On August 29, 2022 Prestige Biopharma Limited reported that the company will become the largest shareholder of Prestige Biologics by acquiring new shares to secure a total of 24.88% of the CDMO company (Press release, Prestige BioPharma, AUG 29, 2022, View Source [SID1234618797]).

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On August 26, the board of directors of Prestige Biopharma approved subscription in Prestige Biologics’ capital increase through third party allotment of 13,787,830 new shares amounting to approximately KRW 59.8 billion. As result, the Company will have management control over Prestige Biologics which will be accounted for as a subsidiary of Prestige Biopharma.

The new structure allows the two companies to maximize synergy and the group to establish a full value chain. Prestige Biopharma can secure a global-scale production facility with 154,000 litres of capability and core bioprocessing technologies on top of its R&D expertise. Prestige Biologics can leverage Prestige Biopharma’s marketing capabilities to obtain more consignment contracts and raise its position as global CDMO. Hence, the group can improve its revenue and continue its robust investment in R&D of new biologics, contributing to long-term financial stability and prosperity.

In addition, the new structure enables integrated business management by operating integrated organization and digital management system. Thus, it is expected to facilitate strategic and efficient management, streamline decision-making process, and strengthen cooperation.

Meanwhile, Prestige Biologics announced the appointment of Duk-Hoon Hyun as new CEO on August 26 and held an inauguration ceremony on August 29. Duk-Hoon Hyun has led Prestige Biologics’ digital transformation project since last year and has successfully introduced the SAP system into the entire organization. Previously, he was a senior executive of SAP, a global ERP company.

Duk-Hoon Hyun, new CEO of Prestige Biologics mentioned: "I feel heavy responsibility to expedite the innovation in production process and produce results as a global CDMO. I will do my utmost to strengthen ICT technology capabilities, which are essential for data management and factory automation, and create new synergy under the reorganized group structure."

Lisa Park, CEO of Prestige Biopharma, mentioned: "The new integral organizational structure of the group will be the foundation of becoming a global comprehensive biopharmaceutical by enhancing the group’s profitability and stability for growth. Welcoming the new CEO of Prestige Biologics, we look forward to building a future together in discovering, developing, and producing biomedicines."

On August 29, 2022 Shanghai UniCar Therapy reported that closed a Series C financing to advance clinical trials of its ssCART-19 injection in patients with leukemia (Press release, Unicar-Therapy Bio-medicine , AUG 29, 2022, View Source [SID1234618796]). Guan Bang Fund and Junci Investment were the two named investors in the C round. UniCar’s ssCART-19 injection, the company’s lead CAR-T 2.0, expresses single-chain antibodies targeting CD19 and IL-6 silencing elements (shRNA). The company expects IL-6 silencing will decrease cytokine release syndrome in patients. UniCar focuses on refining CAR-T products to increase their efficacy. The company said the C round raised "tens of millions of RMB."

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On August 29, 2022 Galapagos NV (Euronext & NASDAQ: GLPG) reported that received a transparency notification from FMR LLC (Press release, Galapagos, AUG 29, 2022, View Source [SID1234618752]).

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Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 25 August 2022 from FMR LLC, who notified that it holds 3,710,782 of Galapagos’ voting rights, consisting of 3,710,782 ordinary shares. FMR LLC controls investment funds Fidelity Management & Research Company LLC, FIAM Holdings LLC, Fidelity Management Trust Company and Strategic Advisers LLC, of which Fidelity Management & Research Company LLC decreased its position to 3,272,828 voting rights, and Strategic Advisers LLC increased its position to 10,322 voting rights. Hence, the first-mentioned controlled undertaking of the FMR LLC group individually crossed below the 5% threshold. FMR LLC’s holding of 3,710,782 Galapagos’ voting rights, including its controlled undertakings’ holdings, represents 5.65% of Galapagos’ currently outstanding 65,728,511 shares. FMR LLC thus remains above the 5% threshold of Galapagos’ voting rights. The full transparency notice is available on the Galapagos website.

On August 29, 2022 Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that the cohort receiving the 180μg dose level in the Phase II clinical trial of STP705 for the treatment of cutaneous basal cell carcinoma (BCC) achieved a 100% complete response (CR), indicating the promising viability of the treatment (Press release, Sirnaomics, AUG 29, 2022, View Source [SID1234618748]). STP705 is a siRNA (small interfering RNA) therapeutic that is composed of two siRNA oligonucleotides, targeting the expression of TGF-β1 and COX-2 mRNA, respectively.

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Apart from achieving a 100% CR, the data among the five subjects treated in the cohort also showed improved or stable cosmetic results with an excellent safety profile (no adverse events) and no significant cutaneous skin reactions. The Company is continuing to explore doses in the ongoing dose escalation study and anticipates a final report in Q1 2023.

"The latest results from the Phase II clinical study of STP705 for BCC treatment, showing an incredible efficacy without any drug related AEs and SAEs, further validated the broad potential of this drug candidate for treatment of non-melanoma skin cancers and beyond", said Dr. Patrick Lu, PhD, founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "Based on the successes of both BCC and isSCC (cutaneous squamous cell carcinoma in situ) clinical studies, Sirnaomics is spearheading the development of the novel polypeptide-based siRNA therapeutics for various types of cancers."

"Achieving a 100% CR is a clear indication that our treatment has the potential to be an alternative to those treatments currently available to patients, which involve surgical excision of lesions," said Dr. Michael Molyneaux, MD, Executive Director and Chief Medical Officer of Sirnaomics. "To reduce the rate of scarring and achieve a superior cosmetic result compared to surgery could be a potential advantage for patients with BCC and other non-melanoma skin cancers."

The Phase II open label, dose escalation study will also expand the number of participating cohorts to continue to evaluate the safety, tolerability, and efficacy of various doses of STP705 administered as localized injections in patients with BCC. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04669808.

About Basal Cell Carcinoma
Basal cell carcinoma (BCC) is a type of nonmelanoma skin cancer (NMSC) that is associated with exposure to ultraviolet radiation from the sun. BCC is the most common form followed by squamous cell carcinoma (SCC), and while they have a lower metastatic potential, they can be locally aggressive and destructive of skin and surrounding structures. The estimated metastasis rate of BCC ranges from 0.0029% to 0.55%, and common metastatic sites are regional lymph nodes, lungs, bones, skin, and liver. In the U.S., according to Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012, the number of new cases of BCC is 2.4 million in 2020 and is projected to increase to 4.2 million in 2030. Standard treatments for BCC are standard surgical excision, Mohs micrographic surgery, topical cream treatments, cryosurgery, laser therapy, electro-desiccation, and radiation therapy. The various forms of surgical modalities carry significant cutaneous adverse events, risk of scar, infection, and bleeding. Currently, there are two drugs approved by U.S. Food and Drug Administration (FDA) for pre-metastatic BCC patients, which can cause skin reactions in some patients.

Treatment of BCC with STP705 shows benefits in cosmetic appearance, especially for patients with lesions on the head, face or neck, and clinical results demonstrate that STP705 has a high complete response compared with currently available topical treatments.

About STP705
Sirnaomics’ leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). STP705 is currently in seven clinical trials for different indications: a Phase IIb for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC), a Phase I/II for keloid scarring, a Phase I/II for hypertrophic scar (HTS), a Phase I/II for facial isSCC, a Phase I for liver cancer (basket), and a Phase I for medical cosmetology treatment.

On August 29, 2022 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that it has achieved a preclinical development milestone in connection with ongoing IND-enabling studies for its Pol Theta Helicase Development Candidate (DC) (Press release, Ideaya Biosciences, AUG 29, 2022, View Source [SID1234618747]).

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"We are excited to advance our Pol Theta Helicase Inhibitor DC toward the clinic. The achievement of this preclinical milestone supplements our balance sheet and reflects the continued progress IDEAYA and GSK are making to enable first-in-human studies with this development candidate in the first half of next year," said Michael White, Senior Vice President and Chief Scientific Officer of IDEAYA Biosciences.

The Pol Theta Helicase Inhibitor DC is a potential first-in-class small molecule inhibitor of the helicase domain of DNA Polymerase Theta. IDEAYA is collaborating with GSK on IND-enabling studies to support the evaluation of the Pol Theta Helicase DC in combination with niraparib, GSK’s PARP inhibitor, for patients harboring tumors with BRCA or other homologous recombination (HR) mutations or homologous recombination deficiency (HRD).

IDEAYA and GSK are targeting an IND submission for the Pol Theta Helicase DC, subject to satisfactory completion of ongoing IND-enabling studies, to enable first-in-human studies in the first half of 2023.

GSK will lead clinical development for the Pol Theta program pursuant to its global, exclusive license to develop and commercialize the Pol Theta Helicase Inhibitor DC. GSK is responsible for all research and development costs for the program. IDEAYA is eligible to receive total development and regulatory milestones of up to $485 million aggregate, inclusive of preclinical and clinical milestones of up to $20 million aggregate for advancing the Pol Theta Helicase DC through early Phase 1 clinical.

Upon potential commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones and tiered royalties on global net sales by GSK, its affiliates and their sublicensees ranging from high single digit to sub-teen double digit percentages, subject to certain customary reductions.