On April 13, 2020 Antengene reported that it has dosed the first patient in Taiwan, China in its phase 1 open-label clinical trial of ATG-019 (KPT-9274), a dual inhibitor of both PAK4 and NAMPT (Press release, Antengene, APR 13, 2020, View Source [SID1234556300]). This trial is being conducted to evaluate the safety and tolerability of ATG-019 monotherapy or ATG-019 combined with niacin ER (vitamin B3/nicotinic acid), for the treatment of advanced solid tumors or non-Hodgkin’s lymphoma.

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!

ATG-019 is a first-in-class, also the only orally bioavailable dual-target inhibitor targeting both p21-activated kinase 4 (PAK4) and nicotinamide phosphoribosyl transferase (NAMPT). PAK4 regulates numerous fundamental cellular processes, including intracellular transport, cellular division, cell shape and motility, immune defense and the development of cancer. PAK4 interacts with many key signaling molecules involved in cancer development such as beta-catenin, CDC42, Raf-1, BAD and myosin light chain. The overexpression and overactivation of PAK4 lead to tumor proliferation and metastasis and show a negative correlation with the infiltration of immune cells, leading to tumor proliferation and metastasis. NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Inhibition of NAMPT can effectively inhibit the energy metabolism and growth of tumor cells.

In May 2018, Antengene entered into a broad strategic collaboration with Karyopharm Therapeutics Inc. (Nasdaq: KPTI) and obtained exclusive rights for development and commercialization of four clinical stage, novel, oral drug candidates, including KPT-9274 (ATG-019), in various Asian countries and regions. As an oral small molecule inhibitor with the novel mechanism with novel targets, ATG-019 inhibits the occurrence, development, invasion and migration of tumors through the precise targeting and inhibiting both PAK4 and NAMPT. Preclinical studies has demonstrated the significant inhibitory effect of ATG-019 on multiple tumors types including lung cancer, multiple myeloma, leukemia, and lymphoma, etc.

"We are pleased that the first patient of ATG-019 was successfully enrolled and dosed. This is our first step in developing PAK4/NAMPT dual-target inhibitor," said Dr. Jay Mei, founder, chairman and CEO of Antengene," In addition to conducting the clinical trial for the treatment of advanced solid tumors and non-Hodgkin’s lymphoma, Antengene is also exploring the potential for ATG-019 in the treatment of different indications and in combination with existing regimens based on the anti-proliferative activity of ATG-019 on cancer cells. We hope to explore its potential from multiple dimensions in the near future. "

On April 13, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the Phase 3 trial evaluating its anti-PD-1 antibody tislelizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC) met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to pemetrexed and platinum chemotherapy alone at the planned interim analysis, as assessed by independent review committee (IRC) (Press release, BeiGene, APR 13, 2020, View Source [SID1234556298]). The safety profile of tislelizumab in combination with pemetrexed and platinum chemotherapy was consistent with the known risks of each study treatment, and no new safety signals were identified.

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!

"We are excited to announce the positive outcome in the interim analysis of this Phase 3 study of tislelizumab in first-line non-squamous NSCLC, following the positive interim analysis in first-line squamous NSCLC earlier this year," said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "These results add to our growing body of evidence demonstrating the efficacy and safety of tislelizumab for the treatment of advanced cancers. We look forward to continuing to evaluate tislelizumab in more than 25 studies, including 15 potentially registration-enabling trials."

BeiGene plans to discuss its plans for filing a supplemental new drug application (sNDA) for tislelizumab as a first-line treatment for non-squamous NSCLC with the Center for Drug Evaluation (CDE) at the National Medical Products Administration (NMPA) in China and present detailed data at upcoming medical conferences.

This trial (NCT03663205, known as BGB-A317-304) is a Phase 3, open-label, multi-center, randomized trial investigating tislelizumab (200mg every three weeks) combined with pemetrexed and investigator’s choice of platinum (either carboplatin or cisplatin) versus pemetrexed and platinum alone in patients with previously untreated stage IIIB or stage IV non-squamous NSCLC and with no EGFR mutations or ALK translocations. The primary endpoint is PFS as assessed by IRC. Key secondary endpoints included overall survival and safety. The study began enrollment in July 2018, and 334 patients were randomized 2:1 to receive tislelizumab in combination with chemotherapy or chemotherapy alone.

"NSCLC is a debilitating disease that comprises approximately 85 percent of lung cancer cases globally. It is estimated that approximately 60 percent of lung cancer diagnoses are made when the disease is in advanced stages and patients need more treatment options. The positive outcome at interim analysis for tislelizumab in this study and in other clinical trials, including for first-line squamous NSCLC, demonstrate that it is a promising option for people living with this advanced cancer," said Shun Lu, M.D., Professor at Shanghai Chest Hospital, Jiao Tong University and lead investigator for the trial.

About Non-Small Cell Lung Cancer

In contrast to most Western countries where lung cancer death rates are decreasing, the lung cancer incidence rate is still increasing in China.1,2 In 2018, there were approximately 770,000 new cases of lung cancer in China and it is the leading cause of cancer-related death in both men and women, with approximately 690,500 deaths.3 Non-small cell lung cancer (NSCLC) comprises the most common form of lung cancer in China.4

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 11 Phase 3 trials and four pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China and is not approved to treat non-small cell lung cancer.

On April 13, 2020 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming virtual poster presentation at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place from April 27-28, 2020 (Press release, Bio-Path Holdings, APR 13, 2020, View Source [SID1234556297]).

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!

Dr. Ana Tari Ashizawa, Senior Vice President of Research, Development and Clinical Design, at Bio-Path Holdings will summarize the Phase 1 study design of BP1002 (liposomal Bcl-2 antisense), the Company’s second drug candidate, for the treatment of lymphomas and chronic lymphocytic leukemia.

Details for the virtual poster presentation are as follows:

Date: Monday, April 27, 2020

Poster Release Time: 12:01 am Eastern Time

Session: Phase I Trials In Progress

Abstract: 9464

Title: "A Phase I Clinical Trial to Study the Safety, Pharmacokinetics, and Efficacy of BP1002 (L-Bcl-2) Antisense Oligonucleotide in Patients with Advanced Lymphoid Malignancies"

On April 13, 2020 DaVita Inc. (NYSE: DVA), reported that it will hold its quarterly conference call to discuss first quarter results on Tuesday, May 5, 2020, at 5:00 p.m. Eastern Time (Press release, DaVita, APR 13, 2020, View Source [SID1234556275]). The company plans to release its results after market close the same day.

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!

This call is also being webcast and can be accessed at the DaVita IR web page. You can join this call as follows:

Tuesday, May 5, 2020
Starting at 5:00 p.m. EDT
Dial in number: 877-918-6630
International dial in: 517-308-9042
Webcast: investors.davita.com

When calling in, please provide the operator the password "Earnings" and provide your name and company affiliation. Investors unable to listen to the conference call will be able to access a replay via our website at investors.davita.com. There will be no telephone replay.

On April 13, 2020 Danaher Corporation (NYSE: DHR) ("Danaher" or "the Company") reported that for the quarter ended April 3, 2020 it expects revenue growth of approximately 3.0% and non-GAAP core revenue growth of approximately 4.5% (Press release, Danaher, APR 13, 2020, View Source [SID1234556274]).

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!

President and CEO Thomas P. Joyce, Jr. said, "We anticipate positive results in each of our three reporting segments in the first quarter, with particular strength in our Cepheid, Radiometer, Pall and ChemTreat businesses. While we had a good start to the year, we saw a meaningful slowdown in demand toward the end of the quarter, particularly in our more instrument-oriented businesses, as the COVID-19 pandemic spread worldwide."

Joyce continued, "We are incredibly proud of our team’s response to these unprecedented challenges. We are directly contributing to the fight against this virus, providing much-needed diagnostic testing capabilities and supporting our customers in pursuit of new treatments and vaccines."

Due to the evolving and uncertain impact of the COVID-19 pandemic, Danaher also announced that it is withdrawing its previously communicated 2020 financial guidance, which was provided on January 30, 2020.

The Company will report first quarter 2020 financial results on Thursday, May 7, 2020. Danaher will webcast its quarterly earnings conference call beginning at 8:00 a.m. ET and lasting approximately 1 hour.

The call and an accompanying slide presentation will be webcast on the "Investors" section of Danaher’s website, www.danaher.com, under the subheading "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation and will remain available until the next quarterly earnings call.

You can access the conference call by dialing 866-503-8675 within the U.S. or +1 786-815-8792 outside the U.S. a few minutes before 8:00 a.m. ET and notifying the operator that you are dialing in for Danaher’s earnings conference call (access code 3845297). A replay of the conference call will be available shortly after the conclusion of the call until May 21, 2020. You can access the replay dial-in information on the "Investors" section of Danaher’s website under the subheading "Events & Presentations."

Danaher’s earnings press release, the webcast slides and other related presentation materials will be posted to the "Investors" section of Danaher’s website under the subheading "Quarterly Earnings" beginning at 6:00 a.m. ET on the date of the earnings call and will remain available following the call.