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

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.