Cellect Bio up on new patents

Thinly traded micro cap Cellect Biotechnology (NASDAQ:APOP) rockets 165% premarket on robust volume in reaction to its announcement that it has been notified that its patent applications in Europe and Israel for a cell-based product and a method of manufacturing a stem and progenitor cell population with enhanced activity by short incubation with an apoptotic ligand will be granted.

The applications cover an ex vivo method for obtaining an improved population of stem and progenitor cells with enhanced engraftment characteristics by activation of TNF family receptors.

The Company’s previous patents covered the negative selection exerted by the ApoGraft process and product translated into clinical safety superiority. The latest patent applications describe and protect the positive effect that the same molecules have on stem cells and translates to the efficacy of the transplanted cells and the yields of the manufacturing processes for clinical use.

https://seekingalpha.com/news/3530042-cellect-bio-up-165-premarket-on-new-patents

Hepion Pharma up 15% premarket potential of CRV431 in NASH

Nano cap Hepion Pharmaceuticals (NASDAQ:HEPA) is up 15% premarket on modest volume on the heels of a just-published paper supporting the rationale of cyclophilin inhibition for the potential treatment of nonalcoholic steatohepatitis (NASH).

The comprehensive review of studies investigating cyclophilins in NASH and NASH-related liver disease, authored by certain Hepion executives, is in the latest edition of the journal Expert Opinion on Investigational Drugs. 

The authors assert that the scientific literature provides “abundant evidence” that cyclophilin inhibition, the mechanism of action of candidate CRV431, could help resolve a range of pathophysiological processes in NASH, including inflammation, mitochondrial dysfunction, liver cell death and fibrotic scarring.

https://seekingalpha.com/news/3530050-hepion-pharma-up-15-premarket-potential-of-crv431-in-nash

Apellis Pharma’s APL-2 successful in PNH study; shares up

Apellis Pharmaceuticals (NASDAQ:APLS) jumps 49% premarket on robust volume in reaction to positive results from a Phase 3 clinical trial, PEGASUS, evaluating pegcetacoplan (APL-2) in adults with paroxysmal nocturnal hemoglobinuria (PNH).

The study met the primary endpoint demonstrating superiority over Alexion Pharmaceuticals’ (NASDAQ:ALXN) Soliris (eculizumab) as measured by the change from baseline in hemoglobin level at week 16. Specifically, patients receiving pegcetacoplan showed an adjusted mean hemoglobin increase of 3.8 g/dL compared to a mean decrease of -1.5 g/dL in the eculizumab arm (p<0.0001).

Pegcetacoplan showed non-inferiority to eculizumab on transfusion avoidance and absolute reticulocyte count.

All patients who completed the randomization period in both groups (n=77/80) entered the 32-week open-label pegcetacoplan treatment period.

Detailed results will be submitted for presentation at a future medical conference.

https://seekingalpha.com/news/3530055-apellis-pharmas-aplminus-2-successful-in-pnh-study-shares-up-49-premarket

Curis up 9% premarket on deal with ImmuNext in cancer

Thinly traded nano cap Curis (NASDAQ:CRIS) is up 9% premarket on light volume in reaction to its agreement with ImmunNext for potential exclusive global rights to develop and commercialize its anti-VISTA antibodies, including lead drug CI-8993 (formerly Johnson & Johnson’s JNJ-61610588), for the treatment of cancer (J&J returned the rights to ImmuNext after a Phase 1 study).

Under the terms of the deal, Curis will pay ImmuNext an undisclosed amount upfront in exchange for an option to exclusively license the latter’s candidate portfolio in oncology. The option is exercisable upon the earlier of four years from the signing of the agreement or 90 days after the database lock in the first Phase 1a/1b study that meets the clinical endpoints. If Curis opts in, it will pay ImmuNext an option exercise fee, milestones and royalties on net sales.

VISTA is a novel negative checkpoint ligand akin to PD-1/PD-L1 that suppresses T cell activation.

https://seekingalpha.com/news/3530079-curis-up-9-premarket-on-deal-immunext-in-cancer

Can-Fite up ahead namodenoson data presentation

Nano cap Can-Fite BioPharma (NYSEMKT:CANF) is up 11% premarket on increased volume on the heels of its announcement that the principal investigator of a Phase 2 clinical trial evaluating namodenoson (CF102) for the second-line treatment of liver cancer with cirrhosis will present safety and efficacy data tomorrow, January 8, at the Israeli Society of Clinical Oncology and Radiotherapy annual conference.

Although the study failed to achieve the primary endpoint of overall survival, there was a positive effect in a subpopulation of patients with Child Pugh B7 (moderately severe liver disease).

https://seekingalpha.com/news/3530091-can-fite-up-11-premarket-ahead-namodenoson-data-presentation

Amgen prevails in appeal of adverse patent ruling on Sensipar

The U.S. Court of Appeals for the Federal Circuit has vacated a lower court ruling clearing Amneal Pharmaceuticals (AMRX -3.6%) of infringing on an Amgen (AMGN -0.8%) patent covering Sensipar (cinacalcet) and has sent the case back to the Delaware district court for further action.

The appeals court found that Zydus Pharmaceuticals’ generic offering infringes while Piramal Pharma Solutions’ does not.

https://seekingalpha.com/news/3530134-amgen-prevails-in-appeal-of-adverse-patent-ruling-on-sensipar

Advaxis up on advancement of prostate cancer candidate into clinic

Nano cap Advaxis (ADXS +22.4%) jumps on a more than double normal volume in reaction to the FDA’s sign-off on its IND for a Phase 1 study evaluating ADXS-504 in prostate cancer patients.

ADXS-504 is the company’s ADXS-HOT candidate for the indication, an off-the-shelf neoantigen that targets hotspot mutations in tumor driver genes.

https://seekingalpha.com/news/3530143-advaxis-up-22-on-advancement-of-prostate-cancer-candidate-clinic