Moleculin’s Breakthrough Discovery of a New Molecule for Cancer Treatment Advances to Development Agreement with the University of Iowa

On June 6, 2018 Moleculin Biotech, Inc., (Nasdaq:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that has entered into an agreement with The University of Iowa Pharmaceuticals for the development of a formulation for WP1732 (Press release, Moleculin, JUN 6, 2018, View Source [SID1234527205]).

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"WP1732, which we believe, based on preclinical testing, is a breakthrough discovery, is now advancing to the stage of formulation development," commented Walter Klemp, Moleculin’s Chairman and CEO. "With the demand for clinical testing of WP1066 continuing to grow, it is easy to forget that we believe WP1732 represents a major expansion of our STAT3 inhibition capability by providing a highly soluble alternative that is ideally suited for IV administration. This agreement marks the beginning of our creating a preclinical package to submit to the FDA in order to request Investigational New Drug status."

Jefferies Global Healthcare Conference Presentation, dated June 2018.

On June 6, 2018 Pieris Pharmaceuticals, Inc. presented the Jefferies Global Healthcare Conference presentation of Pieris Pharmaceuticals, Inc (Presentation, Pieris Pharmaceuticals, JUN 6, 2018, View Source [SID1234527206]).

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Nimbus Therapeutics Announces $65 Million in New Financing to Accelerate Pipeline Progress and Expand Discovery Efforts

On June 5, 2018 Nimbus Therapeutics, a privately held biotechnology company applying deep computational expertise throughout drug discovery and development, reported that it has raised $65 million in new capital to accelerate the company’s pipeline progress and fuel its expansion into new high-value targets aimed at overlapping biological mechanisms in immunology, oncology and metabolic disease (Press release, Nimbus Therapeutics, JUN 5, 2018, View Source [SID1234527171]). Each of the company’s current investors participated in the financing, including Atlas Venture, SR One, Lilly Ventures, Bill Gates, Pfizer Venture Investments, Lightstone Ventures, and Schrödinger. Bruce Booth, Partner of Atlas Venture, Board Chair and co-founder of Nimbus noted, "this round of investment reflects the existing syndicate’s strong and enthusiastic support for Nimbus’ proven management team and exciting new programs."

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"The continued support from our world-class investor base is testament to our team’s repeated success in designing and developing promising candidates through our unique combination of massive computational-chemistry horsepower with founding partner, Schrödinger, coupled with additional cutting-edge technologies in structural biology, cryo-EM, and machine learning-augmented ADMET prediction to rapidly advance our pipeline to the clinic," said Don Nicholson, Ph.D., Chief Executive Officer. "We have made substantial progress across our entire portfolio, including inhibitors of Tyk2 (tyrosine kinase 2) and antagonists of STING (stimulator of interferon genes), both under our immunology alliance with Celgene. Additionally, our wholly owned STING agonist program has generated novel, highly potent, bona fide small molecules with compelling preclinical data."

"This most recent infusion of capital from our investors, together with proceeds from business development activity, enables Nimbus to remain a privately held LLC organization, which has allowed us to transact multiple deals with world leading partners such as Gilead, Celgene, and Genentech," said Jeb Keiper, Chief Financial Officer and Chief Business Officer. "Nimbus’ success has built a nine-figure balance sheet of resources for the rapid advancement and expansion of our pipeline and technology, which will allow us to develop several other undisclosed target programs forward to the clinic in the next few years."

About Tyk2 (tyrosine kinase 2)

Tyk2 is an important signal-transduction kinase for key pro-inflammatory cytokine receptors, including IL-23, IL-12 and interferons α and β. As a result, Tyk2 is a key target for the treatment of several challenging auto-immune disorders, including SLE (lupus), Crohn’s disease, psoriasis, multiple sclerosis, rheumatoid arthritis and others. In addition, some cancers, like T-ALL, appear to be driven by Tyk2 hyper-activation and are responsive to Tyk2 inhibition. Nimbus’ Tyk2 program is partnered under the immunology alliance with Celgene.

About STING (STimulator of INterferon Genes)

STING agonism (turning STING "on") plays a key role in anti-tumor immunity by activation of the innate immune system and induction of the Type-I interferon response, leading to recruitment and activation of cytotoxic T lymphocytes that attack tumor cells. STING agonism provokes anti-tumor responses alone, and in combination with checkpoint inhibitors and cell therapy. Further, STING agonists have been shown to provide benefit in areas of virology, such as efforts to achieve HIV cure. STING antagonists (turning STING "off") may have therapeutic potential in Type-I interferonopathies, such as SLE (lupus), where STING drives an exaggerated interferon response. Nimbus’ STING antagonist program is partnered under the immunology alliance with Celgene, while the STING agonist program remains wholly owned by Nimbus.

IONTAS signs collaboration agreement with LG Chem, Ltd. to identify therapeutic oncology leads

On June 5, 2018 IONTAS Limited (IONTAS), a leader in the discovery and optimisation of fully human antibodies, reported it has signed a collaboration agreement with Korean-based LG Chem, Ltd. for the discovery of therapeutic antibodies targeting undisclosed targets for use in the treatment of cancers (Press release, Iontas, JUN 5, 2018, View Source [SID1234527189]). Under the agreement IONTAS will use its proprietary antibody discovery platforms to deliver antibodies against biological targets selected by LG Chem, Ltd. and to further prove the biological activity of the antibodies.

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Dr Neil Butt, CBO of IONTAS, said: "This new agreement marks IONTAS’ expansion into the Asian market, and we are delighted to have been selected by LG Chem, Ltd., after a rigorous diligence process. The application of our proprietary technologies will assist LG Chem, Ltd. in expanding its current therapeutic pipeline by generating leads against pre-defined specifications agreed at the project outset."

Dr Myung Jin Kim, Executive Vice President / R&D Leader, Life Sciences R&D of LG Chem, Ltd., said: "IONTAS was selected because of its robust track record and technical know-how. We feel confident this collaboration will result in a strong panel of therapeutic leads which will help develop our oncology pipeline."

Dr Neil Butt and Dr Mike Dyson, CTO of IONTAS, will attend the 2018 BIO International Convention (Boston, MA) from June 4 – 7 and Dr John McCafferty, CEO and Founder of IONTAS, will be at Antibody Engineering and Therapeutics Europe (Amsterdam, NL) from 5 – 7 June.

PharmaMar presents in oral session at ASCO the ADMYRE study’s adjusted overall survival with plitidepsin

On June 5, 2018 PharmaMar (MSE:PHM) has reported how crossover has had an influence on the overall survival of the ADMYRE trial (Press release, PharmaMar, JUN 5, 2018, View Source [SID1234527173]). The impact on overall survival of those patients that relapsed after receiving dexamethasone as a single agent and who were subsequently treated with plitidepsin in combination with dexamethasone was analyzed. Of the 84 patients treated from the comparator arm –dexamethasone as a single agent– 44%, 37 patients were treated with the combination with plitidepsin thereafter. This data has been presented as a poster discussion session during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) that is being held from the 1st to the 5th of June in Chicago (USA).

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The ADMYRE study is a pivotal, randomized, open label, international, multicenter, phase III study, which included 255 multiple myeloma patients who had relapsed after having previously received at least 3, but no more than 6 prior lines and that compared both the safety and efficacy of plitidepsin plus dexamethasone against
dexamethasone alone.

The primary endpoint of this study was Progression Free Survival -which resulted to be positive- was to demonstrate a statistically significant reduction in the risk of disease progression or death of 35% against the comparator.

During the presentation, the 2 statistical models used (RPSFT and the two stage method) to correct and measure the impact of crossover on overall survival were discussed, emphasizing the two stage model (Latimer et al.), that was considered the most adequate in the context of the Admyre study..

Accordingly, and taking into account the effect of crossover using the two stage method, a statistically significant increase in overall survival in the plitidepsin plus dexamethasone arm (11.6 months) against the comparator (6.4 months) was
observed.