China's Clover raises $230 million, plans vaccines for COVID-19 variants

 China’s Clover Biopharmaceuticals, a developer of coronavirus vaccines, has raised $230 million from investors, including Singapore’s state investment firm Temasek Holdings, it said on Tuesday, as it develops vaccines for variants.

Clover, which has been developing a vaccine using an immune response-boosting ingredient made by U.S.-based Dynavax Technologies Corp, plans to start mid- to late-stage clinical trials in the first half of 2021.

In a statement, it said the proceeds of the fund-raising would be used to develop vaccines targeting the virus and other diseases, as well as cancer therapies.

“We are working on broadly protective coronavirus vaccine approaches for variant strains of interest,” a spokeswoman said, without identifying the specific strains of SARS-CoV-2 to be targeted by the firm’s new candidates.

The latest round of fund-raising, co-led by Temasek and GL Ventures, an affiliate of Asia-focused private equity Hillhouse Capital, brings Clover’s total capital raised in the last 12 months to more than $400 million.

Clover said it had also started production planning for potentially hundreds of millions of doses of its COVID-19 vaccine this year.

Its global trial is backed by non-profit group the Coalition for Epidemic Preparedness Innovations (CEPI).

https://www.reuters.com/article/health-coronavirus-vaccine-clover/chinas-clover-raises-230-million-plans-vaccines-for-covid-19-variants-idUSKBN2AN0B0

Pfizer's COVID-19 vaccine gets nod in South Korea from first of three expert panels

 The first of three expert panels in South Korea reviewing a COVID-19 vaccine developed by Pfizer Inc and BioNTech gave its recommendation on Tuesday for the government to approve the vaccine.

The national pharmaceutical panel is planning to make its recommendation on Friday, the same day that South Korea will begin its immunisation drive. But, the government will wait for a third panel, which has not said when it will reach its conclusion, before deciding whether to grant approval.

High-risk individuals, prioritised at the start of the vaccination campaign, will be inoculated with a vaccine developed by AstraZeneca and Oxford University.

A day later, however, South Korea will make use of 117,000 doses of the Pfizer/BioNTech vaccine that have been supplied through COVAX, an international coronavirus vaccine sharing programme, bypassing the need for the government’s final approval.

Around 55,000 healthcare workers in COVID-19 treatment facilities will receive the first doses of the Pfizer/BioNTech vaccine on Saturday.

The first panel to report on the Pfizer/BioNTech vaccine advised that it should be administered to people aged 16 and over, taking into account its global trial results and approval in several other countries.

Pfizer has promised to double its supply of the vaccine for the United States by the middle of March and also raised global production expectations for 2021 to at least 2 billion doses.

South Korea reported 357 new coronavirus cases on Monday. The total number of infections now stands at 87,681, with death toll of 1,573.

https://www.reuters.com/article/us-health-coronavirus-southkorea-pfizer/pfizers-covid-19-vaccine-gets-nod-in-south-korea-from-first-of-three-expert-panels-idUSKBN2AN0L0

Frequency Therapeutics Phase 1/2 Data: Improvements in Acquired Hearing Loss Using FX-322

 Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage biotechnology company focused on harnessing the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced the publication of its FX-322 Phase 1/2 study results in Otology & Neurotology, a leading peer-reviewed journal focused on disorders of the ear. The data show hearing improvements in adults with acquired sensorineural hearing loss (SNHL) and the first-known linkage of pharmacokinetics and pharmacodynamics for a potential hearing restoration therapy.

Findings from the Phase 1/2 study of FX-322, the company’s lead product candidate to treat SNHL, showed statistically significant increases in word recognition (WR) and words-in-noise (WIN) scores. Individuals with stable SNHL that received a single dose of FX-322 showed improvements in the number of words recognized in quiet from baseline to day 90 in the WR test (p=0.029) and the level of background noise in which words could be identified in the WIN test (p=0.012). There were no meaningful changes in the WR and WIN scores of the placebo group. FX-322 was also shown to be well tolerated. The publication includes data demonstrating consistent cochlear drug delivery in both preclinical and human studies. FX-322 is currently being evaluated in a larger Phase 2a study, with results anticipated later this quarter.

The study data will be presented today at the leading international hearing research conference, the Association for Research in Otolaryngology 44th Annual MidWinter Meeting.

https://www.businesswire.com/news/home/20210222005818/en/Frequency-Therapeutics-Announces-Publication-of-Phase-12-Data-Showing-Hearing-Improvements-in-Acquired-Sensorineural-Hearing-Loss-Patients-Receiving-FX-322

Moderna moves on plan to up Covid vaccine supply in each vial after FDA feedback

 Moderna said Monday it received “positive feedback” from the Food and Drug Administration on its proposal to increase the number of Covid-19 vaccine doses in each of its vials.

One vial of Moderna’s two-shot vaccine contains ten doses, enough to inoculate five people, according to the Centers for Disease Control and Prevention. CNBC reported last month that Moderna had asked the FDA for permission to fill its Covid-19 vaccine vials with up to five additional doses to ease a bottleneck in manufacturing.

In prepared testimony submitted ahead of a House hearing on Tuesday, Moderna President Stephen Hoge said the U.S. agency has given the company “positive feedback on our proposal, and we are pursuing a plan that may allow up to 15 doses to be drawn from each vial.”

“This will allow us to produce and deliver more doses more quickly,” Hoge told House Energy and Commerce Committee Subcommittee on Oversight and Investigations “We will continue to collaborate with our manufacturing partners and the federal government to increase the efficiency of our production process without compromising quality or safety.”

The disclosure comes as President Joe Biden is trying to pick up the pace of vaccinations in the U.S. Biden announced Feb. 11 that his administration secured deals with Pfizer and Moderna for another 200 million doses of Covid-19 vaccine, bringing the U.S. total to 600 million. Because both authorized vaccines require two doses given about three to four weeks apart, the total of 600 million doses would be enough to inoculate 300 million people. The Biden administration expects all of those doses by the end of July.

It’s unclear if the increase of doses per vial is why Moderna now expects it can deliver 300 million doses by the end of July.

In December, the FDA said health-care providers could use extra doses from vials of Pfizer’s Covid-19 vaccine. Those vials were said to contain five doses, but some providers were able to extract a sixth or even seventh dose. Like with Pfizer, some providers have also been able to draw an extra dose of Moderna’s vaccine using special syringes.

https://www.cnbc.com/2021/02/22/moderna-says-fda-gave-positive-feedback-on-request-to-increase-covid-vaccine-supply-in-each-vial.html

Aclaris (ACRS) Reportedly Hires Bankers to Explore Potential Sale

 Aclaris Therapeutics (NASDAQ: ACRS) has hired two investment banks to explore a potential sale of the company.

https://www.streetinsider.com/Hot+M+and+A/Aclaris+Therapeutics+%28ACRS%29+Hires+Bankers+to+Explore+Potential+Sale+-+Source/18010027.html

Indian vaccine makers say can quickly adapt to tackle variants

 Indian pharmaceutical companies Bharat Biotech and Biological E. Ltd said on Monday they could quickly rework their COVID-19 vaccine products to fight new variants once their genetic sequence is known.

In recent months, India has confirmed the presence of the variants first identified in Brazil, Britain and South Africa, which are believed to explain an upsurge in cases in the Indian states of Maharashtra and Kerala.

In all, India has reported more than 11 million coronavirus infections, the highest number in the world after the United States, and about 156,000 deaths.

“As we are seeing a lot of resurgence of cases, we are picking up samples from hotspots and clusters and we are trying to sequence them,” Nivedita Gupta, deputy director-general of the state-run Indian Council of Medical Research (ICMR), told the BioAsia conference.

ICMR and Bharat Biotech have collaborated to develop India’s first homegrown COVID-19 vaccine, which, along with another licensed from AstraZeneca and Oxford University, is being used in the country’s immunisation campaign that has covered more than 10 million people since mid-January.

India is the world’s biggest maker of vaccines, and its companies have promised to produce billions of doses of COVID-19 shots.

Bharat Biotech Chairman Krishna Ella said his company would mainly need data from the ICMR or the World Health Organization on the genetic sequence of any variant to quickly make an effective vaccine.

Speaking at a conference organised by the state of Telangana, home to India’s vaccine hub Hyderabad, Ella said a product to tackle the South African variant could be made in 15 days and would not require any change to the manufacturing process.

Biological E. Managing Director Mahima Datla said there was no need to be “overly concerned” about the mutations.

“Eventually we don’t know which variant of the virus, which mutants will take over, but we think that it’s prudent to work on technologies that address the new variants as well,” she said.

Biological E., which is developing a vaccine with Houston’s Baylor College of Medicine and Dynavax Technologies, recently completed Phase 1/2 clinical trial in India, Datla said.

Its product uses the recombinant-protein technology in which a harmless agent is used to stimulate an immune response in cells.

“Once you know the variant, when it’s sequenced, it is fairly quick to deploy into a vaccine,” said Datla, whose company will also contract-manufacture Johnson & Johnson’s shot.

https://www.reuters.com/article/health-coronavirus-india-vaccine-idUSKBN2AM21Y

J&J says it can provide U.S. with 20M vaccine doses by April

 Drugmaker Johnson & Johnson says it will be able to provide 20 million U.S. doses of its single-shot COVID-19 vaccine by the end of March, assuming it gets the green light from federal regulators.

J&J disclosed the figure in written testimony ahead of a congressional hearing Tuesday looking at the country’s vaccine supply. White House officials cautioned last week that initial supplies of J&J’s vaccine would be limited.

The company reiterated that it will have capacity to provide 100 million vaccine doses to the U.S. by the end of June. That supply will help government officials reach the goal of having enough injections to vaccinate most adult Americans later this year. On a global scale, the company aims to produce 1 billion doses this year.

U.S. health regulators are still reviewing the safety and effectiveness of the shot, and a decision to allow its emergency use is expected later this week. J&J’s vaccine would be the first in the U.S. that requires only a single shot.

The currently available vaccines from Pfizer and Moderna require two doses spaced several weeks apart. Executives from both companies and two other vaccine-makers will also testify at Tuesday’s hearing.

https://www.post-gazette.com/news/nation/2021/02/22/Johnson-and-Johnson-COVID-19-coronavirus-vaccine-supplies-20-million-shots-doses-congressional-hearing-Pfizer-Moderna/stories/202102220107