On May 28, 2021 Ryvu Therapeutics (WSE: RVU), a clinical stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported that its Clinical Trial Application (CTA) to commence a single-agent, open-label Phase I/II trial, investigating the safety and efficacy of RVU120 (SEL120) in patients with relapsed/refractory metastatic or advanced solid tumors in Poland, has been fully approved by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and the respective Central Ethics Committee (Press release, Ryvu Therapeutics, MAY 28, 2021, View Source [SID1234583282]).

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!

Following the above-mentioned approvals, Ryvu Therapeutics will be able to initiate a clinical study and start enrolling patients in Poland.

The study is designed in two phases. Phase I part has the key objectives of assessing safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RVU120 (SEL120) during dose escalating cohorts, and determination of the recommended phase II dose (RP2D), and the phase II part, subsequently will include specific tumor indications, enrolled at distinct study groups, such as Triple Negative Breast Cancer (TNBC).

"With approvals from Polish Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products and Central Ethics Committee, we are making another important step in the clinical development of our flagship RVU120 (SEL120) program. We are very excited to develop RVU120 (SEL120) as a potential treatment in both hematological and solid malignancies," comments Setareh Shamsili, MD, PhD, Chief Medical Officer, and EVP at Ryvu Therapeutics.

"We are delighted that the new Phase I/II RVU120 (SEL120) study in patients with solid tumors will be conducted in Poland. Clinical Trial Applications in other European countries will be submitted over the coming months," adds Setareh Shamsili.

About RVU120 (SEL120)

RVU120 (SEL120) is a highly selective first-in-class CDK8/CDK19 inhibitor, which has demonstrated efficacy in a number of solid tumor types in in vitro and in vivo models as well as in onco-hematological malignancies. The first-in-human (FIH) phase I study with RVU120(SEL120), in relapsed or refractory AML or high-risk myelodysplastic syndromes (HRMDS), is currently enrolling patients in 5 investigational sites in USA (View Source).

Current translational data suggest that RVU120 (SEL120) is particularly effective in undifferentiated AML STAT5-positive cancers. Administration of RVU120 (SEL120) in orthotopic AML patient derived xenograft models reduced tumor burden to the level undetectable in the peripheral blood, decreased splenomegaly and resulted in partial bone marrow recovery at well tolerated doses, providing therefore a strong rationale for the clinical development of RVU120 (SEL120) as an effective treatment for AML and potentially other hematological malignancies.

On March 25, 2020, the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to RVU120 (SEL120), for the treatment of patients with acute myeloid leukemia (AML).

On April, 2021 U.S. Food and Drug Administration, FDA, placed a partial clinical hold on the first in human Phase Ib, dose escalation clinical trial of RVU120 in patients with relapsed/refractory (R/R) AML and high-risk MDS. Patients who are currently taking RVU120 may continue treatment. Ryvu continues to work closely with the FDA to resolve the partial clinical hold with the objective of resuming enrollment in the study. RVU120 (SEL120) was discovered with the Ryvu Therapeutics discovery engine platform and has received support from The Leukemia & Lymphoma Society Therapy Acceleration Program (TAP), a strategic initiative to partner directly with innovative biotechnology companies and leading research institutions to accelerate the development of promising new therapies for blood cancers. More information about TAP program is available at: View Source

On May 28, 2021 PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company reported that the Ministry of Food and Drug Safety (MFDS) in South Korea has granted Orphan Drug Designation to its lead product candidate, fimaporfin, for combination treatment with gemcitabine in patients with inoperable locally advanced or metastatic bile duct cancer (cholangiocarcinoma) (Press release, PCI Biotech, MAY 28, 2021, View Source [SID1234585150]). No approved treatment alternatives exist today for the first-line treatment of patients with this disease and fimaChem (fimaporfin) has the potential to play a role in this area of high unmet medical need.

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 RELEASE trial has in general shown promise with good recruitment activity in South Korea despite the Covid-19 pandemic. Receiving orphan status from the South Korean authorities is a key step in the development of this important new medicine for Asian cancer patients in need of better local treatments. PCI Biotech’s fimaChem treatment is well suited for treatment of bile duct cancer, with easy light access through routine endoscopic methods." said Dr. Per Walday, CEO of PCI Biotech. "Orphan designation in South Korea, in addition to the already granted orphan designations in EU and USA, are all significant regulatory milestones and recognises the therapeutic benefits we seek to bring to the patients."

About bile duct cancer and the fimaChem technology
The bile duct drains bile from the liver into the small intestine. Bile duct cancer (cholangiocarcinoma) is a cancer that affects the cell lining of the bile duct and represents a patient population with a high unmet medical need. Surgery is the only potential curative option for these patients, but most patients are inoperable at presentation. Inoperable patients are treated with stenting to keep the bile duct open and with chemotherapy. Median survival of inoperable patients is between 11 and 12 months with the current standard of care treatment, which is a chemotherapy combination of gemcitabine and cisplatin. Biliary tract sepsis, liver failure and/or malnutrition and cachexia due to locoregional effects of the disease are the most important causes of death, so there is a high need for better locoregional treatments. The locoregional anti-cancer effect of gemcitabine is significantly enhanced by the fimaChem technology in preclinical studies, and early clinical treatment data suggest encouraging tumour response and survival in bile duct cancer patients.

Bile duct cancer is a rare disease with an incidence rate of 1-2 per 100,000 in the western world. The incidence rates are increasing worldwide and are generally higher in Asian countries. The immediate target for PCI Biotech is first-line treatment of inoperable patients with extrahepatic disease. The fimaChem treatment regimen consists of an intravenous injection of fimaporfin, followed four days later by an intravenous infusion of gemcitabine and a laser light application in the bile duct easily administered through endoscopic methods used routinely in these patients. The patients then follow the standard background treatment with up to 8 chemotherapy cycles of gemcitabine + cisplatin. The fimaChem treatment may be repeated during the background chemotherapy treatment cycles.

On May 28, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that it will participate at the following investor conferences (Press release, Halozyme, MAY 28, 2021, View Source [SID1234583267]):

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 Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021 at 11:20 a.m. ET / 8:20 a.m. ET. Dr. Helen Torley, president and chief executive officer, will represent the company in a fireside chat.
The JMP Securities Life Sciences Conference on Thursday, June 17, 2021 at 3:00 p.m. ET / 12:00 p.m. PT. Elaine Sun, senior vice president and chief financial officer, will represent the company in a fireside chat.
These conferences will be held virtually. Live webcasts of the applicable presentations will be accessible on the company’s website www.halozyme.com under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

On May 28, 2021 Amgen (NASDAQ:AMGN) reported that it will present at the 2021 Jefferies Healthcare Conference at 1:30 p.m. ET on Thursday, June 3, 2021 (Press release, Amgen, MAY 28, 2021, View Source [SID1234583268]). Murdo Gordon, executive vice president of Global Commercial Operations at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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 webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On May 28, 2021, Viracta Therapeutics, Inc. (the "Company") reported that entered into an Open Market Sale AgreementSM (the "Sale Agreement") with Jefferies LLC (the "Sales Agent"), under which the Company may offer and sell up to $50,000,000 of shares (the "Shares") of its common stock, par value $0.0001 per share ("Common Stock"), from time to time through the Sales Agent, acting as the Company’s sales agent (Filing, 8-K, Sunesis, MAY 28, 2021, View Source [SID1234583269]). The sales and issuances, if any, of the Shares by the Company under the Sale Agreement is subject to the effectiveness of the Company’s registration statement on Form S-3 (the "Registration Statement"), filed with the Securities and Exchange Commission on May 28, 2021. The Company makes no assurances as to if or whether the Registration Statement will become effective or, if it does become effective, as to the continued effectiveness of the Registration Statement.

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!

Sales, if any, of the Shares pursuant to the Sale Agreement may be made in negotiated transactions or transactions that are deemed to be "at the market offerings" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on The Nasdaq Stock Market, or sales made into any other existing trading market for the Common Stock. The Sales Agent is not required to sell any specific amount of securities, but will act as the Company’s sales agent using commercially reasonable efforts to sell the Shares from time to time (the "Offering"), consistent with its normal trading and sales practices, applicable state and federal laws, rules and regulations and the rules of The Nasdaq Stock Market, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company has agreed to pay the Sales Agent a commission equal to 3.0% of the aggregate gross proceeds from each sale of Shares pursuant to the Sale Agreement and to provide the Sales Agent with customary indemnification and contribution rights, including for liabilities under the Securities Act. In addition, the Company has agreed to reimburse certain expenses incurred by the Sales Agent in connection with the Offering. The Sales Agent’s obligations to sell the Shares under the Sale Agreement are subject to satisfaction of certain conditions, including customary closing conditions.

The Company is not obligated to sell any of the Shares under the Sale Agreement and may at any time suspend solicitation and offers under the Sale Agreement. The Sale Agreement may be terminated by the Company at any time by giving 10 days’ written notice to the Sales Agent for any reason or by the Sales Agent at any time by giving 10 days’ written notice to the Company for any reason or immediately under certain circumstances, and shall automatically terminate upon the issuance and sale of all of the Shares.

The foregoing description of the Sale Agreement is not complete and is qualified in its entirety by reference to the full text of the Sale Agreement, a copy of which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the 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.