Take­da re­ceives ad­di­tion­al FDA ap­proval for GI drug; Can­cer Re­search UK to test gem­c­itabine for ad­vanced pan­cre­at­ic can­cer

→ The FDA has giv­en the green light to Take­da to ex­tend­ed the in­di­ca­tion of its drug Gat­tex (tedug­lu­tide) for in­jec­tion to pe­di­atric pa­tients 1 year of age and old­er with short bow­el syn­drome (SBS) who need ad­di­tion­al nu­tri­tion or flu­ids from in­tra­venous (IV) feed­ing (par­enter­al sup­port).

→ More than a decade af­ter the FDA first ap­proved Frag­min to treat blood clots in adults, Pfiz­er has won an OK to ex­tend its use in pe­di­atric pa­tients as young as one month old. There’d been no FDA-ap­proved ther­a­pies to treat ve­nous throm­boem­bolism in this pop­u­la­tion, Richard Paz­dur said in a state­ment, who are of­ten suf­fer­ing from a se­ri­ous un­der­ly­ing con­di­tion such as can­cer and con­gen­i­tal heart dis­ease. The ap­proval was based on a sin­gle tri­al with 38 pa­tients, in which “21 pa­tients achieved res­o­lu­tion of the qual­i­fy­ing VTE, sev­en pa­tients showed re­gres­sion, two pa­tients showed no change, no pa­tients ex­pe­ri­enced pro­gres­sion of the VTE and one pa­tient ex­pe­ri­enced re­cur­rence of VTE.”

→ Af­ter whip­ping up some buzz around its gene ther­a­py for “bub­ble boy dis­ease” with ear­ly but hope­ful da­ta, Mus­tang Bio has scored an or­phan drug des­ig­na­tion for an­oth­er as­set in its pipeline: an on­colyt­ic virus to treat ma­lig­nant glioma, an ag­gres­sive type of brain can­cer. The New York-based biotech is li­censed the pro­gram from Na­tion­wide Chil­dren’s Hos­pi­tal, with the in­ten­tion to com­bine it with its an­ti-CD213a2 CAR-T ther­a­py.

→ The Can­cer Re­search UK an­nounced to­day that it will be­gin a clin­i­cal tri­al to test gem­c­itabine in ad­vanced pan­cre­at­ic can­cer. The or­ga­ni­za­tion says that “the study will use PLX7486 to tar­get Trk ki­nas­es, which are be­lieved to help can­cer cells in­vade nerves. It’s hoped that PLX7486, in com­bi­na­tion with the chemother­a­py drug gem­c­itabine, could im­prove pro­gres­sion-free sur­vival and re­duce pain for pan­cre­at­ic can­cer pa­tients.” The tri­al will be con­duct­ed through the Ex­per­i­men­tal Can­cer Med­i­cine Cen­tre (ECMC) net­work, sup­port­ed by Can­cer Re­search UK and the UK Health De­part­ments and let by the Man­ches­ter ECMC and spon­sored by the Uni­ver­si­ty of Glas­gow Clin­i­cal Tri­als Unit. The first pa­tients can ex­pect to start treat­ments in ear­ly June and the tri­al will span four sites across the UK.

Na­tal­ie Cook, chief in­ves­ti­ga­tor of the tri­al and clin­i­cal lead of the Man­ches­ter ECMC, said: “Pre­clin­i­cal mod­els show that giv­ing this drug com­bi­na­tion seems ef­fec­tive at stop­ping the can­cer cells grow­ing and mul­ti­ply­ing. Hope­ful­ly, this will trans­late in­to clin­i­cal ben­e­fits and en­able us to bet­ter con­trol the pain and spread of can­cer in pa­tients.”


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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