Look­ing for fresh start fol­low­ing a Duchenne dis­as­ter, Cataba­sis re­brands; Huadong and In­sil­i­co team up in on­col­o­gy

The lead­ers of Cataba­sis Phar­ma­ceu­ti­cals have de­creed that the biotech’s name is no more. Cataba­sis will be re­brand­ing to As­tria Ther­a­peu­tics ef­fec­tive im­me­di­ate­ly, with the com­pa­ny’s stock tick­er be­ing up­dat­ed on the Nas­daq on Thurs­day.

As­tria will drop the $CATB tick­er and trade un­der $ATXS.

The biotech is al­so re­nam­ing its lead com­pound from QLS-215 to STAR-0215, cur­rent­ly in pre­clin­i­cal de­vel­op­ment for the rare ge­net­ic dis­ease called hered­i­tary an­gioede­ma. As­tria ac­quired the pro­gram in its buy­out of Quel­lis Bio­sciences back in Jan­u­ary. That deal fol­lowed the com­plete col­lapse of their long-run­ning Duchenne MD drug, which flunked a Phase III tri­al last Oc­to­ber.

Their new drug lead is a long-act­ing mon­o­clon­al an­ti­body in­hibitor of plas­ma kallikrein, dosed once every three months or longer, and an IND is ex­pect­ed in mid-2022, the com­pa­ny says.

“The name As­tria em­bod­ies our com­mit­ment to put pa­tients first in all that we do,” said CEO Jill Milne in a state­ment. “Fol­low­ing the ac­qui­si­tion of Quel­lis ear­li­er this year, our com­pa­ny is fo­cused on tack­ling the de­bil­i­tat­ing dis­ease hered­i­tary an­gioede­ma, with the broad­er goal of ad­dress­ing the un­met needs of pa­tients with rare and niche al­ler­gic and im­muno­log­i­cal dis­eases.” — Max Gel­man

Huadong and In­sil­i­co en­ter co-de­vel­op­ment on­col­o­gy part­ner­ship

Chi­nese phar­ma Huadong and Hong Kong’s In­sil­i­co are bring­ing their R&D teams to­geth­er to em­bark on a new project: to try and find mol­e­cules to in­crease tar­get drug­ga­bil­i­ty.

The two com­pa­nies will com­bine their re­sources to look at and test pro­tein-pro­tein in­ter­ac­tions, ac­cord­ing to a joint state­ment re­leased by the com­pa­nies. In­sil­i­co will bring its AI-based plat­form, Chem­istry42, along­side Huadong’s own in-house drug dis­cov­ery plat­forms.

“We look for­ward to col­lab­o­rat­ing with the lead­ing in­ter­na­tion­al AI com­pa­ny In­sil­i­co, by lever­ag­ing re­spec­tive ad­van­tages of both com­pa­nies, in ad­vanc­ing the de­vel­op­ment of po­ten­tial first in class drug mol­e­cules to meet in­creas­ing clin­i­cal med­ical needs,” said Huadong CSO Dongzhou Liu. — Paul Schloess­er

An­oth­er SPAC lands, look­ing for part­ners

Af­ter a sum­mer IPO and SPAC lull, the lat­est blank check com­pa­ny has filed with the SEC.

The SPAC known as Mon­terey Bio Ac­qui­si­tion is pen­cil­ing in a $100 mil­lion raise, sub­mit­ting its S-1 pa­per­work late Tues­day. It’s an out­fit large­ly run by the VC firm North­Star Bio Ven­tures and its man­ag­er, Sandip Pa­tel, who own about 67% of the shares pre-of­fer­ing. There’s al­so a sig­nif­i­cant con­tri­bu­tion from the firm Chardan Mon­terey In­vest­ments, which con­trols 22.2% of shares.

Mon­terey Bio says it plans to use the re­la­tion­ships its board has built with­in the biotech sec­tor to look to merge with a busi­ness that has at least one in-house or in-li­censed pro­gram — a stan­dard boil­er­plate copy and paste job in the S-1.

Run­ning the SPAC will be San­jeev Satyal, who was most re­cent­ly CEO of the biotech pH Phar­ma. Based in Seoul and Sil­i­con Val­ley, pH Phar­ma fo­cus­es on a wide range of in­di­ca­tions, with a lead prod­uct can­di­date in glau­co­ma. There’s al­so a sec­ond can­di­date be­ing re­searched for Al­pha-1 an­tit­rypsin de­fi­cien­cy, NASH and acute res­pi­ra­to­ry dis­tress syn­drome re­lat­ed to Covid-19.

SPAC ac­tiv­i­ty has slowed sig­nif­i­cant­ly since late 2020/ear­ly 2021, when the first three months of the year saw more mon­ey flow in­to blank check com­pa­nies across all sec­tors than the en­tire­ty of 2020. But there are still groups look­ing for part­ners, and Tues­day’s newest SPAC says it will have a year to find one. — Max Gel­man

US biotech Gain shows pos­i­tive ef­fects from re­search on Gauch­er and Parkin­son’s

Mary­land-based biotech Gain Ther­a­peu­tics re­port­ed pos­i­tive ef­fects from stem cell re­search on Gauch­er and a cer­tain type of Parkin­son’s dis­ease.

The com­pa­ny’s study, con­duct­ed at the Uni­ver­si­ty of Mary­land School of Med­i­cine, used stem cells to test two ther­a­py can­di­dates for ef­fi­ca­cy against both Gauch­er and GBA1 Parkin­son’s dis­ease.

“We plan to ful­ly eval­u­ate the re­sults of this study and present a com­plete da­ta set on the up­com­ing Michael J. Fox Foun­da­tion’s In­no­vat­ing from Drug Dis­cov­ery to the Clin­ic we­bi­nar,” Gain CEO Er­ic Rich­man said in a state­ment. Rich­man al­so said that Gain an­tic­i­pates to ini­tial­ize IND-en­abling stud­ies for Gauch­er and Parkin­son’s Dis­ease be­fore the end of the year. — Paul Schloess­er

Bolt Bio­ther­a­peu­tics an­nounces clin­i­cal col­lab­o­ra­tion with Bris­tol My­ers Squibb

Bolt Bio­ther­a­peu­tics will work with Bris­tol My­ers Squibb to in­ves­ti­gate Bolt’s ISAC can­di­date BDC-1001 in com­bi­na­tion with Bris­tol My­ers Squibb’s PD-1 in­hibitor Op­di­vo. This com­bi­na­tion will be test­ed for the treat­ment of pa­tients with HER2-ex­press­ing sol­id tu­mors.

Bolt CEO Ran­dall Schatz­man said:

The com­bi­na­tion of BDC-1001 and Op­di­vo holds po­ten­tial as a treat­ment for can­cer pa­tients, and we wel­come the op­por­tu­ni­ty to in­ves­ti­gate this in a clin­i­cal set­ting. We re­main grate­ful to all of the health­care pro­fes­sion­als, sci­en­tists, pa­tients, and fam­i­lies in­volved with Bolt’s clin­i­cal stud­ies.

Bolt’s can­di­date is cur­rent­ly be­ing in­ves­ti­gat­ed in a Phase I/II clin­i­cal tri­al in pa­tients with sol­id tu­mors that are HER2+ or HER2-low, in­clud­ing breast, gas­troe­sophageal and col­orec­tal tu­mors. Bolt re­cent­ly pre­sent­ed pre­lim­i­nary da­ta de­tail­ing safe­ty, tol­er­a­bil­i­ty, and signs of ac­tiv­i­ty at the 2021 Amer­i­can So­ci­ety of Clin­i­cal On­col­o­gy (AS­CO) An­nu­al Meet­ing.

Bris­tol My­ers will pro­vide Op­di­vo for the com­bi­na­tion dose es­ca­la­tion and com­bi­na­tion dose ex­pan­sion por­tions of the tri­al. The com­bi­na­tion dose es­ca­la­tion is ex­pect­ed to start lat­er this year. — Paul Schloess­er

Eras­ca an­nounces clin­i­cal tri­al col­lab­o­ra­tion and sup­ply agree­ment with Pfiz­er

Cal­i­for­nia biotech Eras­ca will be­gin a clin­i­cal tri­al col­lab­o­ra­tion and sup­ply agree­ment with Pfiz­er for BRAF in­hibitor en­co­rafenib.

This agree­ment will sup­port a clin­i­cal proof-of-con­cept study eval­u­at­ing Eras­ca’s can­di­date ERAS-007, an oral ERK1/2 in­hibitor, in com­bi­na­tion with chemother­a­py drugs en­co­rafenib and ce­tux­imab for the treat­ment of pa­tients with BRAF V600E-mu­tant metasta­t­ic col­orec­tal can­cer.

This com­bi­na­tion will be in­ves­ti­gat­ed as part of the Phase Ib/II HERKULES-3 tri­al ex­pect­ed to start by the end of the year. Eras­ca will spon­sor the study, and Pfiz­er will sup­ply en­co­rafenib. The two com­pa­nies will joint­ly re­view the clin­i­cal tri­al re­sults.

“We are ex­cit­ed to work with Pfiz­er to ex­plore this promis­ing com­bi­na­tion in col­orec­tal can­cer,” said Jonathan E. Lim, Eras­ca’s chair­man, CEO, and co-founder in a state­ment.

World­wide, ap­prox­i­mate­ly 1.8 mil­lion cas­es of col­orec­tal can­cer are di­ag­nosed every year, with BRAF V600E mu­ta­tions oc­cur­ring in ap­prox­i­mate­ly 10% of pa­tients. — Paul Schloess­er

Ala­mar Bio­sciences com­pletes $80M Se­ries B

Cal­i­for­nia biotech Ala­mar closed an $80 Se­ries B fundrais­ing, bring­ing its to­tal fund­ing to $110 mil­lion.

The fund­ing, which was led by Sher­pa Health­care Part­ners, is sup­posed to ac­cel­er­ate Ala­mar’s de­vel­op­ment of a pro­tein re­search plat­form.

“We are very pleased to have these top-tier in­vestors sup­port­ing our next phase of de­vel­op­ment. They bring a tremen­dous amount of ex­per­tise in life sci­ences and di­ag­nos­tics, which will be ex­treme­ly valu­able to us as we build the com­pa­ny,” said founder, chair­man and CEO Yul­ing Luo.

Luo, who found­ed Ala­mar in 2018, is al­so a part­ner with VC firm Il­lu­mi­na Ven­tures, which is one of Ala­mar’s pre­vi­ous in­vestors. — Paul Schloess­er

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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