Sofinnova Partners ‘blasted through its target’ with $550M for 10th early stage fund
DUBLIN – Sofinnova Partners closed out its flagship Capital X fund at €472 million (US$550 million), providing further evidence that private equity investing in European biotechnology and medical technology remains in rude health. It represents, managing partner Graziano Seghezzi told BioWorld, one of the most successful fundraising campaigns in its 30-year history. “We went out and raised this fund in six months.”

Sofinnova Partners ‘blasted through its target’ with $550M for 10th early stage fund
DUBLIN – Sofinnova Partners closed out its flagship Capital X fund at €472 million (US$550 million), providing further evidence that private equity investing in European biotechnology and medical technology remains in rude health. It represents, managing partner Graziano Seghezzi told BioWorld, one of the most successful fundraising campaigns in its 30-year history. “We went out and raised this fund in six months.”
Merck lurks after phase II Moonsong dirge; Atea’s COVID-19 Morningsky to brighten?
Phase II results from Atea Pharmaceuticals Inc. with AT-527 in COVID-19 treatment had pundits scrambling to stack the odds of success for the direct-acting oral antiviral against those of Merck & Co. Inc.’s molnupiravir, though cross-trial comparisons are beset by the usual hurdles, with two especially dramatic ones.
Entasis nears NDA filing for entrant in fight against tough Acinetobacter infections
Top-line results of a phase III trial testing sulbactam-durlobactam, a combination beta-lactam antibiotic and beta-lactamase inhibitor, in patients with carbapenem-resistant Acinetobacter baumannii infections, found the novel combo to be statistically noninferior to colistin in 28-day all-cause mortality, the study's primary endpoint.
Today's news in brief
BioWorld briefs for October 19.
D&D Pharmatech closes $51M series C round, eyes Seoul IPO
D&D Pharmatech Inc., a Korean-American firm commercializing innovation from Johns Hopkins University raised $51 million in a pre-IPO series C round, which sets the stage for an IPO in Seoul early next year.
Galera’s phase III stumble staggers the stock
Based on positive phase IIb data from 2020 for avasopasem manganese (GC-4419) in treating severe oral mucositis (SOM) in patients with locally advanced head and neck cancer, Galera Therapeutics Inc. had been confident about phase III data for the selective small-molecule dismutase. However, the phase III Roman trial failed to hit its primary endpoint of reduction in the incidence of SOM. Mel Sorensen, Galera’s CEO, expressed his surprise at the results and said the company is evaluating the next steps for the program.
Baidu algorithm-based mRNA vaccine neutralizing antibody titer levels exceed benchmark sequence by up to 20x
Baidu Inc.’s preclinical studies showed the mRNA vaccine sequences for COVID-19 designed using its Lineardesign algorithm outperformed the benchmark sequences designed by traditional algorithms in terms of stability, protein expression and immunogenicity. The firm teamed up with Stemirna Therapeutics Co. Ltd., which specializes in the R&D of mRNA vaccines and drugs, to test seven mRNA COVID-19 vaccine sequences designed using Lineardesign.

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Analysis and data insight

Busy agencies regulate global pandemic options; U.S. gains four new NMEs in September
Regulatory
With a 14% increase in regulatory news over this time last year, 2021 has proved to be the busiest that the biopharma industry has ever seen, as companies continue to seek clearances of their late-stage pipeline products with a backdrop of an unprecedented number of COVID-19 pandemic efforts.
ICYMI: Week in review, Oct. 11-15, 2021
A quick look back at top stories.
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-Oct. 14, 2021
Year-to-date money raised in public, private and other financings of biopharma companies.

Financings

Abbisko raises $226M in Hong Kong IPO to develop new solid tumor treatment
Cancer
Abbisko Cayman Ltd. has raised $226 million through an IPO in Hong Kong, where it launched with an initial price of HK$12.46 (US$1.60) per share. The company, doing business as Abbisko Therapeutics, plans to use about a third of the proceeds for research and development of its lead candidate,...

Science

Pandemic learnings could lead to more inclusive clinical trials
Clinical
On the last day of this year’s Molecular Targets meeting, an annual joint conference of the American Association for Cancer Research, the National Cancer Institute and the European Organization for the Research and Treatment of Cancer, the final plenary went from molecular to macro in a lively...

Depression's doldrums linked to diagnostic duality at ECNP
Neurology/Psychiatric
"My fondest hope is that maybe depression and other mental health disorders may be diagnosed by underlying cause, rather than categorized dualistically," Edward Bullmore, director of the Wolfson Brain Imaging Centre, and head of the Department of Psychiatry at the University of Cambridge, told his...
Nobel Prize for Red Hot Chili Pepper and Cool Mint receptors
Neurology/Psychiatric
The 2021 Nobel Prize in Physiology or Medicine was awarded Oct. 4 to David Julius and Ardem Patapoutian “for their discoveries of receptors for temperature and touch.”

Newco news

Sapreme hatches endosomal escape plans with $17M series A round
Series A
DUBLIN – Sapreme Technologies BV is taking a novel approach to the extraordinary inefficiency of intracellular delivery of macromolecular drugs by developing a series of compounds that can dramatically improve the rate with which drugs such as proteins and oligonucleotides can escape the endosome.
Micreos sidesteps antibiotic resistance, targeting superbugs with $37M for endolysin
Infection
Developing the next generation of antibiotics is proving to be a major problem, with research reaching an almost standstill due to a lack of funding because of the poor return on R&D investment from the products.
Startup Accession aiming to create new generation of immunotherapy
Cancer
LONDON – The scientific pioneer behind T-cell receptors has taken the helm of a new biotech he believes has the technology to overcome current shortcomings of cancer immunotherapy. Bent Jakobsen, co-founder and long-term chief scientific officer of Immunocore plc and of CAR T-cell specialist...
NRG gearing up for series A to advance brain-penetrant PTP inhibitors
Neurology/Psychiatric
LONDON – A significant body of research indicates inhibition of the mitochondrial permeability transition pore (PTP) would reduce neuroinflammation and protect neurons, but the difficulty of finding inhibitors that cross the blood-brain barrier to regulate the pore has left the therapeutic...
Binhui moves HSV-2-based oncolytic viral candidate toward U.S. trial
Clinical
Binhui Biopharmaceutical Co. Ltd.’s BS-001, a recombinant human oncolytic herpes simplex virus type-2 expressing GM-CSF for the potential treatment of solid tumors, has gained an IND approval from the FDA. The development marks the first oncolytic viral candidate developed by a Chinese company to...

U.S.

FDA preemption of state law for product labeling at risk in Mississippi court ruling
Regulatory
FDA preemption of state liability law has proven controversial on a number of occasions, a fact of life resurrected by a case arising out of the Supreme Court of the State of Mississippi. The court declared that the FDA must invoke the rulemaking process for its regulation of medical product labels.

Europe

Regulatory submissions ahead on solid phase III data for Valneva’s COVID-19 vaccine
Clinical
LONDON – Valneva SA’s COVID-19 vaccine, VLA-2001, prompted a stronger immune response with fewer side effects than Astrazeneca plc’s product, according to headline data from the phase III trial. Shares in Valneva (NASDAQ:VALN) shot up by nearly 40% to close Oct. 18 at $39.21 when the data were...

Synaptixbio sets off on quest to find therapy for rare CNS disease
Neurology/Psychiatric
U.K.’s Synaptixbio Ltd. has launched, aiming to tackle a rare and often fatal disease of the central nervous system (CNS), TUBB4a leukodystrophy.
BIA Autumn Forum: Keep collaboration, innovation momentum post-pandemic, new UK science minister urges
Conferences
LONDON – After the hard, solitary slog through months of pandemic, U.K. biotech finally convened in person, buoyed by the contribution the sector has made to dealing with COVID-19, and evidently pleased to be face-to-face once more.

Clinical

Phathom posts positive phase III data but the stock drops
Gastrointestinal
Thanks to positive phase III data from Phathom Pharmaceuticals Inc.’s Phalcon-EE study of patients with erosive esophagitis, the company is prepping to file an NDA with the FDA for its lead compound, vonoprazan.
Biogen trumpets another trial-failure-that-isn’t-a-failure, this time in ALS
Neurology/Psychiatric
Biogen Inc.’s phase III trial of tofersen in a form amyotrophic lateral sclerosis (ALS) has missed its main goal, but the company said it is still talking with regulators after seeing positive trends in the data.
Astrazeneca finds anti-CTLA4, anti-PD-L1 drug combo extends OS in liver cancer trial
Cancer
In trials name-checking some of the world’s highest peaks, longest rivers and most famous seas, Astrazeneca plc has long sought the best use of its CTLA4 inhibitor tremelimumab. Now, after a disappointing cruise along the first-line bladder cancer...
Too early to say ‘WEE1,’ but strides made in validating approach to cancer
Cancer
Recent news that The University of Texas MD Anderson Cancer Center is teaming up with Schrödinger Inc. to work on the latter’s WEE1 inhibitor – along with data disclosed at the 2021 meeting of the European Society for Medical Oncology (ESMO) –...
Khondrion heading for pivotal trial as mitochondrial disease competition mounts
Endocrine/Metabolic
Mitochondrial disease, where the tiny energy factories in cells aren’t functioning properly, can have devastating and sometimes fatal consequences. As there are no approved treatments, patients rely on strategies such as strict diets and...
ECTRIMS opens: Biogen therapies did not reduce COVID-19 antibody responses in MS patients
Conferences
Biogen Inc. opened the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting with data showing those treated with its multiple sclerosis (MS) therapies had an effective antibody response...

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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