On July 6, 2020 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that it has raised $15m (£12m) in equity investment (Press release, Mission Therapeutics, JUL 6, 2020, View Source [SID1234561675]). The round was led by existing investor Pfizer Ventures, the venture capital arm of Pfizer Inc. ("Pfizer")(NYSE: PFE).

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!

Mission and Pfizer Inc. have also expanded their relationship by entering into an evaluation and option agreement for DUB target validation.

Fund raising

Pfizer Ventures has been an investor in Mission Therapeutics since 2013. Today it made a further equity investment into the Company, contributing a super pro rata amount. All other existing investors within Mission joined the round on a pro rata basis. No further financial details have been disclosed.

The new capital will support development of Mission’s world-leading DUB platform, as well as growth of its pipeline of DUB inhibitor programmes.

Expansion of Pfizer collaboration

DUBs have attracted significant interest as potential drug targets. Playing an integral role in protein homeostasis, this large family of enzymes is involved in diverse cellular processes and many disease pathologies.

Under the terms of the evaluation and option agreement, Pfizer will access specific DUB inhibitors from Mission’s platform and test these compounds in phenotypic screens to validate promising drug targets. Pfizer will then have the option to negotiate target exclusivity for each of the DUBs of interest.

The agreement does not include any of Mission’s own lead DUB programs, such as USP30.

Commenting on the agreement, Dr. Denis Patrick, Managing Partner of Pfizer Ventures and Member of Mission’s Board of Directors, said:
"Since our initial investment in Mission seven years ago, the company has grown tremendously and the depth of its scientific expertise and capability has grown alongside it. We are proud to expand our relationship with the company and our scientists are looking forward to a successful collaboration in this important area of research."

Dr. Anker Lundemose, CEO of Mission Therapeutics added:
"We are pleased to expand our relationship with Pfizer, one of the world’s premier biopharmaceutical companies. We have benefitted from the valuable contributions of Dr. Denis Patrick as a member of our Board of Directors and we look forward to working with the wider Pfizer team."

On July 6, 2020 Ascentage Pharma (6855.HK), a global, clinical-stage biotechnology company developing novel therapies for cancers, chronic hepatitis B (CHB), and senesce diseases, reported a clinical collaboration with MSD to evaluate the combination of APG-115, Ascentage’s MDM2-p53 inhibitor, and KEYTRUDA(pembrolizumab), MSD’s anti-PD-1 therapy, for the treatment of patients with advanced solid tumors (Press release, Ascentage Pharma, JUL 6, 2020, View Source [SID1234561671]).

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!

Under the agreement, Ascentage will sponsor an open-label, multicenter, phase Ib/II study (NCT03611868) is designed to evaluate the safety and efficacy of APG-115 with KEYTRUDA in multiple cohorts of solid tumors (i,e., NSCLC, melanoma, Urothelial cancer, Liposarcoma, MPNST and ATM mutated/p53 WT tumors resistant or relapsed to PD-1/PD-L1 treatment or without previous PD-1/PD-L1 treatment). The Phase II portion of the study has initiated and is expected to enroll 80 patients at multiple sites in the US. MSD and Ascentage will use a joint development committee to exchange information about the study.

Preclinical studies demonstrated that APG-115 promoted the production of proinflammatory cytokines in T cells, enhanced CD4+ T cell activation, and increased PD-L1 expression on various tumor cells. Enhanced antitumor activity was demonstrated in various tumor models after APG-115 was combined with PD-1 blockade. Results of the phase 1b portion of this trial was recently published at ASCO (Free ASCO Whitepaper)2020 and demonstrated that APG-115 in combination with pembrolizumab is well-tolerated, with encouraging anti-tumor effects in several tumor types.

"We are excited to collaborate with MSD, a pharmaceutical industry leader. APG-115 is a key drug candidate in our development pipeline targeting apoptosis, with great potential in the treatment of advanced solid tumors," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "Based on the promising Phase Ib data, we are looking forward to working closely with MSD to further study the combination of APG-115 with KEYTRUDA, potentially offering more effective treatment options to patients with advanced solid tumors."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About APG-115

APG-115 is an orally administered, selective, small-molecule inhibitor of the MDM2-p53 PPI. APG-115 has strong binding affinity to MDM2 and is designed to activate p53 tumor suppression activity by blocking the MDM2-p53 PPI. Ascentage Pharma has previously commenced three clinical trials of APG-115 in the US, including a Phase I study as single agent, a Phase Ib/II study in combination with pembrolizumab for treatment of metastatic melanoma and other advanced solid tumors, and a Phase I/II study as a single agent or in combination with chemotherapy for treatment of salivary gland cancer. APG-115 is the first MDM2-p53 inhibitor to enter clinical studies in China. A Phase I study as a single agent, and a Phase Ib study as a single agent or in combination with chemotherapy for treatment of AML (acute myeloid leukemia) or MDS (myelodysplastic syndrome) are ongoing in China.

On July 6, 2020 Aichi Cancer Center (*1) and NEC Corporation (NEC; 6701) reported the launch of fundamental research aiming to realize the promise of advanced personalized cancer immunotherapy by improving the performance of NEC’s neoantigen prediction system and developing predictive biomarkers for patient stratification through the fusion of AI and experimental immunology (Press release, NEC, JUL 6, 2020, View Source [SID1234561670]).

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!

This research aims to identify suitable neoantigen for vaccine use by using the neoantigen prediction system which NEC has been working on and the screening techniques using T cells for neoantigen from Aichi Cancer Center. In addition, this research aims to develop biomarkers for patient stratification using AI based on analytical data on a tumor immune microenvironment and clinical data.

The partners will realize the promise of advanced personalized cancer immunotherapy which boosts the immune system especially in combination with immune checkpoint inhibitors (ICIs).

On July 03, 2020 Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) reported that all healthy volunteers now have been dosed in the first of the two studies to demonstrate that HyNap-Dasa is bioequivalent to the original drug Sprycel (dasatinib) (Press release, Xspray, JUL 30, 2020, View Source [SID1234649569]). The first group is conducted under fasting conditions and the second group is conducted under fed conditions.

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 two bioequivalence studies are performed in healthy volunteers under fasting and fed conditions, respectively. All subjects in the first study group have now been fully dosed. The second study, under fed conditions, has been initiated and is expected to be fully dosed in the coming weeks. In both studies, HyNap-Dasa bioequivalence is compared to that of the original drug Sprycel. The preliminary results from the first study are expected in August 2020.

The results of the two clinical trials, together with the results of the ongoing stability studies on the final tablets on HyNap-Dasa, will form the basis of the Company’s first market approval application in the USA.

"This means that we, in spite of the Covid-19 situation, are one step closer to the date of filing for market approval in the US with our first product candidate and we will now initiate our search for commercial partners or purchasers for HyNap-Dasa. We are currently preparing for this process together with our legal and financial advisors and I feel confident that we will be well prepared for a more intensified process following the release of the clinical results," says Per Andersson, CEO Xspray. "Completing the trials with HyNap-Dasa will free up capacity for us to work more intensively with the next products in our portfolio, an improved version of HyNap-Dasa and HyNap-Nilo, which both will follow the 505(b)(2) regulatory pathway."

On July 3, 2020 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, neuroscience and biodefense reported that Kineta will be presenting at multiple virtual investor events in July 2020 (Press release, Kineta, JUL 3, 2020, View Source;utm_medium=rss&utm_campaign=kineta-presents-at-july-2020-virtual-investor-events [SID1234561700]). Shawn Iadonato, Kineta Chief Executive Officer and Craig Philips, President, will present a corporate overview at the following events:

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!

Opal Group ESG Investment Forum 2020
July 8th, 2020 at 12:00-12:20PM Pacific Time

The Moneyshow Accredited Investors Virtual Event
July 23, 2020 at 7:40-8:10AM Pacific time