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Alligator Bioscience Aptevo Therapeutics: Tumor antigen 5T4 associated with many forms of solid tumors identified as the second target for ALG.APV-527

On October 24, 2017 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy and Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics, reported further details of the companies’ collaboration on ALG.APV-527, a bispecific antibody targeting 4-1BB and a tumor antigen, now identified as 5T4, which is found on various types of cancer cells (Press release, Alligator Bioscience, OCT 24, 2017, View Source [SID1234538684]).

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5T4 is a protein predominantly expressed on tumor cells. It is present at very low levels or not at all in normal tissue. This enables the immune-activating effect of ALG.APV-527 to be targeted specifically to the tumor and not against normal tissue, the goal being effective tumor-directed immune activation with minimal side effects. The 5T4 tumor antigen is present on a number of different solid tumors, including breast, cervical, non-small-cell-lung, prostate, renal, gastric, colorectal and bladder cancers, indicating that ALG.APV-527 may be used for the treatment of several different types of cancer.

"The fact that 5T4 is selectively expressed on tumor cells in many different cancer indications, but in very low levels in normal tissue, makes it a very attractive target for tumor-directed immunotherapy," said Professor Peter Stern, Manchester University, UK.

By combining a tumor-binding and an immunomodulatory antibody in one molecule, Alligator and Aptevo have created a drug candidate whose effect is localized to the tumor area, activating the tumor-specific immune cells present there.

About Dr. Peter Stern
Professor Peter Stern, University of Manchester, United Kingdom, advisor to the joint venture, discovered the 5T4 antigen in 1988. He is an expert in tumor-associated antigens and virus-associated tumors. Professor Stern’s research has contributed substantially to the development of both cancer vaccines and antibody-based drugs for cancer treatment.

About ALG.APV-527
ALG.APV-527 is a bispecific antibody (4-1BB x 5T4) intended for tumor-directed treatment of solid cancers. The ALG.APV-527 antibody consists of two parts, one part activating tumor-specific T cells through the co-stimulatory receptor 4-1BB (CD137), the other part binding to the 5T4 protein expressed on the surface of tumor cells.

10-Q – Quarterly report [Sections 13 or 15(d)]

Biogen has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

10-Q – Quarterly report [Sections 13 or 15(d)]

Vical has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

Xspray Pharma får positiva kliniska studieresultat för ANDA-läkemedelskandidaten HyNap-Dasa

Xspray Pharma AB presenterar idag resultaten av en klinisk pilotstudie avseende läkemedelskandidaten HyNap-Dasa (Press release, Xspray, OCT 24, 2017, View Source [SID1234523285]). Pilotstudien undersökte HyNap-Dasas biotillgänglighet av dasatinib som idag marknadsförs som Sprycel för behandling av kronisk myeloid leukemi (KML). För de undersökta HyNap-Dasa-kompositionerna låg de två kritiska parametrarna för absorption av dasatinib i kroppen, AUC och Cmax, nära de värden som observerades för Sprycel. Bolaget avser att med små justeringar ta en vald HyNap-Dasa-komposition vidare till en generisk produkt på den amerikanska marknaden (med regulatorisk ANDA-procedur).

I den avslutade kliniska Fas I-studien deltog 12 friska försökspersoner. Biotillgängligheten för olika formuleringar av HyNap-Dasa testades i jämförelse med Sprycel. Resultaten är positiva och bekräftar validiteten av Xsprays formuleringsverktyg. De redan planerade studier som krävs för att kunna ta HyNap-Dasa till slutliga registreringsstudier kommer nu att utföras som planerat.

"Jag är mycket nöjd med att vi uppnått studiens primära syfte att få fram underlag för vår produktkomposition för planerade studier under första halvåret 2018. Studien visar att den uppnådda absorptionsprofilen av vår HyNap-Dasa komposition är lik originalets och att det verktyg vi har tagit fram fungerar för att justera både AUC och Cmax till de nivåer som krävs för att visa bioekvivalens. Detta är ett viktigt steg i utvecklingen av vårt generiska läkemedel baserat på vår RightSize teknologi. Vi har nu en klar bild av hur formuleringen ska vara sammansatt i kommande studier. Det gör att vi med stor sannolikhet kan hålla vår tidplan för de registreringsstudier som planeras framöver," säger Per Andersson, verkställande direktör.

De kliniska resultaten i sammandrag:

Den totala biotillgängligheten av dasatinib från den valda kompositionen av HyNap-Dasa, mätt som ytan under kurvan AUC, var 7% högre jämfört med Sprycel.
Den maximala koncentrationen av dasatinib i plasma, Cmax, var 13% högre för HyNap-dasa kompositionen jämfört med Sprycel.
Resultaten visar att formell bioekvivalens (Cmax och AUC inom området 80-125% av originalläkemedlet) kan uppnås med ett större antal försökspersoner.

Studieresultaten är i linje med bolagets plan för kliniska studier som finns presenterad i det prospekt som togs fram i samband med introduktionen på First North i slutet av september. Planen är att genomföra nödvändiga studier för att kunna ha en färdig produkt godkänd för försäljning på den amerikanska marknaden 2020 eller senast 2021.

MabVax Therapeutics Expands Intellectual Property Estate by Filing a New Patent Application on its Fully-Human Antibody Discoveries

On October 24, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported that the Company has filed a patent application for its series of HuMab-Tn fully-human monoclonal antibodies that target the tumor associated Thomsen-nouveau (Tn) antigen that will be developed as therapeutic and diagnostic products targeting ovarian, lung and breast cancers (Press release, MabVax, OCT 24, 2017, View Source [SID1234521277]). The Tn target is a carbohydrate antigen significantly expressed on the surface of cancer cells as a result of the transformation of normal cells into cancer cells. The Tn target is present on a broad array of tumor types but not found on normal tissues. This patent represents another valuable antibody asset brought forward by MabVax and the third patent filed on the antibody portfolio created through the Company’s unique discovery platform.

The patent application covers the recovery of anti-Tn antibodies from patients who were vaccinated against their solid tumors with a vaccine that contained the Tn antigen. The discovery of fully human antibodies directly from vaccinated cancer patients is highly unique and has advantages including a potential for greater specificity and reducing the toxicities associated with non-human antibodies. The patent application also covers the additional work done by the Company’s antibody research and development team to optimize the recovered antibodies as well as detailing the resulting positive characteristics of the antibodies selected for patenting. The newly filed patent application, if issued by the U.S. Patent Office, will provide exclusivity for these antibodies until 2038.

“The filing of this patent is an important component of our broad strategy in expanding our robust patent estate. Importantly, this filing is timely as we look to select additional product candidates to fuel our pipeline that have the potential to address significant unmet therapeutic needs,” stated David Hansen, MabVax’s President and Chief Executive Officer.

The Company has demonstrated its ability to translate these discoveries through preclinical development and into clinical development with its HuMab-5B1 program, currently being evaluated in Phase 1 clinical trials as a therapeutic agent, an immunoPET diagnostic agent, and as a radioimmunotherapy (“RIT”). The Company envisions that the HuMab-Tn antibody portfolio has similar applicability, including as a bi-specific antibody, as an antibody conjugated with a payload to form an antibody drug conjugate (“ADC”), with a radionuclide as an immunoPET imaging agent or with a radionuclide as a RIT product.