Uni­corn Mod­er­na joins line­up to list on Hong Kong's ex­change; Proces­sa li­cens­es com­pound from Con­cert

→ Ru­mors are fly­ing that biotech’s biggest uni­corn, Mod­er­na, which was re­cent­ly val­ued at $7 bil­lion, is plan­ning a dual IPO list­ing on both the Nas­daq and the Hong Kong ex­changes. That’s ac­cord­ing to a Wall Street Jour­nal re­port, which cites un­named sources fa­mil­iar with the com­pa­ny’s plans. The list­ing, they say, could be as ear­ly as next year. Mod­er­na would be one of sev­er­al biotechs lin­ing up to list on Hong Kong’s ex­change, which just re­cent­ly an­nounced a rule change that would al­low life sci­ence star­tups to list. An­nounced in De­cem­ber (and tak­ing ef­fect this year), the rule change will al­low com­pa­nies that haven’t earned rev­enue or prof­it to ap­ply for IPOs in Hong Kong — as long as they’re val­ued at HK$1.5 bil­lion (US$192 mil­lion). The com­pa­nies must meet some cri­te­ria first, like be­ing at least 2 years old and hav­ing some patents. An­oth­er biotech uni­corn, Grail, which has raised over $1 bil­lion and whose back­ers in­clude GV (for­mer­ly Google Ven­tures) and Bill Gates, is al­so gear­ing up for a $500 mil­lion Hong Kong list­ing. The rules for the Hong Kong ex­change are ex­pect­ed to be fi­nal­ized in late April. When the gate lifts, we ex­pect to see lots of biotechs trot­ting through.

→ Hanover, Mary­land-based Proces­sa Phar­ma­ceu­ti­cals has picked up a li­cense for a com­pound called CTP-499, which it says has po­ten­tial for mul­ti­ple phar­ma­co­log­i­cal tar­gets. First, the com­pa­ny says its tack­ling a chron­ic, dis­fig­ur­ing con­di­tion called Necro­sis Lipoidi­ca (NL). “The Proces­sa de­vel­op­ment team has al­ready met with the FDA on NL and has a sol­id strat­e­gy for mov­ing for­ward with the de­vel­op­ment of CTP-499 in NL start­ing with a Phase II clin­i­cal tri­al in NL pa­tients in 2018,” said Proces­sa’s CEO David Young in a state­ment. “We al­so hope to meet with the FDA on a sec­ond clin­i­cal stage in­di­ca­tion for CTP-499 in the next few months.” For the li­cense, Proces­sa is pay­ing $8 mil­lion in shares to Con­cert Phar­ma­ceu­ti­cals. Con­cert is el­i­gi­ble to re­ceive roy­al­ties on com­mer­cial sales.

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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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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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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.

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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FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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