On July 19, 2024 Purple biotech presented its corporate presentation (Presentation, Purple Biotech, JUL 19, 2024, View Source [SID1234644977]).

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On July 19, 2024 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare diseases, reported the grant of 19,875 restricted stock units of the company’s common stock to 14 newly hired non-executive officers of the company. The awards were approved by the compensation committee of the company’s board of directors and granted under the Ultragenyx Employment Inducement Plan, with a grant date of July 16, 2024, as an inducement material to the new employees entering into employment with Ultragenyx in accordance with Nasdaq Listing Rule 5635(c)(4) (Press release, Ultragenyx Pharmaceutical, JUL 19, 2024, View Source [SID1234644978]).

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The restricted stock units vest over four years, with 25% of the underlying shares vesting on each anniversary of the grant date, subject to the employee being continuously employed by the company as of such vesting dates.

On July 19, 2024, CASI Pharmaceuticals, Inc., a Cayman Islands incorporated company ("CASI" or the "Company") reported that, with respect to the Company’s previously announced dispute with Juventas Cell Therapy Ltd. ("Juventas"), a court of P.R.C. issued an asset freezing order against Juventas in aid of the arbitration proceedings CASI initiated at the Hong Kong International Arbitration Centre (the "HKIAC") in connection to Juventas’s purported termination of the parties’ agreements with respect to the commercialization of CNCT19 (the "Arbitration Proceeding") (Press release, CASI Pharmaceuticals, JUL 19, 2024, View Source [SID1234644980]).

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In an order dated July 15, 2024 and received by CASI on July 18, 2024, the First Intermediate People’s Court of Tianjin Municipality, where Juventas is headquartered, granted CASI’s application to freeze Juventas’s assets while the Arbitration Proceeding is ongoing and decided to freeze up to RMB 190 million in Juventas’s bank accounts or seize and freeze Juventas’s other assets of equivalent value (the "Asset Freezing Order"). The Asset Freezing Order took effect upon issuance and the court has taken steps to enforce the Asset Freezing Order.

The Company will continue to vigorously assert and enforce its rights against Juventas through all available legal means. The Company cannot predict right now the final outcome of the Arbitration Proceeding or how the parties’ dispute would ultimately be resolved.

On July 18, 2024 Medivir AB (NASDAQ: MVIR) (STOCKHOLM: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that updated data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) has been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Barcelona, September 13-17, 2024 (Press release, Medivir, JUL 18, 2024, View Source;lenvima-in-hcc-at-esmo-conference-in-september-302200401.html [SID1234644962]).

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The abstract, titled "Fostrox (fostroxacitabine bralpamide) plus lenvatinib in patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) progressed on immunotherapy combinations. Results from a multi-center phase 1b/2a study." will be presented by Dr Hong Jae Chon, CHA Bundang Medical Center in Korea.

Updated clinical data from the ongoing phase 1b/2a study with fostrox in combination with Lenvima. will be presented. As patients are able to stay on treatment long-term, it enables a detailed update on the safety and tolerability profile and how it evolves over time. The presentation will also include additional updates on efficacy endpoints.

The poster will be available on Medivir’s website after the presentation.

For additional information, please contact:

Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100.
E-mail: [email protected]

About fostrox

Fostrox is a liver-targeted inhibitor of DNA replication that delivers the cell-killing compound selectively to the tumor while minimizing the harmful effect on normal cells. This is achieved by coupling an active chemotherapy (troxacitabine) with a prodrug tail. This design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in HCC is ongoing where it has shown encouraging anti-cancer efficacy with a good safety and tolerability profile.

About primary liver cancer

Primary liver cancer is the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver and it is the fastest growing cancer in the USA. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1,2. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On July 18, 2024 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported that the first patient has been dosed in Pure Biologics’ exploratory Phase 0 clinical study of PBA-0405 (Press release, Twist Bioscience, JUL 18, 2024, View Source [SID1234644963]). PBA-0405 is a fully human IgG1 antibody that was discovered using Twist Biopharma Solutions’ synthetic antibody phage display libraries. Twist Biopharma Solutions, a division of Twist Bioscience, provides an integrated offering of in vitro, in vivo, and in silico tools for antibody discovery research. This exploratory study is designed to provide early insights into the biological effects of PBA-0405 within the tumor environment.

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"Solid tumors are historically difficult for drug developers to target and treat. This is the first antibody identified using our Twist Biopharma Solutions Library of Libraries to be tested in patients and it validates the potential of our synthetic antibody libraries to be used to discover novel drug candidates for hard-to-treat cancer indications," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "This is one of two of Pure’s candidates discovered using our synthetic antibody libraries and we look forward to seeing their progression."

PBA-0405 targets ROR1, a tumor-associated antigen expressed on many solid tumors and B cell malignancies. PBA-0405 is designed to make tumors visible to the immune system, and to induce an immune response by recruiting and activating tumor-killing cytotoxic immune cells.

Pure Biologics’ multi-center, single arm, open-label pharmacodynamic biomarker Phase 0 trial is designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device. The study will evaluate the pharmacodynamic activity of PBA-0405 in solid tumors including head and neck squamous cell carcinoma, certain subtypes of soft-tissue sarcomas and triple-negative breast cancer. Pure Biologics is conducting the clinical study and holds full responsibility for the development and potential regulatory submission of PBA-0405. ClinicalTrials.gov ID NCT06273852

"With the dosing of the first patient in our exploratory Phase 0 study, PBA-0405 is the first ROR1-targeting compound of its mode of action to enter into studies in patients. We’re encouraged by the preclinical data we’ve seen so far and are eager to evaluate its pharmacodynamic activity in human studies," said Pieter Spee, PhD, Chief Scientific Officer at Pure Biologics. "By working with Twist Bioscience to leverage their synthetic antibody libraries for early-stage discovery, we were able to move quickly to the development stage. We look forward to continuing to advance our pipeline of immuno-oncology antibody candidates and drive toward our goal of delivering first-in-class therapies to patients."

About the Collaboration

PBA-0405 was discovered as part of an ongoing collaboration between Twist Bioscience and Pure Biologics. Under the terms of the agreement announced in 2021, Twist Biopharma Solutions, a division of Twist Bioscience, grants Pure Biologics access to select synthetic antibody phage display libraries derived only from sequences that exist in the human body and further optimized by leveraging state-of-the-art approaches, including artificial intelligence and big data analytics. Certain libraries among the portfolio are deliberately tailored to match chosen classes of biological targets as well as to enhance bispecific antibody forming capabilities. Together, the companies work to discover, validate and optimize new antibody candidates against targets useful for immuno-oncology applications. Pure Biologics will pay Twist annual maintenance fees in addition to future payments for clinical and commercial achievement for any antibodies resulting from the collaboration. The Phase 0 study does not trigger a milestone payment for Twist.