In­hi­brx shares rise on PhI tri­al re­sults; Bragli­a's Helsinn en­ters part­ner­ship with Fo­s­un

Cal­i­for­nia biotech In­hi­brx re­leased in­ter­im re­sults to­day from a Phase I tri­al look­ing at a re­com­bi­nant fu­sion pro­tein pro­gram, IN­BRX-101. The study looked at pa­tients with al­pha-1 an­tit­rypsin de­fi­cien­cy, or AATD.

The study re­vealed in­ter­im phar­ma­co­ki­net­ic da­ta from 21 pa­tients with AATD, all with the ZZ mu­ta­tion of the SER­PINA1 gene, and in­ter­im safe­ty da­ta are from 24 pa­tients with AATD. There were no drug-re­lat­ed se­vere or se­ri­ous ad­verse events at dos­es up to and in­clud­ing 120 mg/kg sin­gle dose, and 80mg/kg mul­ti-dose, ac­cord­ing to a com­pa­ny re­lease. Ad­verse events were pre­dom­i­nant­ly mild with a few mod­er­ate events.

More re­sults re­gard­ing pa­tients’ func­tion­al AAT and bron­choalve­o­lar lavage da­ta are ex­pect­ed in the first half of next year, look­ing at three IN­BRX-101 dos­es of 80 or 120 mg/kg IV ad­min­is­tered every three weeks.

Share prices $IN­BX went on a high af­ter the an­nounce­ment, in­creas­ing over 25% be­fore the mar­ket open and hov­er­ing up 20% to 25% af­ter the open­ing bell.

“These ini­tial da­ta demon­strate the po­ten­tial of IN­BRX-101 to sig­nif­i­cant­ly im­prove treat­ment for pa­tients with AATD by main­tain­ing them in the nor­mal range of func­tion­al AAT and re­duc­ing in­fu­sions from 52 an­nu­al­ly to pos­si­bly as few as 12 an­nu­al­ly,” said In­hi­brx CEO Mark Lappe.

Helsinn and Fo­s­un part­ner up for an­ti-nau­sea and vom­it­ing drugs

Swiss biotech Helsinn an­nounced to­day a new li­cens­ing and dis­tri­b­u­tion part­ner­ship with Shang­hai-based Fo­s­un, ef­fec­tive Oc­to­ber 1.

This part­ner­ship with Fo­s­un grants the Chi­nese biotech li­cense to com­mer­cial­ize and sell three Helsinn drugs in Chi­na, Hong Kong and Macau — an­ti-nau­sea and an­ti-vom­it­ing drugs Aloxi and Akynzeo, along with anorex­ia and ma­lig­nan­cy-as­so­ci­at­ed weight loss treat­ment anamore­lin for pa­tients with NSCLC.

Ad­di­tion­al­ly, Helsinn’s Chi­nese sub­sidiary will pro­vide a Fo­s­un sub­sidiary with cer­tain med­ical, mar­ket­ing and com­mer­cial ser­vices, in­clud­ing co-pro­mo­tion ser­vices in Shang­hai.

Wu Yi­fang, Chair­man and CEO of Fo­s­un Phar­ma, com­ment­ed: “We are look­ing for­ward to work­ing with Helsinn and to mak­ing these ther­a­pies avail­able to pa­tients in these ter­ri­to­ries as soon as pos­si­ble.”

Han­soh and OliX get to­geth­er on siR­NA de­vel­op­ment deal

In an­oth­er Asia-fo­cused col­lab­o­ra­tion, Chi­na’s Han­soh Phar­ma and South Ko­rea RNA biotech OliX Phar­ma­ceu­ti­cals are team­ing up in a new li­cens­ing and col­lab­o­ra­tion agree­ment.

The deal will be to dis­cov­er, de­vel­op and com­mer­cial­ize siR­NA ther­a­peu­tics for cer­tain in­di­ca­tions in Chi­na, Tai­wan, Hong Kong and Macau, ac­cord­ing to a com­pa­ny state­ment.

While OliX will use its plat­form to dis­cov­er and de­vel­op can­di­dates for tar­gets in car­dio­vas­cu­lar, meta­bol­ic, and oth­er dis­eases as­so­ci­at­ed with the liv­er, Han­soh will have ex­clu­sive com­mer­cial rights to these can­di­dates in the four Asian mar­kets.

OliX will re­ceive an ini­tial up­front pay­ment of $6.5 mil­lion, with up to $450 mil­lion in mile­stones plus roy­al­ties, along with rights to the ther­a­peu­tic can­di­dates in the rest of the world.

“We are thrilled to part­ner with OliX Phar­ma­ceu­ti­cals, a leader in siR­NA de­vel­op­ment with an es­tab­lished clin­i­cal stage port­fo­lio, and look for­ward to uti­liz­ing their tech­nol­o­gy plat­form in our de­vel­op­ment process,” said Han­soh board ex­ec­u­tive di­rec­tor Eliza Sun.

Roche’s Spark to li­cense Com­bi­Gene’s epilep­sy gene ther­a­py treat­ment

In yet an­oth­er col­lab­o­ra­tion an­nounced to­day, Com­bi­Gene and Spark signed an agree­ment to ex­clu­sive­ly col­lab­o­rate on the for­mer’s fo­cal epilep­sy gene ther­a­py — with a $300M+ li­cens­ing deal to boot.

The agree­ment gives Roche-owned Spark the world­wide li­cense to de­vel­op, man­u­fac­ture and com­mer­cial­ize CG01 while Com­bi­Gene con­tin­ues parts of the pre­clin­i­cal pro­gram in tan­dem with the com­pa­ny.

Com­bi­Gene will get $8.5 mil­lion up­front from Spark as part of the arrange­ment — with an ad­di­tion­al $50 mil­lion in mile­stones and a po­ten­tial grand to­tal of $328.5 mil­lion. And that does not in­clude roy­al­ties, ei­ther.

Once the gene ther­a­py is com­mer­cial­ized, Com­bi­Gene is el­i­gi­ble for tiered roy­al­ties based on net sales.

“We look for­ward to ad­vanc­ing this po­ten­tial­ly trans­for­ma­tive ther­a­py to­geth­er with Spark for the ben­e­fit of a pa­tient group in need of bet­ter treat­ments,” said Com­bi­Gene CEO Jan Nils­son.

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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