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.

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.
Bully gene thesis at door as Crysvita dances in the round for Ultragenyx
Ultragenyx Pharmaceutical Inc.’s top-line win in January with DTX-301 gene therapy in ornithine transcarbamylase (OTC) deficiency seemed to presage even better things to come later this year, and analysts more recently hailed fourth-quarter earnings that showed satisfying progress with Crysvita (burosumab).
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.
Today's news in brief
BioWorld briefs for Feb. 14.
Belviq bows out of U.S. market amid cancer concerns
Eisai Co. Ltd. is removing Belviq (lorcaserin) from the U.S. market due to the FDA’s concerns about an increased occurrence of cancer in a long-term trial evaluating the cardiovascular effects associated with the weight-loss drug.
Zhittya gains approval for phase I Parkinson’s trial in Mexico
Privately held Zhittya Genesis Medicine Inc. received approval from Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) to begin a phase I trial at the Zambrano Hospital in Monterrey for patients with Parkinson’s disease.
Bench Press for Feb. 14, 2020
BioWorld looks at translational medicine, including: Ebola survivor's antibodies reveal therapeutic targets; JAK inhibitors build bone, no inflammation necessary; Origin story helps ovarian cancer prognosis; Celiac model captures gluten, genetics and gut reactions; New search method, new antibiotic MOA; Nanogold improves MS symptoms; Autophagy helps repair lung injury; How hook(worm)s grapple with nets; Thanks for the memories, myelin; Heat-shock proteins’ subtler cousin.
Holiday notice
BioWorld's offices will be closed in observance of Presidents Day in the U.S. No issue will be published Monday, Feb. 17.

Analysis and data insight

Money raised by biopharma: 2020 vs. 2019
Total raised in public, private and other financings of biopharma companies, comparing 2020 vs. 2019.
Biopharma money raised: Jan. 1-Feb. 13, 2020
Year-to-date money raised in public, private and other financings of biopharma companies.
Regulatory submissions, approvals and other actions: January 2020
Regulatory decisions affecting biopharma products in development, including: Abbvie, Aimmune, Alkermes, Alnylam, Amarin, Biohaven, Biolinerx, Blueberry, Clovis, Cytodyn, Durect, Emergent, Evoke, Exelixis, Fate, F-star, Galapagos, Genmab, Horizon, Incyte, Ipsen, Janssen, Jubilant, Mesoblast,...
Biggest gainers and losers for the week of Feb. 10-14, 2020
The top 10 biopharma stock gainers and losers for the week.

Financings

Shares of Revolution in surgent mode as Wall Street ra-RAS $238M IPO
Cancer
Revolution Medicines Inc. (NASDAQ:RVMD) shares closed at $28.90, a 70% jump above the $17 price in its upsized IPO of 14 million shares, which raised $238 million, showing further confidence in the Redwood City, Calif.-based company’s bid to blast cancer targets once deemed “undruggable.”

Science

Prolactin could explain sex differences in pain syndromes
Neurology/Psychiatric
The hormone prolactin is known for and named after its role in breastfeeding. But that is far from its only role. There are more than 300 identified functions of prolactin, which is present in both men and women, though women have higher levels, and extremely high levels late in pregnancy and...

EEG signature can predict response to SSRIs
Neurology/Psychiatric
For depression, and other mental health disorders, the era of precision medicine has yet to arrive. Symptoms are “very poorly reflective of the underlying biology,” Amit Etkin told BioWorld. Depression can manifest through multiple different symptoms that differ both between and within cultures.
Bench Press for Feb. 7, 2020
BioWorld looks at translational medicine, including: CD47 knockout improves antitumor vaccine; Multiple edits make for durable T cells; Endothelial cells have functional deficits in progeria; Myelin is deregulated in autism spectrum disorder; More enhancers suggest more pathogenicity: study; Just...

Newco news

With a $2M SBIR grant, Eumentis launches to target Alzheimer’s, autism spectrum disorders
Neurology/Psychiatric
Mark Tepper, the founder of newly launched Eumentis Therapeutics Inc., plans to use the company’s recent $2 million Small Business Innovation Research (SBIR) grant to fund IND-enabling studies for EM-036, a nitro-aminoadamantane N-methyl-D-aspartate receptor antagonist to treat Alzheimer's disease and autism spectrum disorders.
Pinning hopes on autophagy, Pinpoint raises $1M
Cancer
Christian Peters, CEO of the newly launched and privately held Pinpoint Therapeutics Inc., said he has a relatively unusual pedigree that allows him a unique perspective in drug development. That combination of working in academia and in the corporate sphere has given him a more well-rounded view than most.
Sonoma to develop regulatory T-cell therapies with its $40M series A
Immune
Privately held Sonoma Biotherapeutics Inc. plans to take its newly raised $40 million series A financing to develop regulatory T-cell therapies to control inflammatory responses in autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease and multiple sclerosis.
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.
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.

U.S.

Budget draft for 2021 eyes NIH cuts along with 10% hit to HHS funding
FDA
In a budget proposal sure to spark opposition, the Trump administration has proposed to provide the National Institutes of Health with only $38 billion in fiscal 2021, several billion dollars short of the agency’s funding for the current fiscal year. The proposal also calls for funding of less than $95 billion for the Department of Health and Human Services, a 10% reduction in funding that includes an adjustment for drug pricing proposals and a $5 million cut to FDA monies for the 21st Century Cures Act.

Europe

Brexit day arrives; industry continues to face lack of clarity as transition period begins
Drugs
LONDON – Brexit finally becomes a reality at midnight central European time on Jan. 31, but for the life sciences industry uncertainty continues, as the U.K. enters an 11-month transition phase during which the terms of its future relationship with the EU must be negotiated.

EU panel CHMPions varied batch of prospective new therapies
Drugs
The EMA’s Committee for Medicinal Products for Human Use (CHMP) looked with favor on a bucketload of would-be drugs, issuing positive opinions for the European Commission to consider across a range of indications.
Ireland’s embrace of genomics remains tentative
Genomics
DUBLIN – “Welcome to the conversation,” Abbvie Inc.’s head of genomic research, Howard Jacob, an early pioneer of genomics-driven medicine, told delegates during a keynote address at the Genomics Summit 2020 event Jan. 23. Ireland is very much a latecomer to that conversation and it has yet, as a...

Clinical

Sanifit seeks benefit in pivotal trial for rare calcification disorder
Phase III
Spain's Sanifit Laboratoris SL, a company developing treatments for calcification disorders, has dosed the first patient in a phase III trial of its lead asset, SNF-472, for the treatment of the rare and sometimes deadly disease calciphylaxis, a calcium accumulation disorder.
Hoth touts preliminary data on lupus skin disease candidate
Dermatologic
New York-based Hoth Therapeutics Inc. said preliminary preclinical data on a topical nanoparticle formulation of the endocannabinoid anandamide it licensed from Zylö Therapeutics Inc. represents "a positive step toward underlining the transformative potential" of the early stage therapy for the skin disease cutaneous lupus erythematous (CLE).
Roche, Lilly drugs fail to slow decline in early onset AD
Neurology/Psychiatric
A high-profile test of two experimental medicines in people with autosomal dominant Alzheimer’s disease (ADAD), a rare inherited form of the disease, found that neither drug significantly slowed rates of cognitive decline vs. placebo, the primary endpoint.
Anxious balance: Biohaven’s troriluzole misses its primary endpoint while rimegepant could be a blockbuster
Neurology/Psychiatric
Top-line results from Biohaven Pharmaceutical Holding Co.’s phase III trial of troriluzole against placebo in treating generalized anxiety disorder (GAD) failed to hit its primary endpoint, prompting the company CEO to say the poor results support halting development plans for the glutamate modulator as a monotherapy in GAD.
Vtv scores phase II TD in T1D as Alzheimer’s bid RAGEs against dying of light
Diabetes
With the Simpliciti-T1 phase II trial testing new-mechanism TTP-399 as adjunct therapy in type 1 diabetes (T1D), High Point, N.C.-based Vtv Therapeutics Inc. nailed the HbA1c endpoint with none of the safety concerns foiling developers of type 2 diabetes (T2D) drugs who sought to broaden their labels.
Oculis’ topical DME drug hits phase II endpoints, validates nanoparticle delivery solution
Diabetes
LONDON – Oculis SA reported positive results for its topical nanoparticle formulation of dexamethasone in the treatment of diabetic macular edema (DME), showing the eye drops reduced central macular thickness (CMT) in the phase II proof-of-concept trial.

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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