Sinovant Sciences Co., Ltd.

Roivant Sciences has funneled $200 million into clinical-stage biopharmaceutical company Immunovant. The financing will be used to advance the company’s IMVT-1401 candidate across several different autoimmune disorder indications. Following the financing announcement, Immunovant shares in premarket trading were 27% lower after ending at $10.46 on Friday. The new funding was obtained by Immunovant after Roivant Sciences purchased 17,021,276 shares in the company’s common stock at $11.75 per share, a move approved by an Immunovant director committee. Roivant launched Immunovant back in 2018, followed by China-based startup Sinovant Sciences. Immunovant was launched specifically for the purpose of developing treatment candidates for autoimmune disorders. At time of the launch, Roivant said Immunovant would be committed to centering its focus on RVT-1401, now known as IMVT-1401, a fully human monoclonal antibody designed to target the neonatal Fc receptor. Giving effect to the funding from Roivant provides Immunovant a pro forma cash balance of up to $600 million. In turn, Roivant increased its ownership stake in the company from a start of 57.5% to 63.8%. “We are excited to announce this significant investment by Roivant, which will expedite our development of IMVT-1401 for a wide range of autoimmune disorders,” said Immunovant’s chief executive officer, Dr. Peter Salzmann, in a statement. “Over the next 12 months, we plan to initiate a pivotal trial for myasthenia gravis, resume our trials in WAIHA and TED and initiate at least two additional clinical studies, including another pivotal trial in 2022.” Roivant Sciences’ CEO, Matthew Gline, explained that the two companies have explored several different potential transactions over recent months. One of these possible transactions included an acquisition by Roivant of the minority interest in Immunovant. Ultimately, however, the two companies agreed on the $200 million strategic investment to further support the development of IMVT-1401. “We are incredibly excited about the prospects for IMVT-1401, and we are eager to support Immunovant through this investment,” said Gline. “We look forward to continuing to work closely with Dr. Salzmann and the Immunovant management team to help develop IMVT-1401 to maximize benefit for patients with high levels of unmet medical need.” Immunovant announced in first quarter financial and corporate updates for 2021 that a program-wide data review showed IMVT-1401 may have “a broader therapeutic window than previously anticipated and that lipid elevations are predictable, manageable, and appear to be driven by reductions in albumin,” a reduction that was reversible upon cessation of the agent. The company says it plans to launch IMVT-1401 in a pivotal trial later this year or early 2022 in myasthenia gravis. In February, Roivant acquired Silicon Therapeutics for $450 million, a deal that includes potential regulatory and commercial milestones. The acquisition will lend Silicon’s artificial intelligence platform to complement Roivant’s targeted protein degradation system to enable improved drug design through a combination of computational physics and machine learning-based approaches. Roivant’s Datavant, a San Francisco-based company focused on health data-sharing technology, recently merged with Ciox Health, another data network company, under a $7 billion transaction deal. The merger was designed to create a combined company, branded “Datavant,” that will be the country’s largest secure and neutral health data ecosystem. The combined company will work toward connecting patients, providers, payers, health data analytics, government agencies, life sciences companies and patient applications for secure and neutral exchange of patient data.

UNIONDALE, N.Y., June 29, 2021 (GLOBE NEWSWIRE) -- Angion Biomedica Corp. (NASDAQ:ANGN), a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases, today announced that its exploratory Phase 2 ALI-201 trial of ANG-3777 in patients with severe COVID-19 related pneumonia at high risk for acute respiratory distress syndrome (ARDS) did not meet the primary or secondary efficacy endpoints. The adverse events and overall safety of the trial were consistent with previously published reports in patients hospitalized with severe COVID-19 pneumonia. “The ALI-201 study sought to address a patient population severely ill with COVID-19, a multi-system inflammatory condition, which differs markedly from our prior and ongoing clinical trials of ANG-3777 related to transplantation and cardiovascular surgery where the acute kidney injury is a discrete event,” stated Dr. John F. Neylan, Angion’s Chief Medical Officer. “Patients in the ALI-201 trial had ongoing and accumulating injury from symptomatic COVID-19 on average 11 days before receiving drug with organ systems under continued attack from the SARS-CoV-2 virus. In contrast, patients in our ongoing trials receive ANG-3777 within 1-3 days after the targeted organ injury. COVID-19 is a severe systemic disease presenting significant challenges to both new and previously approved therapeutics.” “We were pleased to be part of the attempt to help patients severely ill with COVID-19 and extend our deepest gratitude to the patients, their families, investigators, and site staff who participated in this study,” commented Dr. Jay R. Venkatesan, Angion’s President and Chief Executive Officer. “With the increasing availability of approved COVID-19 vaccines and the widespread assumption vaccines will reduce infection rates around the world, we will not continue the development of this COVID-19 program. Based on the promising activity of ANG-3777 in multiple animal models of lung injury, we will continue to evaluate the clinical development of ANG-3777 for acute lung injury populations.” The ALI-201 study was a small exploratory Phase 2 double-blind, randomized, and placebo-controlled trial conducted in Brazil to evaluate the safety and efficacy of four doses of ANG-3777 in the reduction of severity and progression of acute lung injury in patients with COVID-19 associated pneumonia who are at high risk of progressing to ARDS. The primary endpoint of the trial was survival free from the need for mechanical ventilation or dialysis at 28 days. The active arm of the trial did not show a statistically significant difference over the standard of care arm. A total of 120 patients were randomized 1:1 in the trial, with 59 patients in the active treatment arm and 61 patients in the standard of care arm. The number of adverse events, serious adverse events, and fatal events reported in ALI-201 were slightly higher for those subjects in the active treatment arm compared to those in the standard of care control arm, although no new or unexpected safety signals resulted from the trial. None of the fatal events in this trial of advanced COVID-19 patients were attributed by study investigators to either ANG-3777 or standard of care in the control arm. The company expects to report data from the ANG-3777 Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function, by the end of 2021. The company also expects to report data from the ANG-3777 Phase 2 proof of-concept trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery in the second half of 2021. About ANG-3777 ANG-3777 is a small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue repair and organ repair. ANG-3777 has a substantially longer half-life than HGF and Angion believes ANG-3777 has the potential to be a first-in-class therapeutic addressing acute organ injury. The ongoing clinical trials of ANG-3777 include a placebo-controlled Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function and a Phase 2 proof of-concept trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery. In November 2020, Vifor Pharma and Angion signed a license agreement worth up to $1.9 billion in development, commercial, and sales milestones plus royalties on net sales of up to 40% for global rights outside Greater China to commercialize ANG-3777 in nephrology indications. Sinovant Sciences and Angion signed a development and licensing agreement for ANG-3777 in Greater China in 2018. About Angion Angion is committed to transforming the treatment paradigm for patients suffering from acute organ injuries and fibrotic diseases for which there are no approved medicines or where existing approved medicines have limitations. Angion’s lead product candidate, ANG-3777, is a hepatocyte growth factor (HGF) mimetic currently being evaluating in a Phase 3 registration trial for delayed graft function in patients undergoing deceased donor kidney transplantation and a Phase 2 trial in cardiac-surgery associated acute kidney injury. Angion is also currently evaluating ANG-3070, a tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in Phase 1. Additionally, Angion has preclinical programs for a rho kinase 2 (ROCK2) inhibitor and a CYP11B2 (aldosterone synthase) inhibitor. For more information, please visit . Forward Looking Statements Statements contained in this press release regarding matters that may occur in the future are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements in this press release regarding Angion’s expectations regarding the potential safety and efficacy of ANG-3777 and the timing of the availability of and Angion’s disclosure of topline data from such studies. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: Angion’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of ANG-3777 and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete clinical trials; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; and regulatory developments in the United States, and other foreign countries. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, see the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the Securities and Exchange Commission on May 17, 2021, particularly under the caption “Risk Factors,” as well as other documents filed from time to time by the Company with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Angion undertakes no obligation to update any forward-looking statement in this press release, except as required by law. Contact Daniel Ferry LifeSci Advisors 617-430-7576 daniel@lifesciadvisors.com

UNIONDALE, N.Y. and ST. GALLEN, Switzerland, April 29, 2021 (GLOBE NEWSWIRE) -- Angion Biomedica Corp (NASDAQ:ANGN) and Vifor Pharma today announced completion of enrollment for Angion’s AKI-002-15 study, a Phase 2 trial of ANG-3777 in patients at risk of cardiac-surgery associated acute kidney injury (CSA-AKI). This indication is part of the ANG-3777 license agreement both parties signed in November 2020. “CSA-AKI is a frequent complication of cardiac bypass surgery seen in about one third of patients and is associated with prolonged hospitalization, progressive kidney failure, and an increased risk of death,” commented Dr. John Neylan, Angion’s Senior Vice President and Chief Medical Officer. “Currently, there are no approved therapies to prevent this serious condition. This Phase 2 prevention trial was designed to generate data on ANG-3777 in CSA-AKI patients to help guide future development of ANG-3777 in a Phase 3 registration trial for CSA-AKI. We are planning to start the confirmatory trial early in 2022, subject to the results of this Phase 2 trial as well as discussions with the FDA and other relevant health authorities.” Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma Group commented: “We are excited that enrollment in the AKI-002-15 Phase 2 trial has completed. This is an important milestone in a comprehensive clinical program to advance ANG-3777 as a potential treatment option to prevent acute kidney injury following cardiac surgery, an indication with a high unmet medical need. Together with our partner Angion, we now look forward to assessing the results from the trial.” The fully enrolled Phase 2 trial is a randomized, multi-center, double-blind, placebo-controlled clinical trial with trial sites in the United States, Canada, Brazil, and Georgia. Patients at risk for CSA-AKI were randomized one-to-one to receive four intravenous doses of 2.0 mg/kg of ANG-3777 or placebo over four days. The first dose was given within four hours of the completion of surgery with subsequent doses given at 24-hour intervals. The primary endpoint is mean area under the curve of the percent increase in serum creatinine above baseline, starting from 24 hours after the end of cardiopulmonary bypass surgery through day six. An additional important endpoint is the occurrence of Major Adverse Kidney Events at 90 days (MAKE 90), which has previously been agreed by the FDA as a suitable primary endpoint for a registration trial in this indication. A MAKE 90 "event" is death, initiation of renal replacement therapy or a greater than 25% decline in eGFR present 90 days after the surgery. The AKI-002-15 Phase 2 trial was designed as a signal-finding trial with the strategic objective to obtain sufficient evidence of efficacy of ANG-3777 to appropriately power and evaluate potential enrichment strategies for a Phase 3 registration trial. About ANG-3777ANG-3777 is an investigational small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue and organ repair. ANG-3777 has demonstrated a substantially longer half-life than HGF and Angion believes ANG-3777 has the potential to be a first-in-class therapeutic addressing acute organ injury. Enrollment is complete in a Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function, a Phase 2 exploratory trial in cardiac-surgery associated acute kidney injury, and a Phase 2 exploratory trial in patients with acute lung injury associated with COVID-19 pneumonia. In November 2020, Vifor Pharma and Angion signed a license agreement for global rights excluding Greater China to commercialize ANG-3777 in renal indications with up to $1.925 billion in development, commercial, and sales milestones plus royalties on net sales of up to 40%. Sinovant Sciences and Angion signed a development and licensing agreement for ANG-3777 in Greater China in 2018. About AngionAngion is committed to transforming the treatment paradigm for patients suffering from acute organ injuries and fibrotic diseases for which there are no approved medicines or where existing approved medicines have limitations. Angion’s lead product candidate, ANG-3777, is a hepatocyte growth factor (HGF) mimetic currently being evaluating in a Phase 3 registration trial for delayed graft function in patients undergoing deceased donor kidney transplantation, a Phase 2 trial in cardiac-surgery associated acute kidney injury, and a Phase 2 trial in patients with COVID-19 related pneumonia at high risk for acute respiratory distress syndrome. Angion is also currently evaluating ANG-3070, a tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in Phase 1. Additionally, Angion has preclinical programs for a rho kinase 2 (ROCK2) inhibitor and a CYP11B2 (aldosterone synthase) inhibitor. For more information, please visit . About Vifor Pharma GroupVifor Pharma Group is a global pharmaceutical company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit viforpharma.com. Forward Looking StatementsStatements contained in this press release regarding matters that may occur in the future are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements in this press release regarding Angion’s expectations regarding the potential safety and efficacy of ANG-3777, the potential results and outcomes of the AKI-002-15 study, and other studies involving ANG-3777 or other product candidates, the timing of the commencement of future clinical trials and the timing of availability of and Angion’s disclosure of topline data from such studies. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: Angion’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of ANG-3777 and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete clinical trials; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to raise additional capital; the effects of COVID-19 on the Company’s clinical programs and business operations. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 30, 2021, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Angion undertakes no obligation to update any forward-looking statement in this press release, except as required by law.