J&J says in talks with Indian government for trial of single-dose vaccine

 Johnson & Johnson is in talks with India’s government to begin a clinical trial of its single-dose COVID-19 vaccine in the country, the company said on Friday.

The U.S. drugs and healthcare giant’s vaccine is currently approved for use in the United States, the European Union and other nations including Thailand and South Africa.

The news comes as some parts of India face a shortage of vaccine supplies just as the country of 1.3 billion battles a second wave of COVID-19 infections. India’s government, however, has said there is no shortage of shots.

The Indian Express newspaper reported earlier on Friday that J&J had sent a letter to India's Central Drugs Standard Control Organisation (CDSCO) saying it would "very shortly apply for permission to conduct clinical bridging trials in India". 

The CDSCO did not immediately respond to Reuters request for comment.

“We are in discussions with the (government) with the objective of starting a bridging clinical study of our Janssen COVID-19 vaccine candidate in India, subject to local regulatory approvals,” a local J&J representative said via email.

A bridging study tests the safety and immunogenicity of a vaccine, and India has indicated that any vaccine maker must conduct such a trial for a shot to be considered for its immunisation programme.

Separately, J&J has a deal with Indian firm Biological E Ltd to contract-manufacture its vaccine.

India currently has two approved vaccines in use, one developed by Oxford University and AstraZeneca and the other, a shot from local player Bharat Biotech.

There are other vaccine candidates in trials in India including Russia’s Sputnik-V and a shot developed by Cadila Healthcare Ltd.

COVID-19 infections in India rose by a record number for a third straight day on Friday, increasing by more than 130,000, while daily deaths hit their highest in five months.

https://www.reuters.com/article/us-health-coronavirus-india-vaccine/jj-says-in-talks-with-indian-government-for-trial-of-single-dose-vaccine-idUSKBN2BW0HH

LUCIRA COVID-19 Test Kit Identifies Viral Variants

 LUCIRA COVID-19 All-In-One Test Kit reactive to at least 99.9% of all known COVID-19 virus strains

Lucira Health, Inc. (Nasdaq: LHDX), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits, today confirmed it can successfully identify the "double mutant" variant of COVID-19 with its Lucira molecular test kit.

The "double mutant" variant was first identified in India on March 24, 2021, and found in California on March 25, 2021, by Stanford Clinical Virology Lab scientists. Unlike other variants, it has two genetic mutation sequences that the Center for Disease Control (CDC) is tracking.

According to Lucira Health Chief Technology Officer and co-founder Debkishore Mitra, Ph.D., variants occur when viruses replicate themselves. These variants include well-known strains first discovered in England, South Africa, and Brazil. Variants can occur when the genetic code packaged inside the virus starts copying itself and the new copies inadvertently start replicating a new, mutant code. These errors can cause a virus to elude the immune system and become more challenging to detect.

"A test is only helpful if it can detect the virus it’s designed to find," said Dr. Mitra. "That’s why we started routinely monitoring COVID-19 viral variants, even before the FDA’s voluntary guidelines were released this February. As sequences from new virus strains become available, we compare their genetic code with our test using a well-established, extremely accurate computer model.

"Since we began this monitoring, our Lucira test kit has been reactive to more than 99.9% of available COVID-19 viral sequences, which are roughly 30,000 letters long. It’s complex work, but really important since users rely on our test for accurate results."

Dr. Mitra added, "Our focus is on providing a test that’s easy for an individual to use and extremely accurate. If someone uses our ‘gentle swab’ test and has COVID-19, they can know in as few as 11 minutes on-the-spot. If they are not infected, they will know within 30 minutes. Precision and performance matter, and we can’t afford to let any variants escape detection."

https://finance.yahoo.com/news/lucira-covid-19-test-kit-100000630.html

Reneo Pharmaceuticals and VectivBio to Begin Trading on Nasdaq

 The wave of biopharma companies going public continues with two more companies setting sights on publicly trading on a stock exchange. Reneo Pharmaceuticals and VectivBio will both begin trading on the Nasdaq this week.

Reneo Pharmaceuticals

San Diego-based Reneo Pharmaceuticals, which is focused on developing treatments for patients with genetic mitochondrial diseases, is aiming for $100 million in its IPO. The company will trade on the Nasdaq under the ticker symbol “RPHM.” Shares will trade Friday and the price is expected to be between $15 and $17, according to Barron’s. 

Reneo’s IPO comes about four months after the company raised $95 million in a Series B financing round that was supported by Novo Nordisk’s venture arm, Novo Ventures and Abingworth. Reneo’s lead asset is the Phase II-ready REN001, an oral, once-daily investigational drug the company said is known to control several genes involved in mitochondrial activity. 

Reneo is developing REN001 as a first-in-class oral selective peroxisome proliferator-activated receptor delta (PPARδ) agonist aimed at improving cellular energy metabolism through the enhancement of mitochondrial function and also potentially increase the number of mitochondria. 

In March, the U.S. Food and Drug Administration granted Fast Track Designation to REN001 for the treatment of patients with primary mitochondrial myopathies (PMM). REN001 is in clinical development for PMM, a group of rare, and often life-threatening diseases that are caused by mutations in mitochondrial or nuclear DNA. These mutations hinder the ability of affected cells to break down food and oxygen and generate energy.

Currently, there are no approved drugs for the treatment of PMM. Other indications targeted by REN001 are long-chain fatty acid oxidation disorders and glycogen storage disorder type V, more commonly known as McArdle disease.

VectivBio

Like Reneo, Switzerland-based VectivBio is coming off a significant Series B financing round. In October 2002, the company raised $110 million in a crossover financing deal to advance its rare disease assets. The company’s lead asset, apraglutide, is currently in Phase III development as a potential treatment for short bowel syndrome, a malabsorption disorder caused by a lack of functional small intestine. 

Apraglutide is a next-generation, long-acting, potent, synthetic GLP-2 analog that acts as a selective, full agonist of the GLP-2 receptor, according to the company. Apraglutide is designed to enable patients to minimize the burden from parenteral support through the increasing intestinal absorption of fluids, calories and nutrients. VectivBio dosed its first patient in the Phase III study in February. 

For its IPO, VectivBio hopes to raise about $128 million. The company will offer 7.5 million shares of its common stock at $16 to $18 each. The stock is expected to begin trading on Friday under the ticker symbol “VECT.” 

VectivBio’s move to becoming a publically traded company a little more than one year after its launch. VectivBio was founded in 2019 and launched in January 2020 with $35 million in financing. The new company is a spinout of Therachon Holding AG, which was acquired by Pfizer in 2019.

https://www.biospace.com/article/reneo-pharmaceuticals-and-vectivbio-prepare-to-begin-trading-on-the-nasdaq/

Greenwich LifeSciences: Robust Immune Response Phase IIb Breast Cancer Data

 

• Abstract published today at the American Association for Cancer Research (AACR) Annual Meeting shows the GP2 final 5 year immune response data from the Phase IIb clinical trial.

• Poster showing graphs of immune response data over time will be published by AACR on Saturday, April 10th at 8:30 am ET. The Company plans to publish the poster, the abstract, and an audio recording in a joint press release on April 10th.

• Potent immune response data supports the previously reported clinical outcome of 0% metastatic breast cancer recurrences over 5 years of follow-up.

• Statistically significant peak immunity was reached after 6 months of GP2 treatment as measured in both a GP2 specific CD8 T cell dimer binding assay and a delayed-type-hypersensitivity (DTH) skin test.

• HER2 3+ population immune response was similar to the HER2 1-2+ population immune response, suggesting the potential to treat the HER2 1-2+ population (including triple negative breast cancer) with GP2 immunotherapy in combination with trastuzumab (Herceptin) based products and other clinically active agents.

• Broad based immune response suggests that GP2 immunotherapy and Herceptin based products may also have the potential to treat other HER2 1-3+ expressing cancers.

https://finance.yahoo.com/news/greenwich-lifesciences-reports-robust-immune-090000826.html

Hopes fade for novel anaemia pills, but could Glaxo yet prevail?

 Imagine the scenario: Glaxosmithkline, the wild card in the novel anaemia pill race, swoops in with a late but clean pivotal programme with daprodustat, serving up a HIF-PH inhibitor that regulators can approve with confidence. The mechanism finally delivers on its promise in anaemia with chronic kidney disease, with a safe and convenient oral option to replace EPO infusions that risk cardiotoxicity. This seems highly unlikely, unfortunately, given the failure of both Fibrogen and Akebia to generate convincing safety packages with their respective contenders, roxadustat and vadadustat. The former was rocked by a barely believable data error this week, and the latter failed a key cardiac safety test. Regulators therefore have very good reason to be wary of the class. Glaxo’s daprodustat holds the potential to swing opinion, but which way depends on the readout of two major pivotal trials, due in the second half. Consensus forecasts suggest that hopes are low: numbers have come down for vadadustat and daprodustat in the last 12 months, according to Evaluate Pharma, and roxadustat's are likely to follow soon. The HIF-PH inhibitors’ fate should be known by year end; it is hard to picture a resurrection.

The convoluted world of the HIF-PH inhibitors: destined to be big only in Japan?
Company	Rights and regions	Status
Roxadustat
Astrazeneca	US, China and others	Filed in the US; adcom Jul 15
Fibrogen	Certain US and China rights	Filed in the US; adcom Jul 15
Astellas	Japan, Europe and others	Filed in Europe, decision due by mid-year; marketed in Japan (as Evrenzo)
Vadadustat
Akebia	US co-promote/profit share, royalties elsewhere	Awaiting US FDA acceptance of NDA; marketed in Japan (sold by Mitsubishi as Vafseo)
Vifor Pharma	US profit share in dialysis population	-
Otsuka	US co-promote, Europe, China and other regions	Europe fillings due this year
Daprodustat
Glaxosmithkline	WW ex Japan	Ascend-D and Ascend-ND readouts due H2 2021
Kyowa Kirin	Japan	Marketed in Japan (as Duvroq)
Source: Evaluate Pharma.  https://www.evaluate.com/vantage/articles/news/snippets/hopes-fade-novel-anaemia-pills-could-glaxo-yet-prevail

Preclinical cancer biotech Werewolf Therapeutics files for a $100M IPO

 Werewolf Therapeutics, a preclinical biotech developing immune therapies for cancer, filed on Thursday with the SEC to raise up to $100 million in an initial public offering.

The company's lead candidates, WTX-124 and WTX-330, are molecules designed to selectively activate an immune response in the tumor microenvironment. The company plans to file INDs with the FDA for both programs in the 1H22, after which it plans to conduct Phase 1/1b trials in patients with multiple tumor types both as standalone treatments and in combination with an immune checkpoint inhibitor.

The Cambridge, MA-based company was founded in 2017 and plans to list on the Nasdaq under the symbol HOWL. Jefferies, SVB Leerink and Evercore ISI are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: HOWL

https://www.renaissancecapital.com/IPO-Center/News/80577/Preclinical-cancer-biotech-Werewolf-Therapeutics-files-for-a-$100-million-I

As Olympics Loom, Tokyo Tightens Restrictions To Combat COVID Surge

 Days after a surge in infections in Osaka forced the Olympic torch off the street, prompting Taro Kono, Japan’s minister in charge of vaccinations, to warn that Tokyo had also seen a surge in COVID cases driven by "a similar mutation," it looks like the Japanese capital city, which is due to host the 2020 Olympics in three months, is officially dealing with an "emergency surge" of its own.

Tokyo, which came out of a state of emergency on March 21, might be heading back into lockdown after Its governor, Yuriko Koike, told reporters Thursday that she had asked the government to allow her to issue binding orders under a new virus prevention law enacted in February. These penalties could include punishments for business owners who defy government measures, as well as compensation for those who comply.

"It would be a matter of time before Tokyo faces a situation similar to Osaka," Koike said.

She said timing and details of the new measures, including shorter hours for restaurants and bars, will be decided later, possibly on Friday.

Koike said she is alarmed by the rapid spread of the new variants, especially one initially detected in the UK. Tokyo reported 545 cases Thursday, the highest reading since late February.

Kyodo News agency reported Wednesday that Japan is considering prioritizing Olympic athletes for vaccination by late June. Chief Cabinet Secretary Katsunobu Kato on Thursday denied that his government is discussing any details at the moment, but added that he is closely watching discussions among Olympic officials about how to guarantee athletes' safety for the games, which are set to begin in three months.

The latest surge in Japan, which notably weathered COVID with far fewer cases and deaths than other developed nations, started in western Japan, including Osaka, where the daily toll hit a record 905 earlier this week. Gov. Hirofumi Yoshimura asked that the Olympic torch relay scheduled for Tuesday and Wednesday be held at a park and not on the public road. He said more than 70% of hospital beds have been occupied, a threshold for a local medical alert.

https://www.zerohedge.com/geopolitical/olympics-loom-tokyo-asks-tighten-restrictions-combat-covid-surge