Genentech Archives - Medical Design Sourcing

Genentech’s lab in the loop aims to tap the power of quantity for quality drug discovery

[NVIDIA]

We can design chips that power self-driving cars and create physically-realistic video footage based on text descriptions. Yet, as Genentech’s Aviv Regev pointed out in a session about the company’s lab in the loop at NVIDIA’s GTC conference, the humble cells within us operate with a complexity that still eludes our full understanding.

It turns out that a cell is itself like a computational device with circuits and code, Regev said. These molecular “circuits” interact with each other, receive information, make decisions, and execute them. “These molecular circuits — they’re hard to reverse engineer,” she said. That hasn’t stopped scientists from spending decades trying to model and predict their behavior. “Mostly unsuccessfully, I can tell you,” Regev added.

But what if we could harness the same technological power driving those other breakthroughs to unravel t…

Nvidia-Genentech AI drug discovery alliance unites computing brawn with biological brains

NVIDIA BioNeMo AI molecular modeling software can uncover complex biochemical interactions through AI-driven molecular modeling techniques. [Image courtesy of NVIDIA]

Technically, graphics processing and AI hardware powerhouse Nvidia is also a drug discovery company. It may not discover drugs in-house, but it has developed BioNeMo, a comprehensive generative AI platform for drug discovery and Clara, a collection of healthcare frameworks, applications, and tools, including for biopharma. Nvidia partners include Amgen, AstraZeneca, GSK and Insilico Medicine.

Similarly, biotech pioneer and Roche subsidiary Genentech is also an AI company. It has experience in applying machine learning to an array of disease areas, and has extensive biological and molecular datasets and research capabilities. Its initiatives include alliance with firms such as Recursion Pharmaceuticals and Reverie Labs that focus on using AI for nov…

The biggest medical device VC deals of 2022

Enable Injections, which makes the enFuse device, raised $215 million in January 2022. [Photo courtesy of Enable Injections]

Last year was definitely a slower year for medical device VC deals than the year before.

Biofourmis was the only medical device developer in the 10 largest healthcare VC deals of 2022, according to a ranking provided to Medical Design & Outsourcing by Silicon Valley Bank (SVB).

Because we love devices at Medical Design & Outsourcing, we asked SVB for a ranking of 2022’s largest medical device VC deals after Biofourmis, which raised $325 million in its 2022 series D round. (The year before that, CMR Surgical’s $600 million Series D financing round was the largest medical device VC deal of 2021.)

SVB obliged, once again drawing upon its own proprietary information and data from Pitchbook. The dealmakers include device developers with innovative methods for …

Genentech says new Oceanside biologics plant will be one of the world’s most modern

New Oceanside facility rendering. [Image courtesy of Genentech]

Roche (SWX:ROG) division Genentech recently announced that it would build a new biologics manufacturing facility in Oceanside, California. Optimizing for both speed and modularity, the facility will use the latest digital technologies and in-house process improvements to maximize production volumes. Genentech is also designing the facility with sustainability in mind. The plant will reduce energy use, generate renewable electricity and eliminate plastic waste sent to landfills.

The announcement of the new plant follows last year’s opening of a new clinical supply center at its South San Francisco birthplace.

In a recent interview, we spoke with Nazeli Dertsakian, general manager of Genentech’s Oceanside facility, about the technology and sustainability features of the new biologics manufacturing facility. Dertsakian shares insight…

Genentech invests $450 million in Oceanside campus, creating 150 local jobs

Genentech has announced the construction of a new biologics manufacturing facility in Oceanside, California. The facility, located about 35 miles north of San Diego, will use digital technologies to make the production of medicines more efficient and environmentally friendly.

The company hails the plant as one of the world’s most advanced commercial-scale biologics manufacturing facilities.

When operational in 2025, the plant’s modular design will allow for the simultaneous production of multiple medicines. It will also support pivoting quickly from producing one drug to another.

The facility will be the first in the company’s network specifically designed to commercialize biologics for narrower patient populations, including rare diseases and personalized medicines.

Close to talent

Genentech selected the Oceanside campus for its proximity to biotech talent and its clinical supply center in South San Francisco.

Genentech, …

FDA approves bispecific antibody from Genentech

The FDA has approved Genentech‘s Lunsumio (mosunetuzumab-axgb), a novel bispecific antibody for relapsed or refractory follicular lymphoma (R/R FL).

The indication covers R/R FL patients who have received at least two prior systemic therapies.

Patients with the cancer subtype have had limited treatment options and significant morbidity and mortality.

The approval of Lunsumio is the first time the FDA has approved a bispecific antibody to treat one of the most common slow-growing forms of non-Hodgkin’s lymphoma.

Lunsumio is a CD20xCD3 T-cell-engaging bispecific antibody.

Priority review and breakthrough therapy designation

FDA granted priority review to Lunsumio this summer. The agency granted it breakthrough therapy designation (BTD) in 2020.

In the pivotal Phase 2 GO29781 study, 60% (54/90) of Lunsumio recipients who received at least two prior therapies had complete remission. A total of 80% (72/90) of patients had …

At ASH, Genentech showcases expanded hematology portfolio that includes bispecific antibodies

At ASH 2022, Roche (SWX: ROG) subsidiary Genentech presented new data demonstrating the potential of glofitamab and mosunetuzumab, its investigational CD20xCD3 T-cell engaging bispecific antibodies, as fixed-duration, off-the-shelf treatment options for two types of non-Hodgkin’s lymphoma (NHL) – large B-cell lymphoma (LBCL) and follicular lymphoma (FL), respectively. “The new data demonstrated durable and impressive patient responses, including complete remissions, with glofitamab and mosunetuzumab when given for a fixed period of time,” said Dr. Ginna Laport, vice president, global head of lymphoma/CLL development franchise at Genentech.

Dr. Ginna Laport

“Given the findings, we believe our investigational bispecifics offer new hope for people living with these types of lymphoma,” Laport said.

In the following interview, Laport opens up about the promise of CD20xCD3 T-cell engaging bispecific antibod…

Genentech’s clinical supply center rethinks biologics manufacturing

Genentech CSC building exterior, South San Francisco, California [Image courtesy of Genentech]

Genentech has opened a novel clinical supply center at its birthplace in South San Francisco.

The planning for the new $250 million center began in 2019 when Genentech, a member of the Roche Group, began earnest efforts to imagine what the future of biomanufacturing looks like.

“We were looking at where we are going in the industry,” said Jeff Davis, the executive director of the Clinical Supply Center (CSC). “And what does Genentech need? What are the trends across the industry?”

One of those trends is prioritizing personalized medicines focused on small patient groups. Genentech thus determined it needed to supplement its large-volume manufacturing with more agile facilities. It began planning the construction of a fast, agile facility that can produce distinct batches on differe…

Genentech’s crenezumab stumbles in Alzheimer’s trial

Roche (SIX:RO, ROG; OTCQX:RHHBY) subsidiary Genentech announced that a study of the amyloid beta-protein inhibitor crenezumab failed to show statistically significant clinical benefit in Alzheimer’s patients.

The failure is typical. Historically, 99% of Alzheimer’s drug candidate studies fail to show improvement over placebo, according to Alzheimer’s Research & Therapy.

In the research, Genentech partnered with the Banner Alzheimer’s Institute, the University of Antioquia in Colombia and the National Institute on Aging.

The research did find slight differences favoring crenezumab across several endpoints, but they failed to reach statistical significance.

“We’re disappointed that the treatment did not demonstrate a statistically significant clinical benefit,” said Dr. Eric M. Reiman, Banner Alzheimer’s Institute executive director, in a news release. “At the same time, we’re proud of …

Purdue University launches institute for advanced manufacturing of pharmaceuticals

Thanks to a donation from pharma industry veteran William D. Young, Purdue University has announced plans to launch a new institute dedicated to furthering pharmaceutical manufacturing to reduce costs and bolster access to new biotech drugs.

The William D. Young Institute for Advanced Manufacturing of Pharmaceuticals is named after the eponymous chemical engineer, who graduated from Purdue in 1966. Yong went on to become the chief operating officer of Genentech from 1980 to 1999. Young is now a senior advisor to Blackstone Life Sciences (South San Francisco and Cambridge, Massachusetts).

“We’re honored to receive this gift from a man with a global reputation as a talented chemical engineer who built an outstanding technical and management record in pharmaceutical and biotech manufacturing,” said Purdue President Mitch Daniels in a statement. “Everyone in pharma knows that having Bill Young’s name on the sign means we will be working to the highest standards and…

Flywheel working with Roche and Genentech to sift through medical imaging data

The research data platform Flywheel has announced that Roche (OTCMKTS:RHHBY) and its subsidiary Genentech are using its cloud-scale informatics platform to ingest, standardize and analyze medical imaging data to streamline drug discovery.

Minneapolis-based Flywheel says the process provides a swifter and more efficient means to curate data at the terabyte and petabyte scales. Specifically, Roche and Genentech are using the platform to assist in finding answers to core scientific questions related to patient care and outcomes.

“With our platform in place, Roche and Genentech researchers can access high-quality images for complex analysis and machine learning, ultimately speeding the development of innovative therapies,” said Jim Olson, CEO of Flywheel, in a press release. “Before using the platform, this level of collaboration and analysis was simply not possible.”

A number of prominent research institutions, including Stanford University, Columbia Univer…

FDA approves Genentech’s Susvimo drug-eluting eye implant

Genentech’s Susvimo implant. [Image from Genentech]Genentech announced today that it received FDA approval for its Susvimo injection for treating macular degeneration (AMD).

South San Francisco-based Genentech, a member of the Roche Group, designed its Susvimo ranibizumab injection (100 mg/mL) for intravitreal use via ocular implant for treating people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.

Get the full story at our sister site, Drug Delivery Business News.