James Garner, Kazia CEO (PR Newswire)

Kazia swipes an ex-Sanofi mol­e­cule for £1M up­front as they look to repli­cate their Genen­tech snag

Kazia has spent most of its young life try­ing to de­vel­op a sin­gle Genen­tech castoff it swiped for $5 mil­lion in­to a brain can­cer drug. Now, with that mol­e­cule in a piv­otal tri­al, the Aussie biotech is adding an­oth­er old Big Phar­ma as­set to its re­serves.

Kazia an­nounced Mon­day they in-li­censed a small mol­e­cule called EVT801 from Evotec for a nom­i­nal up­front fee – $1.4 mil­lion — and $428 mil­lion in po­ten­tial mile­stones. The com­pa­ny said they plan to launch a Phase I tri­al for the drug, a new VEG­FR in­hibitor, lat­er this year.

Al­though li­censed from Evotec, the drug was orig­i­nal­ly dis­cov­ered by Sanofi. It was part of the €250 mil­lion, 2015 agree­ment that saw Evotec take con­trol of Sanofi’s Toulouse, France op­er­a­tions and at­tempt to build out a broad­er on­col­o­gy pipeline. As with most pro­grams de­vel­oped by the Ger­man dis­cov­ery spe­cial­ist, Evotec would then look to part­ner those out.

Kazia has yet to pro­duce ran­dom­ized da­ta for the Genen­tech can­di­date, pax­al­is­ib, it li­censed in 2016, but da­ta from a small Phase II tri­al point­ed to over­all sur­vival of 17.7 months in glioblas­toma, or what they claimed was about 5 months longer than the stan­dard of care. They are now re­ly­ing on an in­ves­ti­ga­tor-ini­ti­at­ed tri­al from the non-prof­it Glob­al Coali­tion for Adap­tive Re­search to pro­vide piv­otal da­ta. It’s com­par­ing 4 dif­fer­ent treat­ment reg­i­mens across 1030 pa­tients.

That 2016 deal, though, has al­ready proven a ma­jor boon to the com­pa­ny. Then known as Novo­gen, the biotech had a mar­ket cap of less than $40 mil­lion when new CEO James Gar­ner took pax­al­is­ib off Genen­tech’s hands for just $5 mil­lion cash. Based off the Phase II da­ta — and boost­ed by the over­all bio­phar­ma stock boom — they are now worth around $150 mil­lion.

The new deal rep­re­sents an­oth­er low-risk, high-re­ward bet. Al­though VEGF in­hi­bi­tiors — Su­tent, Lenvi­ma, Cabome­tyx — have been around for years, Kazia claims the EVT801 is more se­lec­tive than its pre­de­ces­sors. By hit­ting just VEG­FR3 as op­posed to all VEG­FR re­cep­tors, the drug of­fers a much safer pro­file, they claim.

Kazia said they plan to test the drug in re­nal cell car­ci­no­ma, he­pa­to­cel­lu­lar car­ci­no­ma and soft tis­sue sar­co­ma. In ad­di­tion to monother­a­py, they al­so plan to com­bine the mol­e­cule with im­munother­a­py drugs.

Evotec’s role in de­vel­op­ment will con­tin­ue. They will con­tin­ue to pro­vide CMC ser­vices and Kazia will pay them to de­vel­op a bio­mark­er to test the drug’s ef­fec­tive­ness.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Charles Riv­er keeps adding on to its CD­MO arm, snatch­ing up a vi­ral vec­tor play­er for a tidy $350M

Contract researcher Charles River Laboratories has been on a roll recently to flesh out its manufacturing arm with a specific focus on its capabilities in gene therapy. Now, the firm is putting its name to a big check for a Maryland-based viral vector firm it thinks will add to its growing expertise in the field.

Charles River will dole out $292.5 million for gene therapy CDMO Vigene Biosciences with the possibility for an additional $57.5 million in performance-based payments, the companies said Monday. The deal will close at the start of Q3, a Charles River spokesman said.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Josep Bassaganya-Riera, Landos Biopharma CEO (Landos)

Per­cep­tive's Chi­na up­start Lian­Bio con­tin­ues swing­ing deals, team­ing up with lead Xon­toge­ny biotech Lan­dos in IBD

One of China’s biggest up-and-comers has a brand new partner, and it’s one whose backers are likely familiar with the other’s.

Perceptive’s LianBio has secured a collaboration with Landos Biopharma, the lead company in Chris Garabedian’s Xontogeny fund, to develop and market two programs in Greater China and other countries in the region, the biotechs announced Monday morning. In exchange, Landos is getting an upfront payment of $18 million, up to $200 million in milestones and royalties on sales in the licensed territories.