Gilead nabs stake in cancer therapy developer Pionyr Immunotherapeutics

Gilead Sciences (NASDAQ:GILD) has acquired a 49.9% interest in privately held South San Francisco, CA-based Pionyr Immunotherapeutics, a developer of biologics to treat cancer based on its Myeloid Tuning technology that, it says, alters the tumor microenvironment to favor immune-activating cells over immune-suppressing cells.

Under the terms of the agreement, GILD will pay $275M at closing. It will have an exclusive option to acquire the remaining 50.1% of Pionyr in exchange for a $315M option exercise fee and up to $1.5B in milestones. It will provide additional funding for its PY314 and PY159 programs as well as ongoing R&D efforts.

Pionyr expects to file INDs in the U.S. for the two programs next quarter.

https://seekingalpha.com/news/3585338-gilead-nabs-stake-in-cancer-therapy-developer-pionyr-immunotherapeutics

FibroGen enrolls first patient in pamrevlumab trial for COVID-19

FibroGen (NASDAQ:FGEN) has initiated a Phase 2 Study investigating the efficacy and safety of pamrevlumab in hospitalized patients with acute COVID-19 infection.

This multicenter trial will enroll approx. 130 patients. The primary objective is to assess the effect of pamrevlumab on blood oxygenation in patients with COVID-19 infection, and patients will be randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio.

The primary efficacy assessment is the proportion of hospitalized COVID-19 patients who have not received mechanical ventilation and/or extracorporeal membrane oxygenation and remain alive at Day 28.

https://seekingalpha.com/news/3585349-fibrogen-enrolls-first-patient-in-pamrevlumab-trial-for-covidminus-19

Court cuts J&J talc verdict to $2.1B

Bloomberg reports that a Missouri appeals court has reduced Johnson & Johnson’s (JNJ -0.3%) $4.7B talcum powder verdict to $2.1B.

The company appealed the 2018 state court verdict awarding 22 women with ovarian cancer $4.69B. Six died before the trial started and five since it ended. It still faces talcum powder-related lawsuits from more than 19K plaintiffs.

Last month, the company announced that it would stop selling talc-containing baby powder in the U.S. and Canada citing diminished demand amid safety concerns.

https://seekingalpha.com/news/3585391-court-cuts-j-and-j-talc-verdict-to-2_1b

Karuna to advance lead drug into Phase 3 for psychosis in schizophrenia patients

Fresh off a meeting with the FDA, Karuna Therapeutics (NASDAQ:KRTX) will advance lead candidate KarXT into Phase 3 development for the treatment of acute psychosis in patients with schizophrenia.

The agency is on board with one successful late-stage study, along with additional safety data and results from previously generated trials, to support an NDA filing.

It plans to launch two five-week trials, the first to launch by year-end. The primary endpoint of the 250-subject study will be the change in Positive and Negative Syndrome Scale total score at week 5 versus placebo.

Details of the second efficacy trial will be finalized in Q4 and should launch in H1 2021.

It will also collect long-term open-label safety and tolerability data for up to one year in an outpatient setting.

KarXT is an orally available combination of xanomeline (a novel muscarinic receptor agonist) and trospium (a muscarinic receptor antagonist). The company says it has the potential to be a new treatment option of debilitating CNS disorders but without the unwanted side effects associated with current antipsychotic medications.

https://seekingalpha.com/news/3585267-karuna-to-advance-lead-drug-phase-3-for-psychosis-in-schizophrenia-patients

Chinese firm gets OK to begin human testing for potential coronavirus vaccine

China has approved a coronavirus vaccine candidate developed by Chongqing Zhifei Biological Products’ unit to begin human testing, the company said in a filing on Tuesday.
The potential vaccine, co-developed by Anhui Zhifei Longcom Biopharmaceutical and the Institute of Microbiology of the Chinese Academy of Sciences, has received a certificate from the National Medical Products Administration to launch clinical trials.
Chinese researchers and companies are testing six experimental shots in humans, and more than a dozen vaccines are in different stages of clinical trials globally against the virus that has killed over 470,000 people.
However, none of the them have passed large-scale, late-stage phase 3 clinical trials, a necessary step before entering the consumer market.
https://www.reuters.com/article/us-health-coronavirus-vaccine/chinese-firm-gets-approval-to-begin-human-testing-for-potential-coronavirus-vaccine-idUSKBN23U0JG

Sanofi eyes approval of COVID-19 vaccine by first half of 2021

French drugmaker Sanofi SA (SASY.PA) said on Tuesday it expects to get approval for the potential COVID-19 vaccine it is developing with Britain’s GlaxoSmithKline Plc (GSK.L) by the first half of next year, faster than previously anticipated.

Sanofi, which is hosting a virtual research and development event, and GSK had said in April the vaccine, if successful, would be available in the second half of 2021.
“We are being guided by our dialogue with regulatory authorities,” Sanofi research chief John Reed told reporters, when asked about the accelerated time frame.
There are currently no vaccines to prevent the coronavirus that has infected more than 9 million people and killed over 469,000 globally, and only a couple of medicines that have demonstrated benefit in hospitalized COVID-19 patients in clinical trials.
Many drugmakers are racing to come up with a safe and effective vaccine that can be produced at large scale.
Moderna Inc (MRNA.O), the University of Oxford in collaboration with AstraZeneca Plc (AZN.L), and an alliance of BioNTech (BNTX.O) and Pfizer Inc (PFE.N) grabbed headlines by moving to human trials as early as March.
Sanofi Chief Executive Paul Hudson said the firsts in the race now were not assured of securing victory.
“There are companies moving faster, but let us be brutally clear, speed has three downsides,” he said of competition.

“They are using existing work, in many cases done for SARS; it is likely not to be as efficacious; and there is no guarantee on supply in large volumes,” Hudson said.
The probability of success for Sanofi is “higher than anybody else,” the CEO said.
The comments echoed those of GSK, whose chief medical officer for vaccines told Reuters on Friday the company was aiming at quality before speed.
Sanofi, whose Pasteur vaccines division has a long established reputation, notably in flu, is currently working on two vaccine projects.
One uses an adjuvant made by GSK to potentially boost its efficacy. It has received financial support from the U.S. Biomedical Advanced Research and Development Authority (BARDA).
The other, being developed with U.S. company Translate Bio Inc (TBIO.O), relies on a different technology known as mRNA, similar to the Moderna approach.
Clinical trials of the vaccine developed with GSK, described as a recombinant vaccine because of the use of GSK’s boosting adjuvant, are to start in September. Trials of the mRNA vaccine candidate should begin around the end of the year, the company said.
Sanofi said it had capacity to produce up to 1 billion doses a year of its recombinant vaccine, and that it would be able to supply up to 360 million doses of its mRNA vaccine annually.

In April, Sanofi said it had manufacturing capacity for 600 million doses for its recombinant vaccine, with the ambition to double production by mid-2021.
The company also said it would expand its collaboration with Translate Bio on developing vaccines, in a deal which will give the U.S. group $425 million in upfront payments.
https://www.reuters.com/article/us-health-coronavirus-sanofi-vaccine/sanofi-eyes-approval-of-covid-19-vaccine-by-first-half-of-2021-idUSKBN23U0JN

Pig trial of AstraZeneca’s COVID-19 vaccine shows promise with two shots

A trial in pigs of AstraZeneca’s (AZN.L) experimental COVID-19 vaccine has found that two doses of the shot produced a greater antibody response than a single dose.
Research released by Britain’s Pirbright Institute on Tuesday found that giving an initial prime dose followed by a booster dose of the vaccine elicited a stronger immune response than a single dose. This suggests a two-dose approach may be more effective in getting protection against COVID-19, the disease caused by the new coronavirus.
“The researchers saw a marked increase in neutralising antibodies, which bind to the virus in a way that blocks infection,” the Pirbright team said in a statement. They added, however, that it is not yet known what level of immune response will be required to protect humans.
The ChAdOx1 nCoV-19 vaccine, also known as AZD1222, was originally developed by Oxford University scientists, who are now working with AstraZeneca on development and production.
“These results look encouraging that administering two injections … boosts antibody responses that can neutralise the virus, but it is the response in humans that’s important,” said Bryan Charleston, Pirbright’s director.

AZD1222 is already in human trials, and AstraZeneca says it hopes to have data on efficacy later this year.
Preliminary data from a trial in six monkeys found that some of the monkeys given a single shot developed antibodies against the virus within 14 days, and all developed protective antibodies within 28 days.

More than 100 potential vaccines are being developed around the world to try to control the pandemic, which has already killed hundreds of thousands of people.
Stephen Griffin, an associate professor at Leeds University who was not directly involved in this work, said it was “an encouraging advance” and showed that “a so-called ‘prime-boost’ strategy gives rise to far better responses” than a single dose.
“Whilst these studies will need to be repeated within human subjects…this is a heartening study,” he said.
https://www.reuters.com/article/us-health-coronavirus-vaccine-astrazenec/pig-trial-of-astrazenecas-covid-19-vaccine-shows-promise-with-two-shots-idUSKBN23U1AE