On January 15, 2019 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report fourth quarter and year-end 2018 financial results after the Nasdaq market closes on Tuesday, Feb. 5, 2019 (Press release, Neurocrine Biosciences, JAN 15, 2019, View Source;p=RssLanding&cat=news&id=2383457 [SID1234532654]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a Company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 877-876-9174 (US) or 785-424-1669 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On January 15, 2019 Lytix Biopharma AS reported that dosing of first patient in a Phase II study of its first in class oncolytic peptide, LTX-315, administered in combination with adoptive T-cell therapy in patients with advanced soft tissue sarcoma (Press release, Lytix Biopharma, JAN 15, 2019, View Source [SID1234532655])

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The objective of the trial is to assess the safety and efficacy of intratumoral administration of LTX-315 and adoptive T-cell therapy in patients with advanced soft tissue sarcoma. This proof of concept study will evaluate the potential for LTX-315 to induce T-cell infiltration prior to isolation and expansion of tumor infiltrating lymphocytes (TILs) followed by infusion of the cultured TILs to the patient. An extensive immune profile will be generated to characterise the immune status and nature of anti-tumor immune response. Objective clinical response and duration of response will be assessed.

The first patient has commenced dosing with LTX-315 and will proceed to resection of the injected lesion followed by TIL expansion and infusion (upon positive TIL generation and identification).

Soft tissue sarcoma is an indication with progressive subtypes and limited treatment options. We were greatly encouraged by the results of a recent LTX-315 Phase I study indicating that LTX-315 has the potential to turn cold tumours hot, which may prove to be a vital therapeutic pathway for patients with sarcoma who otherwise would not be able to benefit from immune therapy. We look forward to the outputs of this program to help address a crucial unmet need as well as understand the potential of this combination for other cancer indications. Said Hamina Patel, CMO of Lytix Biopharma AS.

We are really pleased that the first patient has been recruited into the study and will undergo combination treatment with LTX-315 and T-cell therapy. This is an area of substantial unmet need and new, effective treatment options for patients with sarcoma are needed. We anticipate that LTX-315 can provide a viable treatment when utilized in combination with T-cell therapy, since it has already been demonstrated that LTX-315 has the potential to attract relevant immune cells into tumors. Said Inge Marie-Svane, MD, Principle Investigator, Center for Cancer Immune Therapy, Herlev Hospital, Denmark.

On January 15, 2019 Orion Biotechnology Canada Ltd., a developer of novel medical treatments, reported preclinical data produced in collaboration with Charles River Laboratories, evaluating the efficacy of OB-002O (5P12-RANTES) in colorectal cancer (Press release, Orion Biotechnology, JAN 15, 2019, View Source [SID1234532673]). BALB/c mice were inoculated subcutaneously with the CT-26 colorectal cancer cell line. Three days after inoculation intraperitoneal treatment was started with OB-002O, a murine anti-PD-1 antibody, OB-002 + anti-PD-1, or saline placebo. Treatment was given daily or every third day. Treatment with OB-0020 alone led to statistically significant delayed tumor growth at multiple time-points. An even more profound effect on the decrease in mean tumor volume was observed in combination cohort where animals received both, OB-0020 and the anti-PD-1 antibody (p>0.05).

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"There is growing awareness of the role of CCR5 antagonism as an important component of cancer immunotherapy. OB-002O is an extremely potent CCR5 antagonist and we are delighted to see that OB-002O has robust efficacy alone and in combination with an anti-PD-1 antibody in the CT-26 colorectal cancer model. These data support the further preclinical and clinical development of OB-002O for colorectal cancer" said Dr. Ian McGowan, Chief Scientific Officer for Orion Biotechnology.

Mark Groper, President and CEO of Orion Biotechnology added; "We are delighted by these preliminary data and look forward to the later stage development of OB-002O in colorectal cancer as well as exploring the efficacy of OB-002O in other cancer models."

On January 15, 2019 Biomunex Pharmaceuticals, a biopharmaceutical company focused on providing immuno-therapeutics through the discovery and development of bi- and multi-specific antibodies, reported that it has entered into a licensing agreement with Sanofi (Press release, BIOMUNEX Pharmaceuticals, JAN 15, 2019, View Source [SID1234554044]). Under the terms of the agreement, Sanofi will have access to Biomunex’ proprietary technology to generate and optimize bi- and multi-specific antibody therapeutics. Sanofi will be solely responsible for the research, development, manufacturing and global commercialization activities. This agreement, the first of its kind for Biomunex, is in line with the company’s business model, which is to establish licensing or collaboration agreements and to become a clinical-stage company in the short term.

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Biomunex will receive an initial upfront payment and will be eligible to receive further clinical, regulatory and commercial milestone payments. Further financial details were not disclosed.

"This licensing agreement is a major milestone for Biomunex. It demonstrates the high value of the BiXAb technology and is the starting point for our collaboration strategy with pharmaceutical companies to discover and develop cutting-edge bi- and multi-specific antibodies, giving patients new treatment options," said Pierre-Emmanuel Gerard, MD, founder and CEO of Biomunex. "We believe that the proceeds from this deal, together with the funding round that we expect to finalize in the near future, will help us accelerate the development of Biomunex’ proprietary BiXAb bi- and multi-specific antibody programs in immuno-oncology and other therapeutic areas towards clinical development."

About the BiXAb Platform
Biomunex’ Plug-and-Play BiXAb platform generates next-generation bi- and multi-specific antibodies. This universal modular bi- and multi-specific format enables turnkey formatting of BiXAb from any pair of monospecific monoclonal antibodies as building blocks, with minimal engineering, in a timely and cost-effective manner. BiXAb possesses all the key properties expected of an ideal bi-specific antibody technology (modularity, excellent drug-like properties and manufacturability, multi-specificity potential). This enables Biomunex to develop immuno-oncology drug candidates with high anti-tumor activity demonstrating true synergy on their targets. The BiXAb platform is also suitable to generate innovative bi- and multi-specific antibodies in other therapeutic areas, such as immune-mediated inflammatory and infectious diseases.

On January 15, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported PharmaCyte’s partner, Austrianova, has successfully encapsulated the live cells used in PharmaCyte’s therapy for its planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, JAN 15, 2019, View Source [SID1234532656]). The cells are now growing and dividing inside the Cell-in-a-Box capsules.

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We are now in the process of monitoring the growth and division of the live cells as they spend more time in a ‘nutrient bath.’ This will allow the cells to continue to grow and divide and then completely fill the capsules. Once the capsules are completely full of live cells, they will be placed into syringes and frozen. Austrianova will then commence testing the capsules in the frozen syringes to finalize PharmaCyte’s clinical trial material."

Since its pre-production "engineering runs" in late 2018, Austrianova has further enhanced the manufacturing process and equipment. Once the testing of the syringes is successfully completed, the data and reports generated from this process will allow the completion of the Investigational New Drug application (IND) that must be submitted to the U.S. Food and Drug Administration (FDA) to apply for approval to begin a clinical trial in LAPC.