Red­hill spikes — briefly — on pos­i­tive Crohn's da­ta; Dai­ichi inks glob­al li­cens­ing deal with Gly­co­tope

→ Shares of Is­rael’s Red­hill Bio­Phar­ma $RDHL spiked Mon­day morn­ing — then quick­ly be­gan to slide back — af­ter the biotech laid out da­ta demon­strat­ing how their drug for Crohn’s dis­ease edged out the place­bo arm in their first Phase III study.

The drug is RHB-104, an an­tibi­ot­ic com­bi­na­tion that was based on Red­hill’s the­o­ry that Crohn’s is caused by a bac­te­r­i­al in­fec­tion. In their Phase III re­searchers say that 37% of the pa­tients in their drug arm achieved re­mis­sion at 26 weeks, com­pared to a hefty 23% in the place­bo group. That re­sult­ed in a pos­i­tive p val­ue of 0.013.

Sec­ondary end­points in­clud­ed ear­ly re­mis­sion at week 16 — 42% ver­sus 29% — and durable re­mis­sion over weeks 16-52, for an 18% – 9% split be­tween the two arms. Red­hill’s shares ini­tial­ly surged 28% on the news, then start­ed to sub­side. By mid­morn­ing the gain was pared down to 1% for the com­pa­ny, which has a ten­den­cy to push its luck in pro­mot­ing re­sults.

→ Dai­ichi Sankyo and a Berlin-based im­muno-on­col­o­gy com­pa­ny called Gly­co­tope have inked an ex­clu­sive world­wide li­cens­ing agree­ment to de­vel­op an an­ti­body drug con­ju­gate by com­bin­ing the Japan­ese phar­ma gi­ant’s ADC tech with Gly­co­tope’s in­ves­ti­ga­tion­al tu­mor-as­so­ci­at­ed TA-MUC1 an­ti­body gatipo­tuzum­ab. This builds on a pre­vi­ous 2017 op­tion agree­ment.

Un­der the deal, Dai­ichi has glob­al rights to de­vel­op and com­mer­cial­ize gatipo­tuzum­ab as an ADC. Gly­co­tope will re­ceive an up­front pay­ment and is el­i­gi­ble for clin­i­cal, reg­u­la­to­ry and sales mile­stone pay­ments, as well as roy­al­ties on net sales world­wide from Dai­ichi Sankyo. Spe­cif­ic fi­nan­cial terms were not dis­closed.

“With the li­cens­ing of gatipo­tuzum­ab with the in­ten­tion of de­vel­op­ing an ADC, we now have sev­en nov­el AD­Cs in de­vel­op­ment, which demon­strate our com­mit­ment to max­i­miz­ing the po­ten­tial of our pro­pri­etary ADC pay­load and link­er tech­nol­o­gy to help ad­dress the un­met needs of pa­tients with can­cer world­wide,” said Dai­ichi’s Tom Held, VP and head of the com­pa­ny’s An­ti­body Drug Con­ju­gate Task Force, On­col­o­gy Re­search and De­vel­op­ment.

→ Cam­bridge, UK-based Kymab has come up with the pos­i­tive first-in-hu­man da­ta it need­ed to jus­ti­fy mov­ing its mon­o­clon­al an­ti­body in­to Phase II stud­ies. Hav­ing shown that KY1005 has a fa­vor­able safe­ty pro­file and could block T-cell dri­ven in­flam­ma­tion in the skin of healthy vol­un­teers, the clin­i­cal team will now move to launch a Phase IIa tri­al in atopic der­mati­tis late this year. Ac­cord­ing to the biotech, that con­di­tion — where high lev­els of the OX40 lig­and is found — is ex­act­ly the kind of con­di­tion their drug is de­signed to treat. Stud­ies in oth­er im­mune-re­lat­ed dis­eases, in­clud­ing graft-ver­sus-host dis­ease, are al­so in the plans.

→ An­ti­body drug­mak­er Im­munomedics $IM­MU is team­ing up with Yale Uni­ver­si­ty in a clin­i­cal col­lab­o­ra­tion. To­geth­er, they’re test­ing Im­munomedics’ lead drug can­di­date — sac­i­tuzum­ab govite­can, an an­ti­body drug con­ju­gate — as a sin­gle agent in two Phase II stud­ies in en­dome­tri­al and cer­vi­cal can­cers. On top of the two Phase II tri­als, Yale will al­so con­duct a pre­clin­i­cal eval­u­a­tion of sac­i­tuzum­ab govite­can in com­bi­na­tion with poly (ADP-ri­bose) poly­merase (PARP) in­hibitors in an­i­mal in vi­vo mod­els of gy­ne­co­log­ic can­cers. Im­munomedics has al­so en­tered in­to col­lab­o­ra­tions with Yale, Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, and Fred Hutchin­son Can­cer Re­search Cen­ter to fur­ther in­ves­ti­gate sac­i­tuzum­ab govite­can and la­betuzum­ab govite­can (IM­MU-130) in pre­clin­i­cal can­cer mod­els.

We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology

ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development

CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at with any issues.

Endpoints Premium

Premium subscription required

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

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,700+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,700+ biopharma pros reading Endpoints daily — and it's free.

FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,700+ biopharma pros reading Endpoints daily — and it's free.

Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
Endpoints News

Basic subscription required

Unlock this story instantly and join 57,700+ biopharma pros reading Endpoints daily — and it's free.