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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

Paul Grayson, Tentarix CEO (Versant)

Phar­ma vet­er­ans re­group with $50M and a plan to dis­cov­er new mul­ti-specifics

While a horde of drugmakers develops bispecific antibodies to more directly target tumor cells — there were about 100 programs in or nearing clinical trials back in May — a new company is emerging to go one step further.

On Thursday, Tentarix Biotherapeutics unveiled a $50 million Series A round to support its next-gen multi-specifics platform. While the field has largely focused on bispecifics, which engage two targets, Tentarix believes its multifunctional programs have the potential to be even more specific, since more conditions must be met for potent activity to occur.