A medical history and a physical examination are used for glioma diagnosis. Glioma Epidemiology Segmentation DelveInsight estimates that there were approximately 47K incident cases of glioma in the 7MM in 2022. As per our analysis, the United States contributed to the largest incident population of glioma, acquiring ~40% of the 7MM in 2022. The glioma market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total glioma incident cases Glioma grade-specific cases Glioma age-specific cases Glioma type-specific cases Download the report to understand which factors are driving glioma epidemiology trends @ Glioma Epidemiological Insights Glioma Treatment Market Glioma treatment is based on the type of glioma, its size and location, and the patient's unique characteristics. Chemotherapy and radiation therapy will be administered after surgery, particularly in individuals when the tumor cannot be removed entirely because it has invaded critical parts of the brain or is inaccessible. The typical glioma treatment protocol comprises surgery, chemotherapy, and radiation. Chemotherapy may include carmustine (BCNU), lomustine (CCNU), or gleostine (generic), cisplatin, carboplatin, etoposide, and irinotecan in case of low-grade glioma whereas temozolomide (TEMODAR) is the standard chemotherapy used in case of high-grade glioma majorly, Gliadel wafer implants (biodegradable discs injected with BCNU) are usually given as adjunctive treatment after surgery, although usage of Gliadel wafers remains a point of controversy due to its questionable survival benefits. Avastin (Genentech) and Temodar/Temodal (Merck), among others, are approved medications for HGG. However, due to patent expiration, the generic version of Temodar and biosimilars of Avastin are available on the glioma market. As generics and biosimilars are more cost-effective for patients than new medicines, intense competition exists among them. Furthermore, due to a lack of knowledge concerning bevacizumab's overall survival benefit, it is not recommended in unselected patients with newly diagnosed GBM. Currently, only one medication for LGG is approved, Tafinlar (dabrafenib) plus Mekinist (trametinib). Moreover, the current therapeutic market lacks a viable method for curing glioblastoma; therefore, the survival rate of people diagnosed with glioma remains poor. Glioma is incurable, and treatment choices are limited. Furthermore, the tumor has a high recurrence rate and a poor patient prognosis. In addition, there is currently no approved therapy for the unmethylated MGMT patient pool. To know more about glioma treatment guidelines, visit @ Glioma Management Glioma Therapies and Key Companies Regorafenib: Bayer ONC201: Chimerix AV-GBM-1: Aivita Biomedical Enzastaurin (DB-102): Denovo Biopharma DCVax-L: Northwest Therapeutics Ofranergene Obadenovec (VB-111): VBL Therapeutics LAM561 (2-OHOA): Laminar Pharmaceuticals MEDI4736 (durvalumab): MedImmune Tasadenoturev (DNX-2401): DNAtrix ITI-1000 (pp65 DC Vaccine): Immunomic Therapeutics IGV-001: Imvax SurVaxM: MimiVax Berubicin: CNS Pharmaceuticals GLIOVAC (Sitoiganap): Epitopoietic Research Corporation (ERC) Lerapolturev + Pembrolizumab: Istari Oncology SONALA-001 + Exablate 2.0 Device: SonALAsense VAL-083 (dianhydrogalactitol): Kintara Therapeutics Pomalidomide: Bristol Myers Squibb MDNA55: Medicenna Therapeutics BMX-001: BioMimetix Lenvatinib ± Pembrolizumab: Eisai and Merck Sharp & Dohme Paxalisib (GDC-0084): Kazia Therapeutics OKN-007: Oblato Temferon: Genenta Science EO2401: Enterome INO-5401+ INO-9012+ LIBTAYO (cemiplimab): Inovio Pharmaceuticals Selinexor (KPT-330): Karyopharm Therapeutics VBI-1901: VBI Vaccines NOX-A12 (Olaptesed Pegol): TME Pharma Tovorafenib (DAY101): Day One Biopharmaceuticals Vorasidenib (AG-881): Servier Eflornithine: Orbus Therapeutics TVI-Brain-1: TVAX Biomedical AB-218: AnHeart Therapeutics BGB-290: Beigene Mirdametinib: SpringWorks Therapeutics FT-2102 (Olutasidenib): Forma Therapeutics Vinblastine + Bevacizumab: Hoffmann-La Roche Cobimetinib: Hoffmann-La Roche PEMAZYRE (Pemigatinib): Incyte Corporation VERZENIO (abemaciclib): Eli Lilly Learn more about the FDA-approved drugs for glioma @ Drugs for Glioma Treatment Glioma Market Dynamics Glioma market growth can be ascribed to various factors, including an aging population, evolving research, better diagnostic tests, developing surgical procedures, improved radiotherapy techniques, and novel systemic medicines. Commercially, there is a greater emphasis on high-grade glioma than low-grade glioma because patients with low-grade glioma often live longer than those with high-grade glioma. As a result, just a few therapies are in late-stage studies, while the majority are in early-stage trials. In the case of GBM, on the other hand, the pipeline is robust, with numerous potential therapies in late and mid-stage research that have yet to be marketed. The pipeline includes drugs with varied modes of action and administration routes. It is interesting to note that the emerging market of glioma includes budding gene therapy, i.e., ofranergene obadenovec (VB-111) by VBL Therapeutics, followed by four vaccine/immunotherapy candidates such as VBI-1901, AV-GBM-1 and ITI-1000 (pp65 DC Vaccine), tasadenoturev (DNX-2401) by VBI Vaccines, Aivita Biomedical, Immunomic Therapeutics, and DNAtrix, respectively, and these therapies are going to alter the glioma market dynamics in the upcoming years. The current glioma market has been categorized based on the dominant treatment pattern across the 7MM, which shows slight variances in the overall prescription pattern. The forecast model considers surgery, chemotherapy/radiation therapy, bevacizumab + radiotherapy/chemotherapy, and OPTUNE with temozolomide. The anticipated launch of new therapies and improved integration of early patient screening, medication in secondary care and other clinical settings, research on optimum implementation methods, and increased awareness may eventually facilitate the development of successful treatment alternatives. However, there are a few challenges to the timely identification and treatment of these patients, such as a lack of a reliable biomarker that can aid in diagnosis and patient classification and identifying recurrence and signaling medication response. Furthermore, the failure rate of high-phased drug trials is significant, making it impossible to predict trial success, exacerbating the need for medicines that could assist ease the patient segment with this severe kind of cancer. Scope of the Glioma Market Report Therapeutic Assessment: Glioma current marketed and emerging therapies Glioma Market Dynamics: Conjoint Analysis of Emerging Glioma Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, Glioma Market Access and Reimbursement Discover more about glioma drugs in development @ Glioma Clinical Trials Table to Contents Related Reports Glioma Epidemiology Forecast Glioma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted glioma epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Glioma Pipeline Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key glioma companies, including PTC Therapeutics, Ono Pharmaceuticals, Philogen, SpringWorks Therapeutics, Xennials Therapeutics, AnHeart Therapeutics, Istari Oncology, among others. High-Grade Glioma Pipeline High-Grade Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key high-grade glioma companies, including PTC Therapeutics, Aadi, Lee's Pharmaceutical, among others. Malignant Glioma Pipeline Malignant Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key malignant glioma companies, including Bexion Pharmaceuticals, Inc., Lee's Pharmaceutical Limited, Merck & Co, Oblato, Inc., OncoSynergy, Inc, among others. Recurrent Malignant Glioma Pipeline Recurrent Malignant Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key recurrent malignant glioma companies, including Bexion Pharmaceuticals, Inc., Merck, Oblato, OncoSynergy, Inc, among others. Glioblastoma Pipeline Glioblastoma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key glioblastoma companies, including AstraZeneca, BioNTech, Merck, Pfizer, Roche, among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3Phase 2VaccineImmunotherapy

10 Jun 2022

·endpts.com

Amarin fishes for another CFO as downsizing takes hold; CureVac makes a deal, then lines up Novartis exec to lead development

→ Mired in flagging sales for Vascepa , the harsh realities of the current climate in biotech have hit Amarin as they slice 40% of the workforce — the majority of those cuts coming from the US commercial team. And the resignation of CFO Michael Kalb has led Amarin to install Tom Reilly as his replacement, effective June 20. Reilly had been finance chief at Cara Therapeutics since October 2020; after 14 years of financial roles at Novartis , he was Allergan ’s head of finance for the US general medicines unit from 2017-20. Under CEO Karim Mikhail , who succeeded John Thero last year, Amarin hopes the job reduction will save them $100 million in the next year. → The same day that CureVac inked a small deal to buy Frame Cancer Therapeutics for €32 million ($34 million), the German mRNA player also disclosed that chief development officer Klaus Edvardsen is on his way out on June 30. Big Pharma vet Myriam Mendila will take over on Feb. 1, 2023, and Ulrike Gnad-Vogt — CureVac’s SVP area head oncology — will bridge the gap in Edvardsen’s place. Mendila’s oncology chops will come in handy here in light of the buyout: The worldwide head of medical affairs and CMO, oncology at Novartis since 2017, she also led global medical affairs at Roche and US medical affairs at Genentech . “The addition of Frame’s technology and talent to CureVac’s oncology research complements our ability to identify and validate promising neoantigens for our mRNA cancer vaccine programs,” CureVac CEO Franz-Werner Haas said of the M&A deal. → As Edward Conner becomes CMO of Third Harmonic Bio , an inflammatory disease biotech with $155 million worth of funding in the hopper, chief Natalie Holles said in a statement that she’s “thrilled to be working with Ed again.” Conner served as site lead and division head of medical and development at Audentes (now Astellas Gene Therapies ) when Holles was CEO. Conner makes this quick return to Peer Review after taking the CMO gig at Locanabio in July 2021. → With its lead program in Phase I/II trials for ENPP1 and ABCC6 deficiencies, Inozyme has tapped Kurt Gunter as CMO. For the last year, Gunter took on the roles of CMO, cell therapy and head of regulatory affairs at Athenex , feeling the pinch of the bear market with a budget overhaul that included an undisclosed number of layoffs. A Hospira vet, Gunter was the medical chief at Kuur Therapeutics before he joined Athenex last spring. Consequently, Darrel Cohen has answered the call to succeed Gunter as CMO, cell therapy at Athenex after a year as the medical chief of Biosight . Cohen was VP of late-phase clinical development at Pfizer Oncology , but left his post in 2019 to lead clinical development at EUSA Pharma . → San Francisco-based Better Therapeutics is handing over the reins of the company to Frank Karbe , who will begin as president and CEO on July 5. In the interim, current CEO and co-founder Kevin Appelbaum will continue to serve in the role. Karbe makes his way to Better from Myovant , where he was president and CFO. Earlier in his career, Karbe was EVP and CFO of Exelixis and worked as an investment banker at Goldman Sachs . → As Akili Interactive preps commercial launch for its ADHD video game therapy EndeavorRx in the fall, the company is making some room on its leadership team for commercial veteran Matt Franklin as president and COO to help pave the way. Franklin most recently served as general manager of the precision oncology business at Exact Sciences and before that, was chief commercial officer at Thrive Earlier Detection . Earlier in his career, Franklin was CBO for ArcherDX and SVP of global marketing and clinical product strategy at Foundation Medicine . → Cellectis natural killer partner Cytovia , which took the SPAC route to Nasdaq with Isleworth Healthcare Acquisition in April, has pegged Luca Scavo as CFO and James Priour as chief product officer. Peer Review just reported last week that Scavo bolted Evelo Biosciences after a year as finance chief, and he’s a Roche/Genentech vet who was CFO of Roche Diagnostics North America from 2019-21. Priour spent 11 years at Amgen before his appointment as SVP, commercial at Zymeworks in April 2020, eventually earning a promotion to chief commercial officer. → Bob Nelsen is dishing out several promotions at ARCH Venture Partners : Ari Nowacek (to partner); Sean Kendall (to partner, Europe); Corey Ritter (to principal); and Nilay Thakar (also to principal). ARCH is also bringing Olivia Zetter into the fold as a strategic advisor and venture partner. Zetter pivots to ARCH after leading government affairs and AI strategy at Resilience , which backed up the Brinks truck for a hefty $625 million Series D this week. → It’s been a whirlwind for Hubert Chen , so let’s break it all down: As 2021 drew to a close, Chen stepped down as CMO of Metacrine to take the same job at ADARx Pharmaceuticals . But another change of scenery awaits , this time as CSO and president of Forte Biosciences , which has been reduced to a pianissimo after a flop with its lead atopic dermatitis candidate resulted in plummeting shares. Before he was with Metacrine, Chen was chief scientific and medical officer for Pfenex . Incidentally, ADARx has lined up Andrew Seacat as head of toxicology, joining the RNA editing brigade at the San Diego biotech after his time at Zogenix as senior director, pharmacology and toxicology. A former principal scientist at Allergan, Seacat has also worked at La Jolla Pharmaceutical as senior director, preclinical development. → Don’t call him an underdog : Rudy Howard has been appointed as CFO of Houston-based metastatic disease player Aravive . Howard most recently held the same position at vTv Therapeutics and SciQuest , and he has also served as SVP and CFO at MDS Pharma Services . → Led by ex- Forty Seven chief Mark McCamish and having secured a $77 million Series A in January 2021, San Diego oncolytic virus biotech IconOVir has appointed John Huynh as its first chief technology officer. Before his recent year-long run as SVP of technical operations at Ring Therapeutics , Huynh was PTC Therapeutics ’ VP of gene therapy technical operations. → A couple weeks ago, the FDA lifted the partial clinical hold on Alpine Immune Sciences ’ combo trial with davoceticept and Keytruda , and the Mitch Gold -led biotech will now welcome Andrew Sandler as CMO on Aug. 17. Sandler had been CMO of Kiadis , which Sanofi bought for $358 million in November 2020 to beef up its NK capabilities. A former oncology exec at Bayer , Sandler was also CMO at Spectrum Pharmaceuticals and Dendreon . The FDA put up the stop sign on the trial in March after a patient death that was “attributed to cardiogenic shock.” → Over at San Carlos, CA-based cancer biotech Apexigen , William Duke has signed on as CFO. Duke joins Apexigen from the recently shuttered Kaleido Biosciences , where he also served as CFO. He has also served in the same position at Pulmatrix and Valeritas . → ADC-minded Emergence Therapeutics , trying to challenge the Astellas / Seagen drug Padcev with a Series A nearing $100 million back in December, has appointed Hatem Azim as CFO. Most recently, Azim was head of oncology, early clinical development at French pharma Pierre Fabre . Before that, he was VP, head of clinical development at Innate Pharma . → The Omicron variant forced the NIH to pull the plug on enrollment for the ACTIV-2 Phase III trial involving SAB Biotherapeutics ’ polyclonal antibody, and three months later, the Sioux Falls, SD biotech has named Alexandra Kropotova as CMO. Kropotova ended her eight-year association with Sanofi by serving as VP, strategy & strategic planning head, North American medical affairs before leaving in 2016 for Teva , where she was therapeutic area head, global specialty R&D. → Ophthalmology startup Aurion Biotech , which snagged a nice $120 million earlier this year in a bid to scale cell therapy for a form of blindness, has waved in Michael Goldstein as president and CMO. Prior to his new role, Goldstein was president and CMO of Ocular Therapeutix and CMO of Applied Genetic Technologies Corp . Earlier in his career, Goldstein was with Eleven Biotherapeutics , where he held a number of roles, including CMO and VP of clinical research. → While Gilead celebrates its 10-year anniversary in Asia, the company has brought aboard Dustin Haines as VP, general manager, Asia 5. Haines will be responsible for driving the business development of HIV, viral hepatitis including hepatitis B, C and D, as well as Gilead’s commitment to enhance public health and community impact in the Asia 5 markets: Hong Kong, Singapore, South Korea, Taiwan and Malaysia. Haines hails from Next Science , where he was CCO. Prior to that, Haines spent over a decade at ViiV Healthcare (president and general manager for Japan) and GSK . → Liver disease-focused Inipharm has brought on Chuhan Chung as CMO. Chung joins the company from Gilead, where he served as executive director and global development lead and was responsible for clinical studies in NASH and primary sclerosing cholangitis. Prior to Gilead, Chung was an associate professor at Yale University School of Medicine, section of gastroenterology & hepatology. → Taking aim at extrachromosomal DNA (ecDNA) to treat cancer, Boundless Bio has introduced Sara Weymer as VP of clinical operations. From 2016-21, Weymer led clinical operations at Fate Therapeutics , whose iPSC-derived natural killer therapies have run into durability issues that sound the alarm bells but don’t necessarily spell doom. Earlier in her career, Weymer was a senior clinical trial manager at Biogen . → AAV gene therapy outfit Applied Genetic Technologies Corporation has two appointments to announce this week: Eduardo Jacobo as SVP of GMP manufacturing and David Jacobs as SVP of clinical research and medical affairs. Prior to joining AGTC, Jacobo ran GMP gene manufacturing at Sangamo , and he has also held numerous manufacturing positions at Amgen and Eli Lilly . Jacobs comes to AGTC after leading clinical programs at Biogen and Daiichi Sankyo . → On the cusp of a Phase III trial with its dendritic cell therapy ITI-1000 for glioblastoma multiforme, Immunomic Therapeutics has selected Brian Stamper as VP, cell therapy operations. A veteran of Eli Lilly and AstraZeneca Biologics , Stamper had a short run at Lonza before his most recent post as senior director of manufacturing at Kite . → CNS-focused Neuraxpharm Group has tapped Alfredo Barón as the new country manager of Neuraxpharm Spain , taking over for Javier Mercadé — who has been appointed head of growth markets. Barón joins Neuraxpharm from Almirall , where he most recently served as EVP of global commercial operations and CCO. Before his most recent role at Almirall, Barón was director of sales and marketing manager, corporate managing director for south and eastern Europe and EVP and managing director of Europe for the company. → Data management outfit Dotmatics , which was snapped up by Insightful Science last March, has named Larry Samuelson as chief legal officer and Neil Frye as chief people officer. Samuelson most recently served as SVP, general counsel and corporate secretary of Cvent , while Frye is the former chief people officer of Alto Pharmacy and has previously held roles at Dropbox , Google and Accenture . → Duarte, CA-based Prolacta Bioscience has reeled in David Steinberg as CFO. Steinberg joins with experience from previous stints at Jefferies (managing director) and Deutsche Bank under his belt. → The board of directors at NRx Pharmaceuticals has recruited Seth Van Voorhees as CFO and treasurer. Van Voorhees hops aboard from PDS Biotechnology , where he also wore the CFO hat. Prior to that, he served a 10-year gig as CFO for Research Frontiers and for American Pacific . Earlier in his career, Van Voorhees served at Merrill Lynch , UBS Warburg and Wasserstein Perella . → Cambridge, UK-based Metrion Biosciences has appointed Benedetta Montagnini as head of European business development. Montagnini previously served as business development manager at Eurofins Discovery and DiscoveRx . Before that, Montagnini was account manager for the industrial bioprocessing division at Invitrogen . → Putting on a united front last month with other Duchenne drugmakers on why safety problems have dogged the indication, Sarepta has added Michael Chambers and Kathryn Boor to its board of directors. Chambers co-founded and was the longtime CEO of Aldevron , and Boor is the dean of Cornell’s graduate school as well as vice provost for graduate education. → Bahija Jallal’ s Immunocore has appointed Siddharth Kaul to the board of directors. The retired Kaul last served as group treasurer and head of business planning and analysis at Novartis in 2021, where he spent 17 years of his career in such roles as CFO, pharma Europe and CFO, pharma US. → Like Hall of Fame college basketball coach Roy Williams subbing out an entire lineup, Brooklyn ImmunoTherapeutics is putting new board members on the floor after last week’s CEO change. Interim chief Matt Angel leads the list of names, followed by Exacis Biotherapeutics CEO Gregory Fiore , Purchase Capital founder Nicholas Singer and Homer City Holdings chairman and CEO Bill Wexler . Gone are Erich Mohr , Dennis Langer , Heather Redman , and Erin Enright , effective June 5. → With billionaire Ric Kayne suspending his attempt to overhaul the board of directors, Seattle Alzheimer’s biotech Athira Pharma is moving forward with a new scientific advisory board. Chaired by Athira CMO Hans Moebius , the board will consist of Anton Porsteinsson , John Olichney , Marwan Sabbagh , Lon Schneider , Pierre Tairot and Paul Winner . → Ambrx Biopharma has boosted its board of directors with Blueprint Medicines SVP of global medical affairs Janet Loesberg . A 12-year Bristol Myers Squibb vet, Loesberg was briefly the VP, head of portfolio and project management, R&D for J&J ’s Janssen . → Robert Hariri ’s Celularity has elected former Kite head of US commercial Diane Parks to the board of directors. Parks adds the cell therapy biotech to her list of board responsibilities, which includes posts at Calliditas Therapeutics , CTI BioPharma and Kura Oncology . → Life Sciences Advisory managing partner Saira Ramasastry has been given a seat on the board of directors at Mirum Pharmaceuticals . This is the latest in a string of current board appointments for Ramasastry at Vir , Glenmark , Day One Biopharmaceuticals and Akouos . → Cystic fibrosis player Sionna Therapeutics has made room for Paul Clancy on the board of directors. The former CFO of Alexion (2017-19) and Biogen (2007-17) is on the boards of Incyte , Exact Sciences and Xilio Therapeutics . → Jennifer Zachary has clinched a spot on the board of directors at Rockville, MD-based Regenxbio , which has been in a patent squabble over Zolgensma with Novartis. Zachary has been Merck ’s general counsel since April 2018.

CollaborateVaccineGene TherapyAntibodyCell Therapy

07 Jun 2022

·www.biospace.com

Immunomic Therapeutics Appoints Vice President, Cell Therapy

ROCKVILLE, Md.--(BUSINESS WIRE)-- Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein) -mediated nucleic acid-based immunotherapy today announced the appointment of Brian Stamper to Vice President, Cell Therapy Operations. Brian joins the company with over 20 years of experience in cell therapy operations, pharmaceutical manufacturing, and process engineering. Prior to joining ITI, Mr. Stamper held director roles in manufacturing at Kite Pharma, a global biopharmaceutical company whose focus is cell therapy to treat and cure cancer. Prior to that, Mr. Stamper held positions of increasing responsibility in various operational areas at Lonza Pharmaceuticals and Biotechnology, AstraZeneca Biologics and Eli Lilly & Company. “We are delighted to welcome Brian to the Immunomic team,” said William Hearl, Ph.D., Immunomic Therapeutics’ Chief Executive Officer. “Brian’s specific and deep knowledge of cell therapy manufacturing and operations will be invaluable as we prepare for phase 3 testing of ITI-1000, our lead dendritic cell therapy for the treatment of glioblastoma multiforme (GBM).” Mr. Stamper holds a Master of Biotechnology Enterprise and Entrepreneurship Degree (MBEE) from Johns Hopkins University, a Master of Science Degree in Biologics Engineering from Purdue University, and a Bachelor of Science Degree in Biochemistry from Indiana University. About Immunomic Therapeutics, Inc. Immunomic Therapeutics, Inc. (ITI) is a privately held, clinical stage biotechnology company pioneering the development of vaccines through its proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE®), which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. UNITE® has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE® platform to oncology, where it could potentially have broad applications, including antigen-derived antibodies as biologics. The Company has built a pipeline leveraging UNITE® with programs in oncology, animal health, infectious disease, and allergy. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit . View source version on businesswire.com: Contacts ITI Company: Melissa Kemp mkemp@immunomix.com 301-968-3501 ITI Media: Melody Carey mcarey@rxir.com 917-322-2571 Source: Immunomic Therapeutics, Inc. View this news release online at:

VaccineCollaborateAntibodyCell TherapyImmunotherapy

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Glioblastoma	Phase 2	United States	University of Florida	09 Aug 2016
Glioblastoma Multiforme	Phase 2	United States	University of Florida	09 Aug 2016
Recurrent Malignant Glioma	Phase 1	United States	Duke University	05 Oct 2018
Recurrent Medulloblastoma	Phase 1	United States	Duke University	05 Oct 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02465268 (ATTAC-II, CTgov)	Phase 2	Astrocytoma \| Glioblastoma Multiforme \| Glioblastoma ... View more	175	GM-CSF+pp65-shLAMP DC (Arm 1: pp65-shLAMP DC With GM-CSF and Td)	qiehfsgcma(lgfhccckzq) = uxjsnbcsal swxchxpojs (euruovyzwh, 759.9) View more	-	14 Jan 2025
NCT02465268 (ATTAC-II, CTgov)	Phase 2		175	GM-CSF+pp65-flLAMP DC (Arm 2: pp65-flLAMP DC With GM-CSF and Td)	qiehfsgcma(lgfhccckzq) = qsxyiwmoun swxchxpojs (euruovyzwh, 377.5) View more	-	14 Jan 2025
NCT03927222 (I-ATTAC, CTgov)	Phase 2	Glioblastoma	6	Tetanus-Diphtheria Toxoid (Td)+Temozolomide+Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF	vevphicnds(gggwgsivjd) = mofwdqzkoe qcylvgnnen (gqpczuhjqk, zmtwidemkw - duucmumdyj) View more	-	08 Apr 2024
NCT03615404 (ATTAC-P, CTgov)	Phase 1	Recurrent Medulloblastoma \| Glioblastoma Multiforme \| Recurrent Malignant Glioma	11	CMV-DCs with GM-CSF+tetanus toxoid	qfeoeuctlc = uxpldpzefs jxkcudirni (ftqneaornj, chabaokbql - aldwjejued) View more	-	28 Jan 2021

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