Cal­i­for­nia-based biotech Syn­thego has been main­ly fo­cused on de­vel­op­ing CRISPR-based tools to help re­searchers in acad­e­mia and biotech, but its lat­est move now is turn­ing its at­ten­tion more to­wards man­u­fac­tur­ing.

The com­pa­ny has bro­ken ground on a 20,000-square-foot man­u­fac­tur­ing fa­cil­i­ty in the San Fran­cis­co Bay Area, ex­pand­ing its GMP ca­pac­i­ty by 30 times, Syn­thego said in an email to End­points News. The fa­cil­i­ty is al­so go­ing to man­u­fac­ture ma­te­ri­als for trans­la­tion­al and clin­i­cal re­search de­vel­op­ment for cell and gene ther­a­pies as well.

Ac­cord­ing to the com­pa­ny, the fac­to­ry is an ex­pan­sion that will en­able Syn­thego to sig­nif­i­cant­ly ex­pand the pro­duc­tion of its gene-edit­ing tools and pro­duce the el­e­ments nec­es­sary for CRISPR-me­di­at­ed gene ther­a­pies through­out the in­dus­try.

The new fa­cil­i­ty is ex­pect­ed to be built and start op­er­a­tions with­in the year. Ac­cord­ing to the com­pa­ny, a sig­nif­i­cant amount of ca­pac­i­ty has al­ready been pri­or­i­tized for its cus­tomers but it has not spec­i­fied how many cus­tomers the com­pa­ny has.

While the com­pa­ny did not di­vulge the specifics on the cost of the fa­cil­i­ty when the com­pa­ny net­ted their $200 mil­lion Se­ries E in Feb­ru­ary — some of those funds were ded­i­cat­ed to man­u­fac­tur­ing, but no specifics were pre­sent­ed.

“We de­signed this fa­cil­i­ty to de­liv­er our GMP sin­gle guide RNA (sgR­NA) at a scale not on­ly to meet the needs of our bio­phar­ma part­ners but to dri­ve the in­dus­try for­ward and re­al­ize the full po­ten­tial of the rapid­ly ex­pand­ing field of cell and gene ther­a­pies,” said Syn­thego CEO Paul Dabrows­ki.

Ac­cord­ing to the com­pa­ny, the fa­cil­i­ty will con­tain 10,000 square feet of lab space, in­clud­ing ded­i­cat­ed qual­i­ty con­trol and re­search and de­vel­op­ment labs. 7,000 square feet will be a ded­i­cat­ed clean­room space for 24/7 par­al­lel batch pro­duc­tion. This will al­low cus­tomers to scale from ear­ly-phase re­search to process de­vel­op­ment to clin­i­cal re­search and de­vel­op­ment ac­tiv­i­ties need­ed for FDA sub­mis­sions.

Syn­thego has been grow­ing rapid­ly over the past few years as the com­pa­ny net­ted a $100 mil­lion D round in 2020 to build out its plat­form of CRISPR as­says, screens and en­gi­neered cell lines.

CRISPR-re­lat­ed man­u­fac­tur­ing is al­so be­com­ing more and more preva­lent with Alde­vron and In­tel­lia ink­ing deals to es­tab­lish man­u­fac­tur­ing sites or to make spe­cif­ic CRISPR ma­te­ri­als.

With Keytruda bulling its way past the $5 billion mark for Q2 sales, you could say that the top execs at Merck can be believed when they say how keenly interested they are in using its cash reserves for new M&A and licensing deals. Just don’t ask what they’re negotiating to buy right now.

The analysts largely tiptoed around the biggest buzz about Merck today: that it’s engaged in discussions to buy Seagen for $40 billion-plus. They’re a polite bunch that needs to be on a first-name basis with CEO Rob Davis. But Davis was willing to emphasize that the pharma giant has the means and the intent to do more deals.

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While Rich Nelson is out as interim CEO of vTv Therapeutics, he will be continuing as the company’s EVP of corporate development as Paul Sekhri takes the mantle of president and CEO on Aug. 1.

In Nelson’s four short months as head of the North Carolina-based biotech, he saw G42 Healthcare, a UAE health tech company, invest in vTv and agree to collaborate on vTv’s Phase III study for a type I diabetes treatment. Prior to Nelson’s stepping in as CEO, Deepa Prasad had served as CEO, though she too was only there for a few months.

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Most pharma TV commercials include a link at the end of the ad, offering a website link for viewers who want more information. It turns out millions of them do. So far in 2022, AbbVie, Novo Nordisk and AstraZeneca are leading the pharma pack with the most engagements garnered, according to data for the first half of 2022 from TV ad tracker EDO.

AbbVie’s Allergan Vuity eyedrops for age-related blurry vision drove the most searches among pharma TV advertising, generating 3.43 million searches after ad runs. That’s more than double the total for the next searched TV ad at No. 2, Novo Nordisk’s Ozempic, which notched 1.7 million, in EDO’s research.

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AstraZeneca CEO Pascal Soriot has been “pruning the tree” for quite some time, cutting a slate of unwanted programs across a range of indications over the last few quarters. And though the chief executive revealed two new cuts on Friday, he said he’s just about ready to put the clippers down and focus on “trying to grow new branches.”

Soriot expects the next couple of years to be “extremely rich in clinical results,” with more than 20 Phase III readouts slated for next year.

Beyond the back and forth of whether Democrats’ drug price negotiation plan is necessary to bring down costs, or just a thinly veiled attempt at price controls, the nuts and bolts of the deal mean pharma companies will inevitably see the tail ends of certain small molecule and biologic sales peter out before they otherwise would have in today’s marketplace.

While the bill’s text is not set in stone, and the Senate parliamentarian may still take issue with the excise tax that CMS will use to ensure companies comply with the negotiated prices, SVB Securities explained to investors how more than a dozen drugs from Eli Lilly, AstraZeneca, AbbVie and J&J, among others, would lose out on some revenue just before their generic competitors hit the market.

AbbVie’s executive team stayed right on track in Q2, with its Skyrizi franchise — now newly approved for Crohn’s — continuing to rack up impressive sales, making up for some unexpected weakness from a stronger dollar. The erosion of the Imbruvica franchise, however, dragged down the stock price $ABBV 5% Friday.

That set the stage for a bullish presentation by CEO Rick Gonzalez, who carefully steered the conversation around the looming loss of US exclusivity with Humira to the formulary discussions now underway that would allow the megabrand to continue to generate revenue in 2023 and 2024, as AbbVie’s newer entries became better established and some hot pipeline picks get a chance to prove themselves in pivotal trials.

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While Sarepta has three antisense oligonucleotide therapies approved — albeit not without controversy — for Duchenne muscular dystrophy, it has been working on a long-term treatment in the form of a gene therapy.

After posting positive results for its Roche-partnered gene therapy, dubbed SRP-9001, earlier this month, the Cambridge, MA-based biotech says it now intends to pursue an accelerated approval for its latest Duchenne treatment. Sarepta shares $SRPT rose about 10% on the news in early Friday trading.

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Nine years after doling out $50 million upfront to Merck, it appears AstraZeneca’s work in the WEE1 inhibitor space is over.

The UK Big Pharma has ended two studies of adavosertib, a Phase I trial in solid tumors in combo with PD-1 Imfinzi and a Phase II study testing the drug in patients with ovarian cancer, solid tumors and uterine serous cancer.

The company’s top oncology R&D executive, Susan Galbraith, said WEE1 “remains an important target” but the company has gone in a different direction because AstraZeneca wants a pipeline focused on “products that we think have a greater transformative ability for the treatment of patients with cancer.”

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Labcorp announced this morning that it is spinning out most of its CRO business, eight years after its $6 billion Covance acquisition.

Labcorp will keep its core business directed at diagnostic testing, the company said Thursday morning after the Wall Street Journal reported the split earlier in the morning, citing sources familiar with the matter. A tax-free spinout is expected in the second half of next year, the company said.

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

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