AstraZeneca's Tezepelumab Gets Orphan Drug Designation

 AstraZeneca PLC said Friday that its Tezepelumab drug for treating eosinophilic esophagitis--a rare, chronic, inflammatory disease--has been granted orphan drug designation in the U.S.

The London-listed biopharmaceutical company said Tezepelumab is designed to treat eosinophilic esophagitis--a disease that occurs when eosinophils, a type of white blood cell builds up in the esophagus. Along with eosinophils, other cells including mast cells, T-cells and firbroblasts cause further injury, inflammation and detrimental tissue remodeling.

If untreated, the disease can cause difficulty and discomfort in eating, leading to chronic pain, difficulty in swallowing, poor growth, malnutrition and weight loss.

The orphan drug designation qualifies Tezepelumab for government assistance and incentives to continue developing the product despite the extremely rare nature of the disease and consequent lack of profitability.

A decision on Tezepelumab's priority review in patients with asthma in the U.S. is expected in the first quarter of 2022, and the drug is also under regulatory review for asthma in the European Union and Japan.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-s-Tezepelumab-Gets-Orphan-Drug-Designation-in-the-US-36637192/

IsoPlexis Prices IPO Of 8.33 Mln Shares At $15.00/sh

 IsoPlexis Corp. said it has priced its initial public offering of about 8.33 million shares of common stock at $15.00 per share.

The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by IsoPlexis, are expected to be $125.0 million, excluding any exercise of the underwriters' option to purchase additional shares.

IsoPlexis' common stock is expected to begin trading on The Nasdaq Global Select Market on October 8, 2021, under the ticker symbol "ISO." The offering is expected to close on October 12, 2021.

In addition, IsoPlexis has granted the underwriters a 30-day option to purchase up to an additional 1.25 million shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

https://www.nasdaq.com/articles/isoplexis-prices-ipo-of-8.33-mln-shares-at-%2415.00-shr-2021-10-07

Pyxis Oncology, Inc. (PYXS) Prices Upsized 10.5M Share IPO at $16/sh

 Pyxis Oncology, Inc. (Nasdaq: PYXS), a preclinical oncology company focused on developing an arsenal of next-generation therapeutics to target difficult-to-treat cancers and improve quality of life for patients, today announced the pricing of its upsized initial public offering of 10,500,000 shares of common stock at an initial public offering price of $16.00 per share. All of the shares are being offered by Pyxis. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Pyxis, are expected to be $168.0 million. The shares are expected to begin trading on the Nasdaq Global Select Market on October 8, 2021 under the ticker symbol “PYXS.” The offering is expected to close on October 13, 2021, subject to the satisfaction of customary closing conditions. In addition, Pyxis has granted the underwriters a 30-day option to purchase up to an additional 1,575,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

BofA Securities, Jefferies, Credit Suisse and William Blair are acting as joint book-running managers for the offering. LifeSci Capital is also acting as an underwriter for the offering.

https://www.streetinsider.com/Corporate+News/Pyxis+Oncology%2C+Inc.+%28PYXS%29+Prices+Upsized+10.5M+Share+IPO+at+%2416sh/19039846.html

Humanigen in Contract With Clinigen for Lenzilumab Managed Access Program in Europe

 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ announced today it has entered into an arrangement with Clinigen Group plc ("Clinigen") a global pharmaceutical Services and Products company, to implement a Managed Access Program for lenzilumab ("LenzMAP™").

LenzMAP will enable access to lenzilumab on a case-by-case basis for hospitalized patients with COVID-19 where the treating physician deems there to be no suitable alternatives and where regulations allow. LenzMAP will be available in the following 16 European countries: Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, France, Greece, Ireland, Lithuania, Luxembourg, Netherlands, Portugal, Spain, Sweden, and Switzerland. To date there have been over 20 million cases of COVID-19 reported in these countries.1 Lenzilumab is an investigational product and is not currently authorized or approved in any country.

Under the terms of the agreement, Clinigen will manage key elements of the program including regulatory oversight, logistics and access management.

https://finance.yahoo.com/news/humanigen-signs-contract-clinigen-lenzilumab-060000913.html

2 Indian drugmakers seek to end trials of Merck antiviral drug for moderate COVID

 Two Indian drugmakers have requested permission to end their late-stage trials on Merck & Co’s experimental antiviral drug molnupiravir in moderate COVID-19 patients.

The two Indian drugmakers, Aurobindo Pharma Ltd and MSN Laboratories plan to continue late-stage trails of the drug for those with mild COVID-19, the Indian drug regulator’s expert committee said on Friday. The two companies separately sought permission to end trials in the case of moderate COVID-19 patients after having submitted interim clinical trial data around the effectiveness of the drug in treating this category of patients, the committee disclosed, throwing into question the efficacy of the experimental drug in improving outcomes for patients with moderate cases of COVID-19.

Separately, a senior source at India’s drug regulator told Reuters that molnupiravir had shown no “significant efficacy” against moderate COVID-19 cases.

Shares in Merck soared last week after it and partner Ridgeback Biotherapeutics said an interim analysis of a late-stage clinical trial on molnupiravir showed the medicine nearly halved the risk of hospitalisation or death for patients with mild or moderate COVID-19.

It was not immediately clear whether the Indian drugmakers and Merck used identical criteria to define moderate COVID-19 cases.

Aurobindo Pharma, MSN and Merck did not immediately reply to Reuters’ requests for comment.

Merck has entered into voluntary licensing agreements with at least eight Indian drugmakers for molnupiravir, with an aim to turn the South Asian nation into a manufacturing hub for the drug to supply low- and middle-income nations.

Aurobindo has been conducting a clinical trial https://bit.ly/2WYn61G on the drug in 100 patients with moderate COVID-19 since August this year. According to its trial details, moderate patients included those with fever, coughing, breathing difficulties and oxygen deficiency.

Of the eight Indian firms, five – Dr Reddy’s Laboratories, Cipla, Sun Pharma, Torrent Pharmaceuticals and Emcure Pharmaceuticals – are conducting a joint trial for the antiviral drug only in mild COVID-19 patients in an outpatient setting.

The other licenced company, Hetero, in early July announced interim data from its own late-stage trial in treating mild COVID-19 patients and submitted an application for emergency use approval for the same.

Hetero is separately conducting a study on moderate COVID-19 patients and it has said clinical results on the same will be shared in due course.

https://www.metro.us/two-indian-drugmakers-seek/

ChemoCentryx gets FDA nod for drug to treat rare autoimmune disease

 Biopharmaceutical company ChemoCentryx Inc said on Friday the U.S. drug regulator approved its lead drug for treating a rare, fatal autoimmune disease.

The company said it expected to make Avacopan, sold under the brand name "Tavneos" available to clinicians and patients in the next few weeks.

Avacopan is an orally-administered drug candidate to treat antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV) — a group of conditions characterized by destruction and inflammation of small blood vessels and affecting different organs, particularly the kidney.

It had received mixed reviews from an expert panel to the U.S. Food and Drug Administration (FDA) in May, with the committee's vote split 9-9 on whether the efficacy data supported the drug's approval.

Following this meeting, the company submitted in July additional data for its marketing application for Avacopan.

Avacopan works by blocking the activity of a protein called C5a receptor which is responsible for causing numerous inflammatory diseases.

https://finance.yahoo.com/news/1-chemocentryx-gets-u-fda-112829057.html

Mirati to Collaborate with Sanofi on Phase 1/2 Study for Lung Cancer Combo

 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced a non-exclusive clinical collaboration agreement with Sanofi to evaluate the combination of adagrasib, the Company's investigational KRASG12C inhibitor, with Sanofi's investigational SHP2 inhibitor SAR442720, also known as RMC-4630. The Phase 1/2 dose escalation and expansion study will evaluate the combination in patients with previously-treated non-small cell lung cancer (NSCLC) and KRASG12C mutations.   

"Mirati is aggressively advancing a broad adagrasib development program, which includes pursuing novel combination approaches including through this collaboration with Sanofi," said Charles M. Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "There is strong scientific rationale for combining a SHP2 inhibitor with adagrasib, which may help optimize clinical outcomes for patients with KRASG12C-dependent tumors."

SHP2 is upstream of KRAS and mediates cellular signaling through the RAS/MAP kinase pathway and is frequently overactive in various types of cancer. KRASG12C inhibition and SHP2 inhibition have complementary mechanisms of action and have demonstrated additive anti-tumor activity in pre-clinical models. 

Under the terms of the agreement, Sanofi will be responsible for sponsoring and operating the Phase 1/2 study, and jointly with Mirati, will oversee and share costs of the study.

https://www.kpvi.com/news/national_news/mirati-therapeutics-to-collaborate-with-sanofi-on-phase-1-2-study-evaluating-combination-of-adagrasib/article_85166a57-6802-56b7-a833-2a1b586af8ac.html