Søren Møller, Novo Holdings

IDO on the re­bound? Dan­ish out­fit IO Biotech hopes so with over­sub­scribed Se­ries B one month af­ter BTD in melanoma

Less than a month af­ter achiev­ing break­through ther­a­py des­ig­na­tion in melanoma, IO Biotech has se­cured an over­sub­scribed Se­ries B that will help them get their im­mune-mod­u­lat­ing IDO and PD-L1 can­cer vac­cines through a late-stage tri­al.

The Copen­hagen-based com­pa­ny net­ted €127 mil­lion ($154.5 mil­lion) in the round, it re­vealed Wednes­day morn­ing, rais­ing the stakes for its T cell ac­ti­vat­ing ther­a­pies. It’s the biggest fundraise for the biotech since its found­ing in con­junc­tion with No­vo Seeds in 2014, when it pulled in an amount more than 11 times high­er than its Se­ries A about four years ago.

No­vo Seeds man­ag­ing part­ner Søren Møller ac­knowl­edged the com­pa­ny’s quick rise, not­ing an “in­flec­tion point” af­ter IO launched a Phase II study in non-small cell lung can­cer in May 2019 and last month’s BTD. Møller does not sit on IO’s board.

In un­re­sectable or metasta­t­ic melanoma, where IO re­ceived the BTD, the biotech com­bines two of its pro­grams along with Mer­ck’s Op­di­vo. IO’s can­di­dates, IO102 and IO103, work to di­rect T cells against IDO and PD-L1, re­spec­tive­ly, and are spe­cif­ic to­ward their tar­gets.

IDO and PD-1 com­bi­na­tion ap­proach­es have proved a trou­bling ground in the past, as In­cyte’s ef­fort to match its epaca­do­stat can­di­date with Keytru­da in melanoma fell flat in April 2018. A few weeks lat­er, NewLink Ge­net­ics scrapped a Phase III tri­al for its own IDO pro­gram and end­ed up re­verse-merg­ing with Lu­mos in Oc­to­ber 2019 af­ter shares cratered to $1.59 af­ter hov­er­ing over $50.

But IO Biotech is tak­ing a slight­ly dif­fer­ent ap­proach, de­riv­ing pep­tides from IDO and PD-L1 in their ex­per­i­men­tal drugs. Møller notes the ul­ti­mate goal is to ac­ti­vate the body’s im­mune re­sponse in­to elim­i­nat­ing the tu­mor mi­croen­vi­ron­ments.

The da­ta that trig­gered De­cem­ber’s BTD in melanoma came last Sep­tem­ber and en­gi­neered much of the ex­cite­ment sur­round­ing Wednes­day’s raise. In an open-la­bel Phase II tri­al with 30 pa­tients, IO’s com­bo of IO102, IO103 and Op­di­vo showed an over­all re­sponse rate of 79% with 45% of pa­tients achiev­ing a com­plete re­sponse in the first-line set­ting. IO has yet to reach an over­all sur­vival point for the study, Møller said.

Pa­tients were treat­ed with Op­di­vo every oth­er week for as long as there was a clin­i­cal ben­e­fit or no side ef­fects. IO102 and IO103 were giv­en from the start of Op­di­vo ad­min­is­tra­tion and every oth­er week for the first six treat­ments. Af­ter that, the vac­cines were giv­en every fourth week up for up to a year.

With the da­ta, BTD and fund­ing now in hand, the next step is launch­ing the Phase III tri­al in melanoma. Møller ex­pects that to be­gin lat­er this year or in ear­ly 2022, with da­ta read­outs com­ing rough­ly two-and-a-half to three years af­ter­ward. IO’s NSCLC pro­gram, which com­bines IO102 with Keytru­da, should have da­ta some­time in the first half of this year.

Wednes­day’s round was led by HBM Health­care In­vest­ments, and oth­er new in­vestors join­ing the round in­clud­ed Vi­vo Cap­i­tal, Kur­ma Part­ners, Avoro Cap­i­tal, RA Cap­i­tal Man­age­ment, Sam­sara Bio­cap­i­tal, Id­in­vest Part­ners, PFM Health Sci­ences, Soleus Cap­i­tal, Eir Ven­tures and Ser­ra­do Cap­i­tal. In ad­di­tion to No­vo Seeds, ex­ist­ing in­vestors Lund­beck­fonden Emerge and Sun­stone Life Sci­ence Ven­tures al­so par­tic­i­pat­ed.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; Flood, dead­ly fire threat­en As­traZeneca vac­cine plants

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

With patent con­cerns loom­ing, Roche gets a new pri­or­i­ty re­view on block­buster IPF drug

Seven years after the FDA first approved Esbriet, the blockbuster Roche IPF drug is getting an expedited review for a second indication.

On Thursday, the agency gave Esbriet priority review for unclassified interstitial lung diseases, or forms of pulmonary inflammation and scarring that don’t fit easily into the over 200 known types of ILD. The move comes 10 months after Esbriet received breakthrough designation and sets Roche up for a decision by May.