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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.