With can­cer in fo­cus, Am­gen taps Mol­e­c­u­lar Part­ner­s' pre­clin­i­cal im­mune-on­col­o­gy as­set for $50M up­front

Am­gen $AMGN is vy­ing for a big­ger BiTE in can­cer, with a pact worth up to $547 mil­lion with Mol­e­c­u­lar Part­ners for the biotech’s pre­clin­i­cal im­muno-on­col­o­gy drug MP0310.

The mol­e­cule is de­signed to lo­cal­ly ac­ti­vate im­mune cells in the tu­mor by bind­ing to fi­brob­last ac­ti­va­tion pro­tein (FAP) on tu­mor stro­mal cells, while si­mul­ta­ne­ous­ly stim­u­lat­ing T cells. It’s part of Mol­e­c­u­lar’s DARPin plat­form tech, which the com­pa­ny says it de­vel­oped to cre­ate a new class of small pro­tein ther­a­peu­tic agents de­rived from nat­ur­al ankyrin re­peat pro­teins – one of the most com­mon bind­ing pro­teins re­spon­si­ble for cell sig­nal­ing and re­cep­tor bind­ing.

Patrick Am­stutz

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Un­der the deal, Am­gen gets ex­clu­sive glob­al de­vel­op­ment and com­mer­cial rights for MP0310, al­though the two will joint­ly eval­u­ate MP0310 in com­bi­na­tion with Am­gen’s ar­se­nal of on­col­o­gy drugs-in-de­vel­op­ment, in­clud­ing its BiTE mol­e­cules. How­ev­er, Mol­e­c­u­lar will re­tain the right to test its oth­er DARPin pipeline prod­ucts in com­bi­na­tion with MP0310.

Switzer­land-based Mol­e­c­u­lar, which is al­ready work­ing with Al­ler­gan $AGN on a drug for mac­u­lar de­gen­er­a­tion, gets $50 mil­lion up­front and is el­i­gi­ble to re­ceive up to $497 mil­lion in mile­stone pay­ments, as well as roy­al­ties on po­ten­tial sales that emerge from the deal. The com­pa­ny ex­pects the drug to en­ter the clin­ic next year, CEO Patrick Am­stutz said.

Mol­e­c­u­lar’s founders, in­clud­ing Am­stutz, worked to­geth­er as PhD stu­dents and post-docs in the bio­chem­istry de­part­ment at the Uni­ver­si­ty of Zurich where they cre­at­ed their tech plat­form in the hopes of bring­ing to­geth­er mul­ti­ple small pro­teins with the abil­i­ty to in­hib­it mul­ti­ple dis­ease-spe­cif­ic tar­gets in a sin­gle med­i­cine.

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.

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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' 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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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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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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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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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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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.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.