Capricor picks Nippon Shinyaku to sell DMD cell therapy, pending approval
With a potentially pivotal trial of its Duchenne muscular dystrophy (DMD) candidate CAP-1002 starting up, Capricor Therapeutics Inc. has tapped Nippon Shinyaku Co. Ltd. subsidiary NS Pharma Inc. to sell and distribute the cell therapy, pending U.S. FDA approval. The deal brings Capricor $30 million up front to fund the phase III trial, while also lining it up for as much as $705 million in milestone payments from its Japanese partner, which launched its own DMD therapy, Viltepso (viltolarsen), in the U.S. in 2020. Capricor shares (NASADQ:CAPR) rose 21.6% to $3.44 Jan. 25.

Capricor picks Nippon Shinyaku to sell DMD cell therapy, pending approval
With a potentially pivotal trial of its Duchenne muscular dystrophy (DMD) candidate CAP-1002 starting up, Capricor Therapeutics Inc. has tapped Nippon Shinyaku Co. Ltd. subsidiary NS Pharma Inc. to sell and distribute the cell therapy, pending U.S. FDA approval. The deal brings Capricor $30 million up front to fund the phase III trial, while also lining it up for as much as $705 million in milestone payments from its Japanese partner, which launched its own DMD therapy, Viltepso (viltolarsen), in the U.S. in 2020. Capricor shares (NASADQ:CAPR) rose 21.6% to $3.44 Jan. 25.
Australia adds Novavax vaccine and antivirals from Pfizer, MSD to COVID-19 arsenal
PERTH, Australia – In preparation for easing COVID-19 restrictions and opening its international borders, Australia has added a new vaccine and two new oral antiviral therapies to its arsenal to fight the omicron variant of the SARS-CoV-2 virus that is sweeping the globe. Australia’s Therapeutic Goods Administration granted provisional approval on Jan. 20 to Biocelect Pty Ltd. (on behalf of Novavax Inc.) for its COVID-19 vaccine, Nuvaxovid, as well as two oral antiviral treatments.
News in brief
BioWorld Asia briefs for Jan. 25.
Mabwell raises ¥3.48B in Shanghai IPO, though shares meet cool reception
Mabwell Bioscience Co. Ltd. raised ¥3.48 billion ($547.9 million) in a Shanghai STAR Market IPO on Jan. 18 to support company R&D efforts and plans to build an antibody production plant. Though oversubscribed, the offering got a cool market reception, with shares plunging nearly 30% from a ¥32 open (US$27.96), then closing at ¥24.50 on the first day of trading before recovering slightly to ¥27.40 on Jan. 20.
Servatus advances live microbial biotherapeutics after AU$7.5M capital raise
PERTH, Australia – After raising AU$7.5 million (US$5.4 million) in a private placement, biopharma company Servatus Ltd. is advancing its microbial biotherapeutics clinical programs targeting serious autoimmune conditions. The Coolum, Queensland-based private company is focused on identifying and developing live microbial biotherapeutics and engineered proteins to treat chronic and autoimmune diseases, as well as non-antibiotic treatments for bacterial infections.
Australia adds Novavax vaccine and antivirals from Pfizer, MSD to COVID-19 arsenal
PERTH, Australia – In preparation for easing COVID-19 restrictions and opening its international borders, Australia has added a new vaccine and two new oral antiviral therapies to its arsenal to fight the omicron variant of the SARS-CoV-2 virus that is sweeping the globe. Australia’s Therapeutic Goods Administration granted provisional approval on Jan. 20 to Biocelect Pty Ltd. (on behalf of Novavax Inc.) for its COVID-19 vaccine, Nuvaxovid, as well as two oral antiviral treatments.

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Analysis and data insight

Final tally comes in at $118B, second top financings amount in biopharma history
Financings
While the $118.3 billion raised by biopharma companies in 2021 through public and private transactions is 12% lower than the amount raised the prior year, it still represents an impressive financings record, led primarily by IPOs and venture capital rounds.
Drugs to Watch 2022: Seven drugs expected to be blockbusters
Drugs
The pandemic has forced pharma and biotech to be more agile to better navigate the obstacles and still find success. Supply chain gaps are part of the problem, as are clinical trial delays. Yet the industry has successfully forged ahead in the past year to produce the seven drugs Clarivate believes...
Top Trends of 2021: DNA vaccines arrive, while KRAS drugs and CAR T-cell therapies break new ground in cancer
Drugs
There was no slowing of biopharma innovation in 2021, even as industry directed significant resources to, while feeling the impact of, the ongoing COVID-19 pandemic. The year saw big wins for developers of DNA vaccines and biosimilars, while CAR T expanded its reach and a drug target once...
Cancer index remains low on safety issues and BLA withdrawal
Cancer
Continuing its downward trend, BioWorld’s Cancer Index (BCI) has fallen by 19.16% this year, a stark contrast with the broader Nasdaq Biopharmaceutical Index and the Dow Jones Industrial Average, both of which are tracking up by 4.49% and 19.03%, respectively. Two-thirds of the 21 stocks that make...

Financings

Cellusion raises $9.5M to support ocular cell therapy
Ocular
Cellusion Inc. recently closed a ¥1.1 billion ($9.5 million) financing, bringing its total 2021 fundraising to ¥1.7 billion. The company is preparing to enter the clinic with CL-S001, its corneal endothelial substitute cell candidate for treating corneal edema due to endothelial dysfunction, or...

Australia

Australia gears up for clinical trials with psychedelics to treat mental health disorders
Clinical
PERTH, Australia – Australia has recently established new research and discovery centers to study psychedelic treatments for mental health disorders.

Australia is falling behind in accessing innovative drugs, devices
Regulatory
PERTH, Australia – Australia should be at the front of the line among developed nations when it comes to innovative drugs and devices, but health policies must evolve to respond to changes in technology and global trends, Johnson & Johnson (J&J) said. Although Australia’s health policy has served...
Mesoblast shares depressed by Novartis deal termination
Deals and M&A
PERTH, Australia – It’s been a year that Mesoblast Ltd. might like to forget. The company’s stock dropped 17% Dec. 15 on the news that Novartis AG will terminate its licensing agreement with Mesoblast for remestemcel-L.

China

Cansino receives NMPA’s first approval for quadrivalent meningococcal conjugate vaccine
Regulatory
Cansino Biologics Inc. has received marketing approval from the NMPA for its ACYW-135 meningococcal conjugate vaccine, Menhycia, making it the first of its kind to be authorized in China. The approval marks “an important step in accelerating the development of China’s meningococcal vaccine...
Former Harvard researcher with undisclosed China contracts found guilty
Regulatory
A U.S. federal jury convicted Charles Lieber, the former chair of Harvard University’s chemistry and chemical biology department, on charges related to lying to federal authorities about his affiliation with China’s Thousand Talents Plan and the Wuhan University of Technology, as well as failing to...
Antengene receives China’s first approval for oral exportin 1 inhibitor
Regulatory
Antengene Corp. Ltd. received marketing approval from China’s NMPA for ATG-010 (selinexor), a drug that was in-licensed from Karyopharm Therapeutics Inc. It was approved for use in combination with dexamethasone to treat adults with relapsed or refractory multiple myeloma.
Cstone’s PD-L1 antibody wins NMPA approval in NSCLC
Drugs
China’s NMPA has given thumbs up to Cstone Pharmaceuticals Co. Ltd.’s Cejemly (sugemalimab), an anti-PD-L1 monoclonal antibody. It was approved for use in treatment-naïve metastatic (stage IV) non-small-cell lung cancer (NSCLC) patients in combination with chemotherapy.
ITM is made in China with potential $589M+ radiopharmaceutical deal
Deals and M&A
DUBLIN – ITM Isotope Technologies Munich (ITM) SE has secured its first radiopharmaceutical licensing deal in China, a pact with Grand Pharmaceutical Group Ltd. involving two radiopharmaceutical candidates, as well as a companion diagnostic for one of them.

Regulatory

Novavax’s protein-based COVID-19 vaccine wins approval in South Korea
Coronavirus
South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Novavax Inc.’s Nuvaxovid, making it the first protein-based COVID-19 vaccine to be approved for commercial use in the country. The regulatory win for Novavax adds to emergency use authorizations (EUA) for the product, also known...

Newco news

Binhui moves HSV-2-based oncolytic viral candidate toward U.S. trial
Clinical
Binhui Biopharmaceutical Co. Ltd.’s BS-001, a recombinant human oncolytic herpes simplex virus type-2 expressing GM-CSF for the potential treatment of solid tumors, has gained an IND approval from the FDA.

Hopstem targeting stroke with iPSC-derived human forebrain neural progenitor cell product
With a special interest in neurological disorders, Hopstem Biotechnology Co. Ltd. closed a series A++ round to raise nearly ¥100 million (US$15.5 million) to advance hNPC-01, an off-the-shelf induced pluripotent stem cells (iPSC)-derived human forebrain neural progenitor cell product to treat...
Suda Pharmaceuticals to combine new iNKT cell therapy platform with CARs to target blood cancers
Cancer
PERTH, Australia – Suda Pharmaceuticals Ltd. saw its stock shoot up nearly 44% on the heels of an oversubscribed AU$3.65 million (US$2.71 million) capital raise after acquiring a new invariant natural killer T (iNKT) cell therapy platform for oncology.

Science

Preprints age well, manuscript preprint shows
One of the most striking recent changes in the dissemination of biomedical science has been the rapid rise of the preprint.
British Pakistani genomics study illustrates need for diversity
Europe
It is acknowledged that the huge bias toward individuals of European ancestry means studies of the contribution of genetics to disease may not translate well to other ethnicities. That point is underlined in the first large-scale investigation of...
B-cell GABA release blunts tumor immune response
Cancer
Immune system B cells secrete the neurotransmitter gamma amino-butyric acid (GABA), which promotes generation of anti-inflammatory macrophages and blunts the cytotoxic T cell-based response to tumors in mice.
Gut microbiome changes are effect, not cause, of autism spectrum disorders: study
Gastrointestinal
PERTH, Australia – Australian researchers have debunked previous research that suggests autism spectrum disorder behavior may be caused by differences in the composition of the gut microbiota.
Gene in 60% of people of South Asian ancestry doubles the risk of COVID-19 death
LONDON – Researchers have pinpointed a little-studied gene as responsible for doubling the risk of respiratory failure in COVID-19 and shown exactly how it exerts its effect. The gene, leucine zipper transcription factor like 1, is activated by a...
Parkinson’s disease model confirms metabolic, contests anatomic tenets
Neurology/Psychiatric
Investigators at Northwestern University’s Feinberg School of Medicine have used a new mouse model of Parkinson’s disease to confirm a causal role for mitochondrial dysfunction in Parkinson’s disease. More surprisingly, the same model has called...

BioWorld Perspectives

U.S. politicking threatens public trust in the FDA and CDC
BioWorld
The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to...
When it comes to drug quality, is a ‘C’ acceptable?
BioWorld
In releasing its annual report card for drug manufacturing inspections in which the per-country/region grading curve peaked at 77% and bottomed at 68%, the...
A decade of incentives to promote antibiotic development and still no viable route to commercial success
BioWorld
It should be motoring to profitability, but nine months after the U.S. launch of its new antibiotic, Zemdri (plazomicin), Achaogen Inc. has filed for...
BioWorld's Top 10: Biggest newsmakers and trending stories of 2018
BioWorld
In many ways, 2018 resembled the previous year in fast motion. Political turmoil accelerated on both sides of the Atlantic, with Asia swept into the fold,...
Deck the halls, or get decked out: BioWorld’s 12th annual Holiday Gift Guide
BioWorld
The holidays are (already) here again. Much as we try to push back the calendar, those Thanksgiving doorbuster, Black Friday blowout, Small Business...
Price increases - tone deaf or defiant?
BioWorld
Defying the laws of nature, many drug companies seem intent on proving that what goes up doesn’t have to come down. For them, the sky’s the limit when it...
PABNAB – A disappointing distraction at BIO, not associated with BIO
BioWorld
On what planet are the PABNAB (Party at BIO not associated with BIO) organizers living to think it was acceptable to spotlight topless dancers with company...

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