South Ko­re­an drug­mak­er SK looks to take over Philly CD­MO's op­er­a­tions

The hold­ing com­pa­ny of a South Ko­re­an vac­cine mak­er is in the fi­nal talks to make an in­vest­ment in­to a US gene ther­a­py firm.

SK Bio­sciences is in the process of sign­ing a deal with the Cen­ter for Break­through Med­i­cines (CBM), a Philadel­phia-based CD­MO. If fi­nal­ized, the deal will come eight months af­ter SK’s takeover of the French gene and cell ther­a­py com­pa­ny Yposke­si.

With this move, SK takes it­self a step clos­er to es­tab­lish­ing a val­ue chain of syn­thet­ic and bio phar­ma­ceu­ti­cals in the US, Eu­rope and Asia by 2025, the com­pa­ny’s head of the in­vest­ment cen­ter Lee Dong-hoon said in a pre­sen­ta­tion. The CBM is known for its pro­duc­tion of plas­mid DNA. With SK’s in­vest­ment, it will ex­pand man­u­fac­tur­ing fa­cil­i­ty in the Cel­li­con Val­ley cell and gene ther­a­py clus­ter by 699,654 square feet.

That project will be com­plet­ed by 2025, The Ko­rea Her­ald says.

CBM was es­tab­lished in 2019 and of­fers ful­ly-in­te­grat­ed pre-clin­i­cal through com­mer­cial man­u­fac­tur­ing ca­pa­bil­i­ties that in­clude process de­vel­op­ment, plas­mid DNA, and vi­ral vec­tor man­u­fac­tur­ing, cell bank­ing, cell pro­cess­ing, and a full suite of test­ing and an­a­lyt­ic ca­pa­bil­i­ties. The fi­nanc­ing is set to close in De­cem­ber.

“We are thrilled by the op­por­tu­ni­ty to join forces with SK Inc., the per­fect strate­gic part­ner to en­able CBM’s core mis­sion of ex­pe­dit­ing the path to ap­proval for cell and gene ther­a­pies for pa­tients in need,” said co-founder of CBM Au­drey Green­berg in a press re­lease. “SK’s mis­sion of de­liv­er­ing val­ue and hap­pi­ness for all, cul­ture of safe­ty and qual­i­ty, em­pha­sis on ESG val­ues, and glob­al reach cre­ates an ide­al match for CBM. SK has a strong bio­phar­ma port­fo­lio, in­clud­ing con­sid­er­able in­vest­ments in cell & gene ther­a­py com­pa­nies cre­at­ing enor­mous strate­gic val­ue for CBM.  The SK CBM part­ner­ship will bring ca­pac­i­ty to a starved CGT mar­ket­place and ex­pe­dite the de­liv­ery of new ther­a­pies to pa­tients who need them now.”

SK ex­pand­ed its vac­cine pro­duc­tion in a big way over the sum­mer, af­ter it an­nounced it would in­vest $132 mil­lion in pro­duc­tion ca­pac­i­ty in mR­NA and vi­ral vec­tor op­er­a­tions in a project set to be op­er­a­tional by 2024. That ex­pan­sion will add more than 1 mil­lion square feet of pro­duc­tion space in An­dong, and was the first site in the coun­try to get the OK for Covid-19 vac­cine man­u­fac­tur­ing on the con­ti­nent.

It al­so re­ceived back­ing from CEPI, a coali­tion that backed both Mod­er­na and Ox­ford, and with it, $173.4 mil­lion to fin­ish its clin­i­cal tri­als and scale up man­u­fac­tur­ing to work on a vac­cine that de­liv­ers at low dos­es.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Civi­ca, Mayo Clin­ic and oth­ers sound off on FDA draft guid­ance to mit­i­gate drug short­ages

Several pharma groups are laying out the positives and negatives of new FDA draft guidance on how best to handle drug shortages.

The draft is intended to help companies develop and implement risk management plans (RMPs) to assist with any shortages of drugs or biologics. The guidance recommends a framework and factors for stakeholders to develop RMPs for their establishments, API manufacturers and others.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

To avoid short­age of Mer­ck­'s di­a­betes drug, FDA al­lows high­er im­pu­ri­ty lev­els tem­porar­i­ly

The FDA said Tuesday that it recently became aware of a nitrosamine impurity, Nitroso-STG-19 or NTTP, in certain samples of Merck’s type 2 diabetes drug Januvia.

To avoid a shortage of the drug that pulled in more than $10.5 billion for Merck in 2020 and 2021, and to help ensure patients have access to an adequate supply, the FDA said it will not object to the temporary distribution of sitagliptin containing the impurity above the acceptable intake limit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.