Nicholas Green, Avid Bioservices CEO

A Cal­i­for­nia biotech steps in­to the vi­ral vec­tor space with new site build of $75M

As cell and gene ther­a­py gets hot­ter, a Cal­i­for­nia CD­MO has made a play to open an en­tire­ly new arm of its op­er­a­tions to fill a void in the mar­ket.

Avid Bioser­vices will move in­to the cell and gene ther­a­py mar­ket, with the con­struc­tion of a 53,000 square-foot vi­ral vec­tor cGMP man­u­fac­tur­ing site down the road from its Tustin, CA head­quar­ters.

The site will be com­plet­ed with­in 18 months, with CEO Nicholas Green say­ing that Jan­u­ary 2023 is an an­tic­i­pat­ed open­ing date. If the project stays on track, its an­a­lyt­i­cal and process de­vel­op­ment labs could be ready for par­tial use in the next six to eight months.

The in­vest­ment fol­lows an in­vest­ment in man­u­fac­tur­ing in Tustin, which un­der­went phase two of the build­ing process in Feb­ru­ary. The en­tire build will cost some­where in the range of $65 mil­lion — $75 mil­lion, and brings the com­pa­ny’s po­ten­tial rev­enue ca­pac­i­ty up to around $350 mil­lion.

Avid’s de­ci­sion to en­ter this space comes from the CD­MO in­dus­try’s lack of a pres­ence in high qual­i­ty cGMP vi­ral vec­tor man­u­fac­tur­ing.

”We kind of got a lot of our ducks in a row and saw that part of the busi­ness per­form­ing quite nice­ly,” Green said in a call with End­points News Wednes­day. “We start­ed look­ing around the field at the var­i­ous dif­fer­ent ar­eas of bi­o­log­ics man­u­fac­tur­ing that we thought would be of in­ter­est, and in some of my quar­ter­ly calls, I’ve high­light­ed those dif­fer­ent ar­eas…we kind of did some deep dives and dili­gence, and the feed­back we got was what we con­sid­ered to be our core strengths…and this seemed like a sen­si­ble and log­i­cal move.”

Drew Bren­nan

With the an­nounce­ment, the com­pa­ny al­so wel­comed Drew Bren­nan aboard as the new­ly ap­point­ed gen­er­al man­ag­er of vi­ral vec­tor tech­nolo­gies. He comes from No­vasep, a US CD­MO that fo­cus­es on vi­ral vec­tor man­u­fac­tur­ing in which he spent 12 years, and re­cent­ly over­saw the con­struc­tion of sev­er­al new sites in Bel­gium. There will cer­tain­ly be more per­son­nel an­nounce­ments, as Avid be­gins to put its team to­geth­er. But the chal­lenge lies in the need to find a high­ly com­pe­tent team with pri­or vi­ral vec­tor ex­pe­ri­ence.

“It is very spe­cif­ic tech­nol­o­gy, and there­fore, in­di­vid­u­als who have ex­pe­ri­ence in a wide va­ri­ety of dif­fer­ent vec­tors, a wide va­ri­ety of dif­fer­ent ex­pres­sion sys­tems, that’s a huge plus,” Bren­nan said. “Even though a lot of the tech­nol­o­gy is cen­tered now around AAV as well as lentivec­tor, there’s still a lot of oth­er vec­tors out there, retro­virus, al­phavirus. It’s very im­por­tant that we have a team that is well-versed in these types of vec­tor sys­tems.”

In De­cem­ber, the biotech gen­er­at­ed some $34.5 mil­lion in rev­enue when it closed the of­fer­ing of its pub­lic stock. Dur­ing its 2022 Q1 call, the com­pa­ny an­nounced its rev­enue was up 20% from last year, to $30.8 mil­lion.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

John Oyler, BeiGene CEO (Paul Yeung/Bloomberg via Getty Images)

Bris­tol My­ers wants to pull out of its Abrax­ane deal in Chi­na. BeiGene says no way

A year and a half after Chinese officials ordered BeiGene to stop selling Bristol Myers Squibb’s Abraxane in the wake of an alarming inspection of a US facility, the manufacturing issues at the root of the import suspension still appear unresolved.

And Bristol Myers wants to axe the Abraxane supply deal altogether.

But BeiGene, which is currently in arbitration proceedings against its Big Pharma partner, won’t let it off the hook so easily.

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Eric Roman, Pace Analytical CEO

This mid­west­ern CD­MO just picked up 3 ac­qui­si­tions in less than a week

A relatively quiet Minneapolis-based CDMO is making waves, announcing its third acquisition in just one week.

Pace has acquired Velesco Pharmaceuticals Services, which will add to its liquid, semi-solid and oral solid dose manufacturing, the company said. The CDMO has also brought on BC Laboratories out of California and ProScience Analytical Services

The Velesco acquisition allows Pace to broaden its drug delivery options, and tailor them for clients’ modules, dose range and drug delivery route. With the acquisition, Pace will get Velesco’s clinical trial manufacturing capacity, which includes specialized, small-scale customized experiments, softgel capsule, suspension and non-sterile liquid drug support and expertise in non-clinical toxicology studies.