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.

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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."

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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.

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.

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.

On JUN 5, 2018 Sensei Biotherapeutics, Inc., a privately-held biopharmaceutical company developing immuno-oncology therapies that teach the immune system to recognize and attack cancer, reported the publication of data from the company’s multi-center Phase 1 clinical trial to assess safety and immunogenicity of SNS-301 (formerly PAN-301) in patients with biochemically recurrent prostate cancer (Press release, Sensei Biotherapeutics, JUN 5, 2018, View Source [SID1234527190]). Data were published in conjunction with the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

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Sensei announced publication of data from its phase 1 clinical trial of SNS-301 in patients with persistent prostate cancer in conjunction with #ASCO2018.

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SNS-301 is a first-in-class immunotherapy candidate utilizing a bacteriophage viral vector targeting a novel embryonic antigen called human aspartate β-hydroxylase (ASPH). In adults, ASPH is only expressed on the surface of cancer cells and has been detected in more than 20 different types of cancer. SNS-301 was created using Sensei’s SPIRIT platform to optimize for antigen presentation and vaccine immunogenicity.

In the Phase 1 trial, SNS-301 was administered every 21 days via intradermal injection to men with biochemically relapsed prostate cancer, using a fixed dose-escalation schema to establish the recommended Phase 2 dose. A minimum of three doses of SNS-301 were administered to each patient. Fifteen patients who met all other inclusion and exclusion criteria were screened for ASPH expression using a serum-based companion diagnostic test, and 12 of the 15 patients presented the minimum threshold for ASPH expression. These patients received as many as 18 doses of SNS-301 (mean = 10 doses per patient), including a minimum of 3 treatments at the high dose, over the 15-month duration of the study. Highlights of the safety and immunogenicity data published at ASCO (Free ASCO Whitepaper) include:

SNS-301 was well tolerated with a favorable safety profile across all dose levels in the Phase 1 study.
No dose-limiting toxicities were observed at the three dose levels evaluated in the trial.
All patients in the study experienced dose-dependent, ASPH-specific humoral and cellular immune responses, including ASPH-specific B-cell and T-cell responses.
75% (6/8) of evaluable patients achieved improvements in Prostate-Specific Antigen (PSA) doubling time and/or absolute PSA. Improvements in PSA doubling rate are an indicative measure of slowing disease progression.
"We are extremely encouraged by these clinical results from our Phase 1 study of SNS-301 which validate the potential of our proprietary SPIRIT drug development platform to generate novel immuno-oncology therapies," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "SNS-301 exemplifies Sensei Biotherapeutics’ ability to engineer promising therapeutic candidates designed to teach the immune system to recognize and attack cancer."

This Phase 1 study of SNS-301 was initiated in January 2017 and enrollment of 12 patients was completed in February 2018. SNS-301 is the lead clinical candidate from Sensei Biotherapeutics’ proprietary SPIRIT drug development platform. Final results will be presented at a medical meeting in the second half of 2018 and initial enrollment in a Phase 2 efficacy trial is anticipated by the end of the year.

About SNS-301

SNS-301 is a first-in-class immunotherapy candidate utilizing a bacteriophage viral vector that targets human aspartate β-hydroxylase (ASPH), a cell surface enzyme that is normally expressed during fetal development. Following fetal development, the protein is no longer expressed. Expression of ASPH is uniquely upregulated in more than 20 different types of cancer and is related to cancer cell growth, cell motility and invasiveness. ASPH expression levels are inversely correlated with disease prognosis.

Though enhanced antigen presentation and other engineered immunotherapeutic features, SNS-301 is designed to overcome self-tolerance and induce robust and durable humoral and cellular immune responses that are specific to ASPH. SNS-301 is delivered through intradermal injection and avoids time-consuming and uncomfortable infusions, greatly facilitating ease of use.