On January 31, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported that the first patient has been dosed in the multinational Phase 1b/2 trial of its all-oral combination product, Nana-val (nanatinostat and valganciclovir), in patients with Epstein-Barr virus-positive (EBV+) recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) and other advanced EBV+ solid tumors (Press release, Viracta Therapeutics, JAN 31, 2022, View Source [SID1234607522]). The trial is designed to evaluate the safety and preliminary efficacy of Nana-val alone and in combination with the PD-1 inhibitor pembrolizumab.

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"The initiation of dosing in this clinical trial represents an important milestone for Viracta and is a critical step in potentially expanding the clinical applicability of the targeted all-oral Nana-val combination beyond lymphoma," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta. "Advanced NPC patients have poor outcomes and are in urgent need of effective treatment options. We are looking forward to evaluating the clinical profile of this novel combination therapy and exploring potential synergies with a PD-1 inhibitor."

The Phase 1b/2 trial (NCT05166577) is an open-label, multinational trial evaluating Nana-val alone and in combination with pembrolizumab. The Phase 1b dose escalation portion is designed to evaluate safety and to determine the recommended Phase 2 dose (RP2D) of Nana-val in patients with EBV+ R/M NPC. In Phase 2, up to sixty patients with EBV+ R/M NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab, to evaluate safety, overall response rate, and potential pharmacodynamic markers. Additionally, patients with other advanced EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort.

About Nana-Val (Nanatinostat and Valganciclovir)

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat selectively inhibits specific isoforms of Class I HDACs, an activity that is key to inducing viral genes epigenetically silenced in EBV-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-Val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

About EBV-Associated Cancers

Approximately 90% of the world’s adult population is infected with Epstein-Barr virus (EBV), which persists as a life-long latent infection and remains dormant in cell nuclei. Cells containing latent EBV are increasingly susceptible to malignant transformation. EBV infection is directly linked to the development of multiple forms of human lymphoid and epithelial cancers contributing to approximately 2% of all new cancer cases globally. The lack of approved therapies for EBV+ cancers creates a pressing unmet medical need as these malignancies have poor prognoses and are responsible for approximately 180,000 annual deaths.

On January 31, 2022, Oncotelic Therapeutics, Inc. (the "Company") reported that entered into an Unsecured Convertible Note Purchase Agreement (the "Purchase Agreement") with Golden Mountain Partners, LLC (the ("Holder"), pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $0.5 million (the "Note"), which Note is convertible into shares of the Company’s common stock, par value $0.01 per share ("Common Stock") (Filing, 8-K, Mateon Therapeutics, JAN 31, 2022, View Source [SID1234607613]). The Note and Purchase Agreement are both part of a series of a cumulative funding of upto $1.5 million in three equal monthly instalments. The Note was entered into as continuation of the relationship between the Company and the Holder.

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The Purchase Agreements and the Notes contain identical terms to the securities purchase agreements (and promissory notes issued thereunder), to Golden Mountain Partners, LLC on October 25, 2021. The Prior Issuances were previously reported on our Current Report on Form 8-K filed with the Securities and Exchange Commission ("SEC") on October 28, 2021.

The Note carries an interest rate of 2% per annum and matures on the earlier of (a) the one-year anniversary of the date of the Agreement, or (b) the acceleration of the maturity of the Note by Holder upon occurrence of an Event of Default (as defined below). The Note contains a voluntary conversion mechanism whereby the Holder may convert the outstanding principal and accrued interest under the terms of the Note into shares of Common Stock (the "Conversion Shares"), at the consolidated closing bid price of the Company’s Common Stock on the applicable OTC Market as of the date the Company receives a Notice of Conversion (as defined in the Note) from Holder. Prepayment of the Note may be made at any time by payment of the outstanding principal amount plus accrued and unpaid interest. The Note contains customary events of default (each an "Event of Default"). If an Event of Default occurs, at the Holder’s election, the outstanding principal amount of the Note, plus accrued but unpaid interest, will become immediately due and payable in cash. The Purchase Agreement requires the Company to use of the proceeds received under the Note to support payroll.

The issuance of the Note is exempt from the registration requirements of the Securities Act of 1933, as amended ("Securities Act"), in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as provided in Rule 506 of Regulation D promulgated thereunder. The shares of Common Stock issuable upon conversion of the Note have not been registered under the Securities Act or any other applicable securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act.

The foregoing descriptions of the Purchase Agreement and the Note are qualified in their entirety by reference to the full text of such agreements, copies of which are attached hereto as Exhibit 10.1 and 10.2, respectively, and each of which is incorporated herein in its entirety by reference.

On January 26th, 2022 Wuxi, Shanghai, and Shijiazhuang—BioCity, a clinical-stage Chinese biopharmaceutical company, reported the dosing of its first test subject in the Phase I clinical trial of BC3448 (CD3/EGFR bispecific antibody, BsAb) (Press release, Biocity Biopharmaceutics, JAN 31, 2022, View Source [SID1234633309]).

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The trial is a Phase I, open-label, first in-human dose-escalation and -expansion clinical trial evaluating the safety、tolerability、phar-macokinetic characteristics, and pre-liminary efficacy of BC3448 in patients with locally advanced or metastatic malignant solid neo-plasms. The primary objective of the study is to evaluate the safety and tolerability of BC3448 monotherapy in patients with ad-vanced solid tumors.

BC3448 is a CD3/EGFR bispecific antibody that activates T cells to kill tumors cells with EGFR expression. In preclinical in vitro and in vivo studies, BC3448 demonstrated antitumor activities regardless of the mutation status of EGFR, KRAS or BRAF genes.

Professor Caicun Zhou, Director of the Oncology Department at Shanghai Pulmonary Hospital, affiliated to Tongji University, and Director of the Tongji University School of Medicine’s Cancer Institute, stated that, " although there have been breakthroughs in the EGFR-targeted drugs including monoclonal antibodies and EGFR TKIs, challenges remain for patients after their tumors developed resistance to the available EGFR antibodies or TKIs.

Therefore, there is need to explore new approaches such as immunotherapy drugs to deal with the issues of resistance to the available EGFR-targeted agents. The CD3-based EGFR-targeting bispecific antibody BC3448 holds great promise to treat EGFR-expression tumors even after resistance to the current EGFR therapies."

The Co-CEO of Biocity, Dr. Yong jiang Hei said, "BC3448 is a CD3/EGFR bispecific antibodies designed to have a stronger binding affinity for EGFR than that for CD3, which may help re-duce the risk of cytokine release syndrome (CRS), a known safety issue associated with CD3-based bispecific antibodies.

Currently, few companies have CD3/EGFR bispecific antibodies in clinical development globally, and BC3448 is one of the leading programs in this area. We strive to accelerate the clinical development of this innovative molecule in order to better meet the unmet medical needs for patients around the world."

About BC3448

BC3448 is a CD3/EGFR bispecific anti-body independently developed by BioCity, with IND approval from the National Medical Products Administration(NMPA). It is undergoing active clinical development in China.

On January 31, 2022 Imugene Limited (ASX:IMU) a clinical stage immuno-oncology company reported it has received a Notice of Grant from the Japanese Patent Office for Patent Application number 2019-507161 which protects its oncolytic virotherapy CF33, including VAXINIA (CF33-hNIS) and CHECKVacc (CF33-hNIS-antiPDL1) (Press release, Imugene, JAN 31, 2022, View Source [SID1234607525]).

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The patent titled "CHIMERIC POXVIRUS COMPOSITION AND USES THEREOF" (inventors Yuman Fong and Nanhai Chen from the City of Hope) protects the method of composition and method of use of Imugene’s licensed oncolytic virotherapy to 2037.

CF33 is a chimeric vaccinia poxvirus from the lab of inventor Professor Yuman Fong, Chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope, and a noted expert in the oncolytic virus field.

Oncolytic viruses (OVs) are designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival. Imugene MD & CEO Leslie Chong said:

"Imugene receiving this patent grant for the CF33 family of oncolytic viruses from the Japanese patent office is a crucial step forward and is the first of many expected patent grants from multiple countries. The start of our VAXINIA and CHECKVacc OV studies are a significant milestone for clinicians treating patients faced with the challenge of solid tumour cancers."

On January 31, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the closing of its previously announced underwritten public offering of 11,035,000 common shares, including the exercise in full of the underwriters’ option to purchase 1,875,000 additional shares, and, in lieu of common shares to certain investors, pre-funded warrants to purchase up to 3,340,000 common shares (Press release, Zymeworks, JAN 31, 2022, View Source [SID1234607541]). The common shares were offered at a public offering price of $8.00 per common share and the pre-funded warrants were offered at a public offering price of $7.9999 per pre-funded warrant, which represents the per share public offering price for each common share less the $0.0001 per share exercise price for each pre-funded warrant. The gross proceeds to Zymeworks from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Zymeworks, were approximately $115.0 million.

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Jefferies, Evercore ISI, Stifel and Wells Fargo Securities acted as joint book-running managers for the offering. Raymond James acted as lead co-manager for the offering.

An automatically effective shelf registration statement relating to the securities offered in the public offering described above was filed with the Securities and Exchange Commission (the "SEC") on October 1, 2021. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected], Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at [email protected], or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, by telephone at (833) 690-2713, or by email at [email protected].

No securities were offered or sold, directly or indirectly, in Canada or to any resident of Canada.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, 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.