On February 12, 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 it has received the Certificates of Analysis and the records from both batches of its clinical trial product manufactured by Austrianova Singapore (Austrianova) (Press release, PharmaCyte Biotech, FEB 12, 2020, View Source [SID1234554225]). As previously reported, both batches of the company’s clinical trial product have undergone and passed all of the necessary "release tests" required by the U.S. Food and Drug Administration (FDA).

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PharmaCyte has engaged cGMP Validation to review the batch records and the Certificates of Analysis to ensure that they are complete and that they comply with FDA requirements. This is a significant milestone in preparing the documentation for the Investigational New Drug application (IND) PharmaCyte plans to submit to the FDA to commence a Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

PharmaCyte is also working with Facet Life Sciences (Facet), its experienced regulatory and development services organization, to prepare and submit the IND to the FDA. Facet will now begin work with cGMP Validation to populate those modules of the IND that provide detailed information on the release testing and how the clinical trial product was manufactured and tested. This process involves a complex analysis of hundreds of pages of detailed technical information related to the manufacturing and testing of PharmaCyte’s clinical trial product.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We are pleased to have received the Certificates of Analysis and now have access to the batch records from both manufacturing runs. This is a significant step forward. We have been waiting on the Certificates of Analysis to commission important next steps in order to complete the IND and related matters. We now have certification from Austrianova that our product has met the required release testing to demonstrate that our clinical trial product "functions" as it should and is "safe" to use in an FDA clinical trial

"In the coming days, there will be considerable work between our team and Austrianova to make sure everything we have received from Austrianova is cGMP compliant and comports with FDA regulations. Facet will now take the lead, working with our team, to complete the IND."

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 February 12, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that the company plans to present at the following conferences (Press release, Iovance Biotherapeutics, FEB 12, 2020, View Source [SID1234554224]):

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Guggenheim Healthcare Talks | Oncology Day in New York, Feb. 13, 2020
Date/Time: Thursday, Feb. 13, at 2:00 p.m. EST
Webcast: a live and archived webcast of the presentation will be available in the Investors section of the Iovance website at View Source

SVB Leerink 9th Annual Global Healthcare Conference in New York, Feb. 25-27, 2020
Date/Time: Wednesday, Feb. 26, at 3:00 p.m. EST
Webcast: a live and archived webcast of the presentation will be available in the Investors section of the Iovance website at View Source

6th Annual Immuno-Oncology 360° conference in New York, Feb. 26-28, 2020
Presentation Title: Investigating the Power of Tumor Infiltrating Lymphocytes for Treatment of Cancer
Date/Time: Thursday, Feb. 27, at 12:00 p.m. EST

On February 12, 2020 4SC AG (4SC, FSE Prime Standard: VSC) reported that it will attend and present at the World Congress of Cutaneous Lymphomas in Barcelona, Spain, from the 12-14 Feb 2020 (Press release, 4SC, FEB 12, 2020, View Source [SID1234554222]). A summary of the key presentations, abstracts and posters is listed below:

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Oral presentation – HDAC inhibitor resminostat counteracts disease-related gene expression and cytokine secretion in CTCL cells
Poster presentation – Resminostat increases NK cell-mediated lysis of malignant cells beneficially affecting the function of opsonizing antibodies
Poster – RESMAIN Study Update – A multicentre, double blind, randomised, placebo controlled, phase II trial to evaluate resminostat for maintenance treatment of patients with advanced stage (stage IIB IVB) mycosis fungoides (MF) or Sézary Syndrome (SS) that have achieved disease control with systemic therapy.

On February 12, 2020 Revolution Medicines, Inc. (Nasdaq:RVMD) reported the pricing of its initial public offering of 14,000,000 shares of common stock at a public offering price of $17.00 per share, before underwriting discounts and commissions (Press release, Revolution Medicines, FEB 12, 2020, View Source [SID1234554219]). All of the shares of common stock are being offered by Revolution Medicines. In addition, Revolution Medicines has granted the underwriters a 30-day option to purchase up to an additional 2,100,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. Revolution Medicines’ common stock is expected to begin trading on the Nasdaq Global Select Market on February 13, 2020, under the ticker symbol "RVMD". The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Revolution Medicines, are expected to be approximately $238.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on February 18, 2020, subject to the satisfaction of customary closing conditions.

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J.P. Morgan, Cowen, SVB Leerink and Guggenheim Securities acted as joint book-running managers for the offering.

The offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

A registration statement relating to the sale of these securities was declared effective by the Securities and Exchange Commission on February 12, 2020. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On February 12, 2020 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported the closing of a $105 million Series C equity financing (Press release, ALX Oncology, FEB 12, 2020, View Source [SID1234554218]). Vivo Capital was the lead investor with other new investors including funds managed by Logos Capital, Janus Henderson, Foresite Capital, Cormorant Asset Management, BVF Partners, and investor HBM Healthcare Investments. Existing investors venBio and Lightstone Ventures also participated in the financing.

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Financing proceeds will support the expansion of the clinical development of ALX148, a next generation CD47 myeloid checkpoint inhibitor, in combination with anti-cancer therapeutics, into additional solid tumor and hematologic indications.

As part of the Series C financing, Jack B. Nielsen, M.Sc., Managing Director of Vivo Capital, and Graham Walmsley, M.D., Ph.D., Co-Founder and General Partner of Logos Capital, will be joining the Board of Directors.

"We are pleased to have the support and confidence of our new and existing investors to rapidly advance the clinical development of ALX148 into phase 2 trials," said Jaume Pons, Ph.D., President and Chief Executive Officer of ALX Oncology. "The financing from this group of leading life science investors will enable us to realize the potential of ALX148 to benefit patients with cancer."

"From the outset, we believed that we would be best-in-class in the CD47 checkpoint pathway by using a ‘dead’ Fc domain that does not bind to macrophages, thus reducing the cytopenias and other toxicities associated with this class of agents," said Corey Goodman, Ph.D., Co-founder and Executive Chairman of ALX Oncology and Managing Partner of venBio Partners. "It has been encouraging to see the clinical results support our hypothesis and provide the opportunity for higher dosing and increased efficacy."

"We are delighted to lead this financing of top tier investors to help take ALX to the next stage of clinical development," said Jack Nielsen. "We see tremendous opportunity for ALX148 to help cure a wide range of cancer types and become a major new checkpoint inhibitor to combine with a variety of anti-cancer antibodies, checkpoint inhibitors, and other anti-cancer agents."