Glactone Pharma receives new funding from Vinnova

On November 20, 2017 Glactone Pharma reporrted that in strong competition and after external examination, it has been awarded a SEK 886,500 grant (approx. USD 106,000) from Vinnova (Sweden’s Innovation Agency) in the second phase of a program aimed at innovative startup companies (Press release, Glactone Pharma, NOV 20, 2017, View Source [SID1234522150]). The funded project will be used to characterize Glactone Pharma’s lead STAT3 inhibitor, a potential new drug for the treatment of cancers. A STAT3 inhibitor has great potential to address large unmet medical needs and help patients.

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Glactone Pharma’s objective for this project is to generate data on dosing and efficacy in relevant models and to obtain a correlation between pharmacokinetics and pharmacodynamics of the company’s lead compound. Having this data is important for predicting safe and efficacious doses both for non-clinical and clinical studies, thereby increasing the chances of success. STAT3 is a highly promising target in cancer with both preclinical and clinical data supporting the important roles that STAT3 plays in cancer occurrence and progression. Furthermore, STAT3 is involved in mechanisms that enable tumors and cancer cells to evade the immune system. The company’s lead compound has demonstrated the ability to modulate the immune system through STAT3 blockade in a disease model, and thereby acting as a cancer immunotherapy agent.

Immunotherapy is a treatment modality that activates and utilizes the body’s own immune system to recognize and attack tumors and is today the fastest growing and most promising area of cancer research.

Martin Johansson, CEO of Glactone Pharma, says: "The continued development of Glactone Pharma’s STAT3 inhibitor is greatly helped by this funding awarded by Vinnova and we can continue with our focus of bringing a novel drug to the clinic that potentially can help many patients. In addition, the grant is a recognition of the quality of the research that we are conducting at Glactone Pharma."

About STAT3
STAT3 (Signal Transducer and Activator of Transcription 3) is a transcription factor/signaling protein that is frequently activated in many forms of cancer.

STAT3 plays crucial roles in both tumor cells and in the tumor microenvironment and is a highly promising target for cancer therapy. Direct STAT3 inhibitors have the potential to prevent metastasis, reverse drug resistance and induce apoptosis in cancer cells. Furthermore, STAT3 inhibitors can be combined with immunotherapies to increase response rates and efficacy and with targeted drugs and chemotherapy to reverse and overcome resistance and provide efficacious and safe cancer treatments.

STAT3 is an intractable drug target as it is an intracellular protein with no enzymatic activity and is activated by multiple upstream factors. Despite it not being a "classic drug target", Glactone Pharma has developed orally bioavailable small molecule inhibitors that can directly inhibit the function of STAT3.

PledPharma and Solasia enter license agreement to develop and commercialize PledOx® in Asia

On November 17, 2017 PledPharma AB ("PledPharma") (STO: PLED) and Solasia Pharma K.K. ("Solasia") (TSE: 4597) reported that they have entered a license agreement pertaining to the clinical development and commercialization of PledOx in Japan, China, Hong Kong, Macau, South Korea and Taiwan (Press release, Solasia, NOV 17, 2017, View Source [SID1234532512]).

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Under the terms of this agreement, PledPharma grants exclusive development and commercialization rights to PledOx in the territories mentioned and Solasia will pay upfront, development, regulatory and sales milestones of up to ~USD 83 million (SEK 700 million)*. In addition, Solasia will pay industry standard royalty rates on sales applicable for a deal pertaining to an in-licensed asset in Phase III development. Solasia will also fully finance an expansion of the Phase III program to include Asian patients subject to regulatory consultations.

The license agreement is initially focused on the use of PledOx as prevention of chemotherapy induced peripheral neuropathy in colorectal cancer patients. The agreement with Solasia facilitates an expansion of the recently announced global Phase III-program for PledOx with Asian patients, subject to regulatory consultations, aiming to gain sufficient documentation for regulatory approvals in the major Asian markets. In addition, a Phase I study in Japanese and Caucasian Healthy Volunteers with focus on safety, tolerability and pharmacokinetics will be conducted. Following potential regulatory approvals, Solasia will be responsible for the commercialization of PledOx in Japan, China, Hong Kong, Macau, South Korea, and Taiwan.

"We are very excited to announce our partnership with Solasia – an ideal partner during the development, regulatory process and commercialization of PledOx in this very important region. The collaboration will ensure an optimized expansion of the Phase III program to include Asian patients, aiming at further realising the global commercial potential of our drug candidate," said Nicklas Westerholm, Chief Executive Officer and President, PledPharma.

"We are convinced that PledOx, as a novel first in class therapy, will play an important role in fulfilling the significant unmet medical need of preventing chemotherapy induced peripheral neuropathy. Solasia is ideally equipped to support PledPharma during the remaining clinical development and local regulatory processes in Japan, and to effectively launch the product in key Asian markets," said Yoshihiro Arai, President and Chief Executive Officer, Solasia.

As PledPharma announced earlier in November, following interactions with the regulatory authorities, EMA and FDA, the company has finalized the design of the global Phase III program for the drug candidate PledOx. The Phase III studies are anticipated to be initiated at the end of 2017 with top line results expected during 2020.

* The total value of upfront and milestone payments is up to JPY 9.3 billion. The amount given in USD and SEK is subject to exchange rate.

Invitation to corporate presentation
PledPharma will attend the Redeye Life Science Seminar on November 24 at 11:00 CET where PledPharma will provide a company update and an overview of the license agreement with Solasia. The event will be live streamed from Redeyes website www.redeye.se. After the event, the presentation will be available on PledPharma’s website.

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

Eleven Biotherapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Eleven Biotherapeutics, 2017, NOV 17, 2017, View Source [SID1234522142]).

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

KaloBios has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, KaloBios, 2017, NOV 17, 2017, View Source [SID1234522136]).

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Rgenix Reports Phase I Data for Cancer Compound RGX-104

On November 17, 2017 Rgenix Inc. (New York, N.Y.) reported preliminary data from a Phase Ia/Ib trial showing that oral RGX-104 led to 4 cases of stable disease among 12 evaluable patients with advanced solid malignancies and lymphoma (Press release, Rgenix, NOV 17, 2017, View Source [SID1234523091]).

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