French biotech and Pfiz­er find pos­i­tives in da­ta for Ly­me dis­ease vac­cine can­di­date; Al­tim­mune's obe­si­ty drug shows promise in PhI tri­al

French biotech Val­ne­va and part­ner Pfiz­er con­tin­ued to re­veal pos­i­tive re­sults from its Phase II tri­al for its Ly­me dis­ease vac­cine can­di­date.

The Phase II study, which en­rolled 246 healthy adults be­tween 18-65 in the US, met its pri­ma­ry end­point last Oc­to­ber, demon­strat­ing that the can­di­date, known as VLA15, was im­muno­genic across all dose groups test­ed and elicit­ed high an­ti­body re­spons­es one month af­ter the pri­ma­ry vac­ci­na­tion se­ries. Con­tin­ued eval­u­a­tion at Month 18 showed that an­ti­body titers de­clined across all groups, but re­mained above base­line, con­firm­ing the need for a boost­er.

Val­ne­va and Pfiz­er joined forces in a $308 mil­lion deal to com­mer­cial­ize the can­di­date in April 2020. The vac­cine tar­gets the six most com­mon types of Bor­re­lia bac­te­ria that cause Ly­me dis­ease — and Val­ne­va CEO Thomas Lin­gel­bach said he ex­pects to bring the prod­uct to mar­ket in 3-4 years.

VLA15 al­so proved to be safe and well-tol­er­at­ed across all dos­es and age groups test­ed in the tri­al. No re­lat­ed se­ri­ous ad­verse events were ob­served in any treat­ment group, the com­pa­nies said.

“We are ex­cit­ed by these ad­di­tion­al Phase 2 re­sults, which we be­lieve take us a step clos­er to mak­ing a ma­jor con­tri­bu­tion against this se­vere dis­ease, sub­ject to reg­u­la­to­ry ap­proval,” said Val­ne­va CMO Juan Car­los Jaramil­lo in a state­ment.

Al­tim­mune finds ear­ly suc­cess from Phase I tri­al of obe­si­ty drug can­di­date 

Bio­phar­ma Al­tim­mune re­leased promis­ing re­sults from a 12-week, Phase I tri­al for its obe­si­ty drug can­di­date, find­ing sig­nif­i­cant weight loss among some par­tic­i­pants, with high­er rates of nau­sea and vom­it­ing among those on the high­er dos­es.

The Aus­tralian tri­al of the GLP-1/glucagon dual re­cep­tor ag­o­nist pemvidu­tide, for­mer­ly known as ALT-801, in 34 sub­jects showed an av­er­age weight loss of be­tween 5% and 10% at dif­fer­ent dos­es, de­pend­ing on the dose. Those on place­bo av­er­aged 1.6% weight loss, ac­cord­ing to an Al­tim­mune state­ment.

“Giv­en that these weight loss da­ta were ob­tained with­out di­et or be­hav­ioral mod­i­fi­ca­tions, we are ex­cit­ed to see weight loss reach its full po­ten­tial dur­ing the planned 48-week Phase II obe­si­ty tri­al next year,” said Al­tim­mune CMO Scott Har­ris in a state­ment.

Al­tim­mune said back in Ju­ly that the com­pa­ny planned to piv­ot fo­cus back to the obe­si­ty drug can­di­date af­ter dis­ap­point­ing clin­i­cal re­sults with its Covid-19 vac­cine can­di­date. ALT’s stock price was -20% pre-mar­ket as of this morn­ing.

Hill­stream files $17m IPO

Hill­stream Bio­Phar­ma filed an IPO on Mon­day with the SEC to raise up to $17 mil­lion.

The Bridge­wa­ter, NJ bio­phar­ma plans to raise $17 mil­lion by of­fer­ing 3 mil­lion shares at a price range of be­tween $5 and $6. At the mid­point of the pro­posed range, Hill­stream Bio­Phar­ma would com­mand a ful­ly di­lut­ed mar­ket val­ue of $58 mil­lion, ac­cord­ing to a Hill­stream state­ment. Hill­stream plans to list on the Nas­daq un­der the sym­bol $HILS.

The com­pa­ny has been fo­cused on fer­rop­to­sis, a type of pro­grammed cell death be­ing stud­ied for treat­ment re­sis­tant can­cers. The com­pa­ny’s most ad­vanced can­di­date is HSB-1216, an iron me­di­at­ed cell death, or IM­CD in­duc­er for sol­id tu­mors. Hill­stream aims to sub­mit an IND and start a clin­i­cal study with the drug next year.

FDA ac­cepts PD-1 drug Lib­tayo for pri­or­i­ty re­view against cer­vi­cal can­cer

Re­gen­eron an­nounced this morn­ing that the FDA has ac­cept­ed PD-1 in­hibitor Lib­tayo for pri­or­i­ty re­view to po­ten­tial­ly treat dif­fer­ent types of cer­vi­cal can­cer.

The tar­get ac­tion date for the FDA de­ci­sion is Jan. 30, 2022. The sBLA is be­ing re­viewed un­der the FDA’s Pro­ject Or­bis ini­tia­tive, which will al­low for con­cur­rent re­views by oth­er health au­thor­i­ties in Aus­tralia, Brazil, Cana­da and Switzer­land. Re­gen­eron is al­so plan­ning ad­di­tion­al glob­al reg­u­la­to­ry sub­mis­sions, in­clud­ing in the EU, by the end of the year.

Lib­tayo was joint­ly de­vel­oped by Re­gen­eron and Sanofi and first ap­proved in 2018 for lo­cal­ly ad­vanced and metasta­t­ic cu­ta­neous squa­mous cell car­ci­no­ma — then ap­proved in 2021 for NSCLC and basal cell car­ci­no­ma.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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