Peter Bach, new Delfi Diagnostics CMO (Michael Loccisano/Getty Images for New York Times)

Out­spo­ken drug pric­ing re­searcher Pe­ter Bach takes CMO gig at liq­uid biop­sy start­up

Af­ter spend­ing more than a decade crit­i­ciz­ing the in­dus­try over drug pric­ing, Memo­r­i­al Sloan Ket­ter­ing’s out­spo­ken re­searcher Pe­ter Bach is jump­ing over to the C-suite of a liq­uid biop­sy start­up.

Bach, known for his frank tweets and fre­quent ed­i­to­ri­als, is tak­ing the CMO role at Delfi Di­ag­nos­tics, a Bal­ti­more-based biotech that’s look­ing for a bet­ter way to screen the blood for can­cer. The com­pa­ny snagged $100 mil­lion at the be­gin­ning of the year, and a cou­ple months ago ini­ti­at­ed a na­tion­al tri­al for lung can­cer screen­ing.

“It wasn’t hard to spot Delfi ap­pear­ing on the scene be­tween its Se­ries A an­nounce­ment and stun­ning re­sults in Na­ture,” Bach told End­points News in an email.

The Madi­son, WI na­tive spent the last 23 years at Memo­r­i­al Sloan Ket­ter­ing, where he’s di­rec­tor of the Cen­ter for Health Pol­i­cy and Out­comes. His par­ents, who were both pro­fes­sors at the Uni­ver­si­ty of Wis­con­sin, in­spired him to pur­sue a ca­reer in med­i­cine, Bach said dur­ing a 2017 TEDMED talk. But it was a trip to New York City with his un­cle that “ul­ti­mate­ly al­lowed me to un­der­stand US phar­ma­ceu­ti­cal pric­ing.”

Bach com­pared the cur­rent state of drug pric­ing to a New York hus­tler play­ing three-card Monte. The man would shuf­fle three cards — two black and one red — and in­struct passers­by to fol­low the red one. But when­ev­er an au­di­ence mem­ber guessed cor­rect­ly, he would furtive­ly swap it out for a black one.

“That in­sight has helped me un­der­stand what’s wrong with phar­ma­ceu­ti­cal pric­ing,” he said dur­ing the talk. “Ad­just­ed for in­fla­tion and dos­ing over the last 50 years, can­cer drug prices have risen 100-fold … When ris­ing prices dri­ve in­no­va­tion, they lead to in­no­va­tion so high-priced that some peo­ple can’t af­ford it.”

In 2012, he and two oth­er col­leagues pub­lished an ed­i­to­r­i­al in the New York Times about Memo­r­i­al Sloan Ket­ter­ing’s de­ci­sion to re­ject Sanofi’s “phe­nom­e­nal­ly ex­pen­sive” can­cer drug — a move that lat­er led Sanofi to slash the price by about half. He and his team lat­er re­leased Dru­gAba­cus in 2015, an in­ter­ac­tive tool com­par­ing a drug’s val­ue ver­sus its price.

Vic­tor Vel­cules­cu

“There’s a quote Pe­ter and I were just chat­ting about,” Delfi CEO Vic­tor Vel­cules­cu told End­points in an in­ter­view. “Can­cer was a dis­ease of age. We don’t want it to be­come a dis­ease of the poor.”

Delfi thinks it has a cost-ef­fec­tive liq­uid biop­sy ap­proach, which could de­tect can­cer ear­li­er in pa­tients and lead to few­er deaths. The idea is to uti­lize ma­chine learn­ing to con­duct whole genome se­quenc­ing from a pa­tient’s blood. What the team is look­ing for are nat­u­ral­ly oc­cur­ring frag­men­ta­tion pat­terns that are usu­al­ly pret­ty con­sis­tent in healthy in­di­vid­u­als. But in can­cer pa­tients, the pat­tern is dif­fer­ent.

That’s be­cause the DNA in­side the can­cer is ab­nor­mal­ly pack­aged, and when cells die and re­lease the DNA in the blood­stream, it leads to ab­nor­mal break­ages and ab­nor­mal pro­files that can then be de­tect­ed, Vel­cules­cu said. He be­lieves the ap­proach could tell sci­en­tists where the can­cer orig­i­nat­ed, and has the po­ten­tial for use across a va­ri­ety of can­cer types.

Ac­cord­ing to a study in Na­ture, the method de­liv­ered sen­si­tiv­i­ties rang­ing from 57% to over 99% among sev­en dif­fer­ent types of can­cer.

“I know most peo­ple know me for my work in health pay­ment pol­i­cy and phar­ma­ceu­ti­cals, but I ac­tu­al­ly worked for more than a decade in can­cer screen­ing and pre­ven­tion and par­tic­u­lar­ly in lung can­cer screen­ing,” Bach said in an email. “Then I got to know the team of sci­en­tists at the heart of the com­pa­ny and can­not wait to work on de­vel­op­ing a tech­nol­o­gy that could form the ba­sis of a low cost high­ly sen­si­tive test that could help cap­ture the un­re­al­ized gains in lung can­cer screen­ing and more broad­ly.”

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.