Closing in on potential tralokinumab approval, Leo posts supportive data
New articles highlighting phase III data on the IL-13 inhibitor tralokinumab from Leo Pharma A/S have shown that combining it with topical corticosteroids (TCS) as needed was effective and well-tolerated in patients with moderate to severe atopic dermatitis (AD). Monotherapy with the candidate had comparable safety to a placebo and efficacy lasting as long as 52 weeks, the company said. Articles on both outcomes were published in the British Journal of Dermatology. With marketing applications on file in both the U.S. and Europe, the articles helped make the case that, if approved, tralokinumab therapy could be a first-line targeted option when AD isn't controlled by topical therapies, said LEO's R&D chief, Kim Kjoeller.

Closing in on potential tralokinumab approval, Leo posts supportive data
New articles highlighting phase III data on the IL-13 inhibitor tralokinumab from Leo Pharma A/S have shown that combining it with topical corticosteroids (TCS) as needed was effective and well-tolerated in patients with moderate to severe atopic dermatitis (AD). Monotherapy with the candidate had comparable safety to a placebo and efficacy lasting as long as 52 weeks, the company said. Articles on both outcomes were published in the British Journal of Dermatology. With marketing applications on file in both the U.S. and Europe, the articles helped make the case that, if approved, tralokinumab therapy could be a first-line targeted option when AD isn't controlled by topical therapies, said LEO's R&D chief, Kim Kjoeller.
Dren’s $60M series A to propel it through preclinical development
Dren Bio Inc. has closed on a $60 million series A to push its two lead programs through early clinical development. The company’s DR-01 is an antibody-based therapy for treating rare leukemias, lymphomas and specific phenotypes of autoimmune disorders. The company said it is initially targeting neglected hematology-oncology indications.
Today's news in brief
BioWorld briefs for Oct. 19.
SPACs are hot this year, offering alternative route to public market
Even though the appetite for biopharma IPOs this year has been voracious with no signs of a slowdown anytime soon, companies also have a potentially faster route to the public market using special purpose acquisition companies (SPAC) that raise money through an IPO in order to take a company public through an acquisition.
Nectin-4 case built for two? Bicycle puts pedal to the mettle
Cambridge, U.K.-based Bicycle Therapeutics plc’s phase I dosing about a month ago of its first patient with nectin-4-targeting BT-8009 put the company on the road to hoped-for success by pursuing the same mechanism of action as Padcev (enfortumab vedotin-ejfv), the antibody-drug conjugate (ADC) from Astellas Pharma Inc. and Seagen Inc.
Rznomics on track for adenoviruses development plan
HONG KONG – Yongin, South Korea-based Rznomics Inc. is on track to develop adenoviruses for gene therapies, after signing a clinical and commercial agreement with Cologne, Germany based-Cevec Pharmaceuticals GmbH. The partnership will use the German company’s Cap technology to manufacture the adenoviruses, while the therapies, targeting various cancer indications, will be developed using Rznomics’ trans-splicing ribozyme technology.
Cellular 'pantry' of sorts, lipid droplets double as home security system
A multi-institutional team of researchers has implicated lipid droplets, which are key energy storage units of individual cells, in innate immune defense.

Analysis and data insight

ICYMI: Week in review, Oct. 12-16, 2020
A quick look back at top stories.
No time to lose to curb rising tide of antimicrobial resistance
Conferences
In July a major initiative of the International Federation of Pharmaceutical Manufacturers and Associations, designed to combat the rising tide of antimicrobial resistance and accelerate the pace at which new antibiotics are discovered and brought to market, was announced. The $1 billion AMR Action...
Busy year with regulatory news tracking 43% higher than 2019
Regulatory
While the number of FDA approvals in 2020 are lockstep in line with last year, despite disruptions from the COVID-19 pandemic, the amount of regulatory news this year tracked by BioWorld has risen by 43% over 2019. Compared with 2018, it is 52% higher.
Money raised by biopharma: 2020 vs. 2019
Total raised in public, private and other financings of biopharma companies, comparing 2020 vs. 2019.

Financings

Radioheads: Rayzebio closes $45M for targeted radiopharmaceuticals
Cancer
Rayzebio Inc. raised $45 million in a series A round to build a platform company focused on developing targeted radiopharmaceuticals for solid tumor indications.

Science

NCI-MATCH data give insights into late-stage tumors
Cancer
Investigators from the Eastern Cooperative Oncology Group, the American College of Radiology Imaging Network and the National Cancer Institute reported a roughly 40% match rate of patients to molecularly targeted therapies in its NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) trial,...

Natural killer cells dabble in adaptive immunity
BioWorld looks at translational medicine, including: PDAC subtypes point to targeting strategies; Lactose tolerance may be Red Herring.
Unite and conquer approach finds shared weaknesses of coronaviruses
Coronavirus
“It’s coming. We know it’s coming.” That was Nevan Krogan’s blunt reminder that SARS-CoV-2 is not the first virus to wreak temporary havoc on humanity, nor will it be the last.

Newco news

Upgrading with a $10M series B, Janpix advances its protein degrader pipeline
Cancer
Janpix Inc., of Cambridge, Mass., has raised a $10 million series B designed to progress its monovalent small-molecule protein degraders of STAT3 and STAT5 into final preclinical studies and eventually into the clinic to treat various hematological and solid tumor cancers.
Libra launches with a $29M series A to treat neurodegenerative diseases
Neurology/Psychiatric
In the past 10 years, the advances in understanding the etiology of neurodegenerative diseases have been dramatic. “The development of novel biomarkers and other tools as well are key in aiding diagnostic potential and the ability to track disease progression have been phenomenal,” Isaac Veinbergs, CEO of newly created Libra Therapeutics Inc., told BioWorld.
Australia’s Chimeric Therapeutics in-licenses scorpion-derived CAR T from City of Hope
Cancer
PERTH, Australia – Sydney-based Chimeric Therapeutics Ltd. has acquired exclusive worldwide rights to develop and commercialize the City of Hope Cancer Center’s chlorotoxin chimeric antigen receptor cell therapy that uses a peptide derived from scorpion toxin to direct T cells to target glioblastoma.
After AU$45M IPO, Aroa rakes in two new approvals as it ramps up commercial presence
Regulatory
PERTH, Australia – After its initial public offering on the Australian Securities Exchange, soft tissue regeneration company Aroa Biosurgery Ltd. has received new clearances in the U.S. and Europe and is focusing on building up its commercial and manufacturing capacity.
New startup Lianbio brings in late assets to establish presence in China
Newly founded Lianbio, with offices in Shanghai and San Francisco, aims to quickly establish a presence in China and Asia with late-stage assets in-licensed from Bridgebio Pharma Inc. and Myokardia Inc. in two deals amounting to $531.5 million and $187.5 million, respectively.

U.S.

Supreme Court grants cert to three iterations of Arthrex appointments question
Court
The case of Arthrex v. Smith & Nephew at the U.S. Court of Appeals for the Federal Circuit was something of a nuclear option for the patent dispute at hand, as it raised a constitutional question regarding the appointment of administrative patent judges (APJ) at the Patent Trial and Appeal Board (PTAB). The Supreme Court has agreed to hear a consolidation of three petitions for cert arising from the Arthrex case, the outcome of which could force the reopening of a number of cases already decided by the PTAB.

Europe

UK Bioscience Forum: COVID-19 amplifying importance of real world data
Coronavirus
Tracking the pandemic in all its manifestations – from symptoms and spread, to viral genomics and repurposing drugs – has massively increased appreciation of the importance of real world data, with significant implications for the future of drug discovery and clinical development, the use of...

Record summer for U.K. biopharma financing
Financings
LONDON – Facing down the pandemic, U.K. biopharma had a record summer, raising just over £1 billion (US$1.3 billion) from June to August. That was up from £585 million in the second quarter of 2020, and brings the amount raised in the first nine months to £1.9 billion, putting 2020 on target to...
Growing concerns over decline in non-COVID-19 clinical testing, says U.K.’s ABPI
Clinical
LONDON – Industry is calling on the government to set out a plan for the safe and sustainable restart of non-COVID-19 clinical studies that were put on hold when the pandemic struck.

Clinical

Lysogene reveals patient death in phase III Sanfilippo syndrome study
Endocrine/Metabolic
One of 19 children dosed with an experimental gene therapy for Sanfilippo syndrome has died following the treatment, given as part of a phase II/III trial of the medicine run by its developer, Paris-based Lysogene SA. The trial has been on clinical hold since June, but the immediate cause of the death is unknown, the company said.
Anavex reaches pivot(al) point with sigma-1 program in PDD
Neurology/Psychiatric
CEO Christopher Missling said New York-based Anavex Life Sciences Corp. is still deciding on the dose for the pivotal study with Anavex2-73 (blarcamesine) in Parkinson’s disease dementia (PDD), and called the phase II findings “just the first data run,” about which the firm “wanted to immediately inform shareholders.”
Second inactivated SARS-CoV-2 vaccine candidate from China reports clinical data
Coronavirus
DUBLIN – The Lancet Infectious Diseases has published the first clinical data on BBIBP-CorV, an inactivated whole virus vaccine directed against SARS-CoV-2. The early stage phase I/II study tested the Chinese-developed vaccine in 540 healthy volunteers, including 96 older participants. All vaccine recipients seroconverted and the adverse event profile was mild.
Testing of Lilly's COVID-19 antibody continues despite paused trial
Coronavirus
Despite an NIH move to pause enrollment in a trial testing Eli Lilly and Co.'s COVID-19 antibody candidate, LY-CoV555, after a participant's unexplained illness, at least three other studies of the candidate remain underway, the company said Oct. 14.
SCD bid kaput, Cyclerion pedals forth with sGC approach in CNS
Hematologic
Cyclerion Therapeutics Inc.’s phase II blowup with sickle cell disease (SCD) candidate olinciguat ended its development, and attention turned to the Cambridge, Mass.-based firm’s earlier-stage effort with IW-6463, a drug in the same class for central nervous system (CNS) disorders.
Gossamer shares thin on phase II data but asthma hopes find air
Respiratory
Gossamer Bio Inc.’s finding of a subset of especially good responders in the phase IIb study called Leda may have taken some of the edge off two failures with GB-001, an oral DP2 antagonist undergoing tests in asthma and chronic rhinosinusitis. But the Street still wasn’t happy, and shares (NASDAQ:GOSS) of the San Diego-based firm closed Oct. 13 at $10.09, down $3.50, or 26%.

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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