#SITC18: An­oth­er un­der­whelm­ing per­for­mance for STING dam­ages Aduro’s al­ready suf­fer­ing share price

Aduro Biotech ex­ecs $ADRO made as much as they pos­si­bly could of the two par­tial re­spons­es re­searchers tracked among 40 heav­i­ly pre-treat­ed can­cer pa­tients in an ear­ly-stage study of their STING ther­a­py. But their de­fense at SITC wasn’t near­ly enough to save the Berke­ley, CA-based biotech from an­oth­er beat­ing at the hands of un­hap­py in­vestors.

Stephen Isaacs

Mer­ck set the stage at ES­MO last month when re­searchers ac­knowl­edged that their ri­val STING ther­a­py had no ef­fect on tu­mors as a monother­a­py, rais­ing ques­tions about the class and the drug at Aduro — which No­var­tis $NVS plunked down $200 mil­lion in cash to part­ner on. 

Aduro CEO Stephen Isaacs called the mar­gin­al re­sults for ADU-S100 (MIW815) “promis­ing,” which was a bit of a stretch for his in­vestors. They drove the stock down 14% on Fri­day. And you can count Brad Lon­car — an in­de­pen­dent in­vestor in biotech and a reg­u­lar con­trib­u­tor at End­points News — among the grow­ing ranks of skep­tics.

Brad Lon­car

Lon­car’s take: 

The bot­tom line with STING is that mouse mod­els ap­pear to be en­tire­ly non-pre­dic­tive. The ab­sco­pal ef­fect that was so ex­cit­ing pre­clin­i­cal­ly ap­pears to be at best mut­ed in hu­mans.  Some peo­ple were hop­ing for an ‘ah ha’ mo­ment with this one and that’s not hap­pen­ing un­for­tu­nate­ly. It’s too ear­ly to com­plete­ly write it off, and to their cred­it these are heav­i­ly pre­treat­ed pa­tients, but count on years of go­ing back to the draw­ing board for STING.

The com­pa­nies aren’t about to back down at this stage, though. Re­searchers are pur­su­ing a Phase Ib with No­var­tis’ PD-1 spar­tal­izum­ab (PDR001) to check on any syn­er­gies that could ex­ist with the check­point crowd — which is where Mer­ck has been fo­cused. And they added an arm to the ini­tial study which match­es their STING with Bris­tol-My­ers’ oth­er promi­nent check­point, the CT­LA-4 drug Yer­voy.

The biotech has had to deal with a string of set­backs, in­clud­ing the abrupt de­par­ture of J&J from their part­ner­ship a few weeks ago, torch­ing a deal that in­clud­ed more than a bil­lion dol­lars in mile­stones. And last year the com­pa­ny had to punt CRS-207, af­ter that drug al­so per­formed poor­ly in tri­als.

Aduro has al­so been hit this year by some un­ex­plained de­par­tures from the top ranks, in­clud­ing CMO Na­tal­ie Sacks, who left at the be­gin­ning of Oc­to­ber. The CFO, Gre­go­ry Schafer, left in March. 

Back at the end of March, their stock trad­ed at a 2018 high of $9.30. Fri­day’s close at $3.63 leaves the sink­ing stock down 61% off that mark.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

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Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

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US sup­ports ex­ten­sion for Covid-19 IP waiv­er de­ci­sion

After much debate, the US government is now calling for a deadline extension to discuss a controversial potential IP waiver for Covid-19 diagnostics and therapeutics.

Over the last five months, the Office of the United States Trade Representative said it has consulted with members of Congress, public health advocates, organized labor groups, academics, think tanks, companies and trade associations on the WTO’s recent TRIPS agreement, which established a 5-year waiver of certain patent requirements on Covid-19 vaccines.

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Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.

Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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