C4 Therapeutics to Present at the 40th Annual J.P. Morgan Healthcare Conference

On January 3, 2022 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company pioneering a new class of small-molecule medicines that selectively destroy disease-causing proteins through degradation, reported that the Company will present at the 40th Annual J.P. Morgan Healthcare Conference on Monday, January 10, 2022 at 10:30 a.m. EST (Press release, C4 Therapeutics, JAN 3, 2022, View Source [SID1234609971]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.c4therapeutics.com. A replay of the webcast will be archived on the C4T website for at least two weeks following the presentation.

Positive EMA opinion for the use of Teysuno in metastatic colorectal cancer

On January 3, 2022 Nordic Pharma reported that on 16 December 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion Teysuno: Pending EC decision | European Medicines Agency (europa.eu)] recommending the use of 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 3, 2022, View Source [SID1234607538]).

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The CHMP supports including patients who developed these toxicities in the adjuvant setting in addition to metastatic patients.

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

Based on this positive opinion 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 (pending European Committee decision).

New fluoropyrimidine for patients with metastatic colorectal cancer

nordic_pharma_thumbnail_green_colon

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

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 has licenced 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.

This positive CHMP opinion is a first step in providing patients with metastatic colorectal cancer access to Teysuno. EMA’s opinion needs to be adopted by the European Commission, and subsequently country-specific reimbursement applications will be done at the level of each Member State to ensure this access.

Ascletis Announces U.S. IND Filing for In-House Developed Oral PD-L1 Small Molecule Inhibitor ASC61 for Treatment of Advanced Solid Tumors

On January 3, 2022 Ascletis Pharma Inc. (HKEX: 1672) reported the filing of the U.S. Investigational New Drug (IND) application for in-house developed oral PD-L1 small molecule inhibitor, ASC61, for the treatment of advanced solid tumors (Press release, Ascletis, JAN 3, 2022, View Source [SID1234598446]).

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ASC61 is an oral potent and highly selective PD-L1 small molecule inhibitor and blocks PD-1/PD-L1 interaction through inducing PD-L1 dimerization and internalization. As a single agent, ASC61 demonstrated significant antitumor efficacy in multiple animal models such as the humanized mouse model. Preclinical studies showed ASC61 has good safety and pharmacokinetic profiles in animal models. ASC61 oral tablets, which will be used in the clinical trial, were developed with the in-house proprietary technology.

Compared to injectable PD-1/PD-L1 antibodies, ASC61, as an oral PD-L1 inhibitor, has the following benefits: (1) ease of dosing and no need for hospital visits for injections; (2) all-oral combinations with other oral anti-tumor drugs; and (3) rapid titration of doses for better management of immune-related adverse events (irAEs).

"We are excited about filing U.S. IND of ASC61." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. "As we are advancing the phase III clinical trial of ASC40, a fatty acid synthase (FASN) inhibitor, in combination with Bevacizumab for the treatment of recurrent glioblastoma (rGBM), ASC61, as an oral PD-L1 small molecule inhibitor, will further strengthen the Company’s oncology pipeline."

Press Release: Propella Therapeutics Invited to Present at 2022 ASCO Genitourinary (GU) Cancers Symposium and to Participate in the LifeSci Partners 11th Annual Corporate Access Event

On January 3, 2022 Propella Therapeutics, Inc. ("Propella"), a private, clinical-stage biopharmaceutical company developing best-in-class oncology therapeutics, reported that nonclinical data for its lead product candidate, PRL-02, will be presented at the 2022 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium, which is scheduled to take place in San Francisco, CA from February 17-19, 2022 (Press release, Propella Therapeutics, JAN 3, 2022, View Source [SID1234598165]). PRL-02 is being evaluated in an ongoing Phase 1 study for patients with advanced prostate cancer; the recommended phase 2 dose will be selected in Q1 2022 based upon pharmacokinetic, safety, clinical pharmacology, and efficacy results.

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The Company also announced that senior management will be available for one-on-one investor meetings at the LifeSci Partners 11th Annual Corporate Access Event, which is being held virtually from January 5-7, 2022. Investors interested in registering for the event may schedule a meeting with Propella management may click here.

2022 ASCO (Free ASCO Whitepaper) GU Cancers Symposium (San Francisco, CA), February 17-19, 2022:

Abstract Number: 160

Abstract Title: "Abiraterone decanoate (PRL-02): Pharmacology of a single intramuscular (IM) depot injection compared to oral abiraterone acetate (AA) in intact male rats."

First Author and Presenter: William Moore, PhD

Session Information: Poster Session A: Prostate Cancer, February 17, 2022, 11:30 AM-1:00 PM; 5:45 PM-6:45 PM

Dr. Moore will present results from nonclinical studies in male rodent models that evaluated the systemic exposures and pharmacologic activity (testosterone suppression, CYP17 enzyme activity) of PRL-02 compared to daily oral abiraterone acetate, the standard of care for metastatic prostate, at 7 and 14 days after treatment start.

GU ASCO (Free ASCO Whitepaper) received more than 680 abstract submissions, which were reviewed by the Symposium Program Committee. This abstract was accepted as a poster presentation.

About ASCO (Free ASCO Whitepaper) GU Cancer Symposium

The ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium is a three-day scientific and educational meeting designed to provide attendees with in-depth, multidisciplinary analysis of the most timely topics in the study, diagnosis, and treatment of GU malignancies. All members of the cancer care and research community will benefit from the Symposium’s exploration of the latest science in the field and its clinical application.

About Metastatic Prostate Cancer

Prostate cancer is the most common non-skin cancer in men, and the second leading cause of cancer death, developing most often in older men. Metastatic disease occurs when prostate cancer cells travel through the lymphatic system or blood stream to other organs and tissues such as lymph nodes, liver, bone, and lungs. While early or localized prostate cancer remains highly curable, advanced prostate cancer) remains difficult to treat, with a 5-year survival rate of only 30%. Although there are several treatment options for metastatic prostate cancer, the reduction of androgen activity remains the most effective approach.

About PRL-02

PRL-02 is a next generation androgen biosynthesis inhibitor being developed for the treatment of prostate cancer. The only androgen biosynthesis inhibitor approved for the treatment of prostate cancer blocks the CYP17 enzyme that is required for the biosynthesis of androgens, including testosterone. Emerging clinical data support that PRL-02 is CYP17 lyase-selective, thereby potentially avoiding the safety and efficacy limitations associated with CYP17 hydroxylase inhibition. A large body of both historic and modern data support a role for androgens in prostate cancer pathogenesis and progression. PRL-02 is a patented prodrug of abiraterone designed for lymphatic targeting of tissues and tumors that express the CYP17 enzyme. PRL-02 is an intramuscular depot that, when given along with a gonadotropin releasing hormone agonist or antagonist, was engineered to release locally the precise concentration of abiraterone needed to continuously block CYP17 enzyme for 3 months, while avoiding adverse liver and drug-drug interaction effects.

Checkmate Pharmaceuticals to Present at the H.C. Wainwright BioConnect Virtual Conference

On January 3, 2022 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that Alan Fuhrman, Interim CEO and President, will present at the H.C. Wainwright BioConnect Virtual Conference being held on January 10-13, 2022 (Press release, Checkmate Pharmaceuticals, JAN 3, 2022, View Source [SID1234598107]). The pre-recorded webcast will be available on-demand starting on Monday, January 10 at 7:00am ET. Checkmate will also host 1×1 investor meetings during the conference.

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