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.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.