Strug­gling On­colyt­ics Biotech signs $86.6M Asia deal with Chi­na's Ad­lai Nortye

Cal­gary, Cana­da-based On­colyt­ics Biotech has struck an $86.6 mil­lion li­cens­ing deal with Chi­na’s Ad­lai Nortye for its IV im­muno-on­colyt­ic virus. Pay­ing $5.3 mil­lion up­front with the prospect of an­oth­er $16 mil­lion in short-term cash avail­able, Ad­lai gained de­vel­op­ment and com­mer­cial­iza­tion rights to Re­olysin (pelare­o­rep) in Chi­na, Hong Kong, Macau, Sin­ga­pore, South Ko­rea and Tai­wan.

The Hangzhou-based bio­phar­ma agreed to two po­ten­tial­ly quick pay­outs, with $8 mil­lion for eq­ui­ty and then an­oth­er $7.9 mil­lion if On­colyt­ics can hit its marks on cer­tain reg­u­la­to­ry ad­vance­ments. Up­on achieve­ment of the full slate of clin­i­cal, reg­u­la­to­ry and com­mer­cial­iza­tion mile­stones, On­colyt­ics can re­ceive up to an ad­di­tion­al $65.4 mil­lion.

Matt Cof­fey

On­colyt­ics $ON­CYF could use the cash. Its share price soured bad­ly over the past few years on mixed da­ta for its lead drug, with the stock falling in­to pen­ny stock ter­ri­to­ry — which forced a shift to the OTC mar­ket. The found­ing CEO left a year ago and in its most re­cent quar­ter­ly re­port On­colyt­ics re­port­ed that it had $14 mil­lion in cash on hand. Co-founder Matt Cof­fey is now in charge.

More re­cent­ly re­searchers have been up­beat about Re­olysin da­ta, but the strug­gling is far from over.

Li­cens­ing deals for the Chi­na mar­ket have pro­lif­er­at­ed in the past cou­ple years. While some big phar­ma com­pa­nies are start­ing to pull out or low­er ex­pec­ta­tions, oth­er bio­phar­mas are pil­ing in, look­ing to Chi­na’s enor­mous mar­ket in hopes of ex­pand­ing their sales.

That said, this par­tic­u­lar deal ap­pears to be a first for both com­pa­nies. Re­olysin, an en­gi­neered virus de­signed to trig­ger in­nate and adap­tive im­mune re­spons­es, will be Ad­lai’s first late-stage drug (with six oth­ers in the pipeline, some li­censed from with­in Chi­na).

“Giv­en its po­ten­tial in mul­ti­ple on­co­log­i­cal in­di­ca­tions and its abil­i­ty to be used in com­bi­na­tion with mul­ti­ple chemother­a­pies and im­munother­a­pies, Re­olysin will help to broad­en fu­ture ther­a­pies made avail­able by Ad­lai Nortye and ad­vance us to­wards com­mer­cial­iza­tion,” CEO Carsten Lu said in a state­ment.

For On­colyt­ics, which places all its hopes in this sole prod­uct, this is hope­ful­ly just the be­gin­ning.

Fol­low­ing an FDA fast track des­ig­na­tion in May and a re­cent meet­ing with the reg­u­la­tor, On­colyt­ics has hur­ried up to find part­ners in oth­er re­gions such as Eu­rope or Japan. The plan is to start a 400-pa­tient PhI­II study fo­cused on 400 paHR+/HER2- metasta­t­ic breast can­cer. If the EMA hands down its for­mal guid­ance by the end of the year as ex­pect­ed, the com­pa­ny will be­gin en­rolling pa­tients in mid-2018 — thanks in part to the mon­ey gained in this re­gion­al agree­ment with Ad­lai.

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.

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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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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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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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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