TG Ther­a­peu­tics pre­pares to ap­proach reg­u­la­tors with MS drug; In­vestors bet $93M on a life sci­ences tools com­pa­ny

Gear­ing up for a bat­tle with phar­ma gi­ants, TG Ther­a­peu­tics says it’s near­ly ready to ap­proach reg­u­la­tors with its CD20 drug for mul­ti­ple scle­ro­sis.

The biotech read out re­sults from two Phase III tri­als at AAN, which show its can­di­date ubli­tux­imab re­duced pa­tients’ an­nu­al­ized re­lapse rate by 60% and 50% com­pared to Sanofi’s Auba­gio, or ter­i­fluno­mide — an 8-year-old drug that’s of­ten used as a bench­mark.

In­ves­ti­ga­tors fol­lowed re­laps­ing MS pa­tients for 96 weeks, with those in the ubli­tux­imab group re­ceiv­ing a one-hour in­tra­venous in­fu­sion every six months (ex­cept a longer but small­er dose in­fu­sion on day 1 and an­oth­er longer one on day 15). The ter­i­fluno­mide co­hort took the 14 mg oral tablets every day.

Back in Au­gust, No­var­tis got the green light for Kes­imp­ta af­ter demon­strat­ing a sig­nif­i­cant re­duc­tion in ARR of 51% and 59% over the ac­tive con­trol arm in a pair of tri­als.

In ad­di­tion to the pri­ma­ry end­points, ubli­tux­imab al­so met key sec­ondary end­points, ac­cord­ing to TG. In the tri­als, dubbed UL­TI­MATE I and II, pa­tients in the treat­ment arm saw their to­tal num­ber of T1 Gadolin­i­um (Gd) en­hanc­ing le­sions re­duced by 97% and 96% rel­a­tive to the con­trol arm, with a p-val­ue of less than 0.0001. New or en­larg­ing T2 le­sions were redact­ed by 92% and 90%, re­spec­tive­ly, com­pared to the con­trol arm, TG says.

CEO Michael Weiss says he’s aim­ing to file a BLA in Q3 of this year.

In­vestors bet $93M on a life sci­ences tools com­pa­ny

In­vestors have an ap­petite not on­ly for in­no­v­a­tive ther­a­pies, but al­so for the de­vel­op­ers of the tools be­hind them.

Lu­micks, a com­pa­ny that pro­duces equip­ment for dy­nam­ic sin­gle-mol­e­cule and cell avid­i­ty analy­sis, un­veiled a $93 mil­lion Se­ries D round on Fri­day. The round was led by Far­al­lon Cap­i­tal Man­age­ment and Laux­era Cap­i­tal Part­ners, with a hand from Soft­bank Vi­sion 2, funds and ac­counts ad­vised by T. Rowe Price As­so­ci­ates, Par­i­an Glob­al Man­age­ment, Pu­ra Vi­da In­vest­ments, Gilde Health­care Irv­ing In­vestors, and se­lect man­agers of the Lu­micks team.

Most of the funds from this round will back the com­pa­ny’s growth ini­tia­tives, in­clud­ing the ex­pan­sion of its re­cent­ly re­leased z-Movi Cell Avid­i­ty An­a­lyz­er, which rapid­ly mea­sures the bind­ing strength be­tween tar­get and im­mune cells.

Lu­micks got its start in 2014, when it spun out from the re­search group of pro­fes­sors Gi­js Wuite, Er­win Pe­ter­man, and Id­do Heller at the Vri­je Uni­ver­siteit Am­s­ter­dam.

Ideaya reads out pre­lim­i­nary Ph I/II re­sults in melanoma

Ideaya says pa­tients who took its metasta­t­ic uveal melanoma can­di­date darovasert­ib achieved a 57% 1-year sur­vival rate com­pared to a his­toric 37% 1-year sur­vival rate in sim­i­lar pop­u­la­tions, ac­cord­ing to pre­lim­i­nary Phase I/II da­ta.

On Fri­day, the syn­thet­ic lethal­i­ty-fo­cused com­pa­ny of­fered an ear­ly look at stud­ies test­ing darovasert­ib alone and with Pfiz­er’s Mek­tovi in pa­tients with metasta­t­ic uveal melanoma (MUM) and skin melanoma.

Ac­cord­ing to Ideaya, a group of pre­dom­i­nant­ly sec­ond-line, third-line and heav­i­ly pre­treat­ed MUM pa­tients on the monother­a­py achieved a me­di­an over­all sur­vival of 13.2 months. The biotech com­pared the fig­ure to his­toric me­di­an OS in sim­i­lar MUM  pop­u­la­tions, which is about 7 months.

As for the com­bi­na­tion ther­a­py, re­searchers not­ed 2 par­tial re­spons­es out of 9 MUM pa­tients with at least 2 post-base­line scans by RE­CIST 1.1 guide­lines (a stan­dard way to mea­sure how well a can­cer pa­tient re­sponds to treat­ment). And 79% of evalu­able MUM pa­tients with at least 1 post-base­line scan showed tu­mor re­duc­tion, Ideaya said.

“The darovasert­ib sin­gle-agent one-year sur­vival da­ta in MUM is en­cour­ag­ing and com­pares fa­vor­ably to his­tor­i­cal sur­vival rates in this in­di­ca­tion, where a ther­a­py has yet to be ap­proved,” said Mered­ith McK­ean, an as­so­ciate di­rec­tor of melanoma and skin can­cer re­search at Ten­nessee On­col­o­gy’s Sarah Can­non Re­search In­sti­tute.

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.

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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.

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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.

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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

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.

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.

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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.

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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.