Rapid returns for shareholders as Pandion agrees to $1.85B Merck buyout
Merck & Co. Inc. is paying $1.85 billion, or $60 per share, to acquire Pandion Therapeutics Inc. on the back of early stage data in human volunteers for its lead program, PT-101, an engineered interleukin-2 mutein fused to an Fc backbone, which is designed to stimulate targeted expansion of regulatory T cells for use in autoimmune disease indications.

Rapid returns for shareholders as Pandion agrees to $1.85B Merck buyout
Merck & Co. Inc. is paying $1.85 billion, or $60 per share, to acquire Pandion Therapeutics Inc. on the back of early stage data in human volunteers for its lead program, PT-101, an engineered interleukin-2 mutein fused to an Fc backbone, which is designed to stimulate targeted expansion of regulatory T cells for use in autoimmune disease indications.
Yisheng moves COVID-19 vaccine to clinic after $130M series B
Eight months after Beijing-based Yisheng Biopharma Co. Ltd. unveiled its recombinant protein vaccine candidate for COVID-19, YS-SC2-010, the company raised $130 million in a series B round to pave way for the vaccine to enter clinical trials in the second quarter of this year, the company’s CEO David Shao told BioWorld.
Jaguar primed to pounce with portfolio of early stage gene therapies
Jaguar Gene Therapy LLC, a startup reuniting former Avexis Inc. executives to develop a portfolio of potential treatments for severe genetic diseases, announced its public debut Feb. 25 with more than $40 million in series A financing from co-creator Deerfield Management.
Xilio advancing immunotherapies to the clinic with $95M series C
Cancer immunotherapy developer Xilio Therapeutics Inc. has raised $95 million in series C financing to support its efforts to move a duo of tumor-selective candidates into the clinic. IND applications for both its interleukin-2 agonist, XTX-202, and anti-cytotoxic T-lymphocyte-associated protein 4 antibody, XTX-101, are planned for this year.
Today's news in brief
BioWorld briefs for Feb. 25.
Biologic patent thickets, global settlements at stake in 7th Circuit case
The U.S. Court of Appeals for the Seventh Circuit grappled with whether so-called patent thickets and certain global patent settlements constitute antitrust behavior as it heard arguments Feb. 25 in UFCW Local 1500 Welfare Fund v. Abbvie Inc.
Sarepta wins accelerated FDA approval for third DMD therapy, casimersen
As expected, the FDA granted an approval for Amondys 45 (casimersen), a new Duchenne muscular dystrophy (DMD) therapy developed by Sarepta Therapeutics Inc.
Bacterial protease takes on ‘undruggable’ oncoprotein
Scientists, despite their best efforts, have not been able to identify a way to inhibit the oncoprotein Myc. Uropathogenic Escherichia coli, though, has apparently figured it out.
Curocell adds first South Korean IND approval for CAR T to its cart
HONG KONG – Daejeon, South Korea-based Curocell Inc. has received the first IND approval for a CAR T therapy in South Korea from the Ministry of Food and Drug Safety (MFDS).
EMA advises on next-gen COVID-19 vaccines
The EMA issued a guidance Feb. 25 outlining the requirements for manufacturers planning to modify COVID-19 vaccines to address emerging variants of the SARS-CoV-2 coronavirus.

Analysis and data insight

Money raised by biopharma: 2021 vs. 2020 vs. 2019
Total raised in public, private and other financings of biopharma companies, comparing 2021 vs. 2020 vs. 2019.
Biopharma money raised: Jan. 1-Feb. 25, 2021
Year-to-date money raised in public, private and other financings of biopharma companies.
The next phage in combating antimicrobial resistance
Antibiotic
With the clock ticking on the urgent need to develop new antibiotics, the ongoing COVID-19 pandemic has given policy makers a sharp reminder that society should not lose focus on antibiotic resistance as well, which has the potential to dwarf COVID-19 in terms of deaths and economic costs. The...
Beyond Luxturna companies vie to become the next ocular gene therapy
The 2017 FDA approval of Luxturna (voretigene neparvovec-rzyl, Roche Holding AG) spurred a race to create the next gene therapy for the eye. The organ is very amenable to gene therapy given that it's a confined space with post-mitotic cells that has immune privilege and requires substantially...

Financings

Clover bags $230M in series C, moves COVID-19 vaccine to phase II/III
Private
Chengdu-based Sichuan Clover Biopharmaceuticals Inc., known for its Trimer-Tag technology, raised $230 million in a series C financing round. The proceeds will, most notably, help it advance its COVID-19 vaccine candidate, S-Trimer (SCB-2019), to a global phase II/III trial by June. Following its...

Science

Gene variants can increase fat, decrease cardiometabolic risk
Endocrine/Metabolic
In the public mind, fat and unhealthy are more or less synonymous. But reality is more complicated, as reality often is.

Diverse populations, long reads give genome insights
BioWorld looks at translational medicine, including: Movement strengthens bones, and immunity; Atherosclerosis precedes clonal hematopoiesis.
Antidiarrheal drug fights AML
BioWorld looks at translational medicine.

Newco news

For therapeutic RNA, chasing its tail may be the way to go
RNA
RNA has “huge potential” as a therapeutic modality and is beginning to deliver on that potential. But “manufacturing RNA has issues in production, delivery and performance,” Thomas Barnes told BioWorld. Barnes is the CEO of startup Orna Therapeutics LLC, which has the goal of addressing those...
Asalyxa raises a seed financing to develop an ARDS therapy
Respiratory
Asalyxa Bio Inc. has closed on an oversubscribed seed financing of more than $2 million designed to advance its lead candidate, ASX-100, into the clinic in acute respiratory distress syndrome.
China’s Anticancer Bioscience raises $10 million, aims high in China
Cancer
CAJICA, Colombia – China’s Anticancer Bioscience, a company focused on developing precision oncology medicines, has raised ¥66 million (US$10.2 million) to expand its small-molecule and natural product screening libraries and move two programs into IND-enabling studies.
Covicept lands Forbion backing for mission to tackle RNA viruses
Infection
Covicept Therapeutics Inc., a young San Diego-based company focused on developing a small molecule to inhibit the replication and spread of SARS-CoV-2 and other RNA viruses, has launched with $2.3 million in seed funding from European VC firm Forbion. The company, spun out of research at the...
Market ‘solutes’ Nirogy small-molecule flag with $16.5M series A
Cancer
Boston-based Nirogy Therapeutics Inc.’s $16.5 million series A round is meant to enable a pipeline of small-molecule drugs targeting the solute carrier family of transporter proteins (SLCTs) embedded in the cell membrane, and let the firm bring its front oncology runner to the clinic in 2022.

U.S.

Price transparency emphasized in Becerra’s first Senate hearing for HHS job
Coronavirus
The first Senate hearing for the nomination of Xavier Becerra as Secretary of Health and Human Services included the predictable questions about his qualifications, given his position as attorney general for the state of California. However, the candidate repeatedly emphasized price transparency...

Europe

Europe chases COVID-19 variants, updates strategies
Coronavirus
LONDON – The EU is taking concerted action to detect new variants of SARS-CoV-2, investing €225 million (US$270 million) to increase viral genome sequencing to 5% of positive cases across Europe, and to carry out research on their evolution and transmissibility.

Recovery trial shows Roactemra’s benefit in hospitalized COVID-19 patients
Clinical
LONDON – After a number of equivocal small studies, the U.K. Recovery trial has applied its heft to turn in statistically significant evidence that the rheumatoid arthritis treatment Roactemra (tocilizumab) reduces mortality in hospitalized COVID-19 patients.
COVID-19 vaccines should be tested against variants, EMA says
Regulatory
LONDON – The EMA has requested all COVID-19 vaccine developers to investigate if their products offer protection against new variants of SARS-CoV-2 and to submit the relevant data.

Clinical

SERDs heard louder, clearer in BC; Sanofi phase II data this half
Drugs
Astrazeneca plc officials, during the firm’s Feb. 11 conference call on fourth-quarter earnings, highlighted the oral selective estrogen receptor degrader (SERD) camizestrant in breast cancer (BC), which Cristian Massacesi, head of late-stage...
Otonomy's Otividex fails pivotal Meniere's disease trial, crashing shares again
Hopes that a second clinical win for Otonomy Inc.'s phase III Meniere's disease candidate, Otividex, might set the stage for a third-quarter registration of the drug in the U.S. have been dashed, sending company shares (NASDAQ:OTIC) down 44.3% to...
IBAT they can: Albireo, leading with biliary atresia phase III, draws Street favor with blockbuster strategy
Although progressive familial intrahepatic cholestasis (PFIC) tends to draw more hoopla in the race, and Mirum Pharmaceuticals Inc. looks due to beat Albireo Pharma Inc. to market in Alagille syndrome (ALGS), the most revenue likely lies in a...
Real world data show vaccines are cutting risk of severe COVID-19, hospitalizations
Coronavirus
LONDON – The first population-level real world data on COVID-19 vaccines indicate they are having a dramatic impact on severe disease, with a study in Scotland showing a fall of 85% in hospital admissions for people who received the Pfizer...
Pass the SIRPa? Alx sweet on CD47-axis in solid tumors, phase II soon
Drugs
As developers continue their race in the anti-CD47 space, Gilead Sciences Inc. remains high profile with magrolimab, which has reached phase III development for myelodysplastic syndromes. Meanwhile, Alx Oncology Inc., of Burlingame, Calif., is...
Trial diversity takes the guesswork out of treating excluded patients
Coronavirus
The U.S. NIH’s Feb. 17 announcement that it’s funding a study of the effects of remdesivir in treating COVID-19 in pregnant women is welcome news, but it begs the question of why it took so long given the risk of more severe disease in that...

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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