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.”

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.

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.

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.