Come join me dur­ing my round-the-world biotech ad­ven­ture in Oc­to­ber, with events in Lon­don and Shang­hai — plus

A few years ago I had a chance to do a half-day event in Lon­don with a top group of biotech ex­ecs, and I’ve been mean­ing to get back to the Gold­en Tri­an­gle for a re­turn event ever since.

Now, with the Great Around the Biotech World Trip I’m plan­ning for Oc­to­ber, that time has ar­rived.

On Oc­to­ber 10, I’m bring­ing to­geth­er a great group of lead­ers in the biotech com­mu­ni­ty for the first an­nu­al End­points News UK Bio­phar­ma Re­search & De­vel­op­ment Sum­mit, host­ed at the Sil­i­con Val­ley Bank au­di­to­ri­um in Lon­don. 

We’ll be cov­er­ing key is­sues like fi­nanc­ing trends, the ROI of drug de­vel­op­ment and new in­no­va­tion, and how top can­cer drug de­vel­op­ers in the coun­try are nav­i­gat­ing the huge burst of new stud­ies that has swelled the pipeline in re­cent years.

Mene Pan­ga­los

My pan­elists in­clude Mene Pan­ga­los, the EVP of In­no­v­a­tive Med­i­cines, at As­traZeneca; Tim Haines

Kate Bing­ham

from Abing­worth; Kate Bing­ham at SV Health In­vestors; John Pot­tage, CSO at Vi­iV; Nooman Haque at SVB; David Grainger at Medicxi; Jack­ie Hunter from Benev­o­len­tAI; Mike Rea from IDEA; Mal­colm Weir, CEO at Hep­tares; Niall Mar­tin, CEO from Ar­tios and David Chiswell, the leg­endary CAT co-founder who now helms Kymab.

Plus a few we have yet to name.

You can read all about the half-day agen­da here. If you want­ed me to sum up the ob­jec­tive here, I’d say I’m look­ing for a clear up­date on the Gold­en Tri­an­gle’s place in this fast-chang­ing biotech world, with in­vestors act­ing more bull­ish­ly than I’ve ever seen. And I’d like to show the bio­phar­ma world what it looks like from the per­spec­tive of some of the bright­est peo­ple in the field.

We have a lim­it­ed num­ber of seats avail­able for an event that will be record­ed for a lat­er broad­cast. And I’m look­ing for an au­di­ence as great as the pan­elists who are ap­pear­ing to dis­cuss cur­rent biotech events at the sum­mit. Bio­phar­ma ex­ecs look­ing to get in­to the con­ver­sa­tion are hearti­ly wel­come. Plus, we have a beer and wine mix­er at the end, which should be fun.

It’s a good thing that we are near­ly squared away on Lon­don, be­cause af­ter a quick trip to Mu­nich for ES­MO, I’ll be head­ed out to Shang­hai for a 2-day event we’re man­ag­ing with our part­ners in Chi­na, Pharm­Cube: US-Chi­na Bio­phar­ma In­no­va­tion & In­vest­ment Sum­mit. We’re still bring­ing to­geth­er the pan­els for this, but we have head­line events planned with en­tre­pre­neur Saman­tha Du, CEO of Zai Labs, Vivek Ra­maswamy from Roivant, John Oyler, the CEO at BeiGene, Jonathan Wang from Or­biMed Asia and Fa­heem Has­nain, co-founder and ex­ec­u­tive chair­man of Gos­samer, who you may re­call arranged the $7.2 bil­lion sale of Re­cep­tos to Cel­gene and re­cent­ly raised $330 mil­lion for his new ven­ture. 

Plus, we have lots and lots more ex­ecs who will be join­ing us.

We’re go­ing to be talk­ing deals, dol­lars and ren­min­bi at a cru­cial in­ter­sec­tion for US, Chi­nese and Eu­ro­pean play­ers. So why are we ask­ing you to join us? By in­ter­min­gling key play­ers on both sides of the Pa­cif­ic — as well as from Eu­rope — we’d like to spark some new talks on col­lab­o­ra­tions, de­vel­op­ment deals and fi­nanc­ing op­por­tu­ni­ties. Chi­na’s fast-grow­ing in­dus­try is chang­ing every­thing about the glob­al in­dus­try, and this is the time to ful­ly ex­plore it and make some con­nec­tions.

Fi­nal­ly, I’ll be head­ed down to Aus­tralia to keynote the an­nu­al Aus­Biotech gath­er­ing, which I’m re­al­ly look­ing for­ward to. And then I plan to sleep on the en­tire trip back to Ver­mont.

You may have no­ticed that our mot­to here is End­points News: The bio­phar­ma world is here. We weren’t kid­ding around.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

Three­'s a crowd as an­oth­er Kite ex­ec hits the ex­it; Surf­ing tough wa­ters, Celyad On­col­o­gy picks up new CEO

Kite Pharma is losing another exec, as Francesco Marincola leaves his post to join Flagship startup Sonata Therapeutics as CSO. Marincola served as Kite’s SVP and global head of cell therapy research, having joined the company in 2021 after a stint as CSO at Refuge Biotechnologies. Marincola has also served as a distinguished research fellow at AbbVie and spent more than two decades at the NIH and NCI. Marincola’s exit from Kite marks the third, following CEO Christi Shaw and Tecartus global program clinical lead Behzad Kharabi, who both left last month.

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