On June 5, 2019 RhoVac AB ("RhoVac") reported that the Danish Medicines Agency (DMA) has approved RhoVac’s clinical trial application (CTA) on the clinical phase IIb study with the drug candidate RV001 (Press release, RhoVac, JUN 19, 2019, View Source [SID1234555929]). The approval from the DMA is conditioned final approval by the Ethics Committee, which has not yet finalized the review of the application.

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Clinical Phase IIb study

The study, named RhoVac-002 ("BRAVAC") for which RhoVac has received approval to start, targets prostate cancer patients who have completed primary treatment (surgery or radiotherapy) and who show rising values ​​in the prostate cancer marker PSA. It is a randomized, placebo controlled and double blinded study, where the primary goal of the study is to evaluate whether treatment with the drug candidate RV001 can reduce or prevent PSA increase compared to the control group (placebo group).

The study will enrol 150 evaluable patients who will be recruited in at least six countries, of which Denmark is the first. The clinical trial application will now be submitted in the remaining countries and, according to schedule, recruitment of patients to the study will be completed in Q3 2020. Reporting on the primary end-point of the study is expected Q3 2021.

CEO Anders Ljungqvist comments

-In the beginning of April 2019, RhoVac announced that the application to start the clinical phase IIb study, with RV001 had been submitted to the Danish Medicines Agency in Denmark. The fact that RhoVac has now received approval from the DMA means that the study can be initiated, in accordance with the communicated schedule, in the beginning of H2 2019. The first patients will be recruited at the University Hospital in Copenhagen.

Thanks to the rights issue on approximately SEK 181 million (before issue costs), which is currently ongoing, we secure that the study can start without delay. With this issue, we will have funding for the coming three years and can now focus on optimal clinical development and on finding the best possible exit partner, a partner we expect to have in final stage of negotiations when phase IIb study results becomes available.

The combination of advanced preparation for the phase IIb study and financing secured for the coming three years, puts RhoVac in a unique situation, and I am pleased to now continue the journey of the drug candidate RV001 into the next development phase.

On June 19, 2019 Biogen Inc. (Nasdaq:BIIB) reported it will report second quarter 2019 financial results Tuesday, July 23, 2019, before the financial markets open (Press release, Biogen, JUN 19, 2019, View Source [SID1234537168]).

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Following the release of the financials, the Company will host a live webcast with Biogen management from 8:00-9:00 am ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website.

On June 19, 2019 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA;OTCQB: MDNAF), a clinical stage immuno-oncology company, is reported that Dr. Fahar Merchant, Chairman, President and CEO will present an overview of the Company at the Raymond James Life Sciences and MedTech Conference today, Wednesday, June 19th at 8:00 AM ET at the Lotte New York Palace hotel in New York City (Press release, Medicenna Therapeutics, JUN 19, 2019, View Source [SID1234537184]). Dr. Merchant will also be available to meet with investors on a one-on-one basis during the conference.

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This presentation will be made available with a live webcast and may be accessed on the Events & Presentations page by visiting Medicenna’s website at View Source This webcast will be available for 7 days following the presentation.

On June 19, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, and Lonza (SWX: LONN), an integrated healthcare solutions provider, reported that the companies have entered into a strategic manufacturing agreement (Press release, Gamida Cell, JUN 19, 2019, View Source [SID1234537169]). The agreement provides for the future commercial production after potential FDA approval of omidubicel, Gamida Cell’s investigational advanced cell therapy currently in clinical development designed to enhance the life-saving benefits of hematopoietic stem cell (bone marrow) transplant. An international, randomized Phase 3 study of omidubicel in patients with hematologic malignancies is currently ongoing, and omidubicel has not yet been approved for marketing in the United States or any other jurisdiction.

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This agreement follows a successful multi-year clinical manufacturing relationship and provides Gamida Cell with a path to commercial supply of omidubicel. Under this multi-year agreement, Lonza will construct and dedicate production suites at its Geleen, NL site, for the anticipated commercial launch. Additionally, the agreement enables Gamida Cell to increase the number of dedicated production suites over time to ensure commercial supply. Gamida Cell also has the option of expanding further into Lonza’s global cell and gene therapy manufacturing network.

"Gamida Cell and Lonza have had a strong relationship for the clinical supply of omidubicel, and we are pleased to extend our relationship as we prepare to potentially bring omidubicel to patients in a commercial setting after potential FDA approval," stated Julian Adams, chief executive officer of Gamida Cell. "The ability to reliably provide an advanced cellular therapy to patients is critical, and this agreement provides Gamida Cell with access to a top-tier manufacturing site for the long-term commercial supply of omidubicel after potential FDA approval. Additionally, this agreement enables the supply of commercial product as we plan for the build out of Gamida Cell’s own commercial-scale cGMP manufacturing facility to augment production."

"This agreement is an example of our long-term manufacturing partnership capabilities and efforts to drive the industrialization of the cell therapy industry. Our cell therapy experience and expertise will enable us to best support Gamida Cell at this important phase in the development of omidubicel," said Alberto Santagostino, SVP, head of cell & gene technologies at Lonza. "We seek to partner with such innovative companies who are pioneering important new treatment options to patients and look forward to enabling Gamida Cell to deliver omidubicel at a commercial scale after potential FDA approval."

On June 19, 2019 Nouscom, an immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, reported the publication of a paper in the online edition of the peer-reviewed journal, Nature Communications, entitled: Adenoviral vaccine targeting multiple neoantigens as strategy to eradicate large tumors combined with checkpoint blockade (D’Alise et al, reference below) (Press release, NousCom, JUN 19, 2019, View Source [SID1234537185]). The authors describe results from preclinical studies investigating the immunological potency and efficacy of a vaccine based on an adenovirus vector derived from non-human Great Apes (GAd) that encodes multiple neoantigens.

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The study demonstrated that a single administration of Nouscom’s GAd vaccine can eradicate large tumors in mouse models when combined with anti-PD1 or anti-PD-L1 treatment and triples the efficacy of such checkpoint inhibitors in established tumors. Nouscom’s GAd vaccine accommodates multiple neoantigens, up to 31 in these studies, and demonstrates strong and broad CD8+ and CD4+ neoantigen-specific T cell responses following vaccination. The results highlight the potential of these viral vector vaccines for development as personalized cancer vaccines.

Dr. Elisa Scarselli, Chief Scientific Officer and Co-Founder of Nouscom, said: "We are very encouraged by these preclinical results. These exciting data confirm our hypothesis that our GAd vaccine synergizes with checkpoint inhibitors. It also establishes that anti-tumor efficacy positively correlates with the breadth and potency of T cell responses induced by vaccination, including the expansion of the intratumoral T cell repertoire. Our findings have a potential translational impact, suggesting that the changes in intratumoral T cell repertoire induced by the vaccination might be an indicator of treatment efficacy."

Dr. Scarselli added, "These findings provide compelling preclinical evidence that a vaccine encoding multiple neoantigens in combination with anti-PD1 or anti-PD-L1 may be an efficacious approach for the personalized treatment of cancers. We look forward to evaluating our approach with NOUS-PEV, a personalized cancer vaccine, in human trials, which we expect to start in 2020."

References

A.M. D’Alise et al. Adenoviral vaccine targeting multiple neoantigens as strategy to eradicate large tumors combined with checkpoint blockade, Nature Communications 2019.

Online publication: View Source