On March 29, 2021 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for relugolix for the treatment of advanced prostate cancer (Press release, Myovant Sciences, MAR 29, 2021, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-european-medicines-agency-validation [SID1234577282]). The validation of the application confirms the submission is sufficiently complete for the EMA to begin the formal review process.

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"We are delighted that the Marketing Authorization Application for relugolix has been accepted for review by the European Medicines Agency. This is an important milestone in bringing a potential oral treatment option to men with advanced prostate cancer in Europe," said David Marek, Chief Executive Officer of Myovant Sciences, Inc. "Following our recent FDA approval and launch in the U.S., we believe relugolix has the potential to transform the standard of care for men with advanced prostate cancer requiring androgen deprivation therapy. We look forward to making this potential treatment available to more men around the world."

Under the terms of the collaboration between Myovant and Pfizer to develop and commercialize relugolix, Pfizer has an exclusive option to commercialize relugolix in oncology outside of the U.S. and Canada, excluding certain Asian countries. If Pfizer exercises this option, Myovant will receive $50 million and be eligible to receive double-digit royalties on net sales from these markets. Pfizer’s decision to exercise this option is expected in the first half of calendar year 2021.

The MAA is supported by efficacy and safety data from the Phase 3 HERO study, a randomized, open-label, parallel-group, multinational clinical study evaluating the safety and efficacy of relugolix in over 1,000 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Relugolix received U.S. Food and Drug Administration (FDA) approval in December 2020.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S. More than three million men diagnosed with prostate cancer are alive in the U.S., and approximately 250,000 men are estimated to be newly diagnosed in 2021.

Prostate cancer is considered advanced when it has spread or come back after initial treatment and may include biochemical recurrence (rising prostate-specific antigen in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. However, LHRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial surge in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued. Approximately 300,000 men are treated with androgen deprivation therapy each year in the U.S.

On March 29, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that its executive management will host a live webcast on 31 March 2021, at 5:00 p.m. CEST to discuss the company’s full-year and fourth quarter 2020 results and provide a business and financial update (Press release, Allarity Therapeutics, MAR 29, 2021, https://allarity.com/press-release/allarity-therapeutics-invites-investors-for-fy-q4-2020-report-conference-call/ [SID1234577281]). The webcast will follow the publication of Allarity Therapeutic’s FY/Q4 2020 report, also scheduled for release on 31 March 2021.

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Interested parties may register for the event and attend it via this link: View Source

Please connect to the web-conference application prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to access the webcast.

Agenda:

General business update by CEO Steve Carchedi
Financial update by CFO Jens Knudsen
Rights Issue
Q&A
Pre-submitted questions will be prioritized for the Q&A. To pre-submit a question, please email it to [email protected], before 2:30 p.m. CEST on 31 March.

Online webcast/conference call:

Attendees are encouraged to pre-register in order to be able to watch the presentation slides using this link:

·View Source

Attendees who would wish to call in may use the following:

Attendee Dial-in Number: + 1 (312) 248-9348
Attendee Dial-in ID Number: 821771#
Attendee Dial-in Passcode: 7041#
About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.

On March 29, 2021 Cytocom, Inc., a leading biopharmaceutical company creating second generation immune therapies, reported that Mike Handley, President and Chief Executive Officer, will present at the Spring 2021 meeting of the Virtual Oncology Investor Conference, sponsored by the National Foundation for Cancer Research, taking place March 29, 2021 to April 1, 2021 (Press release, Cytocom, MAR 29, 2021, https://www.cytocom.com/2021/03/29/cytocom-to-present-at-the-spring-2021-virtual-oncology-investor-conference/ [SID1234577278]). The presentation will be available for all registered attendees.

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During the presentation, Mr. Handley will provide an overview of Cytocom’s business and recent corporate achievements, as well as the anticipated near-term milestones in clinical programs for COVID-19, pancreatic cancer and Crohn’s disease.

Details of Cytocom’s presentation are as follows:

Event: Spring 2021 Oncology Investor Conference
Date: Tuesday, March 30, 2021
Time: 11:50 a.m. ET
Registration: View Source

Members of the Cytocom’s management team will also be available to participate in virtual one-on-one meetings with investors and representatives of biotechnology and pharmaceutical companies who are registered to attend the conference. Following the conclusion of the event, a recording of Mr. Handley’s presentation will be available under "Recent Presentations" in the Investors section of the Company’s website at www.cytocom.com.

On March 29, 2021 F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer, reported 2020 full-year financial results and provides corporate update (Press release, F-star, MAR 29, 2021, View Source [SID1234577277]).

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2020 was a year of transformation for F-star. The Company successfully listed on NASDAQ and advanced multiple programs into the clinic. F-star also presented Phase 1 data on its most advanced program FS118, and dosed patients in two additional clinical trials with FS222 and FS120. The Company continued to deliver on its long-term collaborations and ended the year with a total of four clinical stage programs, and a robust pipeline generated from its unique tetravalent bispecific platform technology.

Eliot Forster, CEO of F-star Therapeutics, Inc., said, "F-star finished the year in a strong position, having made significant progress towards our mission of transforming the lives of patients with cancer. Listing on NASDAQ at the end of 2020 has accelerated our plans and we now have four programs in the clinic with the potential to help patients where there is currently significant unmet need. FS118 (LAG-3/PD-L1 bispecific), the most advanced of these, showed encouraging signs of clinical activity with a novel mechanism of action for acquired resistance patients and a proof-of-concept trial in PD-1 resistant head and neck cancer patients is now underway. FS222, a potentially best-in-class bispecific antibody targeting CD137 (4-1BB) and PD-L1, is in Phase 1. FS120, a first-in-class CD137/OX40 mAb² dual agonist bispecific antibody, is underway with a Phase 1 in monotherapy and PD-1 combination. SB 11285, a second-generation STING agonist for intravenous administration continues in Phase 1/2 trial, including combination with TecentriqTM."

PROGRAM DEVELOPMENTS

First Patient Dosed in FS222 Phase 1 Clinical Trial: The first patient dosed in a Phase 1 trial evaluating FS222, a potentially best-in-class bispecific antibody targeting CD137 and PD-L1. With Clinical Trial Application (CTA) acceptance in Spain announced in November 2020, this multicenter, open-label, first-in-human trial will evaluate the safety, tolerability, and early signs of efficacy of FS222 in adult patients diagnosed with advanced malignancies.

FS118 European patent protection granted: The European Patent Office (EPO) granted a patent in January 2021 with claims protecting the composition of matter of F-star’s FS118 molecule. The expiry date of the patent, not including any potential extensions to the standard 20-year term of protection, is expected to be June 2037.

First Patient Dosed in FS120 Phase 1 Clinical Trial: The first patient was dosed in December of 2020. Preclinical data for FS120, a first-in-class dual-agonist tetravalent bispecific antibody targeting CD137 (4-1BB) and OX40, showed potential for improved efficacy with either checkpoint inhibitors or chemotherapy to drive anti-tumor responses without the need for Fcg receptor activation.

Multiple Posters at 2020 SITC (Free SITC Whitepaper) Conference: In November of 2020, posters were presented on the FS118 Phase 1 trial, the FS118 unique bispecific mechanism of action and on the SB 11285 second generation STING agonist progress, both in monotherapy and in combination with PD-L1.

FS222 Poster Presentation at AACR (Free AACR Whitepaper): F-star will present a poster at AACR (Free AACR Whitepaper) on April 10, 2021 titled ‘FS222, a Tetravalent Bispecific Antibody Targeting CD137 and PD-L1, is Designed for Optimal CD137 Interactions Resulting in Potent T cell Activation Without Toxicity’.

SUMMARY OF ANTICIPATED PROGRAM MILESTONES

FULL-YEAR 2020 FINANCIAL UPDATE

Cash Position – Cash and cash equivalents totalled $18.5M for the year ended December 31, 2020, compared to $4.9M for the year ended December 31, 2019. The increase in cash and cash equivalents was driven primarily by proceeds from the PIPE financing and cash resulting from the business combination in November 2020, and proceeds from our collaborations, offset by the Company’s operational needs during 2020.

R&D Expense – R&D expenses were $14.1M for the year ended December 31, 2020, compared to $31.4 M for the 2019 prior year end. The decrease in R&D expense was primarily due to the near completion of the FS118 Phase 1 study and the start-up costs of the FS118 proof of concept study in late 2020, decreased manufacturing costs resulting from manufacturing batch runs incurred in late 2019 supplying 2020 needs, a decrease in other R&D costs due to timing of development activities and the annual UK research and development tax credit.

G&A Expense – G&A expenses were $19.5M for the year ended December 31, 2020, compared to $15.3M for the full year 2019. This increase in G&A expense was primarily due to increased compensation related costs, non-cash share-based compensation expense, transaction costs, facilities and IT costs offset by reduced travel and conferences costs, primarily related to COVID-19 travel restrictions.

Net Loss Attributable to Common Shareholders – Net loss attributable to common shareholders was $25.6 million or ($9.69) per share, for the year ended December 31, 2020, as compared to a net loss of $23.0 million or ($14.89) per share for the year ended December 31, 2019.CONFERENCE CALL AND WEBCAST

F-star will host a conference call today, March 29, 2021 beginning at 9:00 AM EDT. To join the webcast, go to website. The recording will be available on the company’s website in the Investors & News section.

On March 19, 2021 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported it has received approval to commence its exploratory patient biopsy study in Eastern Europe evaluating XCART (Press release, Xenetic Biosciences, MAR 29, 2021, View Source [SID1234577276]).

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"The start of this study represents an important step forward in our preclinical development program, and we look forward to evaluating the XCART platform applied to tumor samples from NHL patients currently under evaluation or in treatment at the study site. Access to biopsy and blood samples from patients with various subtypes and stages of disease will allow us to refine the XCART upstream workflow for isolating and screening tumor-specific neoantigens in order to identify and characterize potential tumor-specific CAR constructs. Importantly, the format of this study will also allow us to evaluate certain clinical parameters relevant to potential Phase 1 studies in the future that would involve dosing of patients with XCART-designed autologous CAR T products. We expect the data generated under this exploratory study to position the Company to conduct U.S. IND-enabling studies," stated Curtis Lockshin, Ph.D., Chief Scientific Officer of Xenetic.

The exploratory study will be conducted at the Vitebsk Regional Clinical Oncological Center in Minsk, Belarus, and will enroll adult B-Cell NHL patients. When sufficient experience is gained through this exploratory study, the collaborations being leveraged in the XCART development program may be expanded to include development and qualification of manufacturing processes for producing autologous XCART T-Cells. The work being performed under these collaborations is expected to position the Company to conduct IND-enabling studies in the United States.

Xenetic is leveraging academic collaborations with Scripps Research and PJSC Pharmsynthez to advance the development of the XCART technology for B-Cell malignancies. Both Scripps Research as well as Pharmsynthez and its collaborators have extensive experience with XCART, having co-invented the technology, and have integral roles in the Company’s preclinical development activities.