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MabVax Therapeutics to Present an Interactive Live Webcast at VirtualInvestorConferences.com

On April 30, 2018 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company, reported that David Hansen, MabVax’s President and Chief Executive Officer, will present live at VirtualInvestorConferences.com on May 3, 2018 (Press release, MabVax, APR 30, 2018, View Source [SID1234525833]). The following are the details to access the presentation:

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DATE: Thursday, May 3, 2018
TIME: 10:45 a.m. EDT
LINK: View Source

As part of his presentation, Mr. Hansen will provide a corporate overview, as well as a clinical update and outline anticipated milestones for its Phase 1 clinical programs including the MVT-5873 clinical trial in combination with a standard of care chemotherapy as a first line therapy for patients newly diagnosed with pancreatic cancer, and the MVT-1075 radioimmunotherapy clinical trial for the treatment of pancreatic, colon and lung cancers.

VirtualInvestorConferences.com is a live, interactive online event where investors are invited to ask the company questions in real-time – both in the presentation hall as well as the association’s "virtual trade booth." If attendees are not able to join the event live on the day of the conference, an on-demand archive will be available for 90 days. It is recommended that investors pre-register to save time and receive event updates.

A link to VirtualInvestorConferences.com event will also be available by accessing the MabVax’s IR Calendar in the Investors section of the Company’s website (www.mabvax.com).

About VirtualInvestorConferences.com

Since 2010, VirtualInvestorConferences.com, created by BetterInvesting (NAIC) and PRNewswire, has been the only monthly virtual investor conference series that provides an interactive forum for presenting companies to meet directly with investors using a graphically-enhanced online platform.

Designed to replicate the look and feel of location-based investor conferences, Virtual Investor Conferences unites PR Newswire’s leading-edge online conferencing and investor communications capabilities with BetterInvesting’s extensive retail investor audience network. To learn more, please visit www.VirtualInvestorConferences.com

Inovio Pharmaceuticals to Report First Quarter 2018 Financial Results on May 9, 2018

On April 30, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported that it will host a conference call and live webcast to report its 2018 first quarter financial results on Wednesday, May 9, 2018 at 4:30 p.m. ET (Press release, Inovio, APR 30, 2018, View Source [SID1234525832]).

A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

A replay of the conference call will be accessible two hours after the call at 877-481-4010 (domestic) or 919-882-2331 (international) using replay ID 29009.

FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma

On April 30, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi reported that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery (Press release, Regeneron, APR 30, 2018, View Source [SID1234525830]). Advanced CSCC is the deadliest non-melanoma skin cancer. Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 (programmed cell death protein-1) and was granted Breakthrough Therapy designation status by the FDA in September 2017. The target action date for the FDA decision is October 28, 2018.

The BLA submission is based on a Phase 2 pivotal, single-arm, open-label clinical trial of cemiplimab for advanced CSCC (EMPOWER-CSCC 1) in addition to Phase 1 data from two advanced CSCC expansion cohorts. Both clinical trials enrolled patients with metastatic CSCC and patients with locally advanced CSCC who were not candidates for surgery. Topline results from EMPOWER-CSCC 1 were previously announced in December 2017, and Phase 1 expansion cohort results were presented at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Updated results from both clinical trials will be presented at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting.

In the European Union, the European Medicines Agency accepted for review in April 2018 the Marketing Authorization Application for cemiplimab in patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery.

Cemiplimab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement and was invented by Regeneron using the company’s proprietary VelocImmune technology that yields optimized fully-human antibodies.

Cemiplimab is currently under clinical development, and its safety and efficacy has not been fully evaluated by any regulatory authority.

About CSCC
Cutaneous squamous cell carcinoma (CSCC) is the second most common type of skin cancer in the U.S., with the number of newly diagnosed cases expected to rise annually. Although CSCC has a good prognosis when caught early, the cancer can prove especially difficult to treat effectively when it is advanced, and patients can experience reduced quality of life due to the impact of the disease as it progresses. Advanced CSCC is the deadliest non-melanoma skin cancer, responsible for approximately 7,000 deaths in the U.S. each year. There are currently no FDA-approved treatments for advanced CSCC.

Crescendo Biologics Ltd. Raises $70 Million (€57 Million) in Series B Financing

On April 30, 2018 Crescendo Biologics Ltd (Crescendo) the developer of multi-functional biologics with a focus on novel targeted T-cell engagers, reported that it has completed a $70 million (€57 million) Series B financing(Press release, Crescendo Biologics, APR 30, 2018, View Source [SID1234525829]). The funds will be used to advance the development of its lead programme, CB307, which stimulates local activation of tumour-specific T-cells, into the clinic and further expand its internal pipeline of products.

Crescendo Biologics is developing potent, multi-functional Humabody therapeutics in oncology. It is pursuing novel Humabody-based product opportunities, through in-house development and strategic partnerships. To date, it has a collaboration with Takeda Pharma worth up to $790m.

The Series B round was led by Andera Partners (formerly Edmond de Rothschild Investment Partners) with Europe’s largest life science fund Biodiscovery V, and joined by Quan Capital with its leading life sciences fund, Quan Venture Fund I, and Crescendo’s existing investors Sofinnova Partners, IP Group, EMBL and Takeda Ventures. This is the largest disclosed Series B biotech financing in Europe in 2018.

Gilles Nobécourt, Partner at Andera Partners and lead investor said: "We have been very impressed with the high quality of the novel biology behind multi-functional Humabodies and Crescendo’s growing development portfolio. Crescendo is a true pioneer in the development of targeted T-cell engagement and we are looking forward to working with the team."

Graziano Seghezzi, Managing Partner at Sofinnova Partners added: "We have been supporting Crescendo since its seed round in 2009, and then through the Series A together with IP Group, the substantial size of the round and the participation of new investors of the Series B underlines the
potential and success of VH-based Humabodies."

Marietta Wu, Managing Director of Quan Capital which invested a significant amount in the round, explained: "We have been especially drawn to the Humabody platform that offers multiple potential advantages over the current antibody (IgG) approaches and could enable the Company to quickly build a
substantial portfolio of impactful therapeutics. We look forward to joining our partners to rapidly advance Crescendo’s portfolio into clinical development where we can improve patient lives."

Peter Pack CEO of Crescendo said: "We appreciate the strong support – past and present – from our current investors, who have enabled us to grow the Company to this point. In this round, we are also welcoming two new investors, Andera Partners and Quan Capital. We look forward to taking our leadprogramme, CB307 into the clinic and further exploit our technology platform with new products."

HaiHe Biopharma and 3DMed Sign a Strategic Collaboration Agreement on a New Antitumor Drug

On April 27, 2018 Haihe Biopharma Co., Ltd. and 3D Medicines (Beijing) Co., Ltd. reported that the two sides have reached a strategic collaboration agreement on HaiHe Biopharma’s FGFR inhibitor (coded HH185) project (Press release, 3D Medicines, APR 27, 2018, View Source [SID1234594049]). 3DMed may carry out the R&D, manufacture and commercialization of HH185 in mainland China, Hong Kong, Macao and Taiwan for the treatment of cancer and pulmonary fibrosis.

Dr. Ruiping Dong, CEO of Haihe Biopharma, commented,
"As a potential target in the field of anti-tumor, FGFR is undergoing rapid development in the research of its mechanisms and clinical application and more and more verifications has been made. Therefore, the R&D prospect is so promising. As a highly selective FGFR inhibitor, HH185 overcomes the adverse effect of hepatotoxicity found in the first-generation FGFR inhibitor and has the apparent anti-tumor activity. We look forward to working together with 3DMed on the further development and commercialization of HH185, so as to accelerate the launch of the domestically-manufactured new drugs and to meet the patients’ needs in China."

Dr. Gong Zhaolong, CEO of 3D Med, commented,
"We are very happy to reach the strategic collaboration agreement with HaiHe Biopharma on HH185.HH185 has a good prospect of combination with 3DMed’s PD-L1 antibody in the field of immuno-oncology therapy. Through the collaboration with HaiHe Biopharma and by virtue of 3DMed’s platform and experience in the field of precision cancer care, we hope to be able to develop new drugs that are urgently needed in clinical practice for the benefit of even more patients who suffer from cancer and pulmonary fibrosis."

About HH185
HH185 is a small molecule inhibitor of fibroblast growth factor receptor 1,2,3 (FGFR 1,2,3), which obtained the approval for clinical trial by CNDA in January 2018. Preclinical studies have shown that HH185 has such advantages as strong anti-tumor activity, excellent PD-PK characteristics, low toxicity and high bioavailability and so on. Moreover, it is targeting CSF1-R and is therefore suitable for combination therapy with PD-1/PD-L1 antibodies in the field ofimmune-oncology.