Southern Research-Bionetix Collaboration Seeks Novel Cancer Drug That Targets A Genetic Switch

On October 2, 2017 Southern Research and Bionetix Inc., a South Korea-based biotech firm, reported that they have signed a research and license agreement to develop a new anti-cancer drug that affects a key genetic switch associated with suppression and regulation of the growth of certain types of cancer (Press release, Bionetix, OCT 2, 2017, View Source [SID1234525825]).

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The goal of the research is to develop a novel drug that would block, or inhibit, certain epigenetic processes linked to changes in tumor cell DNA that allow those cells to survive and begin spreading. A new drug that inhibits these processes could also be useful against chemotherapy-resistant tumors in combination with targeted cancer therapeutics and as an adjunct therapy for cancer immunotherapies.

This collaboration is based on the extensive expertise of Southern Research in the discovery of novel cancer therapeutics including promising research on the regulation of tumor growth by controlling how genes are turned on and off in the cell

"The collaborative effort with Bionetix will allow us to accelerate our exploration of an epigenetic approach that could produce life-saving anti-cancer agents as well as continue our commitment to the identification of novel therapeutics," said Mark J. Suto, Ph.D., vice president of Southern Research’s Drug Discovery Division.

Doo Young Jung, CEO of Bionetix, said the teams seek to develop new epigenetic enzyme inhibitors that are more effective than existing drugs so their use can be expanded to successfully treat a broader range of cancers.

"I believe that this collaborative research program will help to expedite the development of novel inhibitors into the clinic so that we can contribute benefits to cancer patients," he said.

Under the Bionetix agreement, Southern Research will conduct studies to identify and optimize new inhibitors of methyl transferases as potential drug candidates. In collaboration with Bionetix, Southern Research will also define the overall development strategy for the new compounds.

"What we are looking at in this exploratory effort is a wide range of specific genes and biomarkers," Suto added. "That will help us identify the types of tumors that should be targeted and which patients would be most likely to benefit from the treatment based on this epigenetic approach."

Southern Research and Bionetix plan to complete the collaborative research program and begin preclinical and clinical development programs by early 2019.

As part of the arrangement, Bionetix can exercise an option to acquire the global exclusive commercialization rights for the optimized inhibitors and the application technologies, and will develop them further independently.

The deal with Bionetix represents the first licensing agreement signed by Southern Research in a decade. Bionetix, based in Suwon, South Korea, is a start-up company backed by venture capital investments.

Bionetix is providing research support for Southern Research, which will provide its extensive expertise in biology and chemistry to move the drug discovery research program forward.

Pipeline Review Check

We can target, starve, penetrate, and destroy tumors. We have demonstrated checkpoint immunomodulation and have been able to show that co-expressing two different moieties on a single cell generates a synergistic response (Company Pipeline, Rubius Therapeutics, OCT 2, 2017, View Source [SID1234520728]). We are building a combinatorial portfolio of binding, stimulation, and killing modalities in a range of hematological and solid tumors.

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Regulation FD Disclosure

Soligenix, Inc. (the "Company") has updated its corporate presentation (the "Presentation") to include updates to the Presentation since it was last included as an exhibit to the Company’s Form 8-K filed with the U.S. Securities and Exchange on June 8, 2017 (Filing, 8-K, Soligenix, SEP 29, 2017, View Source [SID1234520714]).

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The Company updated the Presentation to reflect the receipt of approximately $3.7 million in non-dilutive funding. The National Institutes of Health (the "NIH") awarded the Company approximately $1.5 million over two years to support the conduct of its pivotal Phase 3 clinical trial evaluating SGX301 (synthetic hypericin) as a treatment for cutaneous T-cell lymphoma. Further, the NIH granted the Company an additional award of approximately $1.5 million over two years to support the conduct of its pivotal Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for severe oral mucositis in patients with head and neck cancer receiving chemoradiation therapy. Finally, the Company will be participating in a grant awarded to the University of Hawai’i at Manoa for the development of a thermostabilized Ebola vaccine, with the Company awarded funding of approximately $700,000 over five years.

Additionally, the Company updated the estimated timeframe for the Phase 3 clinical trial of SGX301 development milestone, as its achievement may have the potential to occur later in the year.

TX05 Press Release

On September 28, 2017 Tanvex BioPharma, Inc. reported its plans for an international Phase 3 trial of its biosimilar drug candidate, TX05, its investigational trastuzumab biosimilar (a proposed biosimilar to Herceptin) in patients with early stage breast cancer (Press release, Tanvex BioPharma, SEP 28, 2017, View Source [SID1234524596]). In accordance with advice from the US Food and Drug Administration, the global Phase 3 trial, "A randomized, double-blind, parallel group, Phase III trial to compare the efficacy, safety and immunogenicity of TX05 with Herceptin in subjects with HER2 positive early breast cancer", has been designed to compare the therapeutic equivalence of biosimilar candidate TX05 to Herceptin in HER2-positive, early-stage breast cancer patients based on the pathological complete response rate following neoadjuvant therapy. Approximately 800 patients are anticipated to be enrolled from about 209 study centers in 19 countries. The primary efficacy endpoint, pCR, will be assessed through specimens obtained during surgery and analyzed by a central review of local histopathology reports. Equivalence will be considered to be demonstrated if the 95% confidence interval of the risk ratio of the pCR rates (TX05/Herceptin) is within a predefined interval agreed between Tanvex and FDA.

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Worldwide, nearly 2 million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. Approximately 20% to 30% of primary breast cancers are HER2-positive.

"This represents another major milestone for our company. TX05 will be our second biosimilar product to enter Phase 3 trials and reinforces our commitment to expand access to affordable, high quality products to patients with serious illness," said Allen Chao, PhD, CEO of Tanvex.

US sales of Herceptin were US$2.7 billion in 2016.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

(Filing, 10-K, Propanc, 2017, SEP 28, 2017, View Source [SID1234520831])

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