On November 18, 2019 Shanghai Fosun Pharma reported a $148 million agreement to acquire China rights to SurVaxM, a novel immunotherapy aimed at glioblastoma, from MimiVax of Buffalo, New York (Press release, ChinaBio, NOV 18, 2019, View Source [SID1234551445]). SurVaxM, a novel peptide mimic vaccine, stimulates the immune system to kill tumor cells that contain survivin, a protein that helps cancer cells resist conventional treatments. In a US Phase II trial among glioblastoma patients, SurVaxM showed improved efficacy combined with an acceptable safety profile. MimiVax, which notes that survivin is present in many cancers, is also conducting a multiple myeloma trial.

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On November 18, 2019 Medivir AB (Nasdaq Stockholm: MVIR) reported that the ninth and final patient was recruited to the phase Ia study of MIV-818 in patients with advanced liver cancer (Press release, Medivir, NOV 18, 2019, View Source [SID1234551443]). Based on data from phase Ia, the initial dose of MIV-818 for the phase Ib study has been determined at 200 mg / week. The dosage is given as 40 mg / day for five days.

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The phase I study with MIV-818, evaluating safety, tolerability and pharmacokinetics, consists of two parts: Phase Ia is an interpatient study while phase Ib has a classic 3 + 3 intrapatient dose-escalating design. A recommended dose for phase II will be based on the data in the phase Ib study. Medivir has previously reported that the intended liver-directed effect of MIV-818 could be verified already in the analysis of data from the first six patients. Efficacy data from the complete phase Ia study will be presented next year at a scientific conference.

"The initial data observed in the phase I study support our view that MIV-818 has the potential to provide a clear and much needed improvement in treatment for patients with liver cancer," said Dr. Uli Hacksell, CEO of Medivir. "MIV-8I8 is the most advanced drug candidate in a series of proprietary and wholly owned prodrugs that we intend to develop for the treatment of various cancer indications."

For further information, please contact:

Uli Hacksell, CEO
Medivir AB
phone: +46 (0)8 5468 3100

About MIV-818

MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug to benefit patients with HCC and other forms of liver cancer. A phase I study in patients with liver cancer is ongoing.

About liver cancer

Liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC are capable of extending the lives of patients, treatment benefits are low while death rates remain high. HCC is a very diverse disease with multiple cancer cell types and without specific mutations seen in other tumor types. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On November 18, 2019 RhoVac AB ("RhoVac") reported interim results from ongoing immunological studies at University of Tübingen, Germany concluding that treatment with RV001 can activate CD4+ T-cells and also CD8+ T-cells.

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In July 2019 RhoVac published results on the follow-up phase of the phase I/II clinical study and in relation to the immunological response it could be concluded that 18 patients showing significant treatment related immunological response at completion of treatment. All 18 patients still showed significant response at 3-, 6- and 9-months follow-up. At the 12-months follow-up, 17 out of the 18 responding patients still showed significant immunological response.

Ongoing immunological studies at the University of Tübingen now confirm that treatment with RV001 can activate CD4+ T-cells and also CD8+ T-cells. Confirmation that the drug candidate RV001 can activate CD4+ T cells is important for the clinical value of the treatment. This has been demonstrated in a number of scientific publications of which some are referenced below:

Doonan et al (2010), demonstrated that "activation of CD4+ T cells is required to stimulate and prolong CD8+ T cell activity, and for the development of long-lasting tumor specific memory T cells".
Quezeda et al (2010) concluded in their study that "results highlight the relevance of the CD4+ T cell compartment, and particularly of cytotoxic CD4+ T cells, in cancer immunotherapy, while providing evidence that T cell differentiation in vivo may afford advantages over current approaches using differentiation and expansion in vitro".
Haabeth et al (2014) also concluded that beside CD8+ T cells commonly known as being able to eliminate target cells, CD4+ T cells also have the ability to directly eliminate tumors via T Cell Receptor and peptide:MHC-class II interaction (the pathway linked to CD4+ T cells) and/or to eliminate tumor cells indirectly via the release of immunomodulatory molecules activating surrounding immune cells.
For these reasons the MHC class II tumor antigen presentation pathway (the pathway linked to CD4+ T cells) must be utilized for therapeutic cancer vaccines to have a high clinical value, and interim results strongly indicate that RV001 is well capable of this.

Comment from RhoVac’s CEO, Anders Månsson:

Confirmation of the immunological response concluded based on interim results is obviously important data for the ongoing development of the drug candidate RV001. I am looking forward to the continued collaboration with the team at University of Tübingen.

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."

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.

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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.