Rocket Pharmaceuticals Announces Participation at the Jefferies Virtual Healthcare Conference

On May 26, 2020 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare disorders, reported that Gaurav Shah, M.D., Chief Executive Officer and President of Rocket is scheduled to present on Tuesday, June 2, 2020, at 2:00 p.m. Eastern Time at the Jefferies Virtual Healthcare Conference (Press release, Rocket Pharmaceuticals, MAY 26, 2020, View Source [SID1234558483]).

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A live audio webcast of the presentation will be available on the Investors section of the company’s website, www.rocketpharma.com. A replay of the presentation will be archived on the Rocket website following the conference.

Saniona announces outcome of warrant exercise

On May 26, 2020 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, reported the outcome in the exercise of warrants of series TO 1, that was issued in connection with Saniona’s rights issue and directed issue in the first quarter of 2020 (Press release, Saniona, MAY 26, 2020, View Source [SID1234558482]). During the period May 11th – 25th, 2020, holders of warrants of series TO 1 had the right to subscribe for new shares, by exercise of warrants. In total, 970,797 warrants of series TO 1 were exercised, corresponding to a subscription rate of 65.61 percent. Saniona will thereby receive proceeds of approx. SEK 24.3 million, before issue costs, which amount to approx. SEK 0.4 million.

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Number of shares and share capital
Saniona will receive proceeds of approx. SEK 24.3 million, before issue costs. Issue costs amount to approx. SEK 0.4 million. When the new shares have been registered with the Swedish Companies Registration Office ("Bolagsverket"), the total number of shares in Saniona will amount to 30,383,316 shares and the share capital will amount to SEK 1,519,165.80.

"We are grateful for the support from the shareholders and are of course pleased with the fact that investors see significant potential in the continued development of our pipeline as well as in the ongoing organizational expansion in the U.S.," says Rami Levin, President & CEO. "We are now even better equipped to take the company to the next level."

Financial advisor, legal advisor, and issuing agent
Sedermera Fondkommission is financial advisor and issuing agent and Setterwalls Advokatbyrå is legal advisor to Saniona in connection with the issue and exercise of warrants of series TO 1.

For more information regarding the warrants of series TO 1, please contact Sedermera Fondkommission
Phone: +46 40-615 14 10, Email: [email protected]

This information is such information as Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 06:15 p.m. CEST on May 26, 2020.

PharmaCyte Biotech Announces Final Major Study for IND Submission Has Begun

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]).

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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

CRISPR Therapeutics to Participate in Upcoming Investor Conferences

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]):

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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.

Immunocore announces dosing of first patient with fourth ImmTAC®

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.

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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."