Den 20 oktober, 2017 rapporterade Xspray Pharma att de har fått godkännande för ett sökt patent i USA. Patentet omfattar komposition avseende produktkandidaten HyNap-Dasa (Press release, Xspray, OCT 20, 2017, View Source [SID1234523284]). Det är Xsprays första produktpatent som godkänns på huvudmarknaden i USA. Bolaget har tidigare offentliggjort ett patentgodkännande i Japan och har pågående ansökningsärenden för motsvarande patent i USA, Japan och Europa..

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"Att vi nu får patent beviljat på vår viktigaste marknad bekräftar vårt innovativa arbete samt förbättrar vår kommande förhandlingsposition med tilltänkta partners." säger Per Andersson, vd för Xspray Pharma.

Xspray Pharma har erhållit godkännande ("notice of allowance") för ett patent i USA avseende produktkandidaten HyNap-Dasa som är tänkt för behandling av vissa cancerformer. Det är det första produktrelaterade patentet som beviljas för bolagets produktkandidat på den viktigaste marknaden, USA. Beskedet kommer i enlighet med bolagets plan att söka och erhålla patent för komposition och metod för samtliga tre produktkandidater under utveckling på de tre viktigaste marknaderna, USA, Europa och Japan.

"Vi satsar primärt på att lansera våra produktkandidater på den amerikanska marknaden. En väl fungerande patentstrategi fyller en viktig funktion och det här godkännandet visar att vi har en sådan", kommenterar Xsprays vd Per Andersson.

Xspray Pharmas aktier introducerades den 28 september på Nasdaq First North, efter en lyckosamt genomförd nyemission som tillförde bolaget 132 miljoner kronor före emissionskostnader. Planen är nu att använda kapitalet för att utveckla tre produktkandidater och blivande cancerläkemedel baserade på bolagets egenutvecklade teknologi, samt att introducera de första produkterna på den amerikanska marknaden under perioden 2020-2023.

October 19, 2017 DCPrime BV, a clinical stage company developing dendritic cell vaccines to treat cancer, and apceth Biopharma GmbH, an established contract manufacturing organization in the field of gene and cell therapy, report that they have entered into a strategic manufacturing agreement (Press release, apceth, OCT 19, 2017, View Source [SID1234531599]). The collaboration involves clinical batch production and the development of a commercial scale manufacturing process of cancer vaccines based on DCPrime’s technology platform DCOne. The companies also announce that apceth has recently successfully passed an inspection by the District Government of Upper Bavaria and the Paul-Ehrlich-Institute for the manufacturing license for production of DCP-001, DCPrime’s lead program. This will enable DCPrime to enter into a Phase II Proof of Concept study in Acute Myeloid Leukemia.

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"Precisely because our platform allows, for the first time, production of dendritic cell vaccines in an off-the-shelf manner, and bypasses the costly and complicated manufacturing procedures of patient-derived dendritic cell vaccines, it is crucial for DCPrime to partner with apceth Biopharma, an experienced contract manufacturing company. This collaboration will be instrumental in bringing our innovative therapies to as many patients as possible", says Dr Ada Kruisbeek, founder and CEO & CSO of DCPrime.

"We are pleased that our manufacturing relationship with DCPrime has started in such a successful manner and that after only one year, we can already ensure production of clinical batches and product supply to patients for further development of the first off-the-shelf dendritic cell vaccine to enter Phase II clinical studies", says Dr Christine Guenther, apceth Biopharma’s CEO. "We at apceth are also very pleased that we will continue our relationship in the future, to enable large scale production and therefore product supply to even larger numbers of cancer patients".

"It has been a pleasure working with the professional staff of apceth Biopharma during the early phases of technology transfer of our current production process, and we look forward to the next steps with respect to developing a commercial scale manufacturing process", says Dr Sandra van Wetering, COO of DCPrime.

ATOR-1015 (previously designated ADC-1015) is a bispecific immune activating antibody, developed for tumor-directed immunotherapy. The drug candidate binds to two different immunomodulating target proteins: the inhibitory checkpoint receptor CTLA-4, and the co-stimulatory receptor OX40. The OX40 binding part originates from ALLIGATOR-GOLD, and the CTLA-4 binding part was generated by FIND optimization of CD86, which is a natural binder to CTLA-4.

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ATOR-1015 is capable of binding individual T-cells simultaneously, thereby bringing those cells in close proximity, which may support the immune activating effect. It reduces the number of regulatory T-cells and activates effector T-cells. A strong immune activation is expected to be achieved primarily in environments where both target molecules are expressed at high levels, such as inside a tumor. Taken together, this results in an effective immune activation as well as localization of the effect to the tumor environment, the latter being expected to minimize immune-related side effects. The objective of ATOR-1015 is to be the first CTLA-4 and OX40-binding bispecific antibody to achieve a strong anti-tumor effect, either as a monotherapy or in combination with currently established immunotherapies such as PD-1 and PD-L1 blockers. ATOR-1015 is expected to be suitable for treating a large number of different forms of cancer.

Based on the promising results from concept validation and initial preclinical studies, cell line development, aimed at subsequent large-scale production for clinical trials, was initiated in January 2016. The program is currently in the second phase of production, process development, and is planned to be ready for clinical trials during 2018.

On October 19, 2017 Heidelberg Pharma – formerly WILEX AG – (ISIN DE000A11QVV0 / WKN A11QVV / Symbol WL6) reported that its relocation from Munich to Ladenburg and its name change from WILEX AG to Heidelberg Pharma AG have been successfully completed with its entry in the Mannheim commercial register on 18 October 2017 (Press release, Heidelberg Pharma, OCT 19, 2017, View Source [SID1234526972]). The Company’s shares will continue to be listed on the Regulated Market of the Frankfurt Stock Exchange’s Prime Standard under their old ISIN, German securities identification code (WKN) and symbol. Its subsidiary Heidelberg Pharma GmbH is now doing business as Heidelberg Pharma Research GmbH. The Annual General Meeting on 20 July 2017 adopted a resolution to change the name of the Company and relocate its headquarters from Munich to Ladenburg.

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"Our Company’s core business has been driven by the research and development activities of our subsidiary Heidelberg Pharma GmbH for some time. The renaming and relocation of the Company are part of our strategic realignment and the refinement of our business model," commented Dr. Jan Schmidt-Brand, CEO and CFO of Heidelberg Pharma AG. "In keeping with these changes, the Heidelberg Pharma companies now have a uniform, updated corporate identity, including a new corporate website."

Heidelberg Pharma is working to enhance its value by developing and licensing the proprietary ATAC technology platform, entering into project partnerships and building a proprietary ATAC portfolio. Clinical development of the first proprietary product candidate HDP-101 in multiple myeloma is expected to begin at the end of 2018.

The Company’s new website can be found at www.heidelberg-pharma.com.

On October 19, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that the first patient has been treated in the Phase 1 cohort of INCB01158 (also known as CB-1158) in combination with Keytruda (pembrolizumab), an anti-PD1 immune checkpoint inhibitor (Press release, Calithera Biosciences, OCT 19, 2017, View Source [SID1234535255]). INCB01158 is a potent, selective, oral inhibitor of arginase being developed pursuant to a global collaboration and license agreement with Incyte Corporation.

"Arginase is involved in the metabolism of a key amino acid that is required for optimal anti-cancer immune function," said Susan M. Molineaux, Ph.D., founder, Chief Executive Officer and President of Calithera Biosciences. "In combination with an anti-PD1 therapy, an inhibitor of arginase may reduce immunosuppression caused by myeloid cells and broaden the reach of immuno-oncology therapies."

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The Phase 1 trial (NCT02903914) is designed to evaluate the safety and recommended Phase 2 dose of INCB01158 as a monotherapy, and in combination with immune checkpoint therapy. The trial was initiated in September 2016 and is designed to enroll monotherapy expansion cohorts of patients with advanced non-small cell lung cancer, colorectal cancer and other solid tumors. The recommended Phase 2 monotherapy dose has been selected, and several cohorts of additional tumor types have been added to the trial design. Expansion cohorts of INCB01158 dosed in combination with Keytruda are expected to enroll patients diagnosed with non-small cell lung cancer, melanoma, urothelial cell carcinoma, colorectal cancer, gastroesophageal cancer, squamous cell head and neck cancer and mesothelioma