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Updated: 48 min 4 sec ago

MEI Pharma, Helsinn Scuttle Cancer Drug Trial After Miss on Efficacy

Thu, 07/02/2020 - 14:34

MEI Pharma and its Swiss partner Helsinn are ending a Phase 3 study of an investigational cancer drug for patients with acute myeloid leukemia (AML) after an interim analysis indicated it was unlikely to meet the trial’s main goal of helping patients live longer.

San Diego-based MEI (NASDAQ: MEIP), licensed the compound, pracinostat, from a Singaporean biotech company in 2013. In August 2016 MEI signed an alliance with Helsinn to advance the experimental drug for patients newly diagnosed with AML who are unable to receive intensive chemotherapy due to advanced age—75 years or older—or other health reasons.

Under the deal... Read more »

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Moderna: Speed of COVID 19 Vaccine Hinges On Enrolling Right Patients

Thu, 07/02/2020 - 09:54

Fast enrollment of the right patient populations will be critical to quickly conducting Phase III trials of COVID-19 vaccines and this will likely mean taking concerted steps to reach out to populations that can be harder to recruit for clinical trials, drug industry leaders said on a recent New York Academy of Sciences webinar.

Moderna Inc.’s Chief Medical Officer Tal Zaks said concern around whether his company’s COVID-19 clinical trial can reach “the right population that should benefit the most,” is keeping him up at night. “It is not the concern of is it going to be safe; it is not... Read more »

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Data Quantity, Complexity Drives Use of AI in Drug Discovery and Testing

Thu, 07/02/2020 - 07:41

The quantity of data about medicines, diseases, and biology is growing. So too, are the number of companies that employ artificial intelligence in drug discovery. Most of the low-hanging fruit in drug research has already been picked, and the industry is clamoring to make sense of the new data, according to Jeffrey Lu, CEO and co-founder of Engine Biosciences.

“There’s only one way to do that—use machines to process the complexity,” Lu said.

Lu was one of the speakers featured last week during Xconomy’s Xcelerating Life Sciences San Francisco event. His startup’s technology platform uses AI to uncover gene interactions underlying... Read more »

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Annexon Adds On $100M to Advance Antibodies to Treat Neurodegeneration

Wed, 07/01/2020 - 17:00

Annexon Biosciences, a biotech founded in late 2014 by former Elan Pharmaceuticals executives, has added $100 million to its coffers to move its two clinical-stage programs along and to continue advancing its preclinical pipeline.

The South San Francisco-based company is developing drugs for patients with autoimmune and neurodegenerative disorders that are caused by an abnormal accumulation of the protein C1q. Typically the protein plays a key role in what’s known as the classical complement pathway, a part of the immune system. But when C1q builds up it can trigger a reaction that destroys synapses, leading to neurodegeneration.

Annexon’s C1q inhibitors are... Read more »

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BioNTech’s mRNA COVID-19 Vaccine Shows Early Signs of Sparking Immunity

Wed, 07/01/2020 - 14:33

A BioNTech messenger RNA vaccine candidate for COVID-19 has shown in a small study that it can elicit an immune response to the novel coronavirus.

The 45-patient US study tested three doses of the experimental mRNA vaccine, BN162b1, along with a placebo. Early results now available show higher levels of the antibodies hoped to neutralize the virus compared to what has been observed in patients who recovered from COVID-19. No serious safety problems were reported in the Phase 1/2 clinical trial results announced Wednesday, which were also published in a preprint, a research paper that has not yet been peer reviewed.... Read more »

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Amylyx Adds $30M to Press On With Neuro Drug for ALS, Alzheimer’s

Wed, 07/01/2020 - 08:11

Amylyx Pharmaceuticals’ two-pronged approach to neurodegenerative diseases has shown promise in amyotrophic lateral sclerosis (ALS) testing and the company now has $30 million to complete a separate clinical trial in Alzheimer’s disease.

The Series B round of financing announced Wednesday was led by Morningside Ventures, a firm that had previously invested in the Cambridge, MA-based biotech.

Amylyx’s experimental therapy, AMX0035, combines two currently available drugs, sodium phenylbutyrate and tauroursodeoxycholic acid. The Amylyx compound is intended to block cell death pathways that start in two components of a cell, the mitochondria and endoplasmic reticulum.

In an email, Amylyx Chief Financial Officer Jeffrey... Read more »

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Bolt Bio Adds $93.5M to Move Ahead Immune-Stimulating Cancer Drugs

Wed, 07/01/2020 - 05:31

The Series C funding will support Bolt Bio’s “next generation” antibody conjugate approach to cancer immunotherapy, says CEO Randy Schatzman.

Ten months ago Randy Schatzman was appointed CEO of cancer drug developer Bolt Biotherapeutics, and tasked with getting its first drug candidate into the clinic, building out its C-suite, and raising more money.

On Wednesday Schatzman checked the last box on that priority list, closing a $93.5 million Series C financing round from a group of primarily public-private investors, whose participation in a private financing often signals a company’s intent to go public, plus one biopharma.

“The markets are being... Read more »

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Chiesi Licenses Bioasis Tech to Tackle Brain Symptoms of Rare Diseases

Wed, 07/01/2020 - 04:40

The blood-brain barrier protects the functioning of that essential organ, but it’s also a hurdle to delivering neurological drugs.

Italy’s Chiesi Group has agreed to pay Guilford, CT-based Bioasis Technologies $3 million up front to use the preclinical firm’s technology to facilitate the delivery of enzymes across the blood-brain barrier to treat neurological symptoms associated with four lysosomal storage disorders (LSDs). Such diseases are caused by mutations in the genetic instructions for important enzymes that normally help our cells clear out waste. Without those enzymes, toxic materials build up in the body’s cells over time.

Under the agreement Chiesi is responsible... Read more »

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Ultragenyx Pharma Wins FDA’s First Drug Nod for Rare Metabolic Disorder

Tue, 06/30/2020 - 18:19

Ultragenyx Pharmaceutical won FDA approval Tuesday for a therapy that treats a group of rare metabolic disorders that render the body unable to convert a certain type of fat—such as those found in olive oil, fish, and nuts—into energy.

People who have long-chain fatty acid oxidation disorders (LC-FAOD) typically manage the condition with dietary changes or by taking supplements. The treatment from Novato, CA-based Ultragenyx (NASDAQ: RARE) is a purified, synthetic version of a triglyceride, triheptanoin (Dojolvi). It’s designed to provide fatty acids that a patient’s cells can metabolize as an alternative energy source.

LC-FAOD is a genetic condition and... Read more »

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Mereo BioPharma Appoints John Lewicki Chief Scientific Officer

Tue, 06/30/2020 - 09:59

The new chief scientific officer of Mereo BioPharma Group (NASDAQ: MREO) is acquainted with the London-based company and its lead cancer drug candidate. John Lewicki was previously the CEO of OncoMed, a cancer drug developer whose stumbles in clinical trials led to a 2017 corporate restructuring, and then a reverse merger last year with Mereo. Following the merger, Mereo kept OncoMed’s Redwood City, CA, site.

At OncoMed, Lewicki held research and development roles, including chief scientific officer, prior to being named CEO. He was involved in the discovery and development of etigilimab, an experimental cancer immunotherapy that targets... Read more »

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Akcea Therapeutics Names Tracy Palmer Berns Chief Compliance Officer

Tue, 06/30/2020 - 09:25

Tracy Palmer Berns has joined rare disease drug developer Akcea Therapeutics (NASDAQ: AKCA) as chief compliance officer, the same role she held most recently at AMAG Pharmaceuticals (NASDAQ: AMAG). Her experience also includes compliance and regulatory positions at Medtronic (NYSE: MDT) and Covidien, which Medtronic acquired in 2015. Boston-based Akcea has two commercialized products: hereditary transthyretin amyloidosis treatment inotersen (Tegsedi) and volanesorsen (Waylivra) for familial chylomicronemia syndrome.

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Goldfinch Raises $100M for Kidney Drug Studies Now, Perhaps an IPO Later

Tue, 06/30/2020 - 07:46

Goldfinch Bio, a biotech company employing genetic analysis to develop new medicines for kidney diseases, has raised $100 million to bring its lead drug candidate into mid-stage clinical trials.

The Series B round of financing was led by Eventide Asset Management.

Cambridge, MA-based Goldfinch is taking a big data approach to kidney disease drug discovery and development. The heart of its research is a database of anonymized patient data, called the Kidney Genome Atlas. This database has genomic, proteomic and transcriptomic data that the biotech uses to identify genetic targets that are relevant to kidney disease. As drug candidates progress to... Read more »

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Code for Cures: Life Sciences Thrives on San Francisco’s Software Heritage

Tue, 06/30/2020 - 03:00

A growing population of people with software experience plus an interest in life sciences is boosting drug development in the San Francisco Bay Area, according to panelists at an Xcelerating event.

Innovation in the San Francisco Bay Area may first bring to mind tech behemoths like Facebook and Google. But some drug development companies in the region say its openness to new ideas and the combination of software experience and life sciences expertise are boosting their prospects.

“For us inside the company, having that kind of ‘wet’ and ‘dry’—what Daphne Koller, our founder and CEO, calls that ‘bilingual’—perspective is critically important,”... Read more »

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Roche Gets FDA OK for Injectable Version of Breast Cancer Drug

Mon, 06/29/2020 - 19:07

A new version of a combination drug marketed by Roche for early-stage and metastatic breast cancer with a specific genetic signature received FDA approval Monday for a formulation that can be delivered in minutes rather than an hour or more.

The antibody combo, delivered alongside IV chemotherapy, is intended for women with breast cancer that overexpresses a protein called HER2; each drug—both of which were developed by Roche subsidiary Genentech—is believed to attack tumors differently.

The newly approved drug, Phesgo, is a fixed-dose mix of pertuzumab (Perjeta) and trastuzumab (Herceptin) that uses technology developed by San Diego’s Halozyme Therapeutics (NASDAQ:... Read more »

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FDA Again Dings Heron’s Opioid Alternative Over “Nonclinical Issues”

Mon, 06/29/2020 - 14:39

Heron Therapeutics revealed Monday that its investigational non-opioid drug for treating postoperative pain has again been rejected by the FDA.

The San Diego company’s HTX-011 is an extended-release solution of bupivacaine, a local anesthetic, and meloxicam, a nonsteroidal anti-inflammatory drug. Heron (NASDAQ: HRTX) positioned it as a pain management option that could contribute to a needed reduction in the use of opioid-based medications, which have a high potential for addiction.

According to the company, the FDA’s complete response letter received Friday asked for more information about four “nonclinical” issues. Three relate to excipients—inactive ingredients in a drug formulation—used in... Read more »

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FDA Says “No” to Intercept Pharma’s NASH Drug, Asks for More Data

Mon, 06/29/2020 - 11:08

The FDA has rejected an Intercept Pharmaceuticals drug developed to treat the fatty liver disorder nonalcoholic steatohepatitis, more commonly referred to as “NASH.”

New York-based Intercept (NASDAQ: ICPT) said Monday that the agency’s complete response letter for obeticholic acid (OCA) stated that its review found that the investigational NASH drug’s benefit “remains uncertain” and does not sufficiently outweigh its potential risks. The agency recommended that the company submit more safety and efficacy data from an ongoing clinical study, and continue its long-term evaluation of the drug in NASH patients. Speaking on a conference call, Intercept CEO Mark Pruzanski said the... Read more »

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New Xconomy Special Report: Biopharma and Tech Innovators Summer 2020

Mon, 06/29/2020 - 09:49

Even during the most difficult of times, the life science sector continues to push forward with innovation. The recent rapid progression of drug development, diagnostic tests, and healthcare tools has propelled us into new territory that was unthinkable – or even unknown – just a decade ago. While other sectors beg for bailouts, biopharma has remained buoyant and resilient in the face of COVID-19.

Read our new special report Biopharma and Tech Innovators Summer 2020 to learn more about the cutting-edge companies behind these innovations that are disrupting the sector and revolutionizing the healthcare landscape. Created in partnership with EBD Group.... Read more »

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With Peanut Patch in FDA Purgatory, DBV Plans Layoffs to Stretch Cash

Fri, 06/26/2020 - 15:04

DBV Technologies still expects to receive an FDA decision in early August for its peanut allergy patch. But on Friday the company, which is headquartered in the southern outskirts of Paris, said it would start layoffs and scale down its drug development activities to save cash in case the radio silence it says it has received from the agency since it submitted additional data in April indicates further delays to come.

Once the company was vying with Aimmune Therapeutics (NASDAQ: AIMT) to win the first regulatory OK for a food allergy immunotherapy. In January, Aimmune’s drug, Palforzia, beat DBV’s... Read more »

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Eye Inflammation Dooms AbbVie Wet AMD Drug to an FDA Rejection

Fri, 06/26/2020 - 10:43

The FDA has rejected an investigational AbbVie drug for the “wet” form of age-related macular degeneration, dealing a setback to the company’s bid to wrest market share from blockbuster drugs currently used to treat the condition.

According to AbbVie (NYSE: ABBV), the FDA’s complete response letter states that the drug, abicipar pegol, caused a high rate of inflammation—a safety risk that the regulator concluded outweighs its benefits. The North Chicago, IL-based company said it plans to meet with the agency to discuss its comments and determine the next steps for the drug.

Age-related macular degeneration (AMD) causes blurriness and loss... Read more »

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Artiva Bio Raises $78M to Broaden Access to Cancer Cell Therapies

Fri, 06/26/2020 - 10:04

Creating cell therapies for cancer is a complex process. The business case for them has proven tricky, too.

Biotech veterans Tom Farrell and Peter Flynn have teamed up to start a new San Diego company that aims to develop allogeneic, or off-the-shelf, cell-based immunotherapies using natural killer (NK) cells that can be manufactured at scale and delivered to cancer patients outside of the hospital.

Artiva Biotherapeutics (the name is a portmanteau of “art” and “viva”) emerged from stealth Thursday with $78 million in Series A financing, a partnership with a South Korean company for clinical manufacturing services, and plans to kick... Read more »

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