On May 14, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that will take part in a fireside chat at the UBS Global Healthcare Conference on Tuesday, May 21, 2019, in New York. Giovanni Caforio, M.D., chairman and chief executive officer will answer questions at 2:30 p.m. ET (Press release, Bristol-Myers Squibb, MAY 14, 2019, View Source [SID1234536261]).

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Investors and the general public are invited to listen to a live webcast of the session at View Source Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.

On May 14, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, is reported a development update on its cancer vaccine program, the GD2-GD3 Vaccine (Press release, Y-mAbs Therapeutics, MAY 14, 2019, View Source [SID1234536277]).

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At the Advances in Neuroblastoma Research (ANR) conference in San Francisco in May 2018, Phase 2 data utilizing GD2-GD3 Vaccine for Stage 4 high-risk neuroblastoma was presented. A total of 84 pediatric patients received the GD2-GD3 Vaccine, all of whom had prior relapses and finally regained second or later remissions before vaccine treatment. An interim analysis shows a progression free survival (PFS) of 51% and overall survival (OS) of 90% at 2 years. The GD2-GD3 Vaccine appears to be well tolerated, with no reported grade 3 or grade 4 toxicities. To date, more than 230 patients have been treated with the GD2-GD3 Vaccine at Memorial Sloan Kettering Cancer Center (MSK) in New York under a MSK sponsored IND.

"Since Y-mAbs licensed the GD2-GD3 Vaccine in June 2018, we have explored our options to establish commercial scale cGMP production. We believe we now have a viable route forward for manufacturing, and plan to begin using the newly manufactured cGMP drug product in the fourth quarter of 2019. Establishment of a clear path towards approval has been a prerequisite for advancing the GD2-GD3 Vaccine program and we are very excited to move the program forward. We believe the GD2-GD3 Vaccine for relapsed high-risk neuroblastoma may offer meaningful improvement in the long-term treatment paradigm for pediatric patients, serving as a natural extension post immunotherapy treatment with our naxitamab antibody based product candidate," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Møller, Chief Executive Officer continued, "We believe that the more than 230 patients treated to date represents the largest population ever to receive a neuroblastoma vaccine. The 84 patients reported on at ANR received seven subcutaneous injections of the GD2-GD3 Vaccine in the outpatient clinic without any measurable pain or significant adverse side effects. We are very encouraged with the two year OS of approximately 90% in these 84 patients. We hope to replicate these data with the newly manufactured cGMP drug product in a multicenter trial."

On May 14, 2019 Cytori Therapeutics (NASDAQ: CYTX) ("Cytori" or the "Company") reported Q1 2019 financial results and provided updates on corporate activities (Press release, Cytori Therapeutics, MAY 14, 2019, View Source [SID1234536262]).

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Q1 2019 net loss was $3.2 million, or $0.18 per share. Operating cash burn for Q1 was approximately $3.3 million. Cytori ended Q1 with approximately $3.9 million of cash and cash equivalents.

Cytori is developing two clinical stage chemotherapy drugs. ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, is the lead product candidate. The Company plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) next year based on a successful bioequivalence study completed against the European reference drug. The Company is in the process of completing manufacturing-related activities to support the MAA and is evaluating commercial partners for ATI-0918 with a focus on Europe, which has a current estimated market size of over $120 million.

Cytori is also developing ATI-1123, a patented, albumin-stabilized pegylated liposomal docetaxel. The Company recently received an orphan drug designation from the U.S. FDA for small cell lung cancer and is seeking FDA’s 505(b)(2) new drug application (NDA) and Accelerated Approval pathway.

"The Company’s recent divestiture of its cell therapy businesses allows us to fundamentally reposition and refocus of the Company around our nanotechnology and oncology drug development," said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. We intend to begin communicating our plan later in Q2.

Q1 2019 Financial Performance

Q1 2019 operating cash burn was $3.3 million, compared to $4.1 million for Q1 2018.

Q1 2019 product revenues were $0.7 million, compared to $0.7 million for Q1 2018.

Q1 2019 contract revenues were $0.7 million, compared to $0.9 million for Q1 2018.

Q1 2019 Celution consumable utilization grew by approximately 20% as compared to Q1 2018.

Cash and debt principal balances at March 31, 2019 were approximately $3.9 million and $13.0 million, respectively.

Q1 2019 net loss was $3.2 million or $0.18 per share, compared to a net loss of $4.4 million or $0.73 per share for Q1 2018.

On May 14, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that it will announce its 2019 first quarter results on Wednesday, May 22, 2019 (Press release, Bavarian Nordic, MAY 14, 2019, View Source [SID1234536278]).

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The management of Bavarian Nordic will host a conference call at 2:00 pm CEST (8:00 am EDT) on the same day to present the interim results followed by a Q&A session. A live and replay version of the call and relevant slides will be available at http://bit.ly/2PNW058.

To join the Q&A session dial one of the following numbers and state the participant code 3096344: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations & Communications. Phone +45 61 77 47 43
U.S.: Graham Morrell, Paddock Circle Advisors (US), Tel: +1 781 686 9600

On May 14, 2019 DCprime, the front-runner in the field of relapse vaccines, reported presentations of additional preclinical data sets for its lead program, DCP-001, at the 7th CCBIO Annual Symposium and the 2019 CIMT (Free CIMT Whitepaper) Annual Meeting (Press release, DCPrime, MAY 14, 2019, View Source [SID1234536263]). The data supports key product characteristics and sheds additional light on the mechanism-of-action of DCP-001, a whole cell-based vaccine derived from the company’s proprietary DCOne human leukemic cell line. DCP-001 is currently studied in an international Phase II trial in AML patients who are ineligible for hematopoietic stem cell transplantations.

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"While we are making constant progress evaluating DCP-001 in the clinic in AML and preparing additional trials in MDS and Multiple Myeloma, we continue to strengthen the body of preclinical data supporting this program," commented Dr Jeroen Rovers, CMO of DCprime. "The preclinical results and animal models we have generated in our collaboration with the University of Bergen provide further insights into the vaccine’s mechanism-of-action and confirm several key product characteristics relevant to our approach. Overall, these data strongly support the rationale of DCP-001 as a relapse vaccine providing immune control over residual disease in hematological malignancies."

DCOne cells endogenously express known and unknown tumor-associated antigens. In the DCP-001 manufacturing process, DCOne cells are differentiated and matured into cells with a mature dendritic cell phenotype, which is responsible for the strong immunogenic properties of the vaccine.

In its collaboration with the University of Bergen, Norway, DCprime has established a preclinical mouse model to study DCP-001 vaccinations in monotherapy and in combination therapy settings. The collaboration is supported by the Horizon 2020 EU grant AML-VACCiN. The data which were presented yesterday at the 7th CCBIO Annual Symposium showed that DCP-001 was able to suppress tumor growth in humanized immunocompetent mice. The results also demonstrated that the transformation of DCOne leukemic cells into DCP-001 leads to an immunogenic shift. Whereas the parental leukemic cells were poorly immunogenic, DCP-001 proved highly immunogenic, making it an attractive cancer vaccine candidate. Furthermore, DCP-001 induced the production of a broad range of pro-inflammatory cytokines in peripheral blood mononuclear cells (PBMCs) derived from healthy donors.

In preclinical studies, which will be presented at the upcoming 2019 CIMT (Free CIMT Whitepaper) Annual Meeting, DCprime was able to demonstrate that human antigen presenting cells (APCs) efficiently process DCP-001 through phagocytosis. These in vitro data suggest that in vivo, upon intradermal injection, DCP-001 will induce a strong inflammatory response, and is ingested by both resident and attracted host APCs, which subsequently prime tumor-reactive T cells. These data support the proposed mode of action whereby host APCs present DCP-001 antigens to the host immune system following intradermal vaccination.

The poster presentation at the upcoming 2019 CIMT (Free CIMT Whitepaper) Annual Meeting will take place on May 21, 2019 at the Rheingoldhalle Congress Center Mainz, Germany.