With mon­ey flow­ing, Pli­ant Ther­a­peu­tics heads to pub­lic well

Fresh off rais­ing a $100 mil­lion Se­ries C and send­ing their sec­ond com­pound in­to the clin­ic, Pli­ant Ther­a­peu­tics is head­ed for Wall Street.

The South San Fran­cis­co-based biotech filed this morn­ing for an $86 mil­lion IPO. The mon­ey will help fund clin­i­cal de­vel­op­ment of their lead pro­gram for a rare lung dis­ease and rare liv­er dis­ease and boost pre­clin­i­cal re­search for on­col­o­gy and mus­cu­lar dy­s­tro­phy.

The IPO comes amid a se­ries of large pub­lic fi­nanc­ings for biotechs, as in­vestors fun­nel dol­lars out of in­dus­tries strug­gling dur­ing the pan­dem­ic. Small can­cer biotechs Zen­tal­is and ORIC raised $165 mil­lion and $125 mil­lion a piece, while ADC filed for $125 mil­lion. Yes­ter­day, al­ready pub­lic Im­munomedics was able to raise $459 mil­lion in a new of­fer­ing.

Bernard Coulie

For Pli­ant, the deal comes just two months af­ter a $100-mil­lion No­var­tis-led raise, af­ter which CEO Bernard Coulie ac­knowl­edged an IPO could be com­ing but re­fused to com­ment to Xcon­o­my on when.

Al­though Pli­ant is rais­ing mon­ey in part to push for­ward a lead pro­gram they’ve had since their found­ing, the com­pa­ny’s S-1 al­so sig­nals a shift for the group. Third Rock found­ed the group around tech­nol­o­gy meant to block TGF-β ac­ti­va­tion, a key path­way in fi­bro­sis, and while they long em­pha­sized the ap­pli­ca­tions across dif­fer­ent dis­eases, their first tar­gets were rare dis­eases and liv­er dis­eases.

They de­vel­oped an TGF-β in­hibitor called PLN-74809 and brought it in­to the clin­ic for id­io­path­ic pul­monary fi­bro­sis (IPF), a con­di­tion that in­volves ir­re­versible scar­ring of the lungs, and pri­ma­ry scle­ros­ing cholan­gi­tis (PSC), a pro­gres­sive form of in­flam­ma­tion in the lung and gall­blad­der.

Pli­ant al­so de­vel­oped PLN-1474, an in­hibitor of the same path­way that No­var­tis will try to de­vel­op for NASH. The col­lab­o­ra­tion, an­nounced in Oc­to­ber, paid Pli­ant $80 mil­lion up­front, cov­ered costs for Phase I and sub­se­quent de­vel­op­ment, and al­so grant­ed No­var­tis ac­cess to up to 3 oth­er pre­clin­i­cal can­di­dates. Al­though NASH has seen a slew of fail­ures — most re­cent­ly with Gen­Fit’s Phase III loss yes­ter­day — the dis­ease still rep­re­sents an enor­mous mar­ket for drug com­pa­nies.

Go­ing for­ward, though, the com­pa­ny’s new ex­per­i­men­tal com­pounds will come in can­cer and mus­cu­lar dy­s­tro­phy.

For can­cer, the idea is based in im­muno-on­col­o­gy. The com­pa­ny cit­ed re­search in­di­cat­ing that TGF-β plays a role in a tu­mor’s abil­i­ty to turn down in­flam­ma­tion in its mi­cro-en­vi­ron­ment and evade the im­mune sys­tem. They will try to use an in­hibitor to turn down that an­ti-in­flam­ma­to­ry re­sponse and make tu­mors more sus­cep­ti­ble to check­point ther­a­pies — a com­mon goal for can­cer biotechs.

In mus­cu­lar dy­s­tro­phy, the com­pa­ny is de­vel­op­ing an an­ti­body to al­loster­i­cal­ly in­hib­it an undis­closed in­te­grin they say is up­reg­u­lat­ed in mus­cle cells across dif­fer­ent mus­cu­lar dy­s­tro­phies, in­clud­ing Duchenne mus­cu­lar dy­s­tro­phy.

But both those pro­grams are in the pre­clin­i­cal stage. And for now, most eyes will rest on PLN-74809 and how it per­forms in the clin­ic. The com­pa­ny is re­cruit­ing for a pair of Phase IIa tri­als in IPF and they re­cent­ly were cleared for a Phase IIa in PSC. Covid-19, though, could throw time­lines com­plete­ly in the air. The re­sults could al­so be mud­died:

As a re­sult of the COVID-19 pan­dem­ic and shel­ter-in-place re­stric­tions, com­mence­ment of en­roll­ment of our clin­i­cal tri­als of PLN-74809 in IPF and PSC has been de­layed. We an­tic­i­pate de­lays in site start-up ac­tiv­i­ties of one to two quar­ters for both the PLN-74809 IPF and PSC Phase 2a tri­als, and we could ex­pe­ri­ence slow­er than ex­pect­ed en­roll­ment. In ad­di­tion, af­ter en­roll­ment in these tri­als, if pa­tients con­tract COVID-19 dur­ing par­tic­i­pa­tion in our tri­als or are sub­ject to iso­la­tion or shel­ter in place re­stric­tions, this may cause them to drop out of our tri­als, miss sched­uled dos­es or fol­low-up vis­its or oth­er­wise fail to fol­low tri­al pro­to­cols. If pa­tients are un­able to fol­low the tri­al pro­to­cols or if our tri­al re­sults are oth­er­wise dis­put­ed due to the ef­fects of the COVID-19 pan­dem­ic or ac­tions tak­en to mit­i­gate its spread, the in­tegri­ty of da­ta from our tri­als may be com­pro­mised or not ac­cept­ed by the FDA or oth­er reg­u­la­to­ry au­thor­i­ties, which would rep­re­sent a sig­nif­i­cant set­back for the ap­plic­a­ble pro­gram.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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