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Updated: 29 min 37 sec ago

GlaxoSmithKline Multiple Myeloma Drug Earns FDA’s First Anti-BCMA Nod

Thu, 08/06/2020 - 16:49

Patients with advanced multiple myeloma have a new treatment option with the FDA’s approval of a GlaxoSmithKline drug that targets B-cell maturation antigen, a protein found on the surface of cancerous plasma cells.

The agency OK’d the London-based pharma giant’s cancer drug, belantamab mafodotin (Blenrep), based on the results of a study in which patients with the blood cancer received the drug intravenously every three weeks until their disease progressed or the side effects became too much to handle.

Patients that received the GSK (NYSE: GSK) drug in the trial, dubbed DREAMM-2, had previously undergone a median of seven prior... Read more »

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G1 Vets Launch Arc Therapeutics to Take on New Cancer Target

Thu, 08/06/2020 - 10:49

Three early employees of G1 Therapeutics have launched a new oncology-focused company and raised $6 million to move a preclinical program licensed from their former employer into the clinic.

The startup, Research Triangle Park, NC-based Arc Therapeutics, is headed by Patrick Roberts (pictured above), who most recently served as the head of translational medicine at G1 Therapeutics (NASDAQ: GTHX). He started Arc with Jay Strum, its chief scientific officer, and John Bisi, senior vice president of research and development. Strum was also CSO at G1; Bisi served as senior director of preclinical R&D.

Financing for Arc, in addition to the... Read more »

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Biogen to Pay Denali $1B to Partner on Parkinson’s Drug & Other Neuro Meds

Thu, 08/06/2020 - 08:02

Denali Therapeutics has selected a brain-penetrating Parkinson’s disease drug candidate to advance to late-stage testing and Biogen is paying $1 billion to kick off a partnership on that compound, and potentially others.

According to terms of the deal announced Thursday, the companies will co-develop the small molecule, dubbed DNL151. Biogen (NASDAQ: BIIB) also gains options to develop two additional programs, and the right of first negotiation on two others—all of them for neurodegenerative diseases. Those compounds use Denali’s proprietary technology for delivering drugs across the blood-brain barrier.

Biogen has agreed to pay Denali (NASDAQ: DNLI) $560 million cash up... Read more »

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MeiraGTx Names Immunovant’s Zeldin as Its Chief Medical Officer

Wed, 08/05/2020 - 20:38

Robert Zeldin has joined gene therapy developer MeiraGTx as its chief medical officer. Most recently he held the same role at Immunovant (NASDAQ: IMVT). Prior Zeldin served as CMO at Acceleron Pharma (NASDAQ: XLRN) and at Ablynx. His experience also includes time at Stallergenes, Novartis (NYSE: NVS), and Merck, as well as a stint with the FDA prior to entering industry.

MeiraGTx, of New York and London, recently began planning a Phase 3 trial for one of its clinical-stage programs, a potential treatment for an inherited condition that causes progressive vision loss it is developing with partner Johnson... Read more »

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IgGenix Grabs $10M to Advance Antibody Treatments for Allergies

Wed, 08/05/2020 - 12:01

About six months after the FDA approved the first treatment for peanut allergy, a new biotech, IgGenix, has raised $10 million to discover antibodies that could address that and other common allergies.

The six-person startup, which is based out of the Johnson & Johnson (NYSE: JNJ) JLABS incubator in South San Francisco, raised the Series A cash in a financing round led by Khosla Ventures with participation from Parker Ventures.

IgGenix is taking a very different tack from the one that led the FDA to approve the Brisbane, CA-based Aimmune (NASDAQ: AIMT) drug, Palforzia. That oral immunotherapy delivers precise... Read more »

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As Patients Pivot to Telehealth, Teladoc & Livongo Plan $18.5B Tie-Up

Wed, 08/05/2020 - 11:52

Telemedicine giant Teladoc Health is buying health technology company Livongo Health in an $18.5 billion cash and stock deal that comes as the COVID-19 pandemic drives patients to seek ways to manage their health from home.

Teladoc (NYSE: TDOC) provides “virtual healthcare services” that give patients the ability to visit with a doctor remotely. Most of its clients are large companies and health plans that offer Teladoc’s services to their employees or beneficiaries, though it does have individual users of its behavioral health services. Meanwhile, Livongo (NASDAQ: LVGO) sells software and devices that help patients manage chronic conditions, including... Read more »

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GentiBio Joins Cell Therapy Chase With $20M and New Treg Technology

Wed, 08/05/2020 - 04:00

One of the challenges facing cell therapy developers is collecting enough cells to produce a viable treatment. It’s a particularly pronounced problem for therapies employing regulatory T cells (Tregs), a type of immune cell that’s relatively scarce in the blood, says GentiBio CEO Adel Nada.

Some biotech companies are developing Treg cell therapies from a patient’s own Tregs. GentiBio makes its Treg therapeutic candidates from an entirely different type of immune cell, and Nada says this approach could make Treg cell therapy production more scalable. On Wednesday, the Boston-based startup announced its launch backed by $20 million in funding.

The immune... Read more »

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Black Diamond Makes Fang Ni’s Chief Business Officer Job Permanent

Tue, 08/04/2020 - 19:33

Black Diamond Therapeutics (NASDAQ: BDTX) has appointed Fang Ni to serve as its chief business officer. Ni has held the role on an interim basis since the company emerged from stealth in late 2018.

Ni was most recently a principal and member of the investment team at Versant Ventures, which incubated Black Diamond before launching it with $20 million in Series A financing. During his time at Versant Ni also served as interim CBO for other emerging companies, including Monte Rosa Therapeutics and Bright Peak Therapeutics. Prior to Versant he was a business development and licensing director at Roche.... Read more »

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Aspen Neuroscience Chief Scientific Officer Loring to Step Down

Tue, 08/04/2020 - 19:05

Jeanne Loring, a co-founder of Aspen Neuroscience, is stepping down from her role as its chief scientific officer.

The La Jolla, CA-based company said Loring—professor emeritus at the Scripps Research Institute, where her work on the genomics of induced pluripotent stem cells laid the foundation for the company’s launch—will become a special advisor to the company’s research and development committee.

Earlier this year Aspen raised $70 million to advance its efforts to develop neuron replacement therapies that use a patient’s own living cells to treat Parkinson’s disease.

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Prometheus Taps Conatus’s Marshall as Its Chief Financial Officer

Tue, 08/04/2020 - 17:54

Prometheus Biosciences has appointed Keith Marshall its chief financial officer. Marshall most recently served as chief operating officer and CFO at Conatus Pharmaceuticals, which earlier this year merged with Histogen (NASDAQ: HSTO). Before Conatus, Marshall was CFO and head of corporate development at Flagship Pioneering spinout Torque Therapeutics, since renamed Repertoire Immune Medicines. Marshall started his career in investment banking.

San Diego-based Prometheus is developing targeted therapies for inflammatory bowel disease. The company, formerly known as Precision IBD, last year acquired a gastrointestinal disease diagnostics unit called Prometheus Laboratories from Nestlé Health Science and after combining the firms,... Read more »

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Still Stuck on Adhesion Issues, FDA Rejects DBV’s Peanut Allergy Patch

Tue, 08/04/2020 - 16:00

A skin patch developed by DBV Technologies to desensitize peanut allergy sufferers to the allergen over time has been rejected by the FDA, which says the French company needs to change its design and run another clinical trial testing the modified version if it wants the treatment reviewed again.

DBV (NASDAQ: ticker:DBVT]]), which has its headquarters on the outskirts of Paris and US operations in New York and Summit, NJ, said Tuesday that the FDA letter noted in addition to generating more clinical data, the company must provide more specifications about chemistry, manufacturing, and controls, after reworking the product’s design. All... Read more »

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CymaBay PBC Drug Hits Phase 3 Goals With Signs of Side Effect Advantage

Tue, 08/04/2020 - 14:10

CymaBay Therapeutics’ investigational drug seladelpar succeeded in a late-stage trial in patients with primary biliary cholangitis (PBC), producing results that suggest it could have a key side effect advantage compared to a drug currently used to treat the rare liver disease.

Patients with PBC, which damages the bile ducts of the liver, are initially treated with ursodeoxycholic acid (UDCA). When UCDA isn’t an option or doesn’t work well enough, Intercept Pharmaceuticals (NASDAQ: ICPT) drug obeticholic acid (Ocaliva) is the next option.

However, one of the most common side effects of the Intercept drug is pruritis, or itching—a common PBC symptom... Read more »

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AbbVie Walks From Voyager R&D Pact Spanning Alzheimer’s, Parkinson’s

Tue, 08/04/2020 - 08:05

A partnership between Voyager Therapeutics and AbbVie developing gene therapies for Alzheimer’s and Parkinson’s has ended without a drug for either disease reaching human testing.

Voyager (NASDAQ: VYGR) announced the termination of the research pact after the market close Monday. The Cambridge, MA-based biotech is keeping full rights to its technology for using engineered viruses to deliver gene therapies to the brain. Voyager also keeps the rights to gene therapy candidates designed to code for therapeutic antibodies.

Shares of Voyager opened Tuesday at $10.83 apiece, down 4.4 percent from Monday’s closing price.

Voyager and AbbVie began working together in 2018... Read more »

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Legend Biotech CEO Xu Resigns, Genscript’s Zhang Named Successor

Mon, 08/03/2020 - 14:27

Yuan Xu, the CEO of Legend Biotech (NASDAQ: LEGN) for the past two years, has resigned for “personal reasons,” the company announced Sunday. No other details were given. She has also stepped down from the Somerset, NJ, company’s board of directors.

Frank Zhang, chairman of Legend’s board and CEO of GenScript, the biotech’s largest shareholder, has been appointed Xu’s successor. Zhang founded Legend in 2015 as a GenScript subsidiary, according to the biotech. Legend spun off from its parent with the completion of its June IPO, which raised $424 million. Zhang has stepped down as GenScript’s CEO but will... Read more »

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Bluebird’s Susanna High Jumps to Dyne for Chief Operating Officer Role

Mon, 08/03/2020 - 14:11

Dyne Therapeutics has appointed Susanna High to serve as its chief operating officer, the same position she held most recently at Bluebird Bio (NASDAQ: BLUE). High’s experience also includes senior roles at Alynlam Pharmaceuticals (NASDAQ: ALNY) and Millennium Pharmaceuticals. Last year, Cambridge, MA-based Dyne raised $50 million in Series A financing to support the development of drugs for rare muscular disorders.

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MorphoSys, Incyte Get Early FDA Nod for Antibody Alternative to CAR-T

Mon, 08/03/2020 - 10:59

A MorphoSys antibody drug developed for diffuse large B-cell lymphoma (DLBCL) has won FDA approval, providing an  alternative to cumbersome and risky CAR-T therapies to treat the cancer.

The late Friday approval for the drug, tafasitamab (Monjuvi), covers adults whose DLBCL has relapsed or has not responded to an earlier treatment. MorphoSys (NASDAQ: MOR), a company based in Germany, will co-commercialize the drug in the US with Wilmington, DE-based Incyte (NASDAQ: INCY) under a partnership signed earlier this year.

DLBCL is the most common form of non-Hodgkin lymphoma. It involves rapidly growing masses of cancerous B-cells in the... Read more »

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Kymera Therapeutics Unveils IPO Pitch for Protein Degradation

Fri, 07/31/2020 - 17:44

Kymera Therapeutics has a pipeline of preclinical drug candidates that use an experimental approach to get rid of disease-causing proteins and it’s now looking to tap the public markets to finance tests of the technology in humans.

In paperwork submitted to the Securities and Exchange Commission on Friday, Kymera set a $100 million goal for its IPO. The filing comes three weeks after the Cambridge, MA-based biotech inked a multi-year, multi-product R&D partnership with Sanofi (NYSE: SNY) that paid $150 million up front.

Kymera is developing drugs that harness protein degradation, a cell’s built-in process for recycling or disposing of... Read more »

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AnaptysBio Appoints Paul Lizzul as Its Chief Medical Officer

Fri, 07/31/2020 - 14:07

Paul Lizzul has joined AnaptysBio (NASDAQ: ANAB) as the company’s chief medical officer. He succeeds Marco Londei, who held the roles of CMO and chief development officer at AnaptysBio until earlier this year, when he joined Dutch biotech Gadeta as CEO.

Lizzul most recently served a short stint at Amgen (NASDAQ: AMGN) as global development lead for inflammation. Previously he was CMO at Sienna Biopharmaceuticals, which shuttered in 2019, and senior medical director at cosmetic drug company Kythera Biopharmaceuticals, which Allergan acquired for $2.1 billion in 2015. San Diego-based AnaptysBio is developing antibodies to treat inflammatory disorders; the company... Read more »

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Bio Roundup: Cerevel’s Shell, Thrive’s Rise, Drug Price Drama & More

Fri, 07/31/2020 - 07:20

The biotech IPO market is buzzing but Cerevel Therapeutics is showing that there’s more than one path to the public markets. This week the neuroscience drug developer reached a deal to merge with publicly traded Arya Sciences Acquisition Corp II.

If you’ve never heard of Arya (NASDAQ: ARYBU), it’s a shell company that Perceptive Advisors formed specifically to serve as a vehicle to take a private company public. Cerevel is young, but it’s pretty far along. Bain Capital and Pfizer (NYSE: PFE) launched it in 2018 with neuroscience compounds from the pharma giant’s labs. Now Arya and a... Read more »

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Novartis Pays $75M to Get Hands on Sangamo’s Zinc Fingers for Drug R&D

Thu, 07/30/2020 - 17:34

Another biopharma has signed up to use Sangamo Therapeutics’ gene editing technology to develop therapies that can address disease by heightening or depressing a gene’s activity level.

Sangamo on Thursday announced that Novartis (NYSE: NVS) had agreed to shell out $75 million up front to leverage the biotech’s genome regulation technology to treat certain neurodevelopmental conditions. Brisbane, CA-based Sangamo could earn up to $720 million in milestone payments, plus royalties on any products that emerge from the deal.

The Sangamo (NASDAQ: SGMO) tech uses proteins known as zinc finger nucleases that bind DNA to edit genes. Novartis says it... Read more »

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