Zentalis Pharmaceuticals in Collaboration Agreement With Glaxo

 Zentalis Pharmaceuticals Inc. said it has entered into a clinical collaboration agreement with GlaxoSmithKline PLC.

Zentalis said it will evaluate the combination of ZN-c3, an oral WEE1 inhibitor product candidate, and Zejula niraparib, GlaxoSmithKline's polymerase PARP inhibitor, in patients with advanced epithelial ovarian cancer.

Zentalis is currently conducting clinical studies with ZN-c3 both as a monotherapy and in combination with certain standard of care therapies.

Under the terms of the non-exclusive collaboration, Zentalis is responsible for conducting the study, with GlaxoSmithKline providing all required doses of niraparib. Zentalis will maintain full ownership of ZN-c3.

https://www.marketscreener.com/quote/stock/ZENTALIS-PHARMACEUTICALS-106001589/news/Zentalis-Pharmaceuticals-in-Collaboration-Agreement-With-GlaxoSmithKline-32943693/

Pulmatrix: J&J Terminates License, Development, Commercialization Pact

Pulmatrix Inc. on Monday said Johnson & Johnson has terminated its lung-cancer license, development and commercialization agreement with the company.

The Lexington, Mass., clinical-stage biopharmaceutical company said that as a result of the termination, it will regain full rights to its narrow spectrum kinase inhibitor portfolio, including PUR1800.

Pulmatrix early last year announced the agreement with J&J's Lung Cancer Initiative under which the company received a $7.2 million upfront payment and was eligible for more than $90 million in milestone payments.

Pulmatrix said it plans to continue the development of PUR1800, with ongoing clinical and toxicology studies to support programs in acute exacerbations in chronic obstructive pulmonary disease and other chronic airway diseases.

https://www.marketscreener.com/quote/stock/PULMATRIX-INC-54548233/news/Pulmatrix-nbsp-J-J-Terminates-License-Development-Commercialization-Pact-32944665/

AstraZeneca's diabetes drug Farxiga fails in COVID-19 study

 Data from a late-stage study to test if AstraZeneca’s diabetes drug Farxiga could treat patients hospitalised with COVID-19 and at risk of developing serious complications fell short of its main goals, the drugmaker said on Monday.

The Farxiga data did not achieve statistical significance in cutting the risk of the disease worsening and death in such patients, the Anglo-Swedish drugmaker said.

AstraZeneca has had a rollercoaster ride with its coronavirus vaccine, as nations restricted its use after European and British regulators confirmed possible links to rare blood clots.

However, the company has also been working on developing new treatments and re-purposing existing drugs to prevent and treat coronavirus infections.

In the Farxiga study, the drug was given over 30 days in a global trial of 1,250 patients hospitalised with COVID-19, in addition to the local standard of care, AstraZeneca said.

Patients in the trial also had a medical history of hypertension, cardiovascular disease and heart failure, type-2 diabetes or chronic kidney disease.

The trial did not achieve statistical significance for the main goals of prevention and recovery at 30 days but AstraZeneca said the safety and tolerability profile was consistent with the medicine’s established safety profile.

One of the company’s other treatments is an antibody cocktail called AZD7442, designed to treat the disease rather than prevent it as the vaccine aims to do.

The treatment, which is in late-stage trials, is one of several being developed for COVID-19, including efforts by rivals Moderna Inc and Eli Lilly.

In March, AstraZeneca said it would supply up to half a million extra doses of the antibody cocktail to the United States, building on an October 2020 contract for initial supplies of 200,000 doses, for a value of $726 million.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-treatm/astrazenecas-diabetes-drug-farxiga-fails-in-covid-19-study-idUSKBN2BZ0HG

Asthma drug budesonide speeds recovery for at-home COVID-19 patients

 Treating COVID-19 patients at home with a commonly-used inhaled asthma drug called budesonide can speed up their recovery, according to UK trial results on Monday which doctors said could change the way the disease is treated around the world.

Researchers behind the trial - known as PRINCIPLE - said the findings were only an interim analysis at this stage, but could soon lead doctors to prescribe budesonide inhalers to patients infected with COVID-19 but not sick enough to be hospitalised.

“For the first time we have high-quality evidence of an effective treatment that can be rolled out across the community for people who are at most risk of developing more severe illness from COVID-19,” said Richard Hobbs, a professor at Britain’s Oxford University who co-led the trial.

He noted that unlike other proven COVID-19 treatments, such as the steroid dexamethasone, budesonide is effective in early stages of COVID-19 and can be used at home. “This is a significant milestone for this pandemic,” he said.

The PRINCIPLE results add to recent evidence from a smaller UK study, which found in February that budesonide reduced recovery time and the need for hospitalisation among COVID-19 patients given it within a week of first symptoms.

Budesonide is a safe, relatively cheap and readily available corticosteroid drug used around the world in inhalers to treat asthma and chronic obstructive pulmonary disease (COPD).

“Medical practitioners around the world caring for people with COVID-19 in the community may wish to consider this evidence when making treatment decisions,” said Chris Butler, a family doctor and Oxford professor who co-led the PRINCIPLE study. “It should help people with COVID-19 recover quicker.”

The study involved 961 patients who were randomly assigned to receive inhaled budesonide and compared to 1,819 patients assigned to the usual standard of care. Some 751 people in the budesonide group and 1,028 in the usual care group were SARS-CoV-2 positive and included in the interim analysis.

Doctors asked the budesonide patients to take two puffs on the inhaler, twice a day for a fortnight - giving an inhaled dose of 800 micrograms twice a day for 14 days. All patients were either age 65 plus, or aged over 50 with an underlying health condition that put them at more risk of serious COVID-19.

Interim results, published before peer-review on the medRxiv server, showed that 32% of those on inhaled budesonide, compared to 22% in the usual care group, recovered within the first 14 days and remained well until at least 28 days of follow-up.

Butler’s team said a full analysis with detailed results on time to recovery and hospitalisations would be published when all remaining trial patients have completed follow-up.

https://www.reuters.com/article/us-health-coronavirus-budesonide/asthma-drug-budesonide-speeds-recovery-for-at-home-covid-19-patients-idUSKBN2BZ1RX

J&J begins COVID-19 vaccine supplies to EU

 Johnson & Johnson on Monday began delivering its COVID-19 single-dose vaccine to EU countries, European Union officials and the company said.

The company had initially planned to start its deliveries at the beginning of April, but delayed the rollout due to production issues.

“The first doses are leaving warehouses for member states today,” a European Commission spokesman told a news conference on Monday.

“Johnson & Johnson begins vaccine shipments to the EU today. Very good news,” said Peter Liese, an EU lawmaker from the same party as German Chancellor Angela Merkel.

The U.S. company has committed to delivering 55 million doses to the EU by the end of June and another 120 million in the third quarter, EU industry commissioner Thierry Breton said this month.

“Most recently, it was unclear whether that promise would be kept. However, 50 million doses are certain” for the second quarter, Liese said, noting he received this information from the company and from the European Commission, which coordinates talks with vaccine makers.

A spokeswoman for Johnson & Johnson confirmed that it began deliveries on Monday to EU countries, Norway and Iceland, but declined to comment on supplies for April and the second quarter.

It said it aimed to deliver 200 million doses in 2021 to the EU, Norway and Iceland.

https://www.reuters.com/article/us-health-coronavirus-eu/jj-begins-covid-19-vaccine-supplies-to-eu-50-million-doses-expected-in-second-quarter-lawmaker-idUSKBN2BZ14Q

Indian panel gives emergency approval for Russia's Sputnik V vaccine

 An expert panel of India’s drugs regulator has recommended emergency use approval of Russia’s Sputnik V coronavirus vaccine, two sources said on Monday, which could make it the nation’s third to be approved as infections surge again.

India overtook Brazil to become the nation with the second highest number of infections worldwide after the United States, as it battles a massive second wave, having given about 105 million doses among a population of 1.4 billion.

The panel of the Central Drugs Standard Control Organisation (CDSCO) recommended the authorisation, said two people familiar with the matter, who sought anonymity as they were not authorised to speak to media.

Most panel recommendations are generally accepted by the regulator’s chief.

The Russian Direct Investment Fund, which is responsible for marketing the vaccine abroad, said it was expecting to hear from the Indian drugs authority soon.

“RDIF confirms it is awaiting imminently the recommendation by the Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) of India to approve the use of the Russian Sputnik V vaccine against coronavirus in India,” it said.

The Fund has signed deals to produce more than 750 million doses of Sputnik V in India with six domestic firms.

India is now using two vaccines, one developed by AstraZeneca and Oxford University, and the other by domestic firm Bharat Biotech.

Sputnik V, developed by Moscow’s Gamaleya Institute, has proved 91.6% effective against COVID-19 and has been approved for use in more than 50 countries.

The Indian drugs regulator did not respond to a request for comment on the expert panel’s approval of the Russian vaccine.

Indian pharmaceutical firm Dr. Reddy’s, which is marketing the vaccine in India, said it was awaiting formal word from the authorities.

“Dr. Reddy’s and RDIF are working diligently with the Indian regulatory authorities to obtain the approval for Sputnik V. We are fully committed to playing our part in India’s fight against COVID,” the company said.

Shares of Dr Reddy’s ended up 5% after the Economic Times newspaper first reported the news.

The firm has helped run a small domestic trial to test the vaccine’s safety and ability to generate an immune response.

https://www.reuters.com/article/us-health-coronavirus-india-vaccine/indian-panel-gives-emergency-approval-for-russias-sputnik-v-vaccine-sources-idUSKBN2BZ0ZQ

Taysha Gene Therapies Acquires World Rights to Clinical-Stage AAV9 Gene Therapy Program

 Program invented in the lab of Dr. Steven Gray, Taysha’s Chief Scientific Advisor, immediately transforms Taysha into a sustainable pivotal-stage gene therapy company

Clinical and preclinical data package validates the scientific approach of Dr. Steven Gray, UT Southwestern, and Taysha, with readthrough to existing portfolio

Groundbreaking clinical trial run by the NIH is the first intrathecally dosed gene therapy program in history

Human proof-of-concept data for TSHA-120 demonstrated clear arrest of disease progression and long-term durability at therapeutic dose levels in patients with giant axonal neuropathy

Plans to engage with regulatory agencies in the United States, Europe and Japan as soon as possible

Estimated 2,400 patients in U.S. and Europe represent potentially greater than $2 billion near-term commercial opportunity

Program provides basis for accelerating build-out of commercial infrastructure to support patient identification, payor engagement and product distribution

Conference call and webcast today at 8:00 AM Eastern Time

Taysha management will hold a conference call and webcast today at 8:00 am ET / 7:00 am CT to review its acquisition of the GAN program. The dial-in number for the conference call is 877-407-0792 (U.S./Canada) or 201-689-8263 (international). The conference ID for all callers is 13718632. The live webcast and replay may be accessed by visiting Taysha’s website at https://ir.tayshagtx.com/news-events/events-presentations. An archived version of the webcast will be available on the website for 60 days.

https://finance.yahoo.com/news/taysha-gene-therapies-acquires-exclusive-110000167.html