On May 26, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that the final major study required by the U.S. Food and Drug Administration (FDA) for the submission of PharmaCyte’s Investigational New Drug application (IND) has been initiated (Press release, PharmaCyte Biotech, MAY 26, 2020, View Source [SID1234558481]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study, referred to as the "Stability Study" is a rolling two-year study to demonstrate how the frozen clinical trial product manufactured by Austrianova Singapore (Austrianova) for patients with locally advanced, inoperable, pancreatic cancer (LAPC) performs over time after being frozen for certain periods of time and then thawed and tested for functionality. While the study will continue for 2 years, the FDA requires 3 months of stability data to be included in the IND for its submission.

The tests for the Stability Study started approximately 3 months (the first time point in the 2-year study) from the issuance of the Certificate of Analysis for the second successful manufacturing run and will continue for 24 months. Data from the balance of the Stability Study will be provided to the FDA as the data becomes available.

The Stability Study consists of many of the same tests that were performed as "release testing" that enabled Austrianova to issue to PharmaCyte a Certificate of Analysis for the second successful manufacturing run of the two back-to-back successful runs.

Various tests are taken at one or more of the following time points: month 0, 3, 6, 9, 12, 18 and 24. Month 0 represents the "release testing" for the Certificate of Analysis for the second manufacturing run that PharmaCyte previously announced earlier this year. For example, label integrity takes place on months 0, 3, 6, 9, 12, 18, and 24, while sequencing for the transgene marker takes place on months 0, 6, 12, and 24.

The parameters for testing are: (i) Identity (Assay: label integrity, polymerase chain reaction and sequencing for a transgene marker); (ii) Purity (Assay: appearance post thaw, pH, capsule integrity post-thaw and cultured 3 days) (iii) Viable Cell Number (Assay: determined by cell size); (iv) Potency (Assay: resorufin enzymatic activity) and (v) Integrity (Assay: container-closure integrity).

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented on commencement of the Stability Study saying, "While we had to wait for three months (the first time point in the 2-year study) from our receipt of the Certificate of Analysis for the second manufacturing run to begin the last major study required by the FDA to submit our IND, we are finally in the home stretch of studies we are required to conduct by the FDA. But we do not have to wait until the 24- month Stability Study is completed to submit the IND. We are allowed to supplement the initial 3-months of data from the Stability Study to support the IND as the Stability Study runs its course. That data is currently in the process of being developed.

"We continue to remain laser focused on submitting PharmaCyte’s IND to the FDA. Our team continues to work every day to complete the necessary items that will allow PharmaCyte to submit an IND for its planned Phase 2b clinical trial in LAPC. As each test and item required for the IND is completed, our team of experts are compiling the data from these completed tests items and creating our IND package that will be submitted to the FDA."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On May 26, 2020 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate virtually in the following investor conferences in June (Press release, CRISPR Therapeutics, MAY 26, 2020, View Source [SID1234558480]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jefferies Global Healthcare Conference
Date: Thursday, June 4, 2020
Fireside chat: 1:30 p.m. ET

Goldman Sachs 41st Annual Global Healthcare Conference
Date: Tuesday, June 9, 2020
Fireside chat: 9:40 a.m. ET

A live webcast of these events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following the presentation.

On May 26, 2020 Immunocore (or the "Company"), a pioneering, clinical-stage T cell receptor biotechnology company working to develop and commercialise a new generation of transformative medicines to address unmet needs in cancer, infection and autoimmune disease, reported the start of the first-in-human clinical trial of IMC-F106C, the fourth bispecific developed using the Company’s innovative ImmTAC technology platform (Press release, Immunocore, MAY 26, 2020, View Source [SID1234558477]). Wholly owned IMC-F106C is focused on targeting tumours that express PRAME, a cancer-testis antigen (CTA) that is highly expressed in a broad range of solid and hematologic malignancies, and is being developed by Immunocore.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The trial (IMC-F106C-101) is designed to study the safety and preliminary activity of IMC-F106C as a monotherapy and in combination with a checkpoint inhibitor in patients with PRAME-expressing cancers.

"IMC-F106C is designed to re-direct T cells to attack PRAME expressing tumours. PRAME is an important target since it is broadly expressed in metastatic non-small cell lung cancer and other tumours of unmet need," said David Berman, Head of Research and Development at Immunocore. "The start of this study is another significant milestone for Immunocore and we are pleased that clinical development has continued despite these unprecedented times as we aim to deliver medicines to transform patients’ lives."

On May 26, 2020 Blueprint Medicines Corporation (NASDAQ:BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Friday, May 29, 2020 to review updated clinical data for pralsetinib in RET-altered cancers (Press release, Blueprint Medicines, MAY 26, 2020, http://ir.blueprintmedicines.com/news-releases/news-release-details/blueprint-medicines-host-conference-call-review-updated-clinical [SID1234558476]). The data will also be presented in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program, May 29-31, 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conference Call Information

To access the live call, please dial (855) 728-4793 (domestic) or (503) 343-6666 (international) and refer to conference ID 8585078. A webcast of the conference call will be available in the Investors & Media section of Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On May 26, 2020 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that management will host investor conference calls through June (Press release, Autolus, MAY 26, 2020, View Source [SID1234558475]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

1 June 2020 – Dr. Christian Itin, chairman and chief executive officer, along with the AUTO3 clinical team, will host an investor call and webcast at 8.30 am EDT, 1.30 pm BST to discuss presentations related to its AUTO3 program, the company’s CAR T cell therapy being investigated in the Alexander study, a Phase 1/2 study in relapsed/refractory diffuse large B cell lymphoma (DLBCL), during the Annual Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program. After the conference call, a replay will be available for one week.

4 June 2020 – Dr. Christian Itin, chairman and chief executive officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference at 8.30 am EDT, 1.30 pm BST and will also host virtual one-on-one meetings. A live audio webcast of the fireside chat will be available on the investor relations section of Autolus’ website at View Source An archived replay will be available on the company’s website for a period of 90 days after the conference.

10 June 2020 – Dr. Christian Itin, chairman and chief executive officer, will participate in a fireside chat at the Goldman Sachs Healthcare Conference at 09.40 am EDT, 2.40 pm BST on 10 June. A live audio webcast of the fireside chat will be available on the investor relations section of Autolus’ website at View Source An archived replay will be available on the company’s website for a period of 90 days after the conference.
15 June 2020 – Dr. Christian Itin, chairman and chief executive officer, along with the AUTO1 and AUTO3 clinical teams, will host an investor call and webcast at 8.30 am EDT, 1.30 pm BST to discuss presentations related to its AUTO1 and AUTO3 programs, the company’s CAR T cell therapies being investigated in Phase 1/2 studies of adult Acute Lymphocytic Leukemia (ALL) and relapsed/refractory Diffuse Large B Cell Lymphoma (DLBCL), respectively, at the European Hematology Association (EHA) (Free EHA Whitepaper) EHA (Free EHA Whitepaper)25 Virtual Congress on June 11 – 14, 2020. After the conference call, a replay will be available for one week.

25 June 2020 – Dr. Christian Itin, chairman and chief executive officer, along with the AUTO5, AUTO6NG and AUTO7 clinical teams, will host an investor call and webcast at 8.30 am EDT, 1.30 pm BST to discuss presentations related to its next-generation programmed T cell therapies in T cell lymphoma, small cell lung cancer and prostate cancer, respectively, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II on Jun 22 – 24, 2020. After the conference call, a replay will be available for one week.