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.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.

David Meline (file photo)

Mod­er­na’s new CFO took a cut in salary to jump to the mR­NA rev­o­lu­tion­ary. But then there’s the rest of the com­pen­sa­tion pack­age

David Meline took a little off the top of his salary when he jumped from the CFO post at giant Amgen to become the numbers czar at the upstart vaccines revolutionary Moderna. But the SEC filing that goes with a major hire also illustrates how it puts him in line for a fortune — provided the biotech player makes good as a promising game changer.

To be sure, there’s nothing wrong with the base salary: $600,000. Or the up-to 50% annual cash bonus — an industry standard — that comes with it. True, the 62-year-old earned $999,000 at Amgen in 2019, but it’s the stock options that really count in the current market bliss for all things biopharma. And there Meline did well.

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