Coronavirus waylays China trials, may delay regulatory approvals too
BEIJING – Multiple China-based clinical trials have been put on hold as the country concentrates on its fight against COVID-19. To curb the spread of the novel coronavirus that has infected over 72,000 people and killed nearly 2,000, China has imposed travel and transport restrictions, making trips difficult or even impossible for patients and physicians. In Wuhan, the epicenter of the outbreak, which alone has seen around 18,000 people infected, Yue Wang’s site management organization (SMO) is conducting 51 trials, including 39 oncology studies. She said that many visits have been cancelled.

Coronavirus waylays China trials, may delay regulatory approvals too
BEIJING – Multiple China-based clinical trials have been put on hold as the country concentrates on its fight against COVID-19. To curb the spread of the novel coronavirus that has infected over 72,000 people and killed nearly 2,000, China has imposed travel and transport restrictions, making trips difficult or even impossible for patients and physicians. In Wuhan, the epicenter of the outbreak, which alone has seen around 18,000 people infected, Yue Wang’s site management organization (SMO) is conducting 51 trials, including 39 oncology studies. She said that many visits have been cancelled.
Researchers trace COVID-19’s family tree to battle outbreak and ‘infodemic’
SEATTLE – Tracing the family tree of COVID-19 through its evolving DNA sequence makes it possible to disprove many false claims circulating on social media about the novel coronavirus, and, in particular, that it was generated in a covert biological weapons program. “From everything I’ve looked at, there is zero evidence for genetic engineering; it looks like normal evolution,” said Trevor Bedford, a computational biologist at Fred Hutchinson Cancer Research Center, who has been using genomes sequences taken from patient samples to track the spread of the virus since Jan. 11.
South Korea’s VCs invested a record high $930M in bio and medical ventures last year
HONG KONG – South Korea’s venture capital investment in the biopharma and medical sector set a new record in 2019. According to Korea Venture Capital Association (KVCA), local VC firms invested ₩1.1 trillion (US$930 million) over a total of 299 bio and medical ventures last year, representing 25.8% of the total VC investment executed in 2019.
Kaipharm secures $4.2M in series A funding for drug-induced transcriptome database
HONG KONG – South Korea’s AI-based biotech venture, Kaipharm Co. Ltd. has secured ₩5 billion (US$4.22 million) in series A funding. Founded in 2018, the firm has attracted a total of ₩7 billion in investments. Kaipharm will generate a reference dataset of 2,000 drugs (KMAP_2K) using next-generation sequencing (NGS). The dataset will include all the FDA-approved drugs to date.
News in brief
BioWorld Asia briefs for Feb. 18.
Medicinal cannabis company Zelira raises nearly AU$5 million as it gears up for commercialization
PERTH, Australia – With a capital raise of $AU4.58 million (US$3.07 million) under its belt, Zelira Therapeutics Ltd. will be better positioned to launch multiple medicinal cannabis products that are currently in late-stage clinical trials.
COVID-19 could prove an expensive distraction for life sciences
The latest mutation to the coronavirus, dubbed COVID-19, has sparked a reaction by many national governments, but the expense associated with development of vaccines and diagnostics is considerable.
Clover produces subunit vaccine candidate S-Trimer for coronavirus
BEIJING – Chinese biotech companies are focusing on fighting the novel coronavirus, now named as COVID-19 by the WHO, after the country’s government called for all possible assistance.
Australia ramps up efforts to fight coronavirus with genetic sequence in hand
PERTH, Australia – As of Feb. 12, Australia’s Department of Health confirmed 15 cases of novel coronavirus in Australia.
WHO drawing research roadmap to combat coronavirus, newly named COVID-19
LONDON – As the death toll passed 1,000 and the number of confirmed cases reached 42,000, the World Health Organization on Feb. 11 convened 400 scientists at a global research forum to draw up an R&D blueprint for COVID-19.

Analysis and data insight

Trade deal could help China’s biotech upgrade, if honored
China
HONG KONG and BEIJING – Not just multinational players but domestic Chinese pharmaceutical companies are poised to benefit from China’s promise under a phase one trade deal with the U.S. to better protect intellectual property (IP), even if question marks remain around how the deal will be...
Significant year of growth for regenerative medicine sector
Cell therapy
According to Janet Lambert, CEO of the Alliance for Regenerative Medicine (ARM), in her delivery of the international advocacy group’s state of the industry briefing at Biotech Showcase in San Francisco, 2019 proved to be a significant year of growth for the regenerative medicine sector.
China's financing activity slows as partnering grows, Chinabio say
Conferences
SAN FRANCISCO – Pacing the stage at this year's China Showcase Saturday, Chinabio CEO Greg Scott sounded a touch disappointed. Last year lacked the kind of record-breaking stats he likes to punctuate with iconic explosions, a common image in his widely valued China health care talks. "Simply...
Dec. 30, 2019-Jan.3, 2020: BioWorld hails 2019 as a pretty good year for biopharma
As we entered a new decade, BioWorld writers took the opportunity to review the highs and lows of the past 12 months and they concluded that 2019 was a great year for the sector – save for a few bumps in the road.

Financings

Akeso refiles IPO with HKEX amid coronavirus outbreak
Cancer
BEIJING – Zhongshan-based Akeso Inc., which focuses on bispecific antibodies, is again seeking pre-revenue listing on the Hong Kong Stock Exchange (HKEX), after its first IPO attempt failed to go through in December. The move comes at a time when analysts believe the coronavirus outbreak is weighing on the city’s IPO market. The second application, submitted on Feb. 3, was again supported by Morgan Stanley and J.P. Morgan. The clinical-stage biotech is reportedly seeking $300 million to support its R&D through the IPO, particularly its core asset, AK-104, a PD-1/CTLA4 bispecific antibody.

Australia

Australia’s Mesoblast submits final module of rolling BLA submission for pediatric GVHD stem cell therapy
Immune
PERTH, Australia – Mesoblast Ltd. has filed the final module of its rolling BLA submission for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, after it showed strong survival rates in children with acute steroid-refractory graft-vs.-host disease (aGVHD).

Australia’s TGA proposes fee increases to implement recent drug, device reforms
Asia-Pacific
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year.
Multitrait analysis predicts glaucoma susceptibility, progression
Science
An international collaborative study led by geneticists at the Queensland Institute of Medical Research Berghofer Medical Research Institute (QIMR) in Brisbane, Australia, has used a multivariate approach to develop a polygenic risk score (PRS) for glaucoma.

China

Reactants ignite, China syndrome melts down FDA drug-quality meeting
Drugs
A half-day open meeting intended to examine “how the public perceives and values pharmaceutical quality,” convened by the Robert J. Margolis Center for Health Policy at Duke University in cooperation with the FDA, included a rundown of the agency’s oversight program, results of surveys to measure viewpoints of patients and providers – and tart commentary from a two-member “reactant panel.”
Not yet a pandemic, 2019-nCoV has echoes of MERS, SARS, flu
Science
The drug screens prompted by the SARS and MERS outbreaks have been useful for quickly identifying drug candidates. But in terms of their epidemiology, “SARS and MERS were different from this coronavirus,” Allison McGeer explained at a Feb. 3 webinar by Evercore ISI.
Coronavirus outbreak pushes Chinese biotech stocks higher despite market downturn
Drugs
BEIJING – Share prices of Chinese biotechs that partner with Gilead Science Inc. have surged in China this week, after the U.S. firm’s remdesivir was identified as the most promising drug candidate to treat 2019-nCoV.
Hong Kong researchers create fastest coronavirus diagnostic test to date
Diagnostics
HONG KONG – A team of researchers at Hong Kong University of Science and Technology (HKUST) claim to have invented the world’s fastest portable 2019-nCoV diagnostic device. From sampling to testing, the device is apparently able to detect the novel coronavirus in just 40 minutes. In comparison, the polymerase chain reaction (PCR) technology that is currently in use can take between 1.5 to 3 hours. The device draws on the latest microfluidic chip technology from Shenzhen Shineway Hi-Tech Co. Ltd.
Coronavirus outbreak in China sparks fears of disruption for global drug supplies
Drugs
BEIJING – China’s partial shutdown caused by the 2019-nCoV coronavirus outbreak has sparked global fears of a disrupted supply chain of active pharmaceutical ingredients (API), as the country is a major exporter. Drugs that many depend on, such as ibuprofen and acarbose, could be affected.

Regulatory

Regulatory front for Feb. 11, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Aurolife, CDC, Central Drugs Standard Control Organisation, FDA, Glaxosmithkline, National Institute of Allergy and Infectious Diseases, Sanofi, U.S. Court of Appeals, World Health Organization.

Newco news

Cell therapy firm Agex looks west to expand into Japan
Cell therapy
In its first step into Japan, Agex Therapeutics Inc. accelerates its development of engineering hypoimmunogenic cells, universal cells that can be used on patients who didn’t generate the original cell and without the need to use immunosuppressants.

Novelty Nobility attracts $9M in series A funding for NN2101 GLP tox studies
HONG KONG – South Korean biotech Novelty Nobility Inc. has attracted ₩10 billion (US$9 million) in series A funding to develop therapeutic antibodies inhibiting the stem cell factor (SCF)/c-KIT pathway.
Genesen secures $1.9M for peptide-based autoimmune disease treatment
Immune
HONG KONG – South Korean biopharma Genesen Inc. has secured ₩2.2 billion (US$1.9 million) in seed funding to advance its peptide-based drug candidates for the treatment of autoimmune and inflammatory diseases, including systemic lupus erythematosus (SLE), rheumatoid arthritis and psoriasis.

Science

Researchers cast wide net for rapid-draw weapons in 2019-nCoV fight
Infection
At this very early point in the emerging 2019-nCoV outbreak, knowledge about the virus is insufficient to predict what shape that outbreak will ultimately take.
Glutamine transporter variant identified as new cancer target
Cancer
A mitochondrial glutamine transporter variant is a key regulator of glutamine metabolism and metabolic reprogramming in cancer cells, and targeting such transporters could be a new strategy for controlling tumor growth.
Cobra genome may yield new antivenoms, venom-based drugs
Toxicity/Intoxication
A reference genome from the Indian cobra compiled in an international collaborative study should lead to the development of new safer and more effective antivenoms, while the elucidated genome and predicted associated proteome may be a powerful platform for studies of venomous snakes.
Scientists report insights into the mechanics, literally, of IPF
Respiratory
A Chinese study has established a previously unknown direct mechanistic link between elevated mechanical tension caused by impaired alveolar regeneration and progressive idiopathic pulmonary fibrosis (IPF), highlighting a pathogenic mechanism that may underlie fibrosis.
New PCa treatment strategy may overcome resistance
Cancer
Targeting prostate cancer (PCa) neuroendocrine (NE) cells via inhibition of the C-X-C motif chemokine receptor 2 (CXCR2) is an androgen receptor (AR)-independent therapeutic strategy that can improve the efficacy of treatment for PCa, a leading cause of male cancer mortality.
Australian researchers create kidney tissue from iPS cells
Stem cells
MELBOURNE, Australia – Researchers at the Murdoch Children’s Research Institute in Melbourne are pushing the boundaries on creating kidney tissue from stem cells.

BioWorld Perspectives

A decade of incentives to promote antibiotic development and still no viable route to commercial success
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...
Shoes, ‘Stones’ and surfing: BioWorld’s 12th annual Summer Reading List
BioWorld
Summer arrives with a bang for biopharma in the dueling agendas of the American Society of Clinical Oncology (ASCO) annual meeting, the BIO International...
If no one reads it, what’s the purpose of a drug label?
BioWorld
Robert Califf said it when he was serving as FDA commissioner. Patient advocates have said it when testifying before Congress or commenting at public...

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