On January 31, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that six abstracts highlighting new data for the company’s Decipher urologic cancer tests will be presented at the 2022 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium, taking place in San Francisco, Calif., and virtually, February 17-19, 2022 (Press release, Veracyte, JAN 31, 2022, View Source [SID1234607521]).

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The accepted abstracts include data from a phase 3 study evaluating the Decipher genomic classifier as a prognostic biomarker for patients diagnosed with intermediate-risk prostate cancer from their diagnostic biopsy specimen. This is the first late-stage clinical study validating the use of any gene expression classifier as a prognostic biomarker in this setting.

"At this year’s ASCO (Free ASCO Whitepaper) GU Symposium we look forward to sharing data from multiple studies that reinforce the ability of our Decipher genomic classifiers to guide more informed, individualized treatment for patients with urologic cancers," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "The findings offer new insights into how our tests may help physicians stratify risk and guide treatment decisions for their patients with prostate, bladder and kidney cancers."

Below are details of the Veracyte abstracts, which will be presented as posters at the 2022 ASCO (Free ASCO Whitepaper) GU Cancers Symposium being held at Moscone Center. All poster sessions will take place in Moscone West, Level 1.

Date/Time:

February 17, 2022, 11:30 a.m.-1:00 p.m. PST

Title:

Validation of the performance of the Decipher biopsy genomic classifier in intermediate-risk prostate cancer on the phase III randomized trial NRG Oncology/RTOG 0126

Presenter:

Daniel E. Spratt, M.D., Case Western Reserve University

Session:

Poster Session A

Date/Time:

February 17, 2022, 11:30 a.m.-1:00 p.m. PST

Title:

Comparative genomic analyses between Asian and Caucasian prostate cancers in an 80,829-patient cohort

Presenter:

Adelene Sim, Ph.D., Duke-NUS Medical School

Session:

Poster Session A

Date/Time:

February 17, 2022, 11:30 a.m.-1:00 p.m. PST

Title:

Transcriptomic Discriminators of Response to Apalutamide in Patients with Prostate Cancer (PC) on Active Surveillance (AS)

Presenter:

Michael Schweizer, M.D., Seattle Cancer Care Alliance

Session:

Poster Session A

Date/Time:

February 17, 2022, 11:30 a.m.-1:00 p.m. PST

Title:

Impact of AR-V7 and other androgen receptor splice variant expression on outcomes of post-prostatectomy salvage therapy

Presenter:

Keisuke Otani, M.D., Ph.D., Massachusetts General Hospital, Harvard Medical School

Session:

Poster Session A

Date/Time:

February 18, 2022, 12:30-2:00 p.m. PST

Title:

BioMarker Analysis and Updated Clinical Follow-up from BLASST-1 (Bladder Cancer Signal Seeking Trial) of nivolumab, gemcitabine, and cisplatin in muscle invasive bladder cancer (MIBC) undergoing cystectomy

Presenter:

Shilpa Gupta, M.D., Cleveland Clinic

Session:

Poster Session B

Date/Time:

February 19, 2022, 7:00-8:30 a.m. PST

Title:

Prognostic signatures can further stratify clear cell renal carcinoma clinical risk models in the adjuvant setting

Presenter:

Brian Shuch, M.D., University of California, Los Angeles, Institute of Urologic Oncology

Session:

Poster Session C

On January 31, 2022 NEC reported that Consolidated Financial Results for the Nine-month Period Ended
December 31, 2021 (Press release, NEC, JAN 31, 2022, View Source [SID1234607537]).

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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 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."