On November 24, 2020 Phoenix Molecular Designs (PhoenixMD), an industry leader in the development of precise cancer therapeutics focusing on first-in-class RSK kinase inhibitors, reported that the first patient has been dosed in their Phase 1b clinical trial of PMD-026 (Press release, PhoenixMD, NOV 24, 2020, View Source [SID1234571687]). This RSK targeting trial is a first of its kind in the battle to combat the most aggressive subtype of breast cancer, known as Triple Negative Breast Cancer (TNBC), which claims the lives of thousands of patients each year. This patented small molecule, PMD-026, positions PhoenixMD in the lead to fill an unmet medical need as an effective treatment for this serious medical condition.

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This new trial comes at a critical time as, to date, durable treatment options for TNBC have been extremely limited. PhoenixMD’s lead asset, PMD-026, is the first purpose-built investigational drug specifically designed for TNBC. The company’s goal is to develop a therapy to treat TNBC that offers advantages over current approaches by taking aim at RSK, which is an entirely new drug target. PMD-026 is different from other therapies in that it is an oral capsule that can be taken at home rather than requiring an in-clinic or in-hospital administration. In addition, based on the data obtained in their Phase 1 clinical trial, PMD-026 was well-tolerated without hair loss or peripheral neuropathy, which are side effects of a number of other chemotherapy drugs. This data from their Phase 1 clinical trial of PMD-026 in metastatic cancer will be presented at the San Antonio Breast Cancer Conference Dec 8-12, 2020.

"Our mission is to improve the outcome for TNBC patients. This is a pivotal time for PhoenixMD; our extensive research to finding a path forward has reached the next important clinical milestone. PhoenixMD continues to aggressively pursue the clinical development of PMD-026 in an accelerated timeline while always ensuring that patient care is first and foremost in every decision that we make. As we begin our Phase 1b clinical trial, I am excited about the opportunity to bring this therapy, that uniquely targets the RSK pathway, to women with TNBC who participate in our clinical trial and who so desperately need help not provided by existing treatment options," said Sandra Dunn, Ph.D., Chief Executive Officer, PhoenixMD."

Initially, 20 TNBC patients will be enrolled in this Phase 1b expansion trial. As with the Phase 1 trial, this new trial will be conducted at leading medical centers across the United States.

"As a TNBC survivor, who was diagnosed at 34 years old, and patient advocate in the breast cancer community, I cannot emphasize enough how important this trial could be in the lives of so many. For a long time, there has been an utter lack of treatment options for this vulnerable breast cancer population," said Tara Coleman, Licensed Occupational Therapist, and Lymphedema Therapist. "Trials like this are urgently needed, and it is my hope that this trial proves to be a game-changer for the TNBC community. It has been my honor to work with Sandra and her team; the strides they have made coupled with their enthusiasm and commitment to patient advocate involvement and patient care has been truly incredible."

"Today’s announcement builds on PhoenixMD’s success with our Phase 1 clinical trial in metastatic cancer patients, which PhoenixMD completed in September of 2020," said F. Andrew Dorr, M.D., Chief Medical Officer, PhoenixMD. "At this pivotal time, I would like to recognize the PhoenixMD and SciQuus Oncology teams who have worked so diligently throughout the COVID-19 pandemic and the Phase 1 clinical trial. We are ready to meet the challenges and successes ahead in this next phase. I firmly believe that every step we take is a step closer towards finding a successful treatment for TNBC."

For more information about the Company’s Phase 1b clinical trial of PMD-026 in metastatic triple negative breast cancer, please visit www.clinicaltrials.gov (identifier NCT04115306).

On November 24, 2020 China Biologic Products Holdings, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported its unaudited financial results for the third quarter of 2020 (Press release, China Biologic Products, NOV 24, 2020, View Source [SID1234571686]).

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Third Quarter 2020 Financial Highlights

Total sales in the third quarter of 2020 increased by 0.8% in RMB terms and 1.8% in USD terms to $138.5 million from $136.1 million in the same quarter of 2019.
Gross profit increased by 4.4% to $92.5 million from $88.6 million in the same quarter of 2019. Gross margin increased to 66.8% from 65.1% in the same quarter of 2019.
Income from operations decreased by 1.9% to $52.0 million from $53.0 million in the same quarter of 2019. Operating margin decreased to 37.5% from 38.9% in the same quarter of 2019.
Non-GAAP adjusted income from operations increased by 11.7% in RMB terms and 12.8% in USD terms to $69.4 million from $61.5 million in the same quarter of 2019.
Net income attributable to the Company decreased by 16.0% to $39.5 million from $47.0 million in the same quarter of 2019. Diluted earnings per share decreased to $0.99 compared to $1.21 in the same quarter of 2019.
Non-GAAP adjusted net income attributable to the Company increased by 0.2% in RMB terms and 1.3% in USD terms to $55.1 million from $54.4 million in the same quarter of 2019. Non-GAAP adjusted earnings per diluted share was $1.39 compared to $1.40 in the same quarter of 2019.
NOTE: Detailed financial statements and information are available through this link: View Source

"This quarter China Biologic reported an encouraging rebound in revenue from the second quarter and a slight increase on a year-over-year basis, reflecting our efforts to regain sales momentum following the COVID-19 disruption," said Joseph Chow, Chairman and CEO of China Biologic. "Thanks to recent measures to improve sales and marketing efficiencies, we recorded non-GAAP operating income growth of nearly 12% over the same quarter last year. During the quarter we further optimized our commercial team structure, enhanced our medical marketing support function, implemented a multidimensional evaluation system for staff performance and established better incentive and compensation structures. These strategic initiatives position us to cope with ongoing pandemic-related macro-uncertainties as well as potentially intensifying market competition, in the face of a short-term decline in demand and supply surge as observed in our peer companies’ recent batch approval records."

"Beyond sales and marketing, our long term growth initiatives, including construction of new plasma collection stations and R&D projects, are well on track. We are pleased to report that our newly built collection station in Chongqing city recently passed official inspection with commercial operations to commence soon, and two new collection stations in Shandong province are expected to commercially launch in early 2021. With the continuing expansion of our plasma collection capacity and progress in our product pipeline, CBPO is well positioned to meet the increasing market demands for plasma protein therapeutics in China in the coming years."

Recent Development

As previously announced, on November 19, 2020, the Company entered into a definitive Agreement and Plan of Merger (the "Merger Agreement") with CBPO Holdings Limited ("Parent") and CBPO Group Limited ("Merger Sub"), a wholly owned subsidiary of Parent, which contemplates that Merger Sub will merge with and into the Company, with the Company continuing as the surviving entity and becoming a wholly-owned subsidiary of Parent.

Pursuant to the Merger Agreement, at the effective time of the merger, each ordinary share of the Company issued and outstanding immediately prior to the effective time of the merger will be cancelled and cease to exist in exchange for the right to receive $120.00 in cash without interest, except for Excluded Shares and Dissenting Shares (each as defined in the Merger Agreement). If completed, the merger will result in the Company becoming a privately-held company and its shares will no longer be listed on the NASDAQ Global Select Market.

The closing of the merger is currently expected to occur during the first half of 2021 and is subject to customary closing conditions, including, among others, (i) that the Merger Agreement shall be authorized and approved by an affirmative vote of shareholders representing at least two-thirds of the ordinary shares of the Company present and voting in person or by proxy at an extraordinary general meeting of the Company’s shareholders and (ii) that the aggregate amount of dissenting shares shall be less than 8% of the total outstanding ordinary shares of the Company immediately prior to the effective time of the merger.

The Company does not undertake any obligation to provide any update with respect to the merger or any other transaction, except as required under applicable law.

Conference Call

The Company’s management will hold a conference call at 7:30 a.m. ET on Wednesday, November 25, 2020, which is 8:30 p.m. Beijing Time on November 25, 2020, to discuss third quarter 2020 results. Listeners may access the call by dialing:

A telephone replay will be available one hour after the conclusion of the conference call through December 2, 2020. The dial-in details are:

A live and archived webcast of the conference call will be available through the Company’s investor relations website at View Source

On November 24, 2020 Danaher Corporation (NYSE: DHR) reported that President and Chief Executive Officer, Rainer M. Blair, will be presenting at the Evercore ISI HealthCONx Conference on Tuesday, December 1, 2020 at 8:50 a.m. ET (Press release, Danaher, NOV 24, 2020, https://www.prnewswire.com/news-releases/danaher-to-present-at-evercore-isi-healthconx-conference-301180121.html [SID1234571683]). The audio will be simultaneously webcast on www.danaher.com.

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On November 24, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that a Phase Ib/II clinical study of the company’s novel Bcl-2 inhibitor APG-2575, as a single agent or in combinations for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL) (APG2575CU101; EudraCT#2020-002736-73), has dosed its first patient in Ukraine (Press release, Ascentage Pharma, NOV 24, 2020, View Source [SID1234571682]). This is the first global clinical study conducted by Ascentage Pharma in Europe.

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This global multicenter Phase Ib/II study was designed to evaluate the safety and efficacy of APG-2575 as a single agent or in combinations for the treatment of patients with r/r CLL/SLL. The study has recently obtained Clinical Trial Application (CTA) approvals from the Ministry of Health of Ukraine and the Ministry of Health of the Russian Federation.

CLL is a hematologic malignancy caused by mature B-cell neoplasms and constitutes the most common form of adult leukemia in North America and Europe, accounting for about 30% of all new leukemia cases. The annual incidence rate of CLL is around 2-6 cases per 100,000, and 12.8 cases per 100,000 in the population aged 65 years or older. Despite significant initial responses to current first-line treatments, many patients with CLL need ongoing treatment to maintain these responses, and relapse often portends a poor prognosis. Recent studies in CLL showed that combining a BTK inhibitor with a Bcl-2 inhibitor can deepen responses and shorten treatment durations from long-term to cyclic treatments, making it possible for patients to achieve complete remission and therefore discontinue treatment[1],[2]. These findings have provided a compelling rationale for exploring APG-2575 in combination with BTK inhibitors.

APG-2575 is a novel, orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat several hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. APG-2575 is the first China-developed Bcl-2 inhibitor having entered clinical development in China. APG-2575 has received clearances and approvals for multiple Phase Ib/II clinical studies in China, Australia, and the US, and is currently being developed in a range of hematologic malignancies globally. This year, APG-2575 has been granted two Orphan Drug Designations from the US FDA for the treatment of Waldenström macroglobulinemia (WM) and CLL.

"Dosing the first patient in our first clinical study in Europe marks yet another major milestone for Ascentage Pharma. This is the first step for Ascentage to execute expansion of clinical studies to Europe," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "APG-2575 is a key drug candidate in our pipeline targeting apoptosis, and it has demonstrated great therapeutic potential in the treatment of hematologic malignancies. We will expedite the clinical development of APG-2575 and make strides toward offering more treatment options to patients with CLL/SLL globally including in Europe."

On November 24, 2020 Symvivo Corporation, a clinical-stage biotechnology company advancing a proprietary bacTRL gene delivery platform, reported that it has entered into a research collaboration with Janssen Biotech, Inc. (Janssen), one of the Pharmaceutical Companies of Johnson & Johnson. Under the terms of the agreement, Janssen will have the exclusive option to research, develop and commercialize novel biological therapeutic candidates based on Symvivo’s bacTRL platform technology (Press release, Symvivo, NOV 24, 2020, View Source [SID1234571681]). The agreement was facilitated by Johnson & Johnson Innovation.

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"We are gratified to be collaborating with Janssen on this important research," said Lloyd Mackenzie, President and Chief Operating Officer at Symvivo. "This agreement continues to expand novel applications for the bacTRL platform."