Vi­en­na-based vac­cine de­vel­op­er Themis signs pact with Mer­ck for 'block­buster in­di­ca­tion'

Months af­ter se­cur­ing up to $21 mil­lion in fund­ing from the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions (CEPI) for its Chikun­gun­ya vac­cine — which is be­ing prepped for a late-stage tri­al — Vi­en­na, Aus­tria-based Themis Bio­science en­tered in­to a pact with US drug­mak­er Mer­ck.

The Eu­ro­pean vac­cine de­vel­op­er formed in 2009 and a year lat­er joined forces with the In­sti­tut Pas­teur — gain­ing ex­clu­sive ac­cess to a measles virus vac­cine vec­tor tech­nol­o­gy, which now forms the back­bone of its plat­form.

Con­sid­er­ing it has been used to vac­ci­nate bil­lions of peo­ple, the at­ten­u­at­ed measles virus is one of the most ef­fec­tive and safe vac­cines avail­able, mak­ing it an at­trac­tive can­di­date vec­tor to avert in­fec­tious dis­ease.

In con­trast to oth­er ap­proach­es, Themis has de­vel­oped the tech­nol­o­gy to in­cor­po­rate mul­ti­ple large re­com­bi­nant pro­tein anti­gens in­to the vec­tor, which then acts as a de­liv­ery ve­hi­cle to trans­port the anti­gen pay­load di­rect­ly to macrophages and den­drit­ic cells. Fur­ther, since the vec­tor it­self repli­cates — there­by ex­press­ing anti­gens even af­ter im­mu­niza­tion — Themis’ vac­cine can­di­dates are en­gi­neered to con­fer long-term im­mu­ni­ty, chief Erich Tauber told End­points News.

Apart from its lead ex­per­i­men­tal Chikun­gun­ya vac­cine, Themis has a Zi­ka vac­cine and Las­sa fever in ear­ly-stage de­vel­op­ment. It al­so has a range of pre­clin­i­cal pro­grams, in­clud­ing those for res­pi­ra­to­ry syn­cy­tial virus (RSV), cy­tomegalovirus (CMV), norovirus and Mid­dle East Res­pi­ra­to­ry Syn­drome (MERS).

The vec­tor al­so has the in­trin­sic abil­i­ty to at­tack can­cer cells, which has been demon­strat­ed in var­i­ous pre­clin­i­cal stud­ies, he added. The com­pa­ny is there­fore cap­i­tal­iz­ing on that po­ten­tial by equip­ping the vec­tor with ad­di­tion­al tu­mor-killing pay­loads to de­vel­op on­col­o­gy treat­ments. Themis’s first im­muno-on­col­o­gy vac­cine is set to en­ter the clin­ic this year.

The terms of the Mer­ck $MRK part­ner­ship are shroud­ed in mys­tery. The two will work on a “block­buster in­di­ca­tion” and the New Jer­sey-based drug man­u­fac­tur­er will grant up to $200 mil­lion in mile­stone pay­ments, in ad­di­tion to roy­al­ties. Mer­ck has al­so made an undis­closed eq­ui­ty in­vest­ment in Themis.

Mer­ck, which has been bask­ing in the suc­cess of its flag­ship check­point in­hibitor Keytru­da, caus­ing some to wor­ry it may be lean­ing too heav­i­ly on the block­buster, has sharp­ened its fo­cus on its vac­cine port­fo­lio. In May, its pneu­mo­coc­cal con­ju­gate vac­cine can­di­date aimed at top­pling Pfiz­er’s best­seller, Pre­vnar 13, cleared a mid-stage study — and is al­so be­ing eval­u­at­ed in var­i­ous Phase III tri­als. Mer­ck al­so has a part­ner­ship with mR­NA com­pa­ny Mod­er­na $MR­NA, fo­cused on per­son­al­ized can­cer vac­cines that are cus­tomized for each pa­tient.

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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Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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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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Vikram Sheel Kumar, Clear Creek Bio CEO

In search for next-gen Covid treat­ment, Pfiz­er taps tiny biotech for re­search deal

Pfizer has inked a deal to develop a new Covid therapy with Clear Creek Bio — a 10-person biotech out of RA Capital with an office in Cambridge, MA, but one that operates fully remotely.

Paxlovid has become a big moneymaker for Pfizer this year, projecting $22 billion in sales on the year. But the Big Pharma has begun its search for a next-generation Covid antiviral and potential combination therapies as supply of Paxlovid greatly eclipses actual use of the antiviral.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Alex Martinez, Intrinsic Medicine CEO

They with­drew their IPO. Then, they broke off their SPAC merg­er. Now what?

If at first an IPO doesn’t succeed, try, try a SPAC. But what happens when that fails too?

Intrinsic Medicine and its blank-check partner Phoenix Biotech Acquisition Corp. called off their reverse merger Tuesday night, citing “current market conditions” as the reason it went kaput. The pair decoupled just weeks after agreeing to combine in late October as investors’ appetite for new IPOs and SPACs has been limited, at best.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.