On January 31, 2022 Leica Biosystems, a cancer diagnostics company, reported that it has entered into an agreement with Leap Therapeutics (NASDAQ: LPTX), a biotechnology company, to develop a companion diagnostic to detect Dickkopf-related protein 1 (DKK1) (Press release, Leica Biosystems, JAN 31, 2022, View Source [SID1234607526]). The assay will be used to support clinical development of Leap Therapeutics’ anti-DKK1 cancer therapy, DKN-01, currently being studied in clinical trials.

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DKK1 is a protein often implicated in cancer, enabling tumor cells to suppress the immune system and lead to unregulated growth. Overexpression of DKK1 is associated with poor survival in cancer patients.

Leap Therapeutics is currently advancing the development of DKN-01, a humanized monoclonal antibody that targets DKK1, to treat cancer. The company is currently studying the drug as part of a combination therapy regimen in a Phase 2 clinical trial in patients with gastric or gastroesophageal junction cancer.

The assay developed by Leica Biosystems will utilize RNAscope technology from Bio-Techne on the BOND-III Automated Staining System, which allows for detection of DKK1 with high sensitivity and specificity, to help identify patients most likely to benefit from DKN-01 treatment.

"Companion Diagnostics are a step toward treating cancer patients based on the biomarker makeup of their disease," said Rachel Skelton, Senior Director of Pharma Partnerships at Leica Biosystems. "We are excited to partner with Leap to advance cancer care."

Companion Diagnostics are tests that may be used to determine if a patient’s tumor has the biomarker that will predict the outcome of a treatment with a specific therapy. With expertise in assay development, regulatory approval and commercialization, the Leica Biosystems Companion Diagnostics team partners with pharmaceutical companies to develop assays for a diverse range of technologies. Our flexible approach to partnerships, along with the robust capabilities of the BOND Advance Staining Solutions, supports our mission of Advancing Cancer Diagnostics, Improving Lives.

"DKK1 is novel and broadly applicable biomarker that is often elevated in patients with poor outcomes," said Jason Baum, Vice President and Head of Translational Medicine at Leap Therapeutics. "Patients whose tumors express elevated levels of DKK1 have shown compelling clinical responses when treated with DKN-01-based regimens. We are pleased to partner with Leica to advance the clinical development of our therapy and improve patient lives."

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 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 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 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical needs, reported the receipt of a €4 million milestone payment from AbbVie (Press release, Inventiva Pharma, JAN 31, 2022, View Source [SID1234607520]). It follows the inclusion of the first patient with psoriasis in the ongoing Phase IIb clinical trial with cedirogant (ABBV-157)1, an oral RORg inverse agonist jointly discovered by Inventiva and AbbVie for the treatment of autoimmune diseases.

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The Phase IIb clinical trial initiated by AbbVie with cedirogant is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety and efficacy of the drug candidate in adult patients with moderate to severe plaque psoriasis. The details of the clinical trial are available on clinicaltrials.gov2.

Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: "This new milestone payment and the initiation of a Phase IIb trial in adult patients with psoriasis are excellent news for Inventiva. It is an important step in the development of cedirogant, after the compound showed promising activity as an oral psoriasis agent in a Phase Ib clinical trial led by AbbVie. We are extremely proud to collaborate with AbbVie, a worldwide leader in autoimmune diseases, and we believe cedirogant has the potential to become a new reference treatment in psoriasis and other autoimmune diseases."

In 2012, Inventiva and AbbVie signed a multi-year drug discovery collaboration agreement to identify potent RORg inverse agonists for the treatment of several auto-immune diseases. Through this collaboration, Inventiva leveraged its discovery expertise and technology platforms to develop drug candidates targeting the nuclear receptor RORg, a validated drug target for the treatment of cutaneous inflammatory disorders such as psoriasis.

This collaboration with AbbVie enables Inventiva to receive payments upon the achievement of clinical, regulatory and commercial milestones, as well as tiered royalties on product sales, from mid single-digit to low double-digit.

About psoriasis

Psoriasis is a common skin disease affecting more than 3% of the US adult population3. In moderate and severe cases, psoriatic lesions can be uncomfortable, itchy and disfiguring. Although the precise pathophysiology of psoriasis is unknown, an abnormal cutaneous immunologic/inflammatory response, associated with epidermal hyper proliferation and abnormal differentiation, seems to be involved.

Current treatment of psoriasis is directed toward the alteration of epidermal differentiation, reducing the inflammatory response and slowing the growth of involved skin cells. The extent and severity of the disease typically determine the therapeutic approach. In mild psoriasis, the most commonly used therapy is topical with the addition of phototherapy in refractory cases. In moderate to severe psoriasis, phototherapy or anoral systemic therapy are used.