PepperLime Health Acquisition Corporation Prices $150M IPO

 PepperLime Health Acquisition Corporation (the "Company"), a Cayman Islands exempted company that is a blank check company formed for the purpose of entering into a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses, today announced the pricing of its initial public offering of 15,000,000 units at a price of $10.00 per unit. The Company has granted the underwriter a 45-day option to purchase up to an additional 2,250,000 units at the initial public offering price to cover over-allotments, if any.

While the Company may pursue an initial business combination target in any business or industry, the Company intends to target companies at the intersection of technology and consumer health and wellness. The proceeds of the initial public offering will be used to fund the business combination.

The units will be listed on the Nasdaq Global Market and trade under the ticker symbol "PEPLU" on or promptly after the date hereof. Each unit consists of one Class A ordinary share of the Company and one-half of one warrant. Each whole warrant entitles the holder thereof to purchase one Class A ordinary share of the Company at a price of $11.50 per share. Once the securities comprising the units begin separate trading, the Class A ordinary shares and warrants are expected to be listed on the Nasdaq Global Market under the symbols "PEPL" and "PEPLW," respectively. The offering is expected to close on October 19, 2021, subject to customary closing conditions.

Oppenheimer & Co. Inc. acted as the sole underwriter for the offering.

https://au.finance.yahoo.com/news/pepperlime-health-acquisition-corporation-announces-023200006.html

LAVA Therapeutics Gets FDA Orphan Drug Designation for Leukemia Treatment

  LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for the company’s CD1d targeted GammabodyTM, LAVA-051, for the treatment of chronic lymphocytic leukemia (CLL). CLL is a form of leukemia characterized by progressive accumulation of abnormal lymphocytes in the peripheral blood, bone marrow and lymphoid tissues.

"We are excited to receive our first orphan drug designation from the FDA for LAVA-051, our most advanced product candidate from our off-the-shelf GammabodyTM platform that is designed to unlock the full anti-cancer potential of this specialized effector cell population,” said Stephen Hurly, president and chief executive officer, LAVA Therapeutics. “This designation will be helpful in enhancing our communication with the FDA on our development of LAVA-051. We are grateful to the FDA for highlighting the need for new and improved therapies to address the unmet needs in CLL.”

The GammabodyTM LAVA-051 is a bispecific antibody that recruits the immune system to attack CD1d-expressing cancer cells via the preferential activation of both Gamma Delta T cells and type 1 natural killer T (NKT) cells. Enrollment is underway in the company’s open-label, multi-center, Phase 1/2a clinical trial for the treatment of relapsed and/or refractory CLL, multiple myeloma (MM) and, later in the trial, acute myeloid leukemia (AML) (NCT04887259). Initiated in July 2021, the trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-051. Data from the Phase 1 dose escalation phase of the study are expected in the first half of 2022 with top line clinical data from the Phase 2a expansion cohorts expected in the second half of 2022.

https://finance.yahoo.com/news/lava-therapeutics-receives-fda-orphan-110000871.html

Could J&J Booster Opportunity Be Better Than Pfizer's and Moderna's?

 

• Johnson & Johnson's data supporting booster shots looks promising.
• That vaccine's lower initial efficacy compared to the other FDA-approved COVID-19 jabs could increase the likelihood of it receiving authorization for booster shots.

Pfizer (NYSE:PFE) has already won authorization to inoculate people with boosters of its COVID-19 vaccine, albeit thus far, only those in certain higher-risk groups. Moderna (NASDAQ:MRNA) and Johnson & Johnson (NYSE:JNJ) will now have their first chance to join it with a Food and Drug Administration advisory committee reviewing data for their boosters. In this Motley Fool Live video recorded on Sept. 22, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss whether or not Johnson & Johnson's booster shot opportunity could be greater than Pfizer's or Moderna's.

https://www.fool.com/investing/2021/10/15/could-johnson-johnsons-booster-opportunity-be-bett/

Pfizer's Next mRNA Vaccine Candidate Goes Beyond COVID-19

 

• Pfizer has begun phase 1 testing of an mRNA flu vaccine.
• The big drugmaker is nearly three months behind Moderna, which began testing its flu vaccine in July.
• mRNA vaccines could potentially target more flu strains with one dose than other flu vaccines.

Pfizer (NYSE:PFE) continues to rake in billions of dollars in sales for its messenger RNA (mRNA) COVID-19 vaccine developed with BioNTech (NASDAQ:BNTX). However, the big drugmaker has bigger plans for its mRNA vaccine program. In this Motley Fool Live video recorded on Sept. 29, Motley Fool contributors Keith Speights and Brian Orelli discuss Pfizer's next mRNA vaccine candidate.

https://www.fool.com/investing/2021/10/15/pfizers-next-mrna-vaccine-candidate-goes-beyond-co/

Moderna Gains on FDA Booster Approval; JNJ Booster on Tap

 Moderna  (MRNA) - Get Moderna, Inc. Report stock gained on Friday, rising more than 3% in premarket trading, after a U.S. Food and Drug Administration panel gave its approval to a third half-dose booster shot to some Americans to bolster protection against COVID-19.

A panel of advisers to the FDA on Thursday voted unanimously to recommend a booster shot for seniors, adults with other health problems, jobs or living situations that put them at increased risk for COVID.

The 19-0 recommendation is non-binding but an important step toward expanding the U.S. booster campaign to millions more Americans. Many people who got their initial Pfizer  (PFE) - Get Pfizer Inc. Report shots at least six months ago are already getting a booster after the FDA authorized their use last month.

The FDA is expected to decide on whether to authorize the booster dose within days. The final nod will come from the Centers for Disease Control and Prevention, which is expected to issue a final recommendation as soon as next week.

https://www.thestreet.com/investing/moderna-gains-on-fda-booster-approval-johnson-johnson-booster-nod-on-tap

Antiviral compound blocks SARS-CoV-2 from entering cells

 Scientists at Washington University School of Medicine in St. Louis have developed a chemical compound that interferes with a key feature of many viruses that allows the viruses to invade human cells. The compound, called MM3122, was studied in cells and mice and holds promise as a new way to prevent infection or reduce the severity of COVID-19 if given early in the course of an infection, according to the researchers.

In an interesting twist, the compound targets a key human protein called transmembrane serine protease 2 (TMPRSS2) that coronaviruses harness to enter and infect human cells.

The study is published online Oct. 11 in the Proceedings of the National Academy of Sciences.

"Great vaccines are now available for SARS-CoV-2, but we still need effective antiviral medications to help curb the severity of this pandemic," said senior author James W. Janetka, Ph.D., a professor of biochemistry & molecular biophysics. "The compound we're developing prevents the virus from entering cells. We are examining the therapeutic window within which the molecule can be administered to mice and protect them from disease. Our ultimate goal is to advance the molecules into an inhibitor that can be taken by mouth and that could become an effective part of our armamentarium of inhibitors of COVID-19."

The new drug compound potently blocks TMPRSS2 and another related protein called matriptase, which are found on the surface of the lung and other cells. Many viruses—including SARS-CoV-2, which causes COVID-19, as well as other coronaviruses and influenza—depend on these proteins to infect cells and spread throughout the lung. After the virus latches onto a cell in the airway epithelia, the human protein TMPRSS2 cuts the virus's spike protein, activating the spike protein to mediate fusion of the viral and cellular membranes, initiating the process of infection. MM3122 is blocking the enzymatic activity of human protein TMPRSS2. When the enzyme is blocked, it perturbs the activation of the spike protein and suppresses membrane fusion.

"The SARS-CoV-2 virus hijacks our own lung cells' machinery to activate its spike protein, which enables it to bind to and invade lung cells," Janetka said. "In blocking TMPRSS2, the drug prevents the virus from entering other cells within the body or from invading the lung cells in the first place if, in theory, it could be taken as a preventive. We're now testing this compound in mice in combination with other treatments that target other key parts of the virus in efforts to develop an effective broad-spectrum antiviral therapy that would be useful in COVID-19 and other viral infections."

Studying cells growing in the lab that were infected with SARS-CoV-2, MM3122 protected the cells from viral damage much better than remdesivir, a treatment already approved by the Food and Drug Administration for patients with COVID-19. An acute safety test in mice showed that large doses of the compound given for seven days did not cause any noticeable problems. The researchers also showed that the compound was as effective against the original Severe Acute Respiratory Syndrome coronavirus (SARS-CoV) and Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV).

"The majority of inhibitors of viral infection work by blocking steps of replication once the virus is inside the cell," said co-author Sean Whelan, Ph.D., the Marvin A. Brennecke Distinguished Professor and head of the Department of Molecular Microbiology. "Dr. Janetka has identified and refined a molecule that stops the virus from entering the cell in the first place. As the target of MM3122 is a host protein, this may also pose a larger barrier to the emergence of viruses that are resistant to the inhibitor."

Added Janetka says that "this compound is not just for COVID-19. It could potentially inhibit viral entry for other coronaviruses and even influenza virus. These viruses all rely on the same human proteins to invade lung cells. So, by blocking the human proteins, we prevent any virus that tries to hijack those proteins from entering cells."

Janetka and his colleagues are now collaborating with researchers at the National Institutes of Health (NIH) to test the effectiveness of MM3122 in treating and preventing COVID-19 in animal models of the disease. In animal studies, the drug is given as an injection, but Janetka said they are working to develop an improved compound that could be taken by mouth. He also is interested in developing an intranasal route that would deliver the drug more directly to the nasal passages and lungs.

Working with Washington University's Office of Technology Management (OTM), Janetka co-founded a biotechnology startup company called ProteXase Therapeutics, which has licensed the technology to help develop the compound into a new drug therapy for coronaviruses, including SARS-CoV-2, the original SARS-CoV and MERS-CoV.

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Researchers demonstrate vaccination approach in mice that could prevent future coronavirus outbreaks

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More information: Matthew Mahoney et al, A novel class of TMPRSS2 inhibitors potently block SARS-CoV-2 and MERS-CoV viral entry and protect human epithelial lung cells, Proceedings of the National Academy of Sciences (2021). DOI: 10.1073/pnas.2108728118

https://medicalxpress.com/news/2021-10-antiviral-compound-blocks-sars-cov-cells.html

Noninfectious versions of SARS-CoV-2 provide powerful research tools

 To study a virus as infectious as SARS-CoV-2, researchers need to follow laborious protocols and have access to high-biosafety laboratories. Seeking to make such investigations safer, faster, and accessible to more teams around the world, virologists have created SARS-CoV-2 replicons—self-replicating RNAs that are not infectious but otherwise identical to the real virus.

Replicons mimic nearly every aspect of the viral life cycle. Their RNA has all the information the virus needs to replicate and make copies of itself, but lacks instructions for making spikes, the proteins that enable the virus to enter and infect human cells. Once introduced to cells in a dish, a replicon makes progeny that are unable to spread to neighboring cells.

"With this system, scientists will be able to investigate SARS-CoV-2 and its variants, test drugs against it, and evaluate neutralizing antibodies, all in a faster way and in lower biosafety settings," says Nobel Laureate Charles M. Rice, a Rockefeller virologist who co-led the work with Volker Thiel from the University of Bern and Institute of Virology and Immunology. The study is published in the journal Science. 

Taking the wheels off

Replicon systems have proved instrumental in drug development against other viruses, including hepatitis C. Once Rice and others had created hepatitis C replicons, other scientists were able to develop potent and safe drugs that can effectively cure this chronic virus infection.

Replicons are typically created by cloning viral RNA genomes into DNA fragments in the test tube that can then be used to make RNA artificially. But this method doesn't work well for coronavirus RNA, because it is exceptionally long. So the researchers took a different approach, using a platform developed by Volker Thiel's group, that makes it possible to assemble coronavirus genomes from smaller fragments in yeast, instead of the test tube.

Using this approach, they created a coronavirus genome that lacks the RNA segment with the instructions for the spike protein.

"If the virus were a racecar, we made a version that has no wheels. It has the engine, and all the parts that would allow it to move, but it can't actually go anywhere," says Joseph Luna, a postdoc in the Rice lab and co-first author. 

Removing the spike protein poses a problem, however. Many current studies focus on this very component of SARS-CoV-2—it is the main target of monoclonal antibody therapy, for example. To make the replicons useful for research on therapies such as antibodies, the team expressed the spike protein separately alongside the replicon. The results were replicon delivery particles, single-use viruses that can deliver replicons into cells. These particles are capable of entering cells in a similar manner to coronavirus particles but are limited in infectiousness to exactly one viral life cycle.

A wide scope of applications

The scientists say their replicons can be used to probe how the virus hijacks the cell's own machinery and how it generates new copies of itself. In addition, they might make it possible to identify the human proteins without which the virus cannot replicate. As a proof of concept, the team examined the effects of TMEM41B, a human protein previously found to be necessary for SARS-CoV-2 replication. Just like the authentic coronavirus, the replicons could not replicate in cells lacking this protein.

The replicons can also be used to screen chemical libraries for drug compounds capable of blocking viral replication. In other experiments, the team incubated the replicons with remdesivir, an antiviral known to inhibit the virus. "We found it inhibits the replicon at the same concentrations as it inhibits the actual virus," says co-first author Inna Ricardo-Lax, a postdoc in the Rice lab. "It shows that the replicon system can be a reliable alternative for SARS-CoV-2 to test different drugs." 

More information: Inna Ricardo-Lax et al, Replication and single-cycle delivery of SARS-CoV-2 replicons, Science (2021). DOI: 10.1126/science.abj8430

https://medicalxpress.com/news/2021-10-noninfectious-versions-sars-cov-powerful-tools.html