MannKind Corporation to Present at the Piper Jaffray 31st Annual Healthcare Conference

On November 29, 2019 MannKind Corporation (NASDAQ: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, reported that it will be featured as a presenting company at the Piper Jaffray 31st Annual Healthcare Conference on Tuesday, December 3, 2019 at 3:30 p.m. (ET) at the Lotte New York Palace in New York City (Press release, Mannkind, NOV 29, 2019, View Source [SID1234551784]). Presenting from the Company will be its Chief Executive Officer, Michael Castagna.

The presentation will be webcast live. Interested parties can access a link to the live webcast of the presentation from the News & Events section of the Company’s website at View Source The webcast replay will remain available for 14 days following the live presentation.

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Stemline Therapeutics to Present at Piper Jaffray’s 31st Annual Healthcare Conference

On November 29, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that Stemline management will present at Piper Jaffray’s 31st Annual Healthcare Conference on Tuesday, December 3rd at 1:30 PM EST at the Lotte New York Palace Hotel in New York City (Press release, Stemline Therapeutics, NOV 29, 2019, View Source [SID1234551785]). A live webcast of the presentation can be viewed on the company’s website at www.stemline.com.

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About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

Y-mAbs Initiates Rolling Submission of Biologics License Application to U.S. FDA for Naxitamab for Treatment of Neuroblastoma

On November 29, 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, reported that it has submitted to the U.S. Food and Drug Administration ("FDA") the first portions of its Biologics License Application ("BLA") for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma under the FDA’s Rolling Review process (Press release, Y-mAbs Therapeutics, NOV 29, 2019, View Source [SID1234551786]).

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In August 2018, naxitamab, which is an anti-GD2 monoclonal antibody, received Breakthrough Therapy Designation by the FDA, which facilitates frequent interactions with the FDA review team. The Rolling Review process allows Y-mAbs to submit individual portions of the BLA for review, rather than waiting until all portions are completed and submitted to the FDA for review. Upon potential approval, the Company intends to commercialize naxitamab in the U.S.

"We are excited to announce the initiation of the rolling BLA for naxitamab, a major milestone for Y-mAbs. Dr. Nai-Kong Cheung and his research team at Memorial Sloan Kettering Cancer Center ("MSK") started looking at immunotherapy more than three decades ago when he first studied the anti-GD2 target. Today, high-risk neuroblastoma patients are being treated with naxitamab worldwide in clinical trials addressing clear unmet medical needs of children waiting for new treatment options," said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer further notes, "I am both proud and appreciative of the Y-mAbs team and our clinical investigators, who have helped to make this key milestone possible. We believe that this submission represents an important landmark for Y-mAbs and for neuroblastoma patients."

MSK has institutional financial interests with Y-mAbs in the form of equity and intellectual property interests through licensing agreements. Dr. Cheung is a founder of, holds equity interests in, and has intellectual property rights related to Y-mAbs.

Achilles Therapeutics to Present at the 31st Annual Piper Jaffray Healthcare Conference

On November 28, 2019 Achilles Therapeutics ("Achilles"), a biopharmaceutical company developing personalised cancer immunotherapies, reported that Dr. Iraj Ali, Chief Executive Officer, will present at the 31st Annual Piper Jaffray Healthcare Conference at the Lotte New York Palace in New York City on Wednesday, December 4, 2019 at 11:30 am ET (Press release, Achilles Therapeutics, NOV 28, 2019, View Source [SID1234551772]).

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A new anti-tumour treatment is one step closer to the clinic thanks to a new collaboration between In3Bio and 3P Biopharmaceuticals

On November 28, 2019 3P Biopharmaceuticals, a leading Contract Development and Manufacturing Organization (CDMO) specialized in process development and cGMP manufacturing of biologics, reported that it has been chosen by In3Bio, the UK based Biotech company, to collaborate in the development of a novel anti-tumour treatment (Press release, 3P Biopharmaceuticals, NOV 28, 2019, View Source [SID1234551773]).

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3P Biopharmaceuticals and In3Bio began their partnership in early 2019 with 3P Biopharmaceuticals being selected to be responsible for technology transfer, process development, analytical methods development, scale-up and cGMP production for clinical studies.

In3Bio’s candidate molecule is IN02, a bi-specific biological molecule that was identified through designing fusions of molecules with high binding potential for targeting growth factors.

The technology employed by In3Bio produces new molecules specific to one or multiple growth factors at the same time. In this way, these new candidates have demonstrated a wide potential in the treatment of different cancer indications using established preclinical models, opening the door for developing effective anti-tumour therapy.

As 3P Biopharmaceuticals CEO Dámaso Molero explains, "it is an honour to help develop an anti-cancer treatment and do our best in the field of oncology with the hope of ultimately contributing to a positive effect on society". Besides, Molero added "this innovative project strengthens the experience of 3P Biopharmaceuticals to develop complex therapeutic products applied to health and places us among the most competitive CDMOs in Europe."

Erik D’Hondt, CEO/CSO at In3Bio, added "We at IN3BIO are pleased to cooperate with 3P Biopharmaceuticals, a CDMO with solid and broad experience to support IN3BIO for preparing Clinical batch of a chimeric biological molecule to be used in the clinic".

According to the World Health Organization (WHO), cancer is the second leading cause of death worldwide and was responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths is due to cancer.

Therefore, this development represents an important advance for oncological treatments, which are critically needed given the increasing rates in cancer.h this collaboration, 3P Biopharmaceuticals once again demonstrates its capacity to carry out processes and manufacturing for molecules developed within diverse therapeutic applications.