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.

On January 31, 2022 Nordic Pharma reported that the European Commission (EC) approved the new indication for Teysuno (tegafur/gimeracil/oteracil) for the treatment of patients with metastatic colorectal cancer who cannot continue fluoropyrimidine treatment due to specific toxicities: hand-foot syndrome and cardiotoxicity (Press release, Nordic Pharma, JAN 31, 2022, View Source [SID1234607536]).

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Nordic Pharma received a positive scientific opinion recommending approval of the use of Teysuno in metastatic colorectal cancer from EMA’s Committee for Medicinal Products for Human Use (CHMP) in December 2021.

Based on this approval, Teysuno will be indicated in adults:

for the treatment of advanced gastric cancer when given in combination with cisplatin (current indication).
as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting
New fluoropyrimidine for patients with metastatic colorectal cancer

In metastatic colorectal cancer the typical first-line chemotherapy consists of a fluoropyrimidine used in various combinations.

Teysuno is an oral fluoropyrimidine with similar efficacy, but improved specific safety profile compared with other fluoropyrimidines.

Jean-Michel Quinot, CEO of Nordic Pharma stated: "This is important news for patients with metastatic colorectal cancer. Teysuno offers those patients suffering from toxicities that can cause discontinuation of therapy an alternative fluoropyrimidine therapy which allows them to continue systemic treatment that is known to significantly prolong survival. By being able to meet this medical need, we hope to contribute to improving the lives of these patients. We want to particularly thank medical oncologists and patients in different European countries who contributed to collecting crucial clinical data for this new indication."

Iris van Lakerveld, Global Oncology Lead added: "Fluoropyrimidines are, and will continue to be, the cornerstone of chemotherapy treatment in metastatic colorectal cancer. A significant group of patients can now be offered an alternative, in the event that chemotherapy needs to be delayed, the dose reduced or fully stopped because of hand-foot syndrome or cardiotoxicity. Side effects with chemotherapy are inevitable. With Teysuno, physicians and patients will have an additional therapy when needed, allowing optimal benefit of fluoropyrimidine treatment.

Nordic Pharma licences Teysuno from Taiho Pharmaceutical Co., Ltd. in Japan. In Japan, the product is known as TS-1 and is approved for various solid tumours, including gastric and colorectal cancer. Since 2011 Teysuno has been on the European market in 17 countries. In total, the product is marketed in over 30 countries worldwide. The approval of the European Commission is an important step in providing patients with metastatic colorectal cancer access to Teysuno. Subsequently country-specific reimbursement applications will be done at the level of each Member State to ensure this access.

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 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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