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MimiVax LLC and Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. announce exclusive licensing agreement on SurVaxM for glioblastoma treatment in China

On November 18, 2019 MimiVax LLC and Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma Industrial) reported the companies have entered into a China-exclusive licensing agreement for SurVaxM, a novel anti-cancer immunotherapy in the treatment of glioblastoma brain cancers (Press release, MimiVax, NOV 18, 2019, https://www.prnewswire.com/news-releases/mimivax-llc-and-shanghai-fosun-pharmaceutical-industrial-development-co-ltd-announce-exclusive-licensing-agreement-on-survaxm-for-glioblastoma-treatment-in-china-300958585.html [SID1234551441]).

Fosun Pharma Industrial is a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co. Ltd (Fosun Pharma), a leading healthcare group in China with extensive healthcare business interests worldwide. It is listed on both the Shanghai Stock Exchange and the Hong Kong Stock Exchange.

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Under terms of the agreement, Fosun Pharma Industrial and MimiVax – a clinical-stage biotechnology company in Buffalo, N.Y., USA, developing immunotherapeutics for cancer and autoimmune diseases – will seek to clinically develop and commercialize SurVaxM to make it available for patients in specified territories in China. As part of this agreement MimiVax will receive $10 million USD upfront payment and is eligible to receive additional potential development and sales milestone payments of up to $28 million and $110 million, respectively.

SurVaxM is designed to stimulate the immune system to kill tumor cells that contain survivin, a protein that helps cancer cells resist conventional treatments. SurVaxM triggers T-cell immunity simultaneously with unique antibody-mediated anti-tumor responses.

"MimiVax is committed to disrupting cancer through the development of highly innovative immunotherapeutics aimed at increasing patient survival rates, so we are very excited to be working with Fosun Pharma to bring SurVaxM to China," said Michael J. Ciesielski, Ph.D., MimiVax chief executive officer. "Fosun Pharma has both the expertise and access to reach this fast-growing market."

MimiVax’s proprietary product portfolio is based on technology licensed from Roswell Park Comprehensive Cancer Center that targets survivin. The therapies are designed to stimulate immune responses to control tumor growth and recurrence. The company is now working to initiate a pivotal randomized study of the use of SurVaxM in treating patients with newly diagnosed glioblastoma in 2020 to be performed at cancer centers across the United States and in China.

Fosun Pharma will work with MimiVax on the clinical, regulatory and commercial pathways necessary to bring SurVaxM to China.

"We are pleased to partner with MimiVax to bring such a promising immunotherapy to China," said Yifang Wu, chief executive officer of Fosun Pharma. "The collaboration with MimiVax will enrich Fosun Pharma’s pipeline and provide a potential new therapy addressing clinical unmet needs in the area of neuro-oncology, so we look forward to this new relationship with MimiVax."

Medicenna to Host a Key Opinion Leader Symposium on MDNA55 for Treatment of Recurrent Glioblastoma

On November 18, 2019 Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA,OTCQB: MDNAF), a clinical stage immuno-oncology company, reported that it will host a lunchtime seminar led by key opinion leaders ("KOL"’s) to highlight the current treatment options for recurrent glioblastoma ("rGBM") and the clinical benefits seen with MDNA55, an IL4 receptor targeted therapy in this setting (Press release, Medicenna Therapeutics, NOV 18, 2019, View Source [SID1234551440]). In addition to the Principal Investigators of the recently completed Phase 2b clinical trial, Dr. John Sampson and Dr. Santosh Kesari, the co-inventor of MDNA55 Dr. Raj Puri, will also participate in the symposium. The event will take place during the Society for Neuro-Oncology ("SNO") annual meeting being held at the JW Marriott Desert Ridge Resort at 5350 E. Marriott Drive in Phoenix, AZ.

The symposium is scheduled for Friday, November 22 from 12:15 to 1:15 PM MT in the Grand Sonoran Room G and will feature presentations as follows:

Raj Puri, MD, PhD – Director, Division of Cellular and Gene Therapies, Center for Biologics Evaluation and Research, FDA.

John H. Sampson, MD, PhD, MHSc, MBA – Robert H. and Gloria Wilkins Distinguished Professor and Chair of Neurosurgery, Department of Neurosurgery, Duke University School of Medicine

Santosh Kesari, MD, PhD – Director, Neuro-oncology, Pacific Neuroscience Institute; Chair and Professor, Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute
The panel will discuss the current unmet medical need for treating individuals with rGBM, the most common and uniformly fatal form of brain cancer, and the potential for an IL4 receptor targeted therapy to combat this disease. The presentation will also highlight key safety and efficacy data from the MDNA55 Phase 2b clinical trial and the positive outcomes seen in patients enrolled in this study.

For information on this event, please send an email request to [email protected].

Medicenna intends to follow this event with a KOL call for investors, analysts and business development professionals. Further information on this event and the KOL call will be released as soon as available.

Regulus Therapeutics to Present at the Stifel Healthcare Conference

On November 18, 2019 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported that Jay Hagan, President and Chief Executive Officer of Regulus, will present a company overview at the Stifel Healthcare Conference in New York City on Wednesday, November 20, 2019 (Press release, Regulus, NOV 18, 2019, View Source [SID1234551439]). The company overview will include an update on RGLS4326 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) and the Company’s recent submission to FDA in response to the Partial Clinical Hold.

About ADPKD

ADPKD, caused by the mutations in the PKD1 or PKD2 genes, is among the most common human monogenic disorders and a leading cause of end-stage renal disease. The disease is characterized by the development of multiple fluid filled cysts primarily in the kidneys, and to a lesser extent in the liver and other organs. Excessive kidney cyst cell proliferation, a central pathological feature, ultimately leads to end-stage renal disease in approximately 50% of ADPKD patients by age 60.

About RGLS4326

RGLS4326 is a novel oligonucleotide designed to inhibit miR-17 and designed to preferentially target the kidney. Preclinical studies with RGLS4326 have demonstrated direct regulation of PKD1 and PKD2 in human ADPKD cyst cells, a reduction in kidney cyst formation, improved kidney weight/body weight ratio, decreased cyst cell proliferation, and preserved kidney function in mouse models of ADPKD. The RGLS4326 IND is currently on a Partial Clinical Hold by the U.S. Food and Drug Administration.

Codiak Presents First Preclinical Data for exoASO, Engineered Exosomes Designed to Reprogram Tumor-Associated Macrophages

On November 18, 2019 Codiak BioSciences, Inc., a company at the forefront of advancing engineered exosomes as a new class of biologic medicines, reported the first preclinical data for its engEx Platform program, exoASO. These data, which were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s Special Conference on Tumor Immunology and Immunotherapy, demonstrate the potential of engineered exosomes incorporating an antisense oligonucleotide (ASO) to selectively reprogram tumor-associated macrophages and generate potent anti-tumor activity (Press release, Codiak Biosciences, NOV 18, 2019, View Source [SID1234551438]).

"We continue to expand the therapeutic potential of engEx engineered exosomes and build our pipeline of novel biologics designed to target pathways that have been historically difficult to effectively or safely drug," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "These data show us the utility of exoASO in both selectively targeting classically undruggable transcription factors and successfully reprogramming immunosuppressive macrophages, representing a potentially groundbreaking approach."

Highly immunosuppressive macrophages (M2 phenotype) are immune cells that are potent drivers of tumor growth by creating an immunesuppressive environment in the tumor. Utilizing its proprietary engEx Platform, Codiak developed engineered exosomes exogenously loaded with an ASO as part of its exoASO program. exoASO is designed to selectively deliver ASOs to M2 macrophages, targeting and decreasing the expression of the key immunosuppressive transcription factors, STAT6 and C/EBPβ.

Key conclusions from in vitro and in vivo preclinical studies demonstrate that exoASO effectively reprogrammed M2 macrophages to a pro-inflammatory M1 phenotype, promoting targeted anti-tumor activity. In vitro, exoASO was preferentially taken up by M2 macrophages to a significantly greater extent than free ASO, resulting in greater knockdown of STAT6 and C/EBPβ mRNA. Subsequent gene expression analysis and cytokine assays showed an up to 40-fold increase in TNFα and an up to 29-fold decrease in IL-10 associated with exoASO treatment, consistent with repolarization from immunosuppressive M2 macrophages to immune stimulatory M1 macrophages. In in vivo studies using a PD1-refractory mouse tumor model, both exoASO-STAT6 and exoASO-C/EBPβ showed significant anti-tumor growth inhibition as monotherapies, resulting in 50 percent and 60 percent complete responses, respectively, compared to no complete responses with free ASO. mRNA analysis of tumor samples examining expression of M2 and M1 cytokines was consistent with reprogrammed macrophages from the M2 to M1 phenotype.

Data from the poster titled "Reprogramming of tumor-associated M2 macrophages with antisense oligonucleotides-loaded exosomes results in potent single-agent antitumor activity" (A50) is available for download on the Codiak website.

About engEx Platform

The engEx Platform is Codiak’s proprietary exosome therapeutic engine for engineering and manufacturing novel exosome product candidates designed to target multiple pathways throughout the body. Using this platform, Codiak can design exosomes with precisely engineered properties, incorporate various types of biologically active molecules and direct them to specific cell types and tissues. These exosomes engage by cellular uptake, membrane-to-membrane interaction or a combination of both, and are designed to change the biological functioning of the recipient cells in order to produce the intended therapeutic effect. Codiak is building a broad pipeline of engEx product candidates that may have a transformative impact on the treatment of many diseases.

Sensei Biotherapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of SNS-301 in Patients with ASPH-Positive Head and Neck Cancer

On November 18, 2019 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, reported the dosing of the first patient in its Phase 1/2 clinical trial evaluating SNS-301 in patients with ASPH‑positive head and neck cancer who have previously received immune checkpoint inhibitors (Press release, Sensei Biotherapeutics, NOV 18, 2019, View Source [SID1234551437]). SNS-301 is a first-in-class immunotherapy candidate utilizing a bacteriophage viral vector that targets human aspartate β‑hydroxylase (ASPH), and is the company’s first program to enter clinical development from its proprietary drug discovery platform.

The Phase 1/2 clinical trial is a multicenter, open-label trial designed to evaluate the safety, preliminary efficacy and immunogenicity of SNS-301 in combination with pembrolizumab. The study will include ASPH‑positive patients with locally advanced unresectable or metastatic/recurrent squamous cell head and neck cancer currently receiving pembrolizumab or nivolumab. Sensei expects to enroll approximately 30 patients in this two-stage trial with primary efficacy endpoints including objective response rate, duration of response, and multiple secondary endpoints measuring immune responses.

"We are pleased to advance SNS-301 into a Phase 1/2 clinical trial in head and neck cancer, an indication that continues to have a high unmet medical need. We have previously demonstrated dose-dependent ASPH-specific immunogenicity, encouraging clinical activity and a favorable safety profile in ASPH‑positive patients through proof-of-concept studies with SNS-301," said Ildiko Csiki, M.D., Ph.D., consulting Chief Medical Officer of Sensei Biotherapeutics. "Targeting ASPH represents a novel strategy for treating cancer and we believe that SNS-301 has potentially broad applicability across a wide variety of cancers with its unique mechanism combined with checkpoint inhibition. We look forward to providing preliminary results at a major medical meeting in 2020."

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. Expression of ASPH is upregulated in more than 20 different types of cancer and is related to cancer cell growth, invasiveness, and is inversely correlated with poor disease prognosis. 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.