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Updated: 5 hours 45 min ago

Axsome Plans to Try Again After Failure in Treatment-Resistant Depression

6 hours 27 min ago

An experimental Axsome Therapeutics drug for treatment-resistant depression has fallen short of the main goal of a late-stage test. But the company says the pill is showing enough promise to warrant trying another Phase 3 study.

Axsome (NASDAQ: AXSM) tested its drug, AXS-05, in patients with major depressive disorder who had previously failed to respond to treatment with antidepressants. The study, which enrolled 312 patients, compared the Axsome drug to the antidepressant bupropion. Patients were evaluated according to the Montgomery-Åsberg depression rating scale, a diagnostic questionnaire used to measure the severity of depression episodes. Axsome reported Monday that patients treated... Read more »

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Xcelerating Life Sciences Seattle

10 hours 22 min ago

Stay at the forefront of Seattle’s cancer treatment trends and technologies that are fueling today’s biotech investment and partnership opportunities

There is an outsize presence of cancer work in Seattle compared to other regions, and the investment in personalized diagnostics has grown considerably in the past year. But once companies get big enough to have an impact, they are often acquired like homegrown Juno, Immune Design, and Seagen. What does it take to have a successful merger? And how are acquisitions affecting the life science ecosystem in Seattle?

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San Diego Biotech Entrepreneurs, Innovation Lead to “Maturing” Ecosystem

15 hours 28 min ago

The local biotech ecosystem is growing up thanks to its innovative science and collaborative ecosystem, advantages that put it nearly on par with the nation’s top life science regions, according to industry veterans.

San Diego has long been considered a second-tier primary biopharma hub in terms of number of companies and venture capital raised, falling behind the twin behemoths of Boston-Cambridge and the San Francisco Bay Area on those and other metrics.

At Xconomy’s Xcelerating Life Sciences San Diego event this month, investors, executives, and others noted under-looked strengths contributing to the region’s maturation.

Venture capitalist Nancy Hong recalled that some... Read more »

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Sanofi Adds mRNA COVID-19 Vaccine Bet Through Translate Bio Alliance

Fri, 03/27/2020 - 18:00

Sanofi is joining the array of companies pursuing a COVID-19 vaccine based on messenger RNA (mRNA), an experimental genetic technology intended to coax the body’s cells into producing proteins that treat a disease or spark immunity to one.

Sanofi (NYSE: SNY) announced Friday that it will develop COVID-19 vaccine candidates with Translate Bio (NASDAQ: TBIO), a Lexington, MA-based developer of mRNA therapies. The companies are already partners. In 2018, they began a three-year alliance aiming to develop vaccines for up to five infectious diseases. The COVID 19 research tacks a sixth vaccine target onto that pact.

For Sanofi... Read more »

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Equillium Continues Graft-Versus-Host Disease Trial, Pauses 2 Others

Fri, 03/27/2020 - 15:12

Equillium has halted two clinical trials of its lead drug candidate out of an “abundance of caution” related to the coronavirus outbreak but continues to enroll in a third, which is evaluating the antibody as a treatment for acute graft-versus-host disease.

The decision made by the San Diego biotech, revealed in its annual report filed Thursday with regulators, is one of the latest examples of clinical trial progress being stymied by the deadly virus, which is delaying the development of some new drugs as companies struggle to cope with challenges including site closures, travel limitations, and supply chain interruptions.

In... Read more »

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Bio Roundup: Clinical Trials Paused, New MS Drug, Kallyope’s Cash & More

Fri, 03/27/2020 - 07:03

Finding and enrolling patients for clinical trials is always challenging. The coronavirus pandemic has made it nearly impossible.

Fallout from the spread of COVID-19 infections led several companies to declare this week that they would stop enrolling patients in clinical trials or postpone studies that have not yet started. Eli Lilly (NYSE: LLY) said that many healthcare systems are devoting their resources to treating COVID-19 patients, which makes it difficult for these sites to also start new clinical trials. Pfizer (NYSE: PFE) is delaying new patient recruitment for three weeks. Bluebird Bio (NASDAQ: BLUE) said the pandemic could... Read more »

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Fusion Pharmaceuticals Taps James O’Leary as Chief Medical Officer

Thu, 03/26/2020 - 18:15

Clinical-stage oncology company Fusion Pharmaceuticals has appointed James O’Leary as its chief medical officer.

Fusion is developing new radiopharmaceuticals—pharmaceutical drugs containing radioactive isotopes—to treat a range of types of cancer.

O’Leary’s experience includes roles at biotechs including ImmunoGen (NASDAQ: IMGN), Idera Pharmaceuticals (NASDAQ: IDRA), Array Biopharma, and Deciphera (NASDAQ: DCPH), and pharma companies including Takeda (NYSE: TAK), Bayer, and Pfizer (NYSE: PFE). In his most recent role, at Takeda, O’Leary was a global project team leader for a late-stage asset directing global strategy and regulatory approvals.

Fusion’s lead program, FPI-1434, is in Phase 1 testing, a... Read more »

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Akcea Therapeutics Promotes Damien McDevitt to CEO

Thu, 03/26/2020 - 17:56

Akcea Therapeutics (NASDAQ: AKCA) has appointed Damien McDevitt as its chief executive officer, the company announced Tuesday.

Akcea, a subsidiary of Carlsbad, CA-based Ionis Pharmaceuticals (NASDAQ: IONS), is advancing a group of experimental rare disease drugs discovered by its parent company. McDevitt had been serving as Akcea’s interim CEO since September 2019, when CEO Paula Soteropoulos, president Sarah Boyce, and chief operating officer Jeff Goldberg left the Boston-based company in a sudden management shakeup.

McDevitt joined Ionis as its chief business officer in June 2018 from Acadia Pharmaceuticals (NASDAQ: ACAD), where he served as senior vice president,... Read more »

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Forge Inks Roche Deal For Antibiotic Aimed at Drug-Resistant Infections

Thu, 03/26/2020 - 17:13

Forge Therapeutics has set an agreement with Roche that gives the Swiss pharma giant the option to license a new antibiotic Forge is developing to treat serious drug-resistant bacterial lung infections.

This week the preclinical-stage San Diego-based biotech announced that under the deal Forge will retain control of the program, FG-LpxC LUNG, until Roche decides whether to exercise its exclusive option.

Forge’s experimental antibiotic is intended to address infections most commonly acquired by people with weakened immune systems and chronic lung diseases while in the hospital, such as Pseudomonas aeruginosa, or P.aeruginosa, infections. While generally treated with antibiotics, such... Read more »

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With $80M, ReCode Looks to Advance RNA Therapies for Lung Diseases

Thu, 03/26/2020 - 14:55

Two companies working on treatments for rare genetic lung diseases have combined efforts and raised $80 million to bring into human testing next year two investigational treatments that use types of RNA to tweak mutated proteins.

Dallas company ReCode Therapeutics and Menlo Park, CA-based TranscripTx have merged under the ReCode name and leadership of CEO David Lockhart to advance treatments for progressive pulmonary diseases caused by genetic mutations. On Thursday the company announced it would put proceeds from the Series A financing toward continued preclinical work on its lead programs, investigational therapies for two genetic pulmonary diseases: primary ciliary dyskinesia and... Read more »

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FDA Approves Bristol Myers MS Drug, But Pandemic Will Delay Launch

Thu, 03/26/2020 - 06:58

A multiple sclerosis drug that came to Bristol Myers Squibb via its acquisition of Celgene last year was approved Thursday but don’t expect it to reach patients any time soon. The company says the drug’s launch will be delayed due to the coronavirus pandemic.

The Bristol (NYSE: BMY) drug, ozanimod (Zeposia), is one of the medicines approaching commercialization that the pharmaceutical giant touted as justification for its $74 billion buyout of Celgene. Some analysts have projected that the drug could become a blockbuster seller. But when ozanimod does reach the market, it will compete against other MS medicines in... Read more »

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Oncology Needs Combo Therapies & More Data Analysis, Says Bio-Europe Spring Panel

Thu, 03/26/2020 - 00:52

Future improvements in cancer care are most likely to stem from combinations therapies and data-driven prevention efforts, as well as breakthrough drugs.

That’s the message life sciences experts shared this week during a webcast on the topic of “oncology’s next decade” recorded for the BIO-Europe Spring partnering conference. The event is produced by EBD Group, which is owned by the same parent company as Xconomy, and was held virtually given coronavirus concerns.

“I think the conversion of the coming together of different therapies and different paradigm shifts that we have been through, be it targeted therapy, biologics, or going back earlier,... Read more »

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Regenacy Pharma Raises $30M for Nerve Function Restoring Treatments

Wed, 03/25/2020 - 16:08

Regenacy Pharmaceuticals, a biotech formed as part of Celgene’s acquisition of Acetylon Pharmaceuticals in late 2016, has raised $30 million in Series A financing to move its lead program into a Phase 2 proof-of-concept trial this year.

The Waltham, MA-based company is developing treatments to address the underlying cause of peripheral neuropathies—a form of nerve damage in the fingers and toes that causes numbness and tingling—associated with diabetes and other conditions.

Regenacy plans to first evaluate its lead drug candidate, ricolinostat, in diabetic peripheral neuropathy.

Nerve damage caused by diabetes is a common and serious complication of both type 1... Read more »

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AstraZeneca Joins RNAi Mix, Pledging $80M to Silence Therapeutics

Wed, 03/25/2020 - 12:00

After years of research, technology for silencing a gene—stopping it from producing a disease-causing protein—has reached patients. AstraZeneca is now angling for a position in this burgeoning field through an alliance with Silence Therapeutics, a biotech developing such gene-silencing drugs.

According to deal terms announced Wednesday, AstraZeneca (NYSE: AZN) will pay London-based Silence (LON: SLN) $60 million up front. The pharmaceutical giant will also make a $20 million equity investment in its new partner. The companies initially aim to work on five targets over the next three years. AstraZeneca has the option to expand the pact to another five... Read more »

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Kallyope Gains $112M to Move “Gut-Brain Axis” Programs to the Clinic

Wed, 03/25/2020 - 03:00

Kallyope, one of New York’s best funded biotechs, has secured more than $100 million to move two of its programs into the clinic—including its most advanced, an experimental drug designed to treat obesity.

The company was founded in 2015 with $44 million to leverage new learnings about the “gut-brain axis”—pings of communication between our guts and our central nervous system—to make drugs for a range of diseases.

Since then the company has raised $199 million more across two subsequent rounds of funding, including a $112 million Series C financing announced Wednesday, and advanced two programs to the cusp of human testing.... Read more »

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Chrono Therapeutics Top Executive David Happel Joins Cognoa as CEO

Tue, 03/24/2020 - 09:54

David Happel has been appointed CEO of digital therapeutics developer Cognoa. Brent Vaughan, Cognoa’s co-founder and former CEO, will move into a role at venture capital firm Morningside Group, the Palo Alto, CA-based startup’s largest investor. He will also continue to advise Cognoa. Happel joins the company from Chrono Therapeutics, a digital health startup that developed a smoking cessation technology. Cognoa is developing digital products for diagnosing and treating behavioral conditions. Its first target is autism.

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CytomX Taps Ex-Alder Bio Exec Campoy as Chief Financial Officer

Tue, 03/24/2020 - 09:47

CytomX Therapeutics has appointed Carlos Campoy to serve as its chief financial officer, the same position he held most recently at Alder BioPhrmaceuticals, which was acquired by Lundbeck last year. Campoy’s experience also includes positions at Allergan (NYSE: AGN) and Eli Lilly (NYSE: LLY). South San Francisco-based CytomX develops antibody cancer drugs. This week, the company began a research partnership with Astellas Pharma that will pay $80 million up front to develop cancer immunotherapies based on CytomX’s proprietary technology.

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CytomX Lands $80M to Kick Off Cancer Drug R&D Pact With Astellas

Tue, 03/24/2020 - 08:39

CytomX Therapeutics is teaming up with Astellas Pharma in a research and development alliance focused on developing new cancer immunotherapies based on its antibody technology.

Under deal terms announced late Monday, Astellas is paying CytomX (NASDAQ: CTMX) $80 million up front. South San Francisco-based CytomX will conduct and finance the research up to the selection of drug candidates. Astellas will take the lead from there, funding preclinical and clinical research. Depending on the progress of those programs, Tokyo-based Astellas could pay CytomX up to $1.6 billion more, plus royalties from sales of any approved products.

Shares of CytomX opened at... Read more »

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Palforzia Peanut Allergy Immunotherapy: Aimmune CEO on REMS, Manufacturing

Tue, 03/24/2020 - 05:55

Aimmune Therapeutics Inc. is navigating a host of new challenges as it launches Palforzia, the first peanut allergy immunotherapy to be approved by the US Food and Drug Administration. Most notably, it must get physician practices and individual allergists certified to administer the treatment.

Aimmune (NASDAQ: AIMT) president and CEO Jayson Dallas talked to our sister publication the Pink Sheet about the certification process, part of the company’s Risk Evaluation and Mitigation Strategy (REMS), in an interview in New York last month. He also discussed the complexities involved in manufacturing the food-derived treatment.

Some analysts have speculated that the restriction... Read more »

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Genprex Adds Chief Strategy Officer, Chief Operating Officer to C-Suite

Mon, 03/23/2020 - 16:59

Gene therapy company Genprex (NASDAQ: GNPX) has added two new executives to its management team: Catherine Vaczy as chief strategy officer and Michael Redman as chief operating officer. Both are executive vice presidents.

Vaczy most recently provided strategic advisory services to early stage biotechnology companies. Previously she co-founded and served for a decade on the leadership team at NeoStem, now Caladrius Biosciences (NASDAQ: CLBS). Her prior experience includes time at ImClone Systems, which was acquired by Eli Lily (NYSE: LLY).

Redman was most recently president and CEO of Oncolix. Previously he was CEO of Bone Medical and... Read more »

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