Pharma execs discuss progress on COVID-19 vaccines, challenges of access ahead
LONDON – The CEOs of Pfizer Inc. and Astrazeneca plc both say they are on track to make their COVID-19 vaccines available for use before the end of the year and have promised to manufacture at risk, supply at cost and ensure equitable access.

Pharma execs discuss progress on COVID-19 vaccines, challenges of access ahead
LONDON – The CEOs of Pfizer Inc. and Astrazeneca plc both say they are on track to make their COVID-19 vaccines available for use before the end of the year and have promised to manufacture at risk, supply at cost and ensure equitable access.
Arca’s COVID-19 bid sparks the stock
Arca Biopharma Inc., of Westminster, Colo., is developing AB-201, a selective inhibitor of tissue factor (TF), as a treatment for COVID-19-associated coagulopathy, abnormal blood clotting and related inflammatory response. The move gave the company new life Thursday.
All eyes (virtually) focused on ASCO: Which companies will impress Wall Street?
The American Society of Clinical Oncology (ASCO) annual meeting will be closely watched by analysts and investors alike. There is no doubt that favorable data presented at the event will advance a company's stock valuation significantly. Equally, candidate cancer therapies that do not live up to expectations will see their developers face the ire of investors.
ASCO analysis weighs cancer plus COVID-19 double whammy
The impact of COVID-19 is being felt at the American Society of Clinical Oncology (ASCO) annual meeting as much as anywhere else, typically held at McCormick Place in Chicago but this year conducted virtually because of the pandemic.
Edigene, Immunochina betting on allogeneic CAR T therapy in cancer collaboration
SUZHOU, China – Genome editing startup Edigene Inc. and CAR T developer Immunochina Pharmaceuticals Co. Ltd., both from Beijing, have unveiled joint efforts to develop an allogeneic CAR T therapy for cancer. Terms remain undisclosed.
Today's news in brief
BioWorld briefs for May 28.
Challenges posed to Chinese biotechs in post-pandemic era
SUZHOU, China – With the outbreak tightly contained, business activities are starting to get back to normal in China. Opening in Suzhou on Thursday, the Enmore Bio Conference 2020 is one of the first industry galas to take place since the coronavirus hit the country. In the opening session, Chinese biotech insiders pointed to a bumpy road ahead for Chinese companies in the post-COVID-19 era.
Optimistic Sorrento looking to have COVID-19 antibody ready by October
VANCOUVER, British Columbia – With some positive early data for an antibody to block the COVID-19 virus, San Diego-based Sorrento Therapeutics Inc. is now looking to test a product in a few dozen intensive care patients by the end of July or early August and move into a much broader pool of patients by October.
Centrifugation can be child’s play with fidget spinners
Fidget spinners are hand-held toys based on a roller bearing and three weighted lobes, which can spin freely, creating centrifugal force when activated manually. Generating centrifugal force with a fidget spinner takes neither electricity nor trained staff. And that has suggested to several researchers that such spinners, under the right circumstances, could be used for centrifugation under circumstances where reliably operating a centrifuge, for whatever reason, is a challenge.

Analysis and data insight

IPOing in a pandemic: How to raise $100M+ from your spare bedroom
IPO
The pandemic hasn't kept biotechs from going public. In fact, through the first five or so months of the year, the industry has raised more than $3.3 billion through IPOs, more capital than biotechs have raised during the first five months of any of the previous 20 years.
Week in review for May 18-22, 2020: Biopharmas continue to ramp up their R&D spending
Coronavirus
A quick look back at top stories.
Deals and M&As remain level through April; more than a third for COVID-19
Coronavirus
Of the 160 biopharma deals tracked by BioWorld during the month of April, 36% are for collaborations focusing on the development of therapeutics and vaccines for COVID-19.
Biopharma money raised: Jan. 1-May 21, 2020
Year-to-date money raised in public, private and other financings of biopharma companies.

Financings

Viacyte receives $27M to complete its series D
Diabetes
Privately held Viacyte Inc., of San Diego, has closed on about $27 million in private funding, the remainder of its $80 million series D stock financing from late 2018.

Science

Gnomad identifies rare loss of function variants
Genomics
LONDON – A vast new body of genomics research has identified thousands of rare genetic variants that are predicted to cause loss of function in protein coding genes, providing novel in vivo models of human gene inactivation.

Germline ApoE variants affect melanoma trajectory
Cancer
Variants in the APOE gene are the strongest genetic risk factor for developing Alzheimer’s disease (AD). Now, researchers at Rockefeller University have demonstrated that APOE variants also affected the risk of progression and metastasis as well as the response to immunotherapy, in melanoma.
Bench Press for May 22, 2020
Coronavirus
BioWorld looks at translational medicine, including: SIRPa blockade wakes up macrophages post-infection; Lasting immunity to SARS-CoV-2 looks possible; Atherosclerosis, AD meet at the myelin; T cell aging induces broad senescence; P53 loss leads to immune evasion; Early roots of ALS visible in...

Newco news

China’s Inmagene CEO: Cost-efficient innovation for global medical needs
Immune
BEIJING – After being a health care investor for 21 years, Jonathan Wang decided to co-found biotech startup Inmagene Biopharmaceuticals Co. Ltd. in July 2019 to seek success in the China market using the experience and insights he had accumulated over the years. With $20 million in its war chest so far, the startup aims to excel in immunology-related therapeutic areas in China.
Fountain fires up aging drugs platform with new $6M financing
Series A
Fountain Therapeutics Inc., a California company working to create treatments for age-related diseases, said Khosla Ventures has led a $6 million series A-1 financing of the startup, with participation from Nan Fung Life Sciences, which earlier contributed $5 million to the round.
Italian gene therapy firm Genespire moving toward clinic with financing, preclinical data
Gene therapy
LONDON – After announcing its $17.4 million series A funding in the midst of pandemic in April, Genespire Srl has now gone public on the preclinical research upon which its programs will be based, presenting the data at last week’s American Society of Gene and Cell Therapy (ASGCT) annual meeting.
Repeatome defender: $50M series A lets Rome ransack ‘junk DNA’
CEO and co-founder Rosana Kapeller told BioWorld that Rome Therapeutics Inc.’s $50 million series A will fund early work in an “exploding” new area of biology: the repeatome – “the dark genome” or “junk DNA,” as many previously deemed the roughly 60% of the human genome that consists of repetitive sequences of nucleic acids.
I2O Therapeutics brings in a $4M seed funding
Seed
I2O Therapeutics Inc., of Allston, Mass., raised $4 million in seed funding to further its work on oral formulations of therapies typically limited to injections, such as biologics, large molecules and peptide-based pharmaceuticals.

U.S.

Mammoth Biosciences, GSK team up on CRISPR-based COVID-19 test
Diagnostics
Mammoth Biosciences Inc., of South San Francisco, and London-based Glaxosmithkline plc (GSK) have joined forces to develop a point-of-care test to detect active COVID-19 infections using Mammoth’s CRISPR-based DETECTR platform. The two companies hope to submit an application to the U.S. FDA for emergency use of the test before the end of the year.

Europe

Astrazeneca moving at Warp Speed with $1.2B in BARDA funding for COVID-19 vaccine
Vaccine
LONDON – Astrazeneca plc is to get up to $1.2 billion from the new U.S. COVID-19 vaccines program, Operation Warp Speed, to support further development and manufacturing of a vaccine developed at Oxford University’s Jenner Institute. The company said it will begin to ship the product in September...

EMA’s Rasi laments fragmented clinical trial efforts targeting COVID-19
Clinical
LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.
While companies develop COVID-19 vaccines, politicians debate over future access
Vaccine
LONDON – Geopolitical tensions over the issue of access to COVID-19 vaccines intensified this week, after the CEO of French pharmaceutical company Sanofi SA said the U.S. government would get first access to its product because it was first to fund the research.

Clinical

Wall Street quick to laud efgartigimod, phase III MG marquis
Immune
Argenx SE’s later-stage effort with antibody fragment efgartigimod in generalized myasthenia gravis (gMG) was designed with guidance from the phase II trial that showed 75% of patients had a durable response of at least six weeks.
Plan with the golden arm deals Navidea phase II imaging win in RA
Immune
Navidea Biopharmaceuticals Inc. CEO Jed Latkin said positive findings from the second interim analysis of the phase IIb study called NAV3-31 “were certainly better than what we were looking for” and will “make our partnering discussions a lot more interesting.”
Open Orphan revs up work on challenge study models, raises $14.6M
Vaccine
LONDON – Human challenge specialist Open Orphan plc has raised £12 million (US$14.6 million) in a placing to accelerate development of COVID-19 challenge study models, to meet demand from vaccines and therapeutics developers worldwide.
Entera Bio shares sink on interim phase II osteoporosis data
Musculoskeletal
Shares of Entera Bio Ltd. (NASDAQ:ENTX), a lightly traded Israeli drug delivery specialist, fell 27% on May 21 after the company said an ongoing phase II trial of its oral parathyroid hormone (PTH) candidate in osteoporosis patients found the two lowest doses tested demonstrated "suboptimal increases" in P1NP, an important biomarker of bone formation.
Turtle waxing (not) as skeptics query Galapagos, Gilead UC data
Gastrointestinal
Gilead Sciences Inc. and partner Galapagos NV touched off a round of Wall Street chin-scratching as they disclosed phase IIb/III data showing that JAK1 inhibitor filgotinib in ulcerative colitis (UC) at the 200-mg dose achieved all primary endpoints in the study called Selection.
China’s Carsgen set to start trials for first claudin18.2-targeted CAR T-cell therapy
Cancer
BEIJING – CAR T-cell therapeutics developer Carsgen Therapeutics Co. Ltd., of Shanghai, won IND clearance from the FDA for its first-in-class CT-041 for advanced gastric and pancreatic cancers. The company said it is the first claudin18.2 (CLDN18.2)-targeted CAR T-cell therapy cleared for clinical trials in the world.

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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