Electra Therapeutics, Inc.

ELA026 demonstrated a high overall response rate (ORR) across a range of sHLH patients and a favorable safety profile in this life-threatening hyperinflammatory condition In patients with the poorest prognosis, those with malignancy-associated HLH, early treatment with ELA026 resulted in 100% ORR and improved survival SOUTH SAN FRANCISCO, CA, USA I June 16, 2024 I Electra Therapeutics, Inc. , a clinical stage biotechnology company developing antibody therapies against novel targets for immunological diseases and cancer, announced the presentation of clinical data for ELA026 in secondary hemophagocytic lymphohistiocytosis (sHLH), a life-threatening hyperinflammatory condition. The results were presented today as one of six abstracts selected for oral presentation in a late-breaking session at the European Hematology Association (EHA) Congress in Madrid, Spain. Results were reported for sHLH patients in the ongoing Phase 1b clinical study, which has enrolled a majority of patients with the deadliest sHLH subtype, malignancy-associated HLH (mHLH). In treatment‑naive mHLH patients, ELA026 achieved a 100% overall response rate (ORR) by week 4 and improved survival at two months compared to natural history studies. ELA026 also demonstrated a high response rate across a range of sHLH patients and a favorable safety profile in this patient population. ELA026 is a first-in-class monoclonal antibody that targets signal regulatory protein (SIRP)-α/β1/γ on the cell surface of myeloid cells and T lymphocytes, the pathological immune cells that induce hyperinflammation in sHLH. The Phase 1b study is an ongoing open-label, multi-dose, single-arm, multicenter study designed to evaluate the safety and efficacy of ELA026, assess biomarkers, and identify a dose for Phase 2/3 testing (ClinicalTrials.gov identifier: NCT05416307 ). “These data show very promising results for ELA026 as a potential treatment for sHLH, which is a challenging disease that is devastating for patients and has no approved treatment options,” said Swaminathan P. Iyer, MD, Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. “Notably, the analysis reveals improved survival was achieved with ELA026 in treatment-naïve mHLH patients, suggesting benefit from early treatment intervention for patients with this rapidly progressing disease.” Study Results Presented at EHA 2024 Congress The oral presentation at EHA2024, entitled “ELA026 Targeting of SIRP(+) Immune Cells Results in a High Response Rate and Improved 2-Month Survival of Treatment-naïve Malignancy-associated Hemophagocytic Lymphohistiocytosis in a Phase 1 Study,” was presented by the lead author, Abhishek Maiti, MD, Assistant Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center. The data describe analysis of sHLH patients in three cohorts of the ongoing Phase 1b clinical study, including the following highlights: “We are delighted that the results of the clinical study of ELA026 in sHLH were recognized and selected as a late-breaking presentation at EHA. This interim data is extremely encouraging, particularly with the high response rates and improved survival at two months achieved in treatment-naïve mHLH patients, and suggests ELA026’s promise as a first-line treatment. Survival at two months is a clinically meaningful benefit for this patient population and demonstrates the ability of ELA026 to rapidly extinguish the hyperinflammation in sHLH, enabling mHLH patients to pursue curative therapies for their underlying cancer,” said Kim‑Hien Dao, DO, PhD, Chief Medical Officer at Electra. “We look forward to continuing enrollment in this study and advancing the clinical program to further assess the safety and efficacy of ELA026 in sHLH patients who currently have no approved therapies.” About Secondary Hemophagocytic Lymphohistiocytosis (sHLH) Secondary hemophagocytic lymphohistiocytosis (sHLH) is a rare, life-threatening inflammatory disease for which there is no approved treatment. It can be triggered by cancer (malignancy-associated HLH, or mHLH), infection, autoimmune disease, or immunotherapy. sHLH is associated with a systemic inflammatory response for which patients require immediate intervention. Without treatment, patients may experience multiple organ failure and death. sHLH has a high mortality rate during the first months of diagnosis, with mHLH patients having the poorest outcomes. About Electra Therapeutics Electra Therapeutics is a clinical stage biotechnology company developing therapies against novel targets for immunological diseases and cancer. The company’s lead product candidate, ELA026, is a first-in-class monoclonal antibody that targets SIRP on the cell surface of myeloid cells and T lymphocytes, and precisely depletes pathological immune cells. ELA026 is in clinical development for secondary hemophagocytic lymphohistiocytosis (sHLH), a rare, life-threatening hyperinflammatory condition for which there is no approved treatment, as well as additional disease indications. For more information, please visit www.electra-therapeutics.com and follow us on LinkedIn . 1 Löfstedt A, et al. Blood. 2024 Jan 18;143(3):233-242. SOURCE: Electra Therapeutics

None  Welcome to this week's Chutes & Ladders, our roundup of significant leadership hirings, firings and retirings across the industry. Please send the good word—or the bad—from your shop to Gabrielle Masson and it will be featured here at the end of each week.  3 Sanofi leaders, including CSO Frank Nestle, hit the exit Sanofi Several Sanofi leaders are scattering, including Frank Nestle, M.D., the French pharma’s global head of research and chief scientific officer.   Nestle, who has nearly eight years with Sanofi under his belt, is heading over to Deerfield Management, where he’ll helm the firm's therapeutic discovery and development operations. As CEO of Deerfield Discovery and Development (3DC), Nestle will oversee work advancing early-stage therapeutics from scientific discovery to entering the clinic.   Nestle is not the only one departing Sanofi, with Phillip Dennis, M.D., Ph.D., vice president of lung cancer strategy and global project head of a novel ADC for oncology, also hitting the exit. Dennis will be joining I-Mab, a biotech developing immunotherapies for cancer, as chief medical officer starting June 17. He’s slated to take the place of interim CMO Louie Naumovski, M.D., Ph.D.  Before Sanofi, Dennis served as AstraZeneca’s vice president of lung cancer strategy and global clinical lead.   Meanwhile, Sanofi’s head of corporate affairs Josep Catllà is also leaving, with plans to join Ipsen as executive vice president and chief corporate affairs officer Aug. 19. In the meantime, Gwenan White, Ipsen’s EVP of communications, external affairs and sustainability, is departing to pursue other opportunities.  Lilly bids farewell to CFO, hello to new quality exec Eli Lilly Eli Lilly’s revolving door kept on spinning this week as the Big Pharma heralded a high-profile departure from and new arrival to its C-suite in back-to-back announcements. First, the new appointment: Melissa Seymour was named executive VP of global quality. Most recently, she served as chief quality officer of Bristol Myers Squibb since the fall of 2022. Before that, she spent more than two decades in quality operations at Biogen in a string of increasingly senior roles that culminated in her appointment as chief quality officer for her final two years at the company.   At Lilly, effective July 22, Seymour will replace Johna Norton, who announced her retirement after more than three decades at the company earlier this year. A day later, Lilly announced that Anat Ashkenazi, another longtime employee of the drugmaker, would be leaving her role as chief financial officer. A separate release confirmed that Ashkenazi has been selected to become CFO of Google and its parent company Alphabet.  Ashkenazi originally joined Lilly in 2001. In the ensuing years, she held a variety of leadership roles in strategy and finance, including CFO roles within Lilly Research Laboratories and several other business areas, before being named financial chief of the entire corporation in 2021.  She’ll stay on at Lilly until July 31, at which time she’ll transition into her new role at the tech giant. The search for her replacement at Lilly is already underway, spanning both internal and external candidates, the company said. Amarin taps 3rd CEO in just over a year Amarin Irish-American pharma Amarin is undergoing its third CEO change-up since March 2023, this time tapping former interim chief Aaron Berg for the role. Last year, Berg took the reins for a few months after former CEO Karim Mikhail abruptly departed in March. Berg has been with Amarin since 2012, serving as executive vice president and president of the U.S. arm for the last two years. In July 2023, Berg was relieved of his temporary CEO duties, with Amarin selecting former Cordis executive Patrick Holt for the top spot.  Now, less than a year later, Holt is out the door to “pursue other opportunities,” according to a company press release. Holt’s tenure was marked by various turmoil, including a fight for control with activist investor Sarissa Capital and wide-scale layoffs. Fierce Pharma > Derek Wallace, Takeda’s former vice president and global dengue program head of the vaccine business, has taken over the role of president of the global vaccine business unit as Gary Dubin, M.D., prepares to retire in January 2025. Former president Dubin, who will serve in an advisory role until his retirement, has been with Takeda for nearly nine years and worked in vaccine development at GSK before that, according to a Takeda release emailed to Fierce Biotech. > As UroGen Pharma nears FDA submission of its lead candidate, the company has appointed a new chief commercial officer: David Lin is coming aboard after stints at Johnson & Johnson and Bristol Myers Squibb, the latter of which culminated in a term as head of its U.S. cell therapy franchise. Lin will replace Jeff Bova, who’d headed up UroGen’s commercial strategy since 2017 and stepped down June 3 to pursue other opportunities. Release > Galera Therapeutics is eliminating an executive role in efforts to save cash. That means Chief Operating Officer Robert Beardsley, Ph.D., is headed out the door as the company continues to review strategic alternatives. Release > Rare disease biotech Electra Therapeutics named two new additions to its executive team. Graham Parry, Ph.D., previously of Star Therapeutics and Third Harmonic Bio, has been named chief scientific officer, while Kim-Hien Dao, D.O., Ph.D., who joined Electra in April 2023 as head of clinical development, will take on the title of chief medical officer. Release > Aquestive Therapeutics has promoted Vice President of Operations Cassie Jung to chief operating officer. Jung has been with Aquestive for 20 years, joining the company back in 2004. Release > John Overington, Ph.D., has been appointed chief technology officer of Exscientia. He joined the company in 2021, serving first as VP of discovery initiatives and then, since 2023, as chief data officer. Meanwhile, the AI drug hunter also named Maria-Louise Fjällskog, M.D., Ph.D., as its interim chief medical officer and clinical development lead, replacing Mike Krams, M.D., who’d held the CMO role since 2022. Release > Boston Pharmaceuticals has found a permanent chief medical officer: Margaret Koziel, M.D., is stepping into the role after previously holding the CMO title at Innoviva Specialty Therapeutics and Axcella. She’s taking over from Juan Carlos Lopez-Talavera, M.D., Ph.D., who’d held the CMO title on an interim basis since the end of last year and will continue on at Boston in an advisory role to Koziel. Release > Amid the process of unwinding its controversial acquisition of Grail, Illumina is also shaking up its executive team. The DNA sequencing giant tapped Everett Cunningham–an alum of Exact Sciences, GE HealthCare, Quest Diagnostics and Pfizer–as its new chief commercial officer, filling a spot held on an interim basis since the start of the year by Bas Verhoef, Illumina’s head of Europe, after former CCO Susan Tousi left to become CEO of Delfi Diagnostics. Fierce Pharma  

Data from Phase 1b study of ELA026 in secondary hemophagocytic lymphohistiocytosis (sHLH) to be presented on Sunday, June 16, 2024 SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Electra Therapeutics, Inc., a clinical stage biotechnology company developing antibody therapies against novel targets for a broad range of immunological diseases and cancer, announced today that clinical data for its lead drug candidate, ELA026, will be presented as one of five selected abstracts in a late-breaking oral session at the European Hematology Association (EHA) Congress. The conference is being held in Madrid, Spain and live-streamed on June 13-16, 2024. The oral presentation will describe clinical data from a Phase 1b study of ELA026 for the treatment of secondary hemophagocytic lymphohistiocytosis (sHLH), a rare, life-threatening hyperinflammatory disease for which there is currently no approved treatment. ELA026 is a monoclonal antibody that targets signal regulatory protein (SIRP)-α/β1/γ, enabling precise depletion of pathologic immune cells. The abstract is published on the EHA website here. Details of the oral presentation are as follows: Title: ELA026 Targeting of SIRP(+) Immune Cells Results in a High Response Rate and Improved 2-Month Survival of Treatment-Naïve Malignancy-Associated Hemophagocytic Lymphohistiocytosis in a Phase 1 Study Presenter: Abhishek Maiti, MD, Assistant Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center Session Name: Late-Breaking Oral Session Session Date & Time: Sunday, June 16, 2024, 9:45 – 11:15 a.m. Central European Summer Time Location: Madrid Recinto Ferial Hall Picasso, and livestreamed on the EHA Congress platform Abstract Code: LB3442 About Secondary Hemophagocytic Lymphohistiocytosis (sHLH) Secondary hemophagocytic lymphohistiocytosis (sHLH) is a rare, life-threatening inflammatory disease for which there is no approved treatment. It can be triggered by cancer (malignancy-associated HLH, or mHLH), infection, autoimmune disease, or immunotherapy. sHLH is associated with a systemic inflammatory response for which patients require immediate intervention. Without treatment, patients may experience multiple organ failure and death. sHLH has a high mortality rate during the first months of diagnosis, with mHLH patients having the poorest outcomes. About Electra Therapeutics Electra Therapeutics is a clinical stage biotechnology company developing therapies against novel targets for a broad range of immunological diseases and cancer. The company’s lead product candidate, ELA026, is a monoclonal antibody that targets SIRP on the cell surface of myeloid cells and T lymphocytes, and precisely depletes pathological immune cells. ELA026 is in clinical development for secondary hemophagocytic lymphohistiocytosis (sHLH), a rare, life-threatening hyperinflammatory condition for which there is no approved treatment, as well as additional disease indications. For more information, please visit and follow us on LinkedIn.