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Home » Newsletters » BioWorld

BioWorld

Oct. 2, 2018

View Archived Issues

Checkpoint inhibition work earns Nobel for Kyoto's Honjo, MD Anderson's Allison

LONDON – Braced for canceled classes after Typhoon Trami crossed west Japan overnight on Sunday, Kyoto University instead found itself swept up in a far more genial atmosphere, as news broke Monday that Tasuku Honjo, staff member since 1984, had won the 2018 Nobel prize in physiology or medicine. Read More

Forbion closes $418M fund amid positive EU outlook

LONDON - Forbion Capital Partners announced the final close of its fourth fund, attracting €360 million (US$418 million) for life sciences investments in Europe and North America. Read More

As buzz builds in NK field, Merck's valuable TriNKET found in Dragonfly chest

Dragonfly Therapeutics Inc. CEO Bill Haney told BioWorld that his firm's deal with Merck & Co. Inc. provides "a pretty considerable up-front payment" and gives Merck the option to license exclusive worldwide intellectual property rights to products developed using the TriNKET natural killer (NK) cell technology platform against solid tumors for an undisclosed number of programs. Read More

Avrobio stung on early data from gene therapy candidate in Fabry disease

"Encouraged," apparently, is not a word investors relish when it comes to trial results – even early phase I data – as Avrobio Inc. learned after disclosing findings on the first participants in an investigator-sponsored phase I study and company-sponsored phase II of ex vivo lentiviral (LV) gene therapy AVR-RD-01 in Fabry disease. The Cambridge, Mass.-based company, which priced its June IPO at $19 to raise $114.7 million, including overallotments, and hit a high of $53.70 last week, saw shares (NASDAQ:AVRO) give back more than half their value Monday, falling to $21.58 before closing at $25.13 for a loss of $26.74, or 51.6 percent.  Read More

Velosbio raises $58M series A to back ADCs for cancer treatment

Velosbio Inc., a San Diego-based startup developing antibody-drug conjugates to treat blood cancers and solid tumors, has landed a $58 million series A financing co-led by Arix Bioscience plc and Sofinnova Ventures. Other investors included Pappas Ventures, Chiesi Ventures, Takeda Ventures Inc. and Decheng Capital. While the company has said little about its initial pipeline, the new financing is projected to help it complete a first investigational new drug application soon, Velosbio's CEO Dave Johnson told BioWorld. Read More

Insmed's Arikayce becomes first antibacterial approved under FDA's LPAD pathway

An accelerated approval for Insmed Inc.'s Arikayce (amikacin liposome inhalation suspension) has poised the company, within weeks, to offer the first and only FDA-approved therapy for refractory nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in adults. The drug, which addresses a rare and often chronic infection that can cause irreversible lung damage, is also the first to be granted approval under the agency's limited population pathway for antibacterial and antifungal drugs (LPAD), created by the FDA to spur development of antibiotics for unmet medical needs. Read More

Iceland's Alvotech partners with China's Changchun to develop biosimilars

Alvotech ehf., of Iceland, and an independent sister company of U.S. pharmaceutical firm Alvogen Group Inc., recently joined hands with China's Changchun High & New Technology Industries Group Inc. to develop, manufacture and commercialize Alvotech's biosimilars in the Asian country. The collaboration will see a new joint venture with manufacturing capabilities in China's Jilin province, which will be equally funded by both companies. Read More

Sanofi, Regeneron enter land of immuno-oncology with Libtayo nod in CSCC

Although analyst forecasts ranged from exuberant to temperate, all agreed that approval of Libtayo (cemiplimab-rwlc, previously REGN-2810) marked a new chapter for longtime partners Regeneron Pharmaceuticals Inc. and Sanofi SA. The anti-PD-1 sneaked under the third-quarter wire, a month ahead of its PDUFA date, as the first FDA-approved therapy to treat advanced cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC in individuals who are not candidates for curative surgery or radiation. Read More

Regulatory front

The U.S. Biomedical Advanced Research and Development Authority (BARDA) is partnering with Genentech, a subsidiary of Basel, Switzerland-based Roche Holding AG, to develop a portfolio of medical countermeasures (MCMs) that also have commercial uses. The partnership calls for BARDA to share development costs, have joint oversight, help determine which drugs to develop and collaborate on decisions about which products enter or leave the partnered portfolio. Read More

Financings

Anaptysbio Inc., of San Diego, said it closed its underwritten public offering of 2.53 million shares, including the exercise in full by the underwriters of their option to purchase an additional 330,000 shares, at $94.46 each. Gross proceeds are expected to be approximately $239 million. Read More

Other news to note

Kangstem Biotech Co. Ltd., of Seoul, selected Masthercell Global Inc., a subsidiary of Germantown, Md.-based Orgenesis Inc., as its contract manufacturing partner for the European clinical trials of Furestem-AD, a cell therapy designed to treat atopic dermatitis. Terms of the deal weren't disclosed. Read More

Clinical data for Oct. 1, 2018

Read More

Regulatory actions for Oct. 1, 2018

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