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

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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