Dicer­na scores broad, 'rest of liv­er' deal with No­vo Nordisk, bag­ging $225M in cash to hit some 30 tar­gets with RNAi plat­form

Turns out Dicer­na wasn’t done with deals yet af­ter lock­ing in $200 mil­lion up­front from Roche for a he­pati­tis B cock­tail two weeks ago.

Doug Fam­brough

No­vo Nordisk has signed on as the lat­est part­ner to its GalXC RNAi plat­form, hand­ing over $175 mil­lion in cash to claim any and all tar­gets of in­ter­est in liv­er-re­lat­ed car­dio-meta­bol­ic dis­eases that are not al­ready re­served in pre­vi­ous pacts. The Dan­ish drug­mak­er — which has sig­naled its in­ter­est to ex­pand con­sid­er­ably be­yond its core di­a­betes fran­chise in­to ar­eas like NASH — is al­so pur­chas­ing $50 mil­lion worth of Dicer­na’s eq­ui­ty at a 25% pre­mi­um of $21.93 per share. More re­search pay­ments and mile­stones ex­tend­ing to the bil­lions are on the line.

Dicer­na CEO Doug Fam­brough de­scribes the deal as a “cap­stone” for its part­ner­ing ef­forts in the liv­er space and a fur­ther sign that the biotech has en­tered a more ma­ture phase of part­ner­ing with in­creased scope and val­ue.

In a call with an­a­lysts and in­vestors fol­low­ing the an­nounce­ment, he adopt­ed a re­al es­tate anal­o­gy:

If you think of the liv­er as an is­land, there are in­di­vid­ual prop­er­ties on the is­land that we have part­nered — com­ple­ment with Alex­ion, a cou­ple of par­tic­u­lar tar­gets in NASH with BI, et cetera. The col­lab­o­ra­tion with No­vo has as its purview the rest of the land on the is­land that is not part­nered in any of the four ex­ist­ing col­lab­o­ra­tions and we will not be sell­ing any ad­di­tion­al re­al es­tates, so to speak, that No­vo could choose to de­vel­op. This al­lows new in­sights that come from hu­man ge­net­ics or frankly any source to in­spire No­vo to in­clude a tar­get in the col­lab­o­ra­tion.

Jim Weiss­man

Dicer­na is tasked with dis­cov­ery and pre­clin­i­cal can­di­date se­lec­tion on a num­ber of liv­er cell tar­gets for dis­or­ders span­ning chron­ic liv­er dis­ease, NASH, type 2 di­a­betes, obe­si­ty, and rare dis­eases. No­vo Nordisk has com­mit­ted to $25 mil­lion per year dur­ing the first three years. While the duo hasn’t dis­closed how many years they ex­pect the col­lab­o­ra­tion to run, the plan is to ex­plore around 30 through­out the pe­ri­od.

But Dicer­na’s am­bi­tions here go be­yond start­ing pro­grams for big­ger com­pa­nies to take over. It has ne­go­ti­at­ed an op­tion to opt in­to two drugs for more preva­lent ail­ments af­ter view­ing clin­i­cal da­ta gen­er­at­ed by No­vo — al­low­ing their clin­i­cal team to buy in­to suc­cess­es with­out bear­ing the cost, Fam­brough high­light­ed. Un­der the deal, it can al­so ini­ti­ate the de­vel­op­ment of two or­phan drugs that the big­ger part­ner can opt in to.

The “re­al­ly broad” col­lab­o­ra­tion is de­signed to fo­cus less on in­di­vid­ual genes than the po­ten­tial of dif­fer­ent com­bi­na­tion ap­proach­es in a num­ber of liv­er dis­eases, COO Jim Weiss­man said.

Bob Brown

In­ter­nal­ly, Dicer­na has been ap­ply­ing its plat­form rou­tine­ly to ex­am­ine a list of genes as­so­ci­at­ed with dif­fer­ent car­diometa­bol­ic dis­eases, ac­cord­ing to CSO Bob Brown.

“We just rou­tine­ly knock them out and then use the GalXC mol­e­cules we iden­ti­fied there to in­ter­ro­gate the gene func­tion in the rel­e­vant dis­ease mod­els that we run rou­tine­ly in house,” he said on the call. “There’s no di­rect align­ment of lists yet, but we’ve in­ter­ro­gat­ed ap­prox­i­mate­ly 40 genes this way in dif­fer­ent mod­els of car­diometa­bol­ic dis­ease.”

No­vo has yet to iden­ti­fy the genes that they would like to start with, but Fam­brough not­ed that the tar­gets they have ex­pressed in­ter­est in are still “very much avail­able.”

Adding to pre­vi­ous deals with Boehringer In­gel­heim, Alex­ion, Eli Lil­ly and Roche, the in­flux of cap­i­tal from No­vo should keep Dicer­na ful­ly fund­ed for at least a year af­ter the en­vi­sioned com­mer­cial launch of their lead pro­gram in pri­ma­ry hy­per­ox­aluria, the man­age­ment said.

So­cial im­age: AP Im­ages

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.

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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Sum­i­to­vant sub­sidiaries En­zy­vant and Al­ta­vant merge in­to com­bined com­pa­ny

Two Sumitovant Biopharma entities are merging under one name, effective immediately.

Enzyvant Therapeutics and Altavant Sciences announced they have merged to form a singular entity focused on developing therapies for patients with rare diseases. The combined company will keep the name Enzyvant and along with clinical development will eventually include in-house manufacturing.

Bill Symonds, the current CEO of both Altavant and Enzyvant, is now CEO of the merged company.

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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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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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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