On December 10, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported that its Chinese partner, EOC Pharma will commence a new Phase II clinical trial in up to 152 metastatic breast cancer patients in China (Press release, EOC Pharma, DEC 10, 2020, View Source [SID1234572640]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Similar to Immutep’s AIPAC study, the EOC Pharma trial will be a randomised, double-blind, placebo-controlled phase II clinical study with the study endpoints including progression free survival, overall survival and overall response rate. It is expected take place across 20 clinical trial sites in China over 24 months and will evaluate Immutep’s lead product candidate eftilagimod alpha ("efti", designated EOC202 in China) in combination with paclitaxel in HER2-negative/HR positive metastatic breast cancer patients who have progression after endocrine therapy.

EOC Pharma has received positive scientific advice from the Chinese competent authority, the Chinese National Medical Products Administration, enabling the first patient in to be enrolled and dosed in the trial in Q1 of calendar year 2021.

EOC Pharma CEO, Xiaoming Zou, said: "Breast cancer is now the most common cancer in Chinese women, with more than 1.6 million people being diagnosed and 1.2 million people dying of the disease each year1. It is very important that we find new ways to enhance paclitaxel chemotherapy which continues to be a standard of care for HER2-negative/HR positive metastatic breast cancer patients. Immutep’s recent encouraging interim AIPAC results give us hope we can boost the body’s immune system to deliver better outcomes to patients."

Immutep CEO Marc Voigt said: "EOC Pharma shares our growing excitement about the potential for the combination of efti with paclitaxel chemotherapy in metastatic breast cancer. Our ongoing AIPAC study evaluating the same combination is already reporting very encouraging data, including a statistically significant survival benefit of 7.1 months in patients under 65 years of age and 9.4 months for patients with a low starting monocyte count. EOC Pharma’s new trial in China brings this innovative new treatment much closer to market for metastatic breast cancer patients."

EOC Pharma is the exclusive licensee of efti from Immutep for the Chinese market. Under its agreement with Immutep, it will make further milestone payments to the Company if efti achieves specific development milestones as well as undisclosed royalties on sales and is also required to fund the Chinese development of efti.

Webcast Details
Immutep will discuss the recent AIPAC data in a global webcast for investors. Details are as follows:

Date & Time: Friday 11 December at 8.30 am Australian Eastern Daylight Time (AEDT)
Register: View Source
Questions: Investors are invited to submit questions in advance via [email protected].

A replay of the webcast will also be available at www.immutep.com from the day after the event.

On December 10, 2020 Protagonist Therapeutics, Inc. (Nasdaq: PTGX), a clinical stage biopharmaceutical company, reported that it has commenced an underwritten public offering of $100,000,000 of shares of its common stock (Press release, Protagonist, DEC 10, 2020, View Source [SID1234572638]). All of the shares of common stock are being offered by Protagonist. In connection with this offering, Protagonist expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the public offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

J.P. Morgan Securities LLC, SVB Leerink LLC, Piper Sandler & Co. and BMO Capital Markets Corp. are acting as joint book-running managers for the offering. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed or the actual size or terms of the offering.

A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission (SEC) on December 10, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Prospective investors should read the preliminary prospectus supplement, when available, and the accompanying prospectus and other documents Protagonist has filed with the SEC for more complete information about Protagonist and the offering. Copies of the prospectus supplement and the accompanying prospectus related to the offering may be obtained, when available, from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by email at [email protected]; from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected]; or from BMO Capital Markets Corp., Attn: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, tel: (800) 414-3627, email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 10, 2020 Biocept, Inc. (Nasdaq: BIOC), a leading commercial provider of molecular diagnostic assays, products and services designed to provide physicians with clinically actionable information to improve patient outcomes, reported results from a prospective study showing Target Selector was highly accurate in monitoring HER2 alterations in patients with metastatic breast cancer (Press release, Biocept, DEC 10, 2020, View Source [SID1234572637]). The results were featured yesterday in a poster presentation by Vered Stearns, M.D., professor of oncology, breast cancer research chair in oncology, and director of the Women’s Malignancies Disease Group at Johns Hopkins University School of Medicine/Johns Hopkins Sidney Kimmel Cancer Center, at the virtual 2020 San Antonio Breast Cancer Symposium (SABC). The poster can be found under the "breast cancer" tab here.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Approximately 20% of newly diagnosed breast cancer is HER2 positive, but during treatment and as the disease progresses, HER2 receptor conversion may occur," said Dr. Stearns. "Once breast cancer metastasizes, it may be difficult to access multiple sites or perform serial tissue biopsies to monitor for conversion. In this study, liquid biopsy testing proved to be a highly sensitive and specific mechanism for monitoring HER2 receptor changes over time."

"Target Selector has been shown to be a highly sensitive blood-based testing method for identifying changes in HER2 status, and is less invasive, more time efficient and more cost effective compared to tissue biopsy," said Michael Nall, President and CEO. "Target Selector provides critical information to identify patients who may benefit from the addition of anti-HER2 therapy and those on anti-HER2 therapy for whom additional therapeutic options may warrant consideration."

About SABCS
Since 1977 the San Antonio Breast Cancer Symposium (SABCS) has been the leading scientific conference for basic scientists, physician-scientists, clinical investigators and breast care providers, and advocates seeking an exchange of new information in experimental biology, etiology, prevention, diagnosis and therapy of premalignant breast disease and breast cancer. Founded, owned and operated by UT Health San Antonio, the symposium has grown to a five-day event attended by an international audience of academic investigators and private physicians from over 80 countries to attain information through abstract presentations, panel discussions, research findings and state-of-the-art educational sessions. UT Health San Antonio, the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine support SABCS, which provides education and accessibility to the latest information regarding the prevention, diagnosis and treatment of premalignant breast cancer and breast disease. For more information about the symposium, please visit www.sabcs.org.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On December 10, 2020 Denovo Biopharma, a pioneer in applying precision medicine to develop innovative therapies, reported it has licensed its seventh late-stage drug asset: endostatin (now named DB108) from Jiangsu Wuzhong Pharmaceutical Group Corporation ("Wuzhong Pharmaceutical" (Press release, Denovo Biopharma, DEC 10, 2020, View Source [SID1234572636]). Denovo gains global rights (except China) to develop, manufacture and commercialize endostatin.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

DB108 is a recombinant protein drug that inhibits tumor growth and metastasis by inhibiting angiogenesis. DB108 is obtained by expression in E. coli, has a molecular weight of 20KDa, a total of 184 amino acids, and the same amino acid sequence as naturally-occuring human endostatin. Wuzhong Pharmaceutical studied DB108 as a first-line treatment for non-small cell lung cancer (NSCLC ) in a Phase 3 clinical trial. This trial demonstrated DB108 had a good safety and tolerability profile. Although DB108 showed no significant difference in median overall survival versus control, it had a significant efficacy benefit in median progression-free survival.

Denovo Biopharma expands into protein therapeutics with DB108 acquisition

Dr. Michael F. Haller, Denovo Biopharma’s Chief Business Officer, said, "Wuzhong Pharmaceutical’s pioneering work on DB108 has laid a good foundation for our follow-up research and development. We plan on developing a targeted product through our whole-genome scanning platform technology to predict the efficacy of DB108 in a specific patient population. This product enables our expansion into the field of protein therapeutics."

Mr. Yao Jianlin, Chairman of Wuzhong Pharmaceutical, said, "Denovo Biopharma is a leading precision medicine company with superb biomarker research and development capabilities. Recombinant human endostatin injection is a novel medicine developed by Wuzhong Pharmaceutical that may provide better treatment options for clinical patients worldwide."