On January 22, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its full year and fourth quarter 2018 financial results on Tuesday, February 5, 2019 after the financial markets close (Press release, Vertex Pharmaceuticals, JAN 22, 2019, View Source [SID1234532818]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

On January 22, 2019 TC BioPharm (TCB), a developer of CAR-T immuno-oncology products, including Gamma Delta T (GDT) cell therapies, reported it has completed formulation of its first allogeneic GDT cell banks (Press release, TC Biopharm, JAN 22, 2019, View Source [SID1234532819]). The T cell banks provide TCB with core technology to develop a deep portfolio of next-generation CAR-T products directed against a wide variety of different cancer types, both hematological and solid tumors. The project was supported by funding from the European Union’s Horizon 2020 (H2020) Research and Innovation program via a €4million grant, the largest such EU award to any UK company for development of a healthcare therapeutic product.

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The GDT cell banks are collected and stored from healthy donors, providing a source for TCB to manufacture next-generation ‘off-the-shelf’ GDT cell therapies for future clinical product development. Using allogeneic material from healthy donors offers several advantages over conventional autologous CAR-T therapies, which use the patient’s own cells to treat their tumor, as TCB’s proprietary allogeneic CAR-T cells are not prone to ‘on-target, off-tumor’ toxicities. Additionally, a larger population of cancer patients can be treated with a single reproducible product, ‘campaign-manufactured’ in bulk to keep costs lower, consequently increasing accessibility and reducing financial burden for healthcare systems.

Benefitting from H2020 support, TCB is rapidly progressing its clinical evaluation of allogeneic therapies. Having recently demonstrated safety and efficacy of large-dose autologous gamma-delta T cells in cancer patients, TCB is commencing treatment of cancer patients with an allogeneic variant. By building on its exclusive CAR-T platform, the company also plans to treat leukemia patients with an allogeneic CD19-directed GDT CAR-T product.

Angela Scott, Co-Founder and Chief Operating Officer, TCB, said: "I am delighted we have completed manufacture of our first allogeneic cell banks. By combining allogeneic GDT therapy with our unique CAR-T platform it will allow us to develop the next generation of safe, cost-effective immunotherapy for cancer, improving patient outcomes and quality of life."

Dr Michael Leek, Co-Founder and Chief Executive, TCB, commented: "Availability of clinical-grade allogeneic GDT cell banks is an important commercial milestone for TCB. This allows us to transition our therapeutic approach from expensive and complex personalized therapy using patient’s own cells, to a more cost-effective ‘pharmaceuticalized’ approach."

This project has received funding from the European Union’s Horizon 2020 Research and Innovation program.

On January 21, 2019 BerGenBio ASA (OSE:BGBIO), reported that the first patient has been dosed in a phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumour efficacy of ADCT-601, an AXL-targeting antibody drug conjugate (ADC), in patients with advanced solid tumours (Press release, BerGenBio, JAN 21, 2019, View Source [SID1234532796]).

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ADCT-601 is composed of a humanised monoclonal antibody against human AXL (BGB601) discovered by BerGenBio, conjugated to a pyrrolobenzodiazepine (PBD) dimer toxin. BGB601 was out-licensed for ADC development to ADC Therapeutics SA (ADCT). In preclinical studies, ADCT-601 has demonstrated potent and specific anti-tumour activity in multiple in vivo models and was stable and well tolerated, as reported by ADCT at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual congress in 2018.

The open-label, multi-centre, single arm phase I trial will enrol approximately 75 patients with selected tumour types and will be managed and sponsored by license partner ADC Therapeutics. For more information see View Source (accessing trial identifier NCT03700294).

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We congratulate ADC Therapeutics on reaching this important milestone. We are pleased to now see three of our AXL-targeting modalities in clinical development with the potential to address large patient populations. Our focus remains on completing our ongoing oncology phase II programme with bemcentinib, a first-in-class highly selective oral AXL inhibitor, and start randomised, potentially pivotal trials later this year. In the meantime, we look forward to providing updates on the development of BGB149, a therapeutic AXL antibody, and ADCT-601, an anti-AXL ADC, as they progress through phase I testing."

END

About ADCT-601
BerGenBio out-licensed two novel and proprietary anti-AXL monoclonal antibodies invented by the Company to ADC Therapeutics SA (ADCT) for the development of an antibody drug conjugate (ADC).

ADCT-601 is composed of BGB601, a humanised monoclonal antibody that binds to human AXL, conjugated using GlycoConnect technology to a linker with a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to an AXL-expressing cell, ADCT-601 is internalised into the cell where enzymes release the PBD-based warhead. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and ultimately killing the cancer cell. ADCT-601 is currently undergoing Phase I clinical testing (NCT03700294).

Under the license, a series of development, regulatory and sales-based milestones are due to BerGenBio from ADCT upon the achievement of certain specified events. The first milestone payment is triggered during the phase I clinical study.

About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

On January 21, 2019 ISA Pharmaceuticals B.V., a clinical-stage company dedicated to the development of rationally designed immunotherapeutics, reported randomization of the first patient in a Phase 2 combination trial of its lead compound ISA101b and Regeneron´s (NASDAQ: REGN) anti-PD-1 antibody cemiplimab (REGN2810) (Press release, ISA Pharmaceuticals, JAN 21, 2019, View Source [SID1234532797]).

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This double blind, placebo-controlled, randomized, phase 2 study (NCT03669718) will enroll approximately 164 patients with HPV16-positive oropharyngeal cancer (OPC), who have failed first-line chemotherapy. Patients will be randomly allocated on a 1:1 basis to the combination of cemiplimab/ISA101b or cemiplimab/placebo. In both study arms, patients will receive treatment in cycles of 3 weeks for up to 24 months. The primary efficacy objective of this trial is to assess whether the addition of ISA101b to cemiplimab will elicit a higher Overall Response Rate (ORR, as per RECIST 1.1 criteria) compared to cemiplimab plus placebo. Secondary endpoints include Progression Free Survival (PFS), Overall Survival (OS), as well as safety and tolerability of cemiplimab plus ISA101b (as compared to cemiplimab plus placebo). The study will be conducted at approximately 50 investigative sites in the USA and Europe.

ISA Pharmaceuticals´ lead compound ISA101 is a clinical-stage SLP immunotherapy targeting HPV16-induced diseases such as cervical cancer and head–and-neck cancer. It induces specific immune responses to the oncogenic E6 and E7 antigens of HPV16. Cemiplimab, also known as REGN2810, is currently under review by EMA and was approved by the U.S. Food and Drug Administration in September 2018 under the brand name Libtayo as monotherapy for patients with advanced cutaneous squamous cell carcinoma. Regeneron, in collaboration with Sanofi, is developing cemiplimab both alone and in combination with other therapies for the treatment of various cancers.

"We are excited about this new clinical trial with ISA101b and cemiplimab," said Dr. Leon Hooftman, CMO of ISA Pharmaceuticals. "ISA101b has already demonstrated very promising results when combined with nivolumab in a previous study in advanced HPV16-positive cancers. Particularly in patients with relapsed head-and-neck cancer the percentage of patients with a meaningful tumor response appeared to be twice as high as achieved with nivolumab alone. The objective of the current randomized trial is to confirm such clinical benefit of ISA101b in a controlled setting."

"In our collaboration with Regeneron that was announced in December 2017, this is the first of two indications in which we jointly aim to develop novel combination immunotherapies for cervical cancer and head-and-neck cancer," said Gerben Moolhuizen, CEO of ISA Pharmaceuticals. "I am very proud of the efforts of the joint team that allowed us to advance quickly to this stage. We look forward to the first read-out from the trial, which is expected in the second half of 2020."

Oropharyngeal cancer, a subtype of head-and-neck cancer, affects tissues of the throat (oropharynx), e.g. the base of the tongue, the tonsils, the soft palate, and the walls of the pharynx. Oropharyngeal cancers can be divided into two types: HPV-positive, which are related to human papillomavirus infection, and HPV-negative cancers, which are usually linked to alcohol or tobacco use.

On January 21, 2019 Biocure Technology Corp. ("CURE" or the "Company") (CSE:CURE; OTCQB: BICTF) BiocurePharm, Korea ("BPK"), a wholly owned subsidiary of Biocure Technology Inc. ("CURE") reported that it has arranged a non- brokered private placement through its Korean Subsidiary BiocurePharm, Korea ("BPK"), BPK will be issuing up to 100,000 shares at 11,40 CAD per share for gross proceeds of $1.14 Million or more, depending on investor interest (Press release, Biocure Technology, JAN 21, 2019, View Source [SID1234628758]). Finder’s fees or commissions may be payable by the Company in connection with this Private Placement.

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The net proceeds from the non-brokered private placement are intended to be used for general working capital and research and development.