On March 11, 2021 Bristol Myers Squibb (NYSE:BMY) reported that it will announce results for the first quarter of 2021 on Thursday, April 29, 2021 (Press release, Bristol-Myers Squibb, MAR 11, 2021, View Source [SID1234576472]). During a conference call at 9 a.m. ET on April 29, 2021, company executives will review financial results and address inquiries from investors and analysts.

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!

Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 800-458-4121 or international +1 313-209-6672, confirmation code: 3705525, or using this link which becomes active 15 minutes prior to the scheduled start time and entering your information to be connected. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 12:30 p.m. ET on April 29 through 12:30 p.m. ET on May 13, 2021. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 3705525.

On March 11, 2021 Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported financial results for the full-year ended December 31, 2020 and provided a corporate update (Press release, Addex Therapeutics, MAR 11, 2021, View Source [SID1234576471]).

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 ended 2020 in a strong financial position, which was supplemented by our successful $11.5 million fundraising at the beginning of 2021," said Tim Dyer, CEO of Addex. "Throughout 2020, we advanced preparations for the start of clinical studies targeting large underserved market opportunities. Clinical studies starting in the first half of 2021 include two internal programs, dipraglurant in Parkinson’s disease LID and blepharospasm. Additionally, our partner, Janssen is expected to start clinical studies with ADX71149 for epilepsy in the second quarter. Our collaboration with Indivior continues to move forward at a rapid pace and expect to deliver compounds for IND enabling studies by the end of this year."

Select Upcoming Milestones:

Q2 21 – Phase 2a study starting: ADX71149 for epilepsy. Partnered with Janssen
H1 21 – Phase 2b/3 study starting: dipraglurant for Parkinson’s disease LID (Uncontrolled, involuntary muscle movement)
H1 21 – Phase 2a study starting: dipraglurant for blepharospasm (Uncontrolled squeezing or twitching of the eyelids)
Q4 21 – Phase 2a data: dipraglurant for blepharospasm
H1 22 – Phase 2a data: ADX71149 for epilepsy
Q4 22 – Phase 2b/3 data: dipraglurant for Parkinson’s disease LID (PD-LID)
2020 Operating Highlights:

Ended 2020 with a strong cash position of $20.2 million (CHF 18.7 million), coupled with an additional $11.5 million fundraising on January 11, 2021, provides runway till mid 2022
Ensured dipraglurant is ready to start pivotal registration study in levodopa induced dyskinesia associated with Parkinson’s disease (PD-LID) following delay due to the global Covid-19 crisis; study initiation expected H1 2021
Prepared dipraglurant exploratory placebo-controlled clinical trial in blepharospasm patients, which is scheduled to start in H1 2021
Partner, Janssen prepared the start of a Phase 2a proof of concept clinical study of ADX71149 for epilepsy, which is scheduled to start in Q2 2021
GABAB PAM research program entered clinical candidate selection phase
Extended research agreement with Indivior until June 30, 2021, with a commitment for an additional funding of $2.8 million
Awarded CHF600K Innosuisse grant in collaboration with SIB (Swiss Institute of Bioinformatics) to identify new therapeutic indications for ADX10061 (D1 antagonist) program
Appointed Darryle D. Schoepp, PhD, one of the world’s leading and most successful neuroscience drug developers as Chairman newly formed scientific advisory board
Advanced Eurostars / Innosuisse funded mGlu7 negative allosteric modulator research program for post-traumatic stress disorder
Continue to advance remaining preclinical programs to their next value inflection points
Listed American Depositary Shares (ADS) representing our ordinary shares on the Nasdaq Stock Market on January 29, 2020
Financial Summary:
Income increased by CHF 1.0 million to CHF 3.9 million in 2020 compared to CHF 2.8 million in 2019, primarily due to amounts received under the licensing and research agreement with Indivior, recognized as related costs are incurred.

R&D expenses decreased by CHF 2.1 million to CHF 10.4 million in 2020 compared to CHF 12.4 million in 2019, primarily due to delays in starting certain clinical development activities due to the global coronavirus pandemic. R&D expenses consist primarily of costs associated with research, preclinical and clinical testing, and related staff costs. They also include depreciation of laboratory equipment, costs of materials used in research, costs associated with renting and operating facilities and equipment, as well as fees paid to consultants, patent costs and other outside service fees and overhead costs. These expenses include costs for proprietary and third-party R&D.

G&A expenses increased by CHF 0.7 million to CHF 5.7 million in 2020 compared to CHF 5.0 million in 2019 mainly due to the increase of CHF 1.3 million relating to increased directors and officer’s liability insurance premiums partially offset by a decrease of CHF 0.5 million in audit and legal fees.

The net loss for 2020 was CHF 12.9 million compared to CHF 14.8 million for 2019 primarily due to the decrease in R&D costs. Basic and diluted loss per share decreased to CHF 0.48 for 2020, compared to CHF 0.56 for 2019.

Cash and cash equivalents amounted to CHF 18.7 million at December 31, 2020 compared to CHF 31.5 million at December 31, 2019. This decrease of CHF 12.8 million is mainly due to the net loss.

2020 Condensed Consolidated Interim Financial Statements:
The full-year 2020 financial report can be found on the Company’s website in the investor/download section here.

Conference Call Details:
A conference call will be held today, March 11, 2021, at 16:00 CET (15:00 GMT / 10:00 EST / 07:00 PST) to review the financial results. Tim Dyer, Chief Executive Officer, Roger Mills, Chief Medical Officer and Robert Lütjens, Head of Discovery Biology will deliver a brief presentation followed by a Q&A session.

On March 11, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the titles and authors of the two abstracts/posters that were accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will be held in a virtual format from April 10-15, 2021 (Press release, Greenwich LifeSciences, MAR 11, 2021, View Source [SID1234576470]).

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!

The AACR (Free AACR Whitepaper) plans to publish the abstracts on April 9, 2021 at 12:01 am EST and the posters on April 10, 2021.

Snehal Patel, CEO of Greenwich LifeSciences, commented, "The first AACR (Free AACR Whitepaper) abstract and poster will focus on the final 5 year analysis of the immune response over time for all patients in our Phase IIb clinical trial. The immune response data will be critical to finalizing the Phase III clinical trial design, including the interim analysis and immune response monitoring strategy. For example, one could conceivably monitor the quality of dosing at each clinical site by monitoring immune response by clinical site, as well as assess immune response by multiple HLA types, separating responders from non-responders."

Mr. Patel further added, "Sufficient manufacturing progress has been made in the 1st quarter of 2021, such that the completion of GP2 manufacturing is planned for 2nd/3rd quarter of 2021. Thus, with the updated AACR (Free AACR Whitepaper) data and finalization of the clinical trial protocol and with the shipment of GP2 drug product to clinical sites, enrollment of the first patients in the Phase III clinical trial could commence in the 3rd/4th quarter of 2021."

Mr. Patel concluded, "In addition to our strategy for HER2/neu 3+ patients stated above, analysis of the immune response data in the HER2/neu low to intermediate expressing (HER2/neu 1-2+) patient populations in our Phase IIb clinical trial may be helpful in designing strategies to treat these patients, which include triple negative breast cancer patients, an area of substantial unmet need. It may be possible to design trials that combine GP2 and Herceptin antibody drug conjugates (ADCs) with other clinically active HER2/neu peptides and immune stimulating therapies, such as checkpoint inhibitors. This multi-technology strategy could also be used to treat the many other types of HER2/neu expressing cancers."

Final 5 Year Recurrence Rate / Disease Free Survival Data: In December 2020, the Company presented the Phase IIb clinical trial efficacy data, including clinical outcome and recurrence rate data. The Kaplan Meier analysis of disease free survival for HER2/neu 3+ patients treated with GP2 immunotherapy showed 100% disease survival over 5 years of follow-up (0% breast cancer recurrences, p = 0.0338) if the patients received their primary GP2 treatments following surgery and Herceptin treatment.

Final 5 Year Immune Response Data: At the upcoming AACR (Free AACR Whitepaper) 2021 conference, in the first abstract and poster, the Company will present the Phase IIb clinical trial final 5 year immune response data over time across all patient populations to complement the December 2020 efficacy data. The immune response is the primary mechanism of action that is critical to developing dosing and booster treatment strategies designed to achieve and sustain peak immunity. The presentation will include analysis of delayed type hypersensitivity skin tests and immunological assays used to measure immune responses for both HER2/neu 3+ and HER2/neu 1-2+ patient populations, such as a comparison of peak immune response versus baseline immune response at multiple time points.

Final 5 Year Safety Data: At a future conference in 2021, the Company plans to present the Phase IIb clinical trial final 5 year safety data. To date, the Company has administered GP2 immunotherapy to 138 patients in four clinical trials, where no serious adverse events and a well tolerated safety profile have been reported.

Updated Phase III Clinical Trial Design: At the upcoming AACR (Free AACR Whitepaper) 2021 conference, in the second abstract and poster, the Company and the Baylor College of Medicine will present the updated design of the planned Phase III clinical trial. The clinical trial is designed as a single registration trial that will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data read out followed by the submission of a Biologics Licensing Application (BLA). Additional features of the clinical trial design will be presented to breast cancer key opinion leaders as the Company and the Principal Investigators recruit clinicians and clinical sites for participation in the Phase III clinical trial.

The numbers, titles, and authors of the Company’s abstracts and E-posters are as follows:

Abstract/Poster Number & Title: CT183 – Final five year median follow-up data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, phase IIb study evaluating a time series of immune responses using HER2/neu peptide GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer

Authors can be viewed here: View Source!/9325/presentation/5254

Abstract/Poster Number & Title: CT256 – A prospective, randomized, multicenter, double-blinded, placebo-controlled phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer

Authors can be viewed here: View Source!/9325/presentation/4862

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On March 11, 2021 BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), reported the publication of proof-of-concept data on a novel, fully human FcγRIIB-blocking antibody, BI-1607, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, being held virtually April 10-15 and May 17-21 (Press release, BioInvent, MAR 11, 2021, View Source,c3303983 [SID1234576469]).

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!

"The data on BI-1607 are very exciting and provide proof-of-concept of its ability to enhance anti-cancer immunity, illustrated by its ability to boost activity and overcome resistance to CTLA-4-based therapy," said Martin Welschof, CEO of BioInvent. "We are looking forward to advancing BI-1607 into clinical development and expect to submit a clinical trial application during H2 2021. It will be BioInvent’s fourth drug candidate in clinical development, further demonstrating the strength and productivity of our technology platform."

Understanding mechanisms and overcoming resistance to distinct classes of antibody drugs has the potential to further improve cancer outcomes, explains the AACR (Free AACR Whitepaper) abstract, entitled "A novel FcγRIIB-blocking antibody to enhance FcγR-dependent antitumor immunity". BI-1607 has a novel mechanism-of-action and is designed to enhance FcγR-dependent antitumor immunity. The abstract outlines how BI-1607 enhances the therapeutic activity of anti-CTLA-4 in responsive (MC38) or resistant (CT26) experimental disease models (syngeneic immune competent) and that a triple combination – of BI-1607, anti-PD-1 and low dose anti-CTLA-4 – significantly enhanced survival in a B16 tumor model not responsive to checkpoint blockade. For further information and access to the full abstract, visit View Source!/9325/presentation/2743.

BioInvent’s lead compound BI-1206, evaluated in two separate Phase I trials for hematological or solid tumors, is one of three ongoing drug candidates in clinical development. The company initiated a Phase I/IIa trial of anti-TNFR2 antibody BI-1808 in January 2021 and a Phase l/lla trial of the novel oncolytic vaccinia virus BT-001, together with partner Transgene, in March 2021.

On March 11, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported the submission of a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication (Press release, Astellas Pharma, MAR 11, 2021, View Source [SID1234576468]). If approved, enfortumab vedotin would be the first antibody-drug conjugate (ADC) available in Japan for people living with this form of urothelial cancer.

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!

The submission is based on two global clinical trials with sites in Japan. The Phase 3 EV-301 trial evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. The Phase 2 EV-201 trial evaluated enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (cohort 1) and those who have not received a platinum-containing chemotherapy and who are ineligible for cisplatin (cohort 2).1,2

Enfortumab vedotin met the primary endpoints of overall survival (EV-301) and confirmed objective response rate per blinded independent central review (EV-201).3,4,5

"More than 24,000 people in Japan are diagnosed with urothelial cancer each year. For those whose cancer progresses despite treatment with chemotherapy and immunotherapy, there is no standard treatment option currently," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. "Based on data from two global clinical trials, and following the Ministry of Health, Labour and Welfare’s review, enfortumab vedotin may offer a new option for these patients."

About Urothelial Cancer
Urothelial cancer is the most common type of bladder cancer (90 percent of cases), and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra.6 Globally, approximately 549,000 new cases of bladder cancer and 200,000 deaths are reported annually.7 In Japan, it is estimated that 24,300 patients are diagnosed with this form of cancer and 9,500 deaths are reported annually.8

Locally advanced and metastatic urothelial cancer is an aggressive disease that is associated with poor survival and high healthcare costs.9 Five-year relative survival rates for metastatic disease are estimated to be approximately 7 percent.10

About the EV-301 Trial
The EV-301 trial (NCT03474107) is a global, multicenter, open-label, randomized phase 3 trial designed to evaluate enfortumab vedotin versus physician’s choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in approximately 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1 or PD-L1 inhibitor and platinum-based therapies.1 The primary endpoint is overall survival of participants treated with enfortumab vedotin compared to those treated with chemotherapy. Secondary endpoints include progression-free survival, duration of response, and overall response rate, as well as assessment of safety/tolerability and quality-of-life parameters. Results of the EV-301 trial were published in the New England Journal of Medicine.

About the EV-201 Trial
The EV-201 trial (NCT03219333) is a single-arm, pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1 or PD-L1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (cohort 1) and those who have not received a platinum-containing chemotherapy in this setting and who are ineligible for cisplatin (cohort 2). The trial enrolled 128 patients in cohort 1 and 91 patients in cohort 2 at multiple centers internationally.2 The primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability. Results of the first cohort from the EV-201 trial were published in The Journal of Clinical Oncology and results from the second cohort were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancer Symposium.

About Enfortumab Vedotin
Enfortumab vedotin is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.11,12 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).11

About the Astellas and Seagen Collaboration
Astellas and Seagen Inc. are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration. In the United States, Astellas and Seagen co-promote enfortumab vedotin under the brand name PADCEV (enfortumab vedotin-ejfv). In the Americas outside the US, Seagen holds responsibility for commercialization activities and regulatory filings. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.