Fosun to Pay up to $148 Million for China Rights to MimiVax Glioblastoma Treatment

On November 18, 2019 Shanghai Fosun Pharma reported a $148 million agreement to acquire China rights to SurVaxM, a novel immunotherapy aimed at glioblastoma, from MimiVax of Buffalo, New York (Press release, ChinaBio, NOV 18, 2019, View Source [SID1234551445]). SurVaxM, a novel peptide mimic vaccine, stimulates the immune system to kill tumor cells that contain survivin, a protein that helps cancer cells resist conventional treatments. In a US Phase II trial among glioblastoma patients, SurVaxM showed improved efficacy combined with an acceptable safety profile. MimiVax, which notes that survivin is present in many cancers, is also conducting a multiple myeloma trial.

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PharmaCyte Biotech Successfully Completes Final Manufacturing Run of Clinical Trial Product

On November 18, 2019 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 its partner, Austrianova Singapore (Austrianova), has successfully completed the second and final GMP manufacturing run to produce PharmaCyte’s clinical trial product (Press release, PharmaCyte Biotech, NOV 18, 2019, View Source [SID1234551429]). The product is now ready for "release testing." The data from the "release testing" of both manufacturing runs will be included in an Investigational New Drug application (IND) and submitted to the U.S. Food and Drug Administration (FDA) to support PharmaCyte’s planned clinical trial in patients with locally advanced, inoperable pancreatic cancer (LAPC).

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The capsules, which are fully filled with genetically modified live cells, were immediately put into PharmaCyte’s clinical trial syringes and then frozen. Austrianova has shipped a representative sample of the frozen syringes to third-party laboratories in Europe to undergo "release testing" related to the "safety" of the product. Austrianova will conduct "release testing" in-house related to the "functionality" of the encapsulated cells.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "Today is a great day at PharmaCyte. We have cleared what was a major hurdle for us and have completed our most impactful milestone to date. Successfully completing two manufacturing runs is a milestone that has now been met as we progress toward our submission of an IND to the FDA so we can begin our clinical trial in LAPC.

"Our GMP consultant, cGMP Validation, has informed us that while two successful manufacturing runs are not required by the FDA to request a Phase 2b clinical trial, it could go a long way in demonstrating to the FDA that our manufacturing process is robust and reproducible – manufacturing qualities that are highly embraced by 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

Entry into a Material Definitive Agreement.

On November 18, 2019, Phio Pharmaceuticals Corp. (the "Company") reported that it has entered into a Placement Agency Agreement (the "Placement Agency Agreement") with H.C. Wainwright & Co., LLC, as placement agent, pursuant to which the Company agreed to issue and sell, in a registered public offering of the Company (the "Offering"), 10,000,000 shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock") to certain investors (Filing, 8-K, Phio Pharmaceuticals, NOV 18, 2019, View Source [SID1234551513]). The offering price was $0.10 per share of Common Stock .

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Each purchaser in the Offering was required, as a condition to such purchase, to execute a subscription agreement pursuant to which they (i) agreed, effective until November 19, 2019, the record date of our next stockholder meeting, not to sell, dispose or otherwise transfer, directly or indirectly any shares of our Common Stock that they own or control as of the closing of this Offering and (ii) agreed to vote at our next stockholder meeting the shares of our Common Stock that they own or control as of the closing of this Offering in favor of an amendment of our articles of incorporation to undertake a reverse stock split of our Common Stock.

The Placement Agency Agreement contains customary representations and warranties, agreements and obligations, conditions to closing and termination provisions.

The net proceeds to the Company from the Offering is approximately $725,000, after deducting fees and expenses. The Company intends to use substantially all of the net proceeds of the Offering primarily for the development of the Company’s immuno-oncology program, for other research and development activities and for general working capital.

Pursuant to the Placement Agency Agreement, the Company agreed to pay the placement agent a cash fee of 7.5% and a management fee of 1.0% of the aggregate gross proceeds of the Offering We also agreed to pay the placement agent up to $40,000 for legal expenses and reimburse the placement agent up to $10,000 for clearing expenses. In addition, the Company, upon closing of the Offering, issued to the placement agent warrants to purchase up to 750,000 shares of Common Stock (the "Placement Agent Warrants"), or 7.5% of the aggregate number of shares of Common Stock sold in the Offering. The Placement Agent Warrants are immediately exercisable at a price of $0.125 per share of Common Stock, subject to adjustment in certain circumstances, may be exercised on a cashless basis under certain circumstances, and expire on November 19, 2024.

The shares of Common Stock sold in the Offering were offered and sold pursuant to a prospectus, dated April 6, 2018, and a prospectus supplement dated November 18, 2019, in connection with a takedown from the Company’s shelf registration statement on Form S-3 (File No. 333-224031), which was declared effective by the Securities and Exchange Commission on April 6, 2018. The Offering was made only by means of a prospectus forming a part of the effective registration statement.

The foregoing descriptions of the Placement Agency Agreement and the Placement Agent Warrants are not complete and are qualified in their entirety by reference to the full text of the Placement Agency Agreement and the forms of the Placement Agent Warrant, copies of which are filed as Exhibit 1.1 and Exhibit 4.1 to this Current Report on Form 8-K and hereby incorporated by reference herein. Attached as Exhibit 5.1 is an opinion of counsel regarding the due authorization of the Common Stock sold in the Offering.

BioCryst Announces Full Exercise of Underwriters’ Option to Purchase Additional Shares and Completion of Public Offering of Common Stock

On November 18, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported the completion of an underwritten public offering of 43,620,690 shares of its common stock, including 5,689,655 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares (Press release, BioCryst Pharmaceuticals, NOV 18, 2019, View Source [SID1234551414]). The gross proceeds from this offering to BioCryst, including from the shares sold pursuant to the underwriters’ option to purchase additional shares, were approximately $63.3 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioCryst.

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BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory and commercial activities for the prophylactic BCX7353 program, primarily focusing on the U.S., EU and Japan; development of the BCX9930 program; development of the BCX9250 program; post-approval commitments for RAPIVAB/ALPIVABTM; funding clinical development of pipeline assets; and capital expenditures and other general corporate expenses.

J.P. Morgan acted as sole book-running manager for the offering. JMP Securities and H.C. Wainwright & Co. acted as lead managers for the offering.

A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

This offering was made by means of a prospectus supplement and related prospectus. A prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: 1-866-803-9204.

MATEON THERAPEUTICS TO PRESENT NEW AND UPDATED DATA FOR OT101 (TRABEDERSEN) ACTIVITY AGAINST BRAIN TUMORS AT THE 2019 SOCIETY FOR NEURO-ONCOLOGY (SNO) ANNUAL MEETING

On November 18, 2019 Oncotelic Inc. ("Oncotelic"), a wholly owned subsidiary of Mateon Therapeutics Inc. (OTCQB:MATN) dedicated to the development of innovative treatments for cancer, reported that it will present data updates regarding the anti-brain tumor activity of its 1st-in class RNA therapeutic OT101 during the upcoming 2019 Society for Neuro-Oncology (SNO) Annual Meeting on November 20-November 24 in Phoenix, Arizona (View Source (Press release, Mateon Therapeutics, NOV 18, 2019, View Source [SID1234551430]).

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"We look forward to sharing the latest data on the clinical impact potential of OT101 that will add to the body of evidence supporting its potential as a future treatment option for high-grade glioma patients," said Fatih Uckun, M.D., Ph.D., Chief Medical Officer, Mateon Therapeutics. "These presentations underscore our continued efforts to advance the standard of care and improve treatment expectations for brain tumor patients," added Vuong Trieu, Ph.D, the Chief Executive Officer and President of Mateon Therapeutics.

On November 22, for the first time, the Mateon team will present a poster regarding the predictors of response and treatment outcome. Presentation details:
Abstract #: ATIM-10
Abstract Title: Clinical predictors of response for recurrent/refractory glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA, WHO grade III) patients treated with the anti-TGF ß 2 RNA therapeutic OT-101
Session: Poster Session
Date: Friday November 22, 2019
Presentation Time: 7:30 PM – 9:30 PM

On November 23, Dr. Uckun will give a talk as oral abstract speaker on the comparison between OT101 and the standard chemotherapy drug temozolomide in high-grade anaplastic astrocytoma patients. Presentation details:
Abstract #: ATIM-06
Presentation Title: Treatment of recurrent/refractory (R/R) anaplastic astrocytoma (AA, WHO grade 3) patients with anti-TGFß2 RNA therapeutic OT-101 versus temozolomide is associated with improved overall survival
Session: Concurrent Session 3B: Surgery/Radiation Therapy/CNS Metastasis (3B)
Date: Saturday November 23, 2019
Presentation Time: 1:40 PM – 1:50 PM

Later on November 23, the Mateon team will present a second poster with post-hoc analysis of the single agent efficacy of OT101 with prolonged follow-up results from the G004 Phase 2 clinical study. Presentation details:
Abstract #: ATIM-03
Abstract Title: Anti-TGFß2 RNA therapeutic OT-101 induces durable objective responses in patients with recurrent/refractory (R/R) glioblastoma multiforme (GBM, WHO grade 4) or anaplastic astrocytoma (AA, WHO grade 3)
Session: Poster Session
Date: Saturday November 23, 2019
Presentation Time: 5:00 PM – 7:00 PM

"The durable objective responses achieved in adult patients with recurrent/refractory high-grade gliomas after treatment with our lead anti-TGF beta2 compound OT-101 contribute to our optimism that new treatment strategies leveraging OT101 may favorably change the therapeutic landscape for difficult-to-treat brain tumors with a very poor prognosis," Dr. Uckun explained.

Last month, US Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for OT101/Trabedersen for the treatment of diffuse intrinsic pontine glioma (DIPG) as a drug for a "rare pediatric disease," as defined in section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act. "Our recently published in silico validation of the TGF beta2 gene product, which is the molecular target for OT101/Trabedersen, as a target for immunotherapy in pediatric high-grade gliomas, especially DIPG, indicates that OT101 may also have future potential for the treatment of pediatric DIPG, an orphan disease with a low survival rate and no established or effective standard of care," explained Dr. Uckun.

Dr. Trieu stated: "There is no standard treatment for progressive DIPG after the failure of radiation therapy and no salvage regimen has been shown to extend survival. Therefore, there is an urgent need for therapeutic innovations for treatment of DIPG. Further development of OT-101 may offer renewed hope for salvage therapy of pediatric DIPG patients who have this rare and fatal disease."