On June 10, 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 successfully completed development of the "change history" information and data for CypCaps (2nd generation product) compared to CapCell (1st generation product) (Press release, PharmaCyte Biotech, JUN 10, 2020, View Source [SID1234560973]). The history of the changes to the manufacturing of the two generations of product is a critical component of PharmaCyte’s Investigational New Drug application (IND) and is specifically required by the U.S. Food and Drug Administration (FDA).

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!

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, "We are very pleased that our partner Austrianova developed the needed information and data to be in a position to satisfy our cGMP consultant and our regulatory consultant that the information and supporting data should be sufficient to meet the FDA comparability requirements of the two generations of encapsulated live human cells.

"The first generation of product was referred to as "CapCell", and the current generation of product is referred to as "CypCaps." Although the cellulose material is basically the same, a material of improved quality is used in the 2nd generation product. The differences relate to control of impurities with heavy metal content and microbial and endotoxin levels being below the limits in the relevant literature for powdered cellulose. In addition, the production process for the cellulose is more closely controlled in the 2nd generation product. The original cell line used is also now better characterized at the genetic level. Lastly, the encapsulated cells undergo a maturation process in the 2nd generation product and are stored frozen for a longer shelf life.

"In short, while both generations of product use the identical cell line, the CypCaps have improved quality and control of the cells, improved encapsulation material reproducibility, better controlled cell filling and a much-improved shelf life, resulting in a more robust product overall."

The FDA requires that all relevant information and data from different generations of the same manufactured medicinal product be compared to one another to ensure that the original manufactured product is essentially the same as the current one. There can be improvements to the product, but to use the data from the two clinical trials in the 1990s to support PharmaCyte’s Phase 2b clinical trial, it was imperative to develop information and data to support that the two generations of the products are essentially the same – the only difference being improvement to the overall product using the same manufacturing process.

Austrianova also had to gather the data for the release specifications for each generation of encapsulated cells and explain why changes were made and how the changes made for an improved product using the same manufacturing process. Information and data about the capsule maturation and storage were also developed.

In addition, the quality control release assay information and supporting data had to be assembled. This involved capsule diameter; viability of encapsulated cells; sterility; pyrogenicity; potency; cell identity; endotoxins; enzymatic activity; capsule count; label check; and pH.

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 June 10, 2020 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a leader in personalized cannabinoid medicine focused on cancer and its side effects, reported that it has signed a Memorandum Of Understanding with Cannomed Medical Cannabis Industries Ltd. (TASE: CNMD), to develop cannabis cultivars targeted to treat cancers of different types (Press release, Cannabics Pharmaceuticals, JUN 10, 2020, View Source [SID1234571032]).

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 collaboration will allow Cannabics to further expand its portfolio of cannabinoid compositions that will be extracted from Cannomed’s 17 unique strains, thus contributing to its compound library matrix. Cannabics will proceed to utilize its High Throughput Screening (HTS) facility in Israel to extract the active ingredients and examine their anti-tumor properties on a variety of human cancer cells of various types.

Cannomed, a publicly traded Israeli company, is a vertically integrated manufacturer and cultivator which holds distribution agreements in regulated markets in Europe. Cannomed cultivates 17 unique cannabis cultivars originating from proprietary genetics developed by the company. These cultivars will be assessed and screened for their anti-tumor potential.

Dr. Eyal Ballan, CTO and Co-Founder of Cannabics Pharmaceuticals said:" Cannomed and Cannabics will collaborate to develop cannabinoid products based on Cannomed’s cannabis cultivars. We have seen in the past similar collaborations yielding valuable data in pre-clinical studies held at our facility, and we are looking forward to revealing what anti-tumor potential Cannomed’s strains may hold".

Mr. Kfir Gindi, CEO and Co-Founder of Cannomed, said: "We are excited to be able to collaborate with Cannabics Pharmaceuticals to explore the medicinal qualities of our unique genetic proprietary cannabis strains. This will potentially yield the development of cannabis-based products that will eventually be manufactured and distributed in European regulated markets, where Cannomed has distribution agreements".

On June 10, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 3,902,440 of the Company’s American Depositary Shares (ADSs), at a purchase price of $2.05 per ADS, in a registered direct offering (Press release, Can-Fite BioPharma, JUN 10, 2020, View Source [SID1234560974]). Can-Fite has also agreed to issue and sell to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 1,951,220 ADSs. Each ADS represents thirty (30) ordinary shares, par value NIS 0.25 per share, of Can-Fite. The offering is expected to close on or about June 12, 2020, subject to satisfaction of customary closing conditions.

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!

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $2.50 per ADS and will be exercisable at any time upon issuance and will expire four and one-half years from the date of issuance.

The gross proceeds from the offering (without taking into account any proceeds from any future exercises of warrants issued in the concurrent private placement), before deducting the placement agent’s fees and other estimated offering expenses payable by the Company, are expected to be approximately $8.0 million. Can-Fite intends to use the net proceeds for funding research and development and clinical trials, payment of a consulting fee, and for other working capital and general corporate purposes.

The ADSs (but not the warrants or the ADSs underlying the warrants) are being offered by Can-Fite pursuant to a "shelf" registration statement on Form F-3 (File No. 333-220644) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on September 26, 2017 and declared effective by the SEC on October 11, 2017. The offering of the ADSs is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the ADSs being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

On June 10, 2020 Mateon Therapeutics Inc. (OTCQB:MATN) reported the fruition of its licensing of OT-101/IL-2 combination to Autotelic BIO based on an agreement entered into between Oncotelic and Autotelic BIO, a South Korean Company, during 2018 (Press release, Mateon Therapeutics, JUN 10, 2020, View Source [SID1234560975]).

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!

OT-101 has received orphan drug designation for glioblastoma, melanoma, and pancreatic cancer. Furthermore, FDA recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is also effective against coronavirus including COVID-19 and being deployed against the COVID-19 epidemic.

OT-101 has demonstrated robust efficacy against pancreatic cancer, glioblastoma, and melanoma during phase 2 clinical trials. The demonstration that OT-101 will synergize with IL-2 further demonstrate its utility as adjunct to other immunotherapies. Interleukin-2 (IL-2, Aldesleukin, PROLEUKIN) Immunotherapy is cancer treatment that stimulates the body’s immune system to fight cancer, such as melanoma.

"In addition to additional milestone payments under said agreement, Mateon also entitled to profit sharing and royalties arising from the commercialization and/or licensing of OT-101/IL-2 by Autotelic BIO," stated Amit Shah, CFO of Mateon Therapeutics. "We look forward to continue our collaboration with Autotelic BIO and to make this unique immunotherapy available to patients."

On June 10, 2020 NantKwest, Inc. (Nasdaq: NK), a clinical-stage, natural killer cell-based therapeutics company, reported the publication of two peer-reviewed manuscripts in the Journal of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, NantKwest, JUN 10, 2020, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-announces-studies-collaboration-national-cancer?field_nir_news_date_value[min]= [SID1234560976]). These invitro and in-vivo studies, conducted in collaboration with the National Cancer Institute pursuant to a Cooperative Research and Development Agreement, support the mechanism and functionality of NantKwest’s clinical-stage engineered natural killer (NK) cell lines, haNK and first-in-class PD-L1 t-haNKTM, as effecting anti-tumor activity in treatment-refractory cancer types even in the hypoxemic setting of the solid tumor microenvironment.

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!

"These published studies provide important insight and validation for the mechanism and activity of our novel first-in-class engineered NK cells for use in notoriously difficult solid tumor types," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest. "NK cells have the potential to kill tumor cells; however, the hypoxic nature of the suppressive tumor environment has been shown to curb primary NK cell function. These published data indicate that our engineered haNK cells remain active in hypoxic conditions, which may be an important new mechanism of its anti-tumor activity. In addition, our NK cells appear to be resistant even to acute hypoxia and are capable of maintaining tumor killing activity in conditions comparable to a suppressive tumor microenvironment."

Dr. Soon-Shiong continued, "In addition, we are encouraged to observe anti-tumor activity in every cancer cell line tested by the investigators at NCI. The positive data in the in-vivo models of solid tumors with PD-L1 t-haNK, our engineered haNK cell line that also expresses a PD-L1 CAR, provides a novel approach to target tumors expressing PD-L1. This highly targeted NK cell therapy has the potential to address the evolution of tumors as they become resistant to chemotherapy, antibody therapy and, ultimately, checkpoint immunotherapy. We have hypothesized that cancer undergoes a quantum change and adapts to the therapy administered, resulting in the selection of resistant, cancer stem-like cells. It is at this stage of evolution where intractable tumors such as in patients with metastatic pancreatic cancer and triple negative breast cancer, are deemed incurable. It is our belief that these cancer "stem" cells, which do not divide and hence are untouchable by chemotherapy, become resistant and render checkpoint therapy futile by not expressing t-cell receptor ligands. In the face of this immunosuppressive milieu, our PD-L1 t-haNK cells can act to kill these otherwise highly resistant cancer cells, as demonstrated by these two important reports by our colleagues at the NCI. Our clinical results in the first patient with advanced metastatic pancreatic cancer to have received PD-L1 t-haNK demonstrated a durable complete response."

Study highlights from the publication titled "Overcoming hypoxia-induced functional suppression of NK cells" include:

NantKwest haNK cells engineered to express a high-affinity CD16 receptor as well as internal interleukin (IL)-2 for increased antibody-dependent cellular cytotoxicity (ADCC) and activation maintained killing activity under hypoxic conditions comparable to those of the suppressive tumor microenvironment, while healthy donor NK cell activity was significantly impaired
NK killing, serial killing and ADCC were maintained under hypoxia in haNK cells
haNK cells’ IL-2 is likely a driver of maintained killing capacity under hypoxic conditions
Study highlights from the article titled "PD-L1-targeting high-affinity NK cells (PD-L1 t-haNK) induce direct antitumor effects and target suppressive MDSC populations" include:

PD-L1.t-haNK cells engineered to express a high-affinity CD16 receptor, an internal interleukin (IL)-2 and PD-L1-specific chimeric antigen receptor (CAR) broke down all 15 human tumor cell lines tested, including those modelling historically treatment-refractory cancers (triple negative breast cancer, lung, and urogenital cancer)
In vitro, the cytotoxicity of PD-L1 t-haNK cells was correlated to the PD-L1 expression of the tumor targets
In mouse models of solid tumors, PD-L1 t-haNK inhibited the growth of engrafted TNBC, lung and bladder tumors in mice without toxicity