In bid to avoid immunotherapy toxicities, Cartography charts a course toward modality-agnostic drugs – Endpoints News

2022-07-22 20:32:37 By : Mr. Frank Lee

In the early days of the Covid-19 pandemic, Kevin Parker was wrapping up his PhD work on regenerative medicine and stem cell biology at Stanford. By the end of 2020, he was setting up a new biotech to squash toxicity issues with immunotherapies by charting an atlas of antigens that might point to more precise targets.

Parker and his co-founders — Stanford professors Howard Chang and Ansu Satpathy, a faculty fellow at Carolyn Bertozzi’s ChEM-H institute  — secured seed financing in 2020 from Andreessen Horowitz and have now lined up a $57 million Series A, marking the unveiling of the Foster City, CA-based biotech. Parker tells Endpoints News the Series A was raised at the end of 2021 and will likely bring the startup toward the clinic, with a Series B needed to translate preclinical work into human studies.

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When gene editing exploded onto the scene over three decades ago, it brought previously inconceivable disease treatment and potentially curative therapies into view. Today, gene editing remains one of the most gripping topics in biopharma — and a recent wave of partnerships may move the industry even closer to broad, curative treatment for genetic disease.

Discoveries across the natural environment deriving in vivo and ex vivo biotechnologies have ushered a floodgate of development possibilities. With giants like Bayer, Moderna, Vertex and others signaling that gene editing will be a key driver of their future pipelines, how will the industry leverage this new frontier of genomic technology?

Roche CEO Severin Schwan will be moving to the board chairman role in a few months, making room for Thomas Schinecker — the current chief of the diagnostics division — to take the helm of the Swiss pharma conglomerate.

The changeover will take place at the company’s annual general meeting in March as Christoph Franz, chairman since 2014, decided not to seek re-election to the board.

The shuffle at the top comes as Roche has steadily beefed up its early-stage pipeline while vigilantly guarding its position as one of the top drugmakers around the world. By Evaluate’s estimate, it is set to rank second on the list of largest pharmas by 2028, falling just a tad behind AbbVie.

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With demand rising for Bavarian Nordic’s smallpox vaccine, European officials have given the thumbs up to expand the label to include monkeypox.

Imvanex, marketed as Jynneos in the US, has been approved in Europe to treat smallpox since 2013. On Friday, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended adding a monkeypox indication to the label, as global cases surge past 15,000. The label expansion still needs to be approved by the European Commission before it’s official.

How does a cancer drug cross the FDA finish line 3-5 months before its PDUFA date? That’s where the Real-Time Oncology Review comes in.

For the last five years, FDA’s Oncology Center of Excellence under Rick Pazdur has been quietly tapped into RTOR to allow sponsors to provide even earlier, segmented submissions of critical efficacy and safety data, thereby enabling these faster evaluations of applications.

After Olympic gold medalist Lindsey Vonn’s first major knee surgery in 2013, she couldn’t sleep. That was the beginning of a cycle of more injuries, added anxiety and stress snowballing into an eventual diagnosis of insomnia.

Now Vonn’s teaming up with Idorsia Pharmaceuticals on its sleep drug Quvivic as its newest celebrity patient ambassador. Vonn appeared in media interviews this week, including on the Today Show and People magazine, talking about her struggles with sleep, along with overall mental health issues.

Lonza’s recent building spree and contracts have the manufacturer looking positive as it enters the second half of the year.

According to Lonza’s financial report for H1, which was released on Friday, the Swiss manufacturer posted sales of CHF 3 billion, or $3.1 billion, granting them a total of 16.8% growth in sales.

The first half’s core EBIDTA for Lonza also rose 33.1% according to the company. The company is still targeting low to mid-teen sales and EBIDTA growth for the year.

The room was packed and electric. That’s how it felt hosting an event in person for Endpoints News readers last month in San Diego.

It exceeded all our expectations, which wasn’t a given, with the pandemic changing the nature of live events. We hadn’t done one in over two years. And Endpoints grew a lot during that time. We quickly built a serious virtual events platform and developed big audiences around those online channels. But there’s nothing quite like being with your colleagues at a live event. Endpoints has a tradition of convening our audience of biopharma pros in major hubs worldwide since our start in 2016. And we’re thrilled to jump right back in.

A California developer is following up on one of the hottest trends in biotech, taking out a loan to extend its operating runway while the biotech sector takes a beating on Nasdaq.

Vaccine outfit Gritstone bio put out word Thursday that it entered into an $80 million credit facility with Hercules Capital and Silicon Valley Bank. The facility, a type of loan, breaks down in the following: $20 million drawn by Gritstone at closing, with another $10 million available to withdraw by March 15, 2023. The remaining $50 million will become available in tranches through June 15, 2024 as Gritstone achieves certain, unspecified milestones.

After 20 years of service at GSK — leading global vaccines R&D for the last seven — Emmanuel Hanon left last year for a wellness company with a gut microbiome focus called Viome.

One of the major reasons for the departure, according to him, was in essence to learn something new and to be exposed to a new environment.

But it didn’t take long for him to return to the vaccine world full-time. Hanon has now taken the top position at a Medicxi-backed biotech working on a vaccine for RSV called Vicebio.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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