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Latest Espero Biopharma News
Jan 20, 2023
Seagen just scored another approval for one of its lead drugs. Tukysa won accelerated approval from the FDA on Thursday to be used in combination with Roche’s Herceptin for patients with a specific type of HER2-positive colorectal cancer. This is the first FDA-approved treatment in HER2-positive metastatic colorectal cancer, Seagen said in a statement. FDA, which had given Tukysa (tucatinib) breakthrough therapy designation and priority review in this indication, said that it was approved based on a readout from a Phase II trial that saw a 38% overall response rate in 84 patients, with three complete responses and the median duration of response being 12.4 months. Tukysa was first approved back in 2020 — in combination with Herceptin and capecitabine — for HER2-positive breast cancer. Thanks to the accelerated approval pathway, continued approval is still contingent on data from confirmatory trials. — Paul Schloesser RNA drug developer snags fresh capital ADARx Pharmaceuticals said it has secured another $46 million to take its first three RNA drugs into the clinic. The San Diego biotech started testing its siRNA duplex oligonucleotide drug ADX-324 last month. The Phase I study is expected to enroll 53 patients, including healthy volunteers and an expansion cohort in people with hereditary angioedema, or severe swelling on different parts of the body. The startup’s RNA platform is looking at inhibiting, degrading and editing applications, with new oligonucleotide delivery tech, the company said. ADARx has nine active programs across genetic, cardiometabolic and central nervous system diseases, according to the biotech’s website. On the RNA editing front, ADARx says its first program, which aims to edit a single base, will go after alpha-1 antitrypsin deficiency, an inherited disorder that can lead to liver or lung disease. Ascenta Capital led the Series B-1, along with OrbiMed, SR One Capital Management, Lilly Asia Ventures and Sirona Capital. The biotech previously raised a $75 million Series B , disclosed in the fall of 2021. — Kyle LaHucik Cardio biotech raises minuscule IPO for PhIII A new Florida biotech leaped onto Nasdaq on Friday morning less than a year after forming to take on blood clots. Cadrenal Therapeutics raised about $7 million by pricing its shares $CVKD at $5 a piece. The stock price was down nearly 10% after the opening bell. The biotech secured the rights to orphan drug-designated tecarfarin last April. Cadrenal bought the rights from a secured lender of Espero BioPharma, which had taken the anticoagulant through multiple mid-stage tests. Espero had submitted a Phase III design to the FDA in 2019 for testing the drug as a preventative tool for blood clots of cardiac origin in patients with end-stage renal disease and atrial fibrillation. Cadrenal, in an SEC filing , said it will submit its Phase III design to the agency using the same protocol as its predecessor. The biotech hopes to start the potentially pivotal trial in the second half of this year, but the drug developer said in its IPO paperwork that it would likely need to raise another $40 million to complete the late-stage study. The relatively small Nasdaq entry comes after a drastic drop in Wall Street debuts for biotech startups over the past year, following an industry boon during the early days of the Covid-19 pandemic. Hypertension drugmaker Mineralys lined up its IPO ambitions yesterday after a few other biotechs in recent months. — Kyle LaHucik AUTHORS Kyle LaHucik Associate Editor The FDA flashed a red light on Eli Lilly’s investigational Alzheimer’s drug donanemab, spurning hopes of two new medications for the disease this month. The Big Pharma put out word after the markets closed Thursday saying the US regulator denied the accelerated approval “based on limited number of patients with 12-month drug exposure data” in the submission. Patients in the trial were allowed to wean off treatment once a certain amount of amyloid protein was cleared from their brains, meaning some patients did not receive the study drug for 12 months. “No other deficiencies were identified,” Lilly said in a statement. Keep reading Endpoints with a free subscription Unlock this story instantly and join 156,500+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Kyle LaHucik Associate Editor Ipsen’s cancer drug Onivyde, when combined with chemotherapy, performed better than standard of care at extending the lives of patients with a certain pancreatic cancer. The biopharma said the trial results mark the first time an investigational drug has shown better overall survival and progression-free survival as a first-line treatment than standard of care for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). This year, about 64,000 people in the US will be diagnosed with pancreatic cancer, which has the worst five-year survival rate, according to the American Cancer Society. Keep reading Endpoints with a free subscription Unlock this story instantly and join 156,500+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Katherine Lewin News Reporter Hematology-focused Disc Medicine has agreed to pay a $10 million down payment to Mabwell Therapeutics to develop and commercialize a portfolio of monoclonal antibodies for blood disorders. It’s the first deal Disc has made since it went public in August. The initial $10 million is a small piece of a potential $412.5 million of milestone payments and royalties of “close to two digit percentage” of net sales. Disc will have rights in the US, Europe and other unnamed territories outside of China and Southeast Asia. The monoclonal antibodies target transmembrane serine protease 6. Read More
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Espero Biopharma's headquarters is located at 14286-19 Beach Blvd, 270, Jacksonville.
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