Tiny In­nate re­ports a PhI­Ib dis­as­ter, bat­ter­ing shares — and a NY con­gress­man

Reps. Chris Collins, R-NY, left, and Robert Pit­tenger, R-NC, leave a meet­ing of the House Re­pub­li­can Con­fer­ence in the Capi­tol on June 7, 2017. CQ Roll Call


Just about every­thing the lit­tle Aus­tralian biotech In­nate Im­munother­a­peu­tics tracked in its Phase IIb study of its ex­per­i­men­tal drug for mul­ti­ple scle­ro­sis points to a dis­as­ter. The da­ta on all 93 pa­tients in the study demon­strate a clear fail­ure of the drug to de­liv­er an im­prove­ment for pa­tients on any of “mul­ti­ple” end­points. The dropout rate in the drug arm was high. And the rate of se­ri­ous ad­verse events was high­er in the drug arm than in the con­trol group.

Rep. Chris Collins (R-NY)

In­nate (ASX Code: IIL) is go­ing back over the da­ta to see if the per pro­to­col re­sults on just the pa­tients who had com­plet­ed a siz­able por­tion of the study did any bet­ter. But in­ves­ti­ga­tors aren’t try­ing to en­cour­age any­one to be­lieve in MIS416, de­liv­ered by IV once a week for a year. They say there is no rea­son to ex­pect a change in out­comes.

All that is bad enough on its own. But even so, you may nev­er have heard about any of this but for one fact: A promi­nent US con­gress­man bet the ranch on this com­pa­ny’s stock — and ev­i­dent­ly lost vir­tu­al­ly all of it. In­nate’s stock al­most dis­ap­peared af­ter in­vestors got a look at the da­ta, falling to a few pen­nies a share.

Bloomberg re­porters, who have been cov­er­ing this sto­ry, did the math and con­clud­ed that New York Re­pub­li­can Chris Collins, In­nate’s biggest share­hold­er and a long­time be­liev­er, lost $16.7 mil­lion af­ter tak­ing the fli­er. And ev­i­dent­ly a num­ber of oth­er Re­pub­li­cans, in­clud­ing HHS Sec­re­tary Tom Price, al­so lost mon­ey as well.

HHS Sec­re­tary Tom Price

The con­nec­tions be­tween law­mak­ers in charge of health­care pol­i­cy and In­nate have now re­port­ed­ly in­spired an ethics in­ves­ti­ga­tion in­to the role Collins played in at­tract­ing in­vestors to the com­pa­ny. And in a sto­ry this morn­ing, The Buf­fa­lo News re­port­ed that the FDA had just grant­ed the biotech an IND to launch tri­als in the US, void­ing the con­gress­man’s claim that he had no con­flicts be­cause the biotech nev­er had busi­ness in front of US reg­u­la­tors.

The biggest les­son from all this, though, may be that any­one who bets a large por­tion of their wealth on a biotech long shot like this — based in Syd­ney — doesn’t know much about in­vest­ing, biotech or health­care. Collins, for his part, doesn’t agree. “For those that in­vest­ed in In­nate, in­clud­ing me, we all were so­phis­ti­cat­ed in­vestors who were aware of the in­her­ent risk,” Collins says in a pre­pared state­ment. He adds: “For every suc­cess­ful drug, there are count­less num­bers that fail. That’s how to­day’s sys­tem works.”

Si­mon Wilkin­son, In­nate Im­munother­a­peu­tics’ chief ex­ec­u­tive said: “These re­sults are a shock and def­i­nite­ly not what we were ex­pect­ing based on our pre­vi­ous clin­i­cal ex­pe­ri­ence with MIS416 and the re­port­ing of treat­ment ben­e­fits we have re­ceived from many com­pas­sion­ate use pa­tients over an ex­ten­sive 8-year pe­ri­od. These da­ta will be as dis­tress­ing to them as they will be for all the stake­hold­ers who were re­ly­ing on the out­come of this study.”

Wilkin­son can count his biggest in­vestor and biggest los­er as one of the most bad­ly shocked of all.

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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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.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

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.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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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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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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.