Humanigen Announces First Patient Dosed at MedStar Washington Hospital Center in Phase 3 Clinical Study of Lenzilumab in COVID-19
Humanigen, Inc. (HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with lenzilumab, today announced that MedStar Washington Hospital Center in Washington, D.C. treated its first COVID-19 patient with lenzilumab. The primary goal of this Phase 3 randomized, double-blind, multicenter, placebo-controlled clinical trial is to determine if lenzilumab can help hospitalized patients with COVID-19 recover faster. As many as 89% of hospitalized patients with COVID-19 are at risk of a complication called cytokine storm, a harmful inflammation that has been the leading cause of COVID-19 death. MedStar Washington Hospital Center is one of 18 sites in the U.S. approved to enroll eligible patients to study lenzilumab, designed specifically to stop this storm. Eligible patients can participate in this trial while also receiving other standard-of-care therapies as recommended by their treating physician.
“Given the growing number of cases in the D.C. area seen in the past few weeks, we were particularly motivated to ensure our Phase 3 study was enrolling and accessible,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “We have been impressed with the hospital leadership and trial investigators at MedStar Washington, and worked together with speed and efficiency to get this trial location ready to enroll patients.”
For more information on participating in the Phase 3 COVID-19 trial of lenzilumab, please visit StopStorm.com, and talk to your doctor to see if you may be eligible to participate.
More details on Humanigen’s programs in COVID-19 can be found on the Company’s website at www.humanigen.com under the COVID-19 tab, and details of the U.S. Phase 3 potential registration study can be found at clinicaltrials.gov using Identifier NCT04351152.
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company’s immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab™ as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical
CinCor Pharma Announces First Patient Dosed with CIN-107 in Phase 2 Study in Treatment Resistant Hypertensive Subjects
CINCINNATI, Oct. 20, 2020 (GLOBE NEWSWIRE) — CinCor Pharma, Inc. (“CinCor”), a clinical-stage biopharmaceutical company developing medications targeting cardiovascular disease, announced today that they have dosed the first subject in the brigHTN study. The brigHTN study is a Phase 2 clinical trial evaluating the blood pressure lowering effects of CIN-107, a novel, once daily, and highly selective aldosterone synthase inhibitor (ASI) in subjects with treatment resistant hypertension. CIN-107 is currently being developed for both treatment resistant hypertension and primary aldosteronism (PA).
The brigHTN clinical trial is a randomized, double-blind, placebo-controlled, dose-ranging study designed to assess the safety and efficacy of CIN-107 in subjects who have not achieved goal blood pressures, despite receiving multiple anti-hypertensive agents. The study is being conducted at approximately 70 sites in the U.S.
“There is such strong evidence that in those hypertensive patients who are able to achieve goal blood pressures, the risk of adverse cardiovascular outcomes is significantly reduced. Despite the availability of multiple anti-hypertensive agents, often used in combination, a substantial number of adherent hypertensive patients are not able to reduce their blood pressures to optimal levels. CIN-107 represents a new class of anti-hypertensive agents that has the possibility of providing significant anti-hypertensive effects to treatment resistant patients, as well as to the broader hypertensive population.” said Jon Isaacsohn, M.D. FACC, CEO of CinCor.
CinCor is a clinical-stage biopharmaceutical company with a mission to advance promising clinical candidates toward marketing approval. CinCor’s focus is on cardiovascular, metabolic and kidney diseases. CinCor Pharma, Inc. was founded by Jon Isaacsohn, M.D. FACC, and Catherine Pearce, DHSc, MBA, in 2018. CinCor investors include Sofinnova Investments, Sofinnova Partners, 5AM Ventures and CinRx Pharma.
CIN-107 works through the renin-angiotensin-aldosterone system (RAAS), which is responsible for regulating the body’s fluid and electrolyte balance. CIN-107 is a highly selective aldosterone synthase inhibitor being developed for large unmet medical needs, including resistant hypertension and primary aldosteronism. Hypertension guidelines were changed in 2017 by the Joint National Committee (JNC) based on overwhelming data demonstrating that reducing blood pressures to less than 130/80 mmHg reduced the risk of cardiac events, particularly heart attacks and stroke. With this target blood pressure, approximately 17% of the hypertensive population do not achieve goal levels despite the use of combinations of blood pressure lowering medications and are considered treatment resistant. Data have shown the risk of MI, stroke, and death in adults with resistant hypertension to be 2- to 6-fold higher than in hypertensive adults who achieve goal levels.
Brittany Karle, 513-579-9911, ext. 12039