Chris Cardon, Ziphius Vaccines CEO

Spurred on by Mod­er­na and Pfiz­er's suc­cess, a Bel­gian biotech has big am­bi­tions for its self-am­pli­fy­ing RNA vac­cine play

With the first wave of mR­NA-based Covid-19 vac­cines pro­vid­ing proof of con­cept to the en­tire field, in­vestors are see­ing dol­lar signs for plat­form plays once con­sid­ered moon­shots. Now, a Bel­gian biotech is get­ting in on the craze with a hefty ear­ly fundrais­ing haul for its own RNA plat­form.

Ziphius Vac­cines closed a $29.8 mil­lion Se­ries A, with a $6.13 mil­lion con­vert­ible loan to boot to de­vel­op its RNA plat­form, start­ing with Covid-19 and then mov­ing in­to oth­er in­fec­tious dis­eases, it said Tues­day.

Start­ed up as a play at RNA ther­a­peu­tics for cys­tic fi­bro­sis and Duchenne mus­cu­lar dy­s­tro­phy, Ziphius switched gears in 2020 to chase an RNA Covid-19 vac­cine. CEO Chris Car­don told Na­ture that the com­pa­ny was look­ing to raise about $37 mil­lion to ad­vance its 14 pre­clin­i­cal pro­grams.

Ziphius is rid­ing the promise of what is called “self am­pli­fy­ing” RNA vac­cines, which would give the RNA pay­load the tools to repli­cate it­self in hu­man cells. By do­ing so, the vac­cines could sig­nif­i­cant­ly length­en the ther­a­peu­tic win­dow and po­ten­tial­ly cre­ate the first one-shot RNA vac­cine.

Ear­li­er this year, the com­pa­ny said ZIP-1642, its Covid-19 can­di­date, showed pos­i­tive pre­clin­i­cal da­ta that in­di­cat­ed a stronger vi­ral neu­tral­iza­tion po­ten­tial than the tra­di­tion­al mR­NA vac­cines as well as the abil­i­ty to quick­ly re­spond to vari­ants. The com­pa­ny al­so high­light­ed a longer du­ra­tion of ex­pres­sion and high­er po­ten­cy of pro­tec­tion. Phase I/II clin­i­cal tri­als are ex­pect­ed to start in Q4.

“We are ex­treme­ly pleased with this val­i­da­tion of our sa-RNA plat­form and look for­ward to fur­ther de­vel­op­ing ZIP-1642 in­to the clin­ic. While cur­rent SARS-CoV-2 vac­cines re­port 95% ef­fi­ca­cy, our tech­nol­o­gy has the po­ten­tial to add the re­main­ing 5% and re­main high­ly rel­e­vant to any fu­ture coro­n­avirus mu­ta­tions,” Car­don said in a De­cem­ber re­lease.

Amid Covid-19, Ziphius has seen rapid growth, which at one point forced the firm to house lab con­tain­ers in the park­ing lot to man­age its em­ploy­ee growth. The biotech has open­ly opined that its plat­form could have use in a much broad­er group of in­fec­tious dis­eases, in­clud­ing HIV, malar­ia, in­fluen­za and more.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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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.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Time for round 2: Il­lu­mi­na-backed VC snags $325M for its next fund

Illumina Ventures closed off its second investment fund with a total commitment of $325 million, offering fresh fuel to back a slate of startups that have already included a smorgasbord of companies, covering everything from diagnostics to biotech drug development and genomics.

Fund II brings the total investment under Illumina Ventures’ oversight to $560 million, which has been focused on early-stage companies. And it has a transatlantic portfolio that includes SQZ, Twist and Encoded Therapeutics.