Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lil­ly is ex­pand­ing its part­ner­ship with Chi­na’s In­novent in a deal in­volv­ing a di­a­betes drug sit­ting in its Phase I re­serves.

The two com­pa­nies had joint­ly de­vel­oped one of Chi­na’s first home­grown PD-1 agents, scor­ing an ap­proval for Tyvyt (sin­til­imab) late last year for re­lapsed/re­frac­to­ry clas­si­cal Hodgkin’s lym­phoma. This time around, Lil­ly is out-li­cens­ing a piece of its di­a­betes pipeline, a lead­ing fran­chise that has his­tor­i­cal­ly pro­duced the top-sell­ing Trulic­i­ty and Hu­ma­log.

But the In­di­anapo­lis-based drug­mak­er al­so has a com­pli­cat­ed his­to­ry with the drug class in ques­tion.

The oxyn­to­mod­ulin ana­log known as OXM3 is a dual GLP-1 and glucagon re­cep­tor ag­o­nist de­signed for once-week­ly in­jec­tion. Ear­ly-stage tri­als have shown po­ten­tial for po­tent weight loss and im­proved glycemic con­trol, ac­cord­ing to In­novent.

On the sur­face, the pro­file is sim­i­lar to that of TT401, an ex­per­i­men­tal drug from Tran­si­tion Ther­a­peu­tics that Lil­ly ini­tial­ly part­nered on but even­tu­al­ly spurned in 2016. Af­ter re­view­ing Phase II da­ta, Lil­ly had de­cid­ed the ad­van­tages in low­er­ing HbA1c were not sig­nif­i­cant enough to war­rant a Phase III.

“De­spite the avail­abil­i­ty of var­i­ous OXM pep­tides and ana­logues there­of, there is still a need for more po­tent, sta­ble, long-act­ing, and well-tol­er­at­ed OXM pep­tide ana­logues hav­ing a ra­tio of Gc­gR/GLP-1R ac­tiv­i­ty which has been op­ti­mized such that the po­ten­cy and in­sulinotrop­ic ac­tiv­i­ty of the pep­tide pro­vides ef­fec­tive treat­ments for di­a­betes, prefer­ably type 2 di­a­betes and re­lat­ed dis­or­ders,” read Lil­ly’s patent ap­pli­ca­tion for an OXM ana­log.

Michael Yu

We don’t know much about the com­pound that In­novent is in­tro­duc­ing to Chi­na, ex­cept that it is deemed “po­ten­tial best-in-class” and will be ush­ered in­to mid-stage stud­ies. There’s al­so men­tion of ap­pli­ca­tion in NASH.

The li­cens­ing deal al­so marks In­novent’s first for­ay in­to the di­a­betes field. While it lists au­toim­mune as one of four re­search ar­eas, the com­pa­ny has so far fo­cused on rheuma­toid arthri­tis, anky­los­ing spondyli­tis, lu­pus and asth­ma.

“Chi­na has a greater num­ber of di­a­bet­ic pa­tients than any oth­er coun­try in the world with around 114 mil­lion peo­ple suf­fer­ing from the dis­ease,” CEO Michael Yu not­ed in a state­ment.

Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Trevor Martin (Mammoth)

Eye­ing in-vi­vo edit­ing, Mam­moth li­cens­es Jen­nifer Doud­na’s new CRISPR en­zyme

Last month, Jennifer Doudna revealed in Science a new, “hyper-compact” CRISPR enzyme that was half the size of traditional CRISPR enzymes and could, she suspected, offer a new, more versatile tool for gene editing.

Now, the University of California-Berkeley has licensed that enzyme, known as Casφ, exclusively to a biotech startup she and two former students set up three years ago: Mammoth Biosciences. It’s the second new CRISPR protein Mammoth has licensed from Doudna’s lab, after they licensed Cas14 in 2019.