CEO Brian Thomas and COO Jian Irish (center) at the ribbon cutting for Metagenomi's new manufacturing facility (courtesy Metagenomi)

Af­ter rop­ing in $175M+ at the be­gin­ning of the year, Metageno­mi opens the doors to a new man­u­fac­tur­ing site

The gene edit­ing biotech Metageno­mi has been on a roll for the past few years. Com­ing out of the gate in 2020, it had $65 mil­lion in cash from Bay­er’s in­vest­ment arm, and just this year it brought in a $175 mil­lion Se­ries B. Now it has tak­en the next step and opened a GMP man­u­fac­tur­ing fa­cil­i­ty on its 50,000 square-foot cam­pus in Emeryville, CA.

The fa­cil­i­ty, which will have two clean rooms and a mod­u­lar de­sign, will aim to pro­duce the biotech’s gene edit­ing tools as well as scale up the pro­duc­tion of nu­cle­as­es for ei­ther part­nered or in-house ther­a­peu­tic pro­grams.

Metageno­mi COO Jian Irish told End­points News that the com­pa­ny went ahead with build­ing a new GMP fa­cil­i­ty as it will al­low it to gain ex­per­tise in CMC de­vel­op­ment.

“In the cell and gene ther­a­py space, CMC de­vel­op­ment has emerged as one of the im­por­tant top­ics for many com­pa­nies in this space as was with the reg­u­la­to­ry agen­cies. So, we be­lieve it is very im­por­tant for us ear­ly on to amass CMC ex­per­tise,” Irish said.

Irish said Metageno­mi on­ly took a year to fin­ish con­struc­tion on the fa­cil­i­ty, and with it be­ing ful­ly in­te­grat­ed in­to its cam­pus, it will al­low the com­pa­ny to trans­late its re­search in­to a clin­i­cal set­ting faster and more seam­less­ly. How­ev­er, Irish did not dis­close the to­tal cost of the fa­cil­i­ty to End­points. Pro­duc­tion at the fa­cil­i­ty is slat­ed to be­gin lat­er this year.

As for the em­ploy­ee count at the GMP fa­cil­i­ty, Irish said that Metageno­mi cur­rent­ly has 30 work­ers em­ployed but would like that num­ber to climb to around 50.

The new fa­cil­i­ty is a crit­i­cal step Metageno­mi, Irish not­ed, and will be key in pro­duc­ing its gene edit­ing pro­grams in the months and years ahead.

“So, when the time comes, when we’re ready for IND fil­ing, the CMC mod­ule will be ready to go,” Irish said. “I think that tim­ing is very im­por­tant for (us) as we build the clin­i­cal pipeline.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.