Lyn­parza se­cures third EU nod; Pro­tein degra­da­tion biotech grabs $16M launch round from Chi­nese VCs; Wave shares tum­ble on tri­al de­lay

Lyn­parza, the first PARP in­hibitor from As­traZeneca $AZN to win US ap­proval in 2014, has se­cured its third EU ap­proval. The drug won the EMA nod for use pa­tients with germline BR­CA1/2-mu­ta­tions and who have hu­man epi­der­mal growth fac­tor re­cep­tor 2 (HER2)-neg­a­tive lo­cal­ly ad­vanced or metasta­t­ic breast can­cer, part­ner Mer­ck $MRK said on Wednes­day.

→ A new pro­tein degra­da­tion biotech has raised a $16 mil­lion launch round from a pair of Chi­nese ven­ture groups. San Diego-based Cull­gen says it plans to put the mon­ey to use on its tech plat­form us­ing ubiq­ui­tin-me­di­at­ed, small mol­e­cule-in­duced pro­tein degra­da­tion to go af­ter can­cer, in­flam­ma­to­ry, and au­toim­mune dis­eases. Se­quoia Cap­i­tal Chi­na and High­light Cap­i­tal pro­vid­ed the cash. “Since our found­ing in ear­ly 2018 we have made sig­nif­i­cant ad­vance­ment of our tar­get­ed pro­tein degra­da­tion plat­form which has di­rect­ly led to the iden­ti­fi­ca­tion of sev­er­al pre-clin­i­cal as­sets that we are rapid­ly ad­vanc­ing to­wards the clin­ic,” notes Ying Luo, chair­man and pres­i­dent of Cull­gen.

→ Shares of Wave Life Sci­ences $WVE tum­bled 15% Wednes­day morn­ing af­ter the biotech re­vealed that it has to de­lay a top-line read­out from their Phase Ib/IIa study of 2 new Hunt­ing­ton’s dis­ease ther­a­pies un­til the end of the year. Re­searchers blamed the de­lay on slow­er than ex­pect­ed pa­tient re­cruit­ment.

→ Pfiz­er $PFE has joined forces with Con­cer­to HealthAI to col­lab­o­rate on us­ing re­al world da­ta to help de­vel­op as well as use can­cer ther­a­pies. Con­cer­to gath­ers da­ta from elec­tron­ic health records and in­sur­ance claims to cre­ate their data­base. This is the sec­ond new pact for Con­cer­to in a mat­ter of days, fol­low­ing an ear­li­er al­liance with Bris­tol-My­ers Squibb $BMY.

→ The transPa­cif­ic biotech Edi­GENE has raised $15 mil­lion in the first tranche of its B round. The com­pa­ny is work­ing with CRISPR on new gene edit­ing pro­grams for ge­net­ic dis­eases caused by mal­func­tion­ing pro­teins. UTokyo In­no­va­tion Plat­form joined a syn­di­cate that in­cludes SBI In­vest­ment, Fast Track Ini­tia­tive, SM­BC Ven­ture Cap­i­tal, Mizuho Cap­i­tal, CareNet Group. The com­pa­ny says it has de­vel­oped CRISPR-GNDM (Guide Nu­cleotide Di­rect­ed Mod­u­la­tion) to nor­mal­ize lev­els of gene ex­pres­sion with­out cut­ting the DNA or RNA. 

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,200+ biopharma pros reading Endpoints daily — and it's free.

FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

Endpoints Premium

Premium subscription required

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

Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,200+ biopharma pros reading Endpoints daily — and it's free.

Sanofi, Cel­lec­tis team up to pair Lem­tra­da with al­lo­gene­ic CAR-Ts; Bris­tol My­ers joins Evotec's dri­ve to ad­vance UK sci­ence

Sanofi is partnering up with Cellectis on their allogeneic CAR-Ts.

Cellectis struck a deal to use the French pharma’s drug alemtuzumab (Lemtrada, an MS agent) as part of its lymphodepletion regimen — used to sideline host immune cells and improve CAR-T cell expansion and persistence.

The Sanofi drug is already used in some clinical trials, and now the pharma giant is on the hook for clinical studies as they engage in negotiations over a commercial pact. — John Carroll

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,200+ biopharma pros reading Endpoints daily — and it's free.

A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

Endpoints Premium

Premium subscription required

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

Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.