On June 5, 2018 VBL Therapeutics (NASDAQ:VBLT) reported data on its novel MOSPD2 program in oncology and inflammation at the 2018 BIO International Convention in Boston, Massachusetts (Press release, VBL Therapeutics, JUN 5, 2018, View Source [SID1234527188]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our research has shown that MOSPD2 plays a key role in the regulation of cell motility," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We have generated data indicating that MOSPD2 is required for directional movement, or chemotaxis, of tumor cells and certain immune cells, and therefore appears to play a central role in both oncology and inflammation. We continue to advance our exciting VB-600 series of antibodies as drug candidates for oncology and inflammatory indications."

MOSPD2 can be found in many types of solid tumors, and is highly expressed on tumor cells when they start invading tissues or creating metastatic lesions. VBL’s data indicate that knock-out of MOSPD2 in tumor cells may reduce metastasis by up to 95%. At the AACR (Free AACR Whitepaper) conference in April this year, VBL presented a late-breaking proof-of-concept study demonstrating antibody-mediated killing of MOSPD2-expressing cancer cells.

VBL research has also shown that knocking-out the MOSPD2 gene in mice could protect the animals from developing some inflammatory diseases. The Company has generated antibodies that block immune cell migration and show efficacy in a model of multiple sclerosis.

VBL is developing the VB-600 platform of biologic drug candidates for oncology and inflammatory indications. The Company plans to file an IND in this program by year-end 2019. For a webcast of VBL’s presentation at BIO see: LINK

On June 5, 2018 Polaris Group, a biopharmaceutical company focused on developing novel drugs for cancer, reported results from a phase 1 clinical study that features Polaris lead therapeutic candidate ADI‑PEG 20 in combination with pemetrexed and cisplatin (ADIPEMCIS) in first-line treatment for argininosuccinate synthetase (ASS1) deficient metastatic uveal melanomas (Press release, Polaris Pharmaceuticals, JUN 5, 2018, View Source [SID1234527207]). The results were presented by Dr. Peter Szlosarek from Barts Cancer Center in the UK (abstract No.2589) at the American Society Clinical Oncology’s 2018 annual meeting.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ADIPEMCIS was well tolerated in a cohort of 10 patients. The best response was stable disease; which was observed in 7 of 10 patients and hence a disease control rate of 70%. The 12-month survival rate was 50% and the median overall survival is 11.5 months, with 1 patient still alive at 27.1 months.

Metastatic uveal melanoma has been resistant to systemic therapies, with low response rates and low overall survival. There is clearly an unmet medical need that requires the development of an effective and safe treatment for these patients. It has been observed previously that ADI‑PEG 20 had efficacy as a monotherapy in several earlier melanoma studies and now the combination with PEM/CIS has further enhanced the activity.

"ADIPEMCIS showed activity in these metastatic uveal melanoma patients," said John Bomalaski, M.D., Executive Vice President, Medical Affairs, of Polaris. "We believe that ADI‑PEG 20 would benefit these patients, for whom there is no established treatment regimen. Based on this encouraging data as well as for ADI‑PEG 20 monotherapy in uveal melanoma, a trial of ADI‑PEG 20 in combination with checkpoint inhibitors, including programmed death and CTLA-4 antibodies is planned for uveal melanoma patients."

About ADI-PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.

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."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.