On May 24, 2024 Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeting photoimmunotherapy based on its proprietary Alluminox platform, reported the updated safety and efficacy findings from an interim evaluation of an open-label Phase 1b/2 study (ASP-1929-181/ClinicalTrials.gov Identifier: NCT04305795) of photoimmunotherapy using ASP-1929 in combination with anti-PD-1 for recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) (Press release, Rakuten Medical, MAY 24, 2024, View Source [SID1234643694]). The data will be presented in a poster at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2024) on June 2, 2024.

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The updated interim evaluation (data cut-off: August 31, 2023) of 19 enrolled patients in ASP-1929-181 study suggests that the novel treatment approach of ASP-1929 photoimmunotherapy in combination with anti-PD-1 showed promising early results in patients with locoregional and/or metastatic HNSCC. Median overall survival (OS) was not reached at data cut-off, with an estimated survival rate of 52.4% at 24 months, and an objective response rate (ORR) of 35.3%. Adverse events were generally manageable, and the combination therapy was generally tolerated with an absence of synergistic serious adverse events.

The encouraging early efficacy and safety outcomes warrant additional clinical studies to substantiate and reinforce these interim findings. Rakuten Medical recently completed a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for the combination of ASP-1929 photoimmunotherapy and anti-PD-1 in the first-line recurrent HNSCC setting and discussed the key details for a multi-regional registrational study. Based on these results, Rakuten Medical plans to initiate this global phase 3 clinical trial with a primary endpoint of OS in the second half of 2024.

Disclaimer: These interim findings may change upon completion of follow-up and final data analysis.

Key findings

[Efficacy]

Clinically meaningful activity was observed
Median Overall Survival (OS) was not reached, with an estimated survival rate of 52.4% (95% CI: 25.9-73.4) at 24 months
The objective response rate (ORR) was 35.3% (6 patients, 95% CI: 14.2-61.7), which included 4 complete responses (CR) (23.5%, 95% CI: 6.8-49.9) and 2 partial responses (PR) (11.8%, 95% CI: 1.5-36.4)
Median time to response of 1.4 months
Median progression-free survival (PFS) was at 2.9 months (95% CI 1.4-14.6)
[Safety]

Adverse events were manageable and generally tolerated
No fatal serious adverse events (SAEs)
Two Grade 4 SAEs: laryngeal edema related to photoimmunotherapy and tumor hemorrhage unrelated to study treatment, both of which resolved
No synergistic SAEs due to ASP-1929 and anti-PD-1
Upcoming Rakuten Medical’s Poster Presentation at ASCO (Free ASCO Whitepaper)

Abstract Title: Recent safety and efficacy findings from a phase 1b/2 open-label combination study of ASP-1929 photoimmunotherapy with anti-PD-1 therapy in EGFR-expressing advanced head and neck squamous cell carcinoma (HNSCC)
Abstract Number: 6083
Abstract Link: View Source
Session Name: Poster Session – Head and Neck Cancer
Session Date: Sunday, June 2, 2024
Session Time: 9:00 a.m. – 12:00 p.m., CDT
First Author: David M. Cognetti, Department of Otolaryngology – Head and Neck Surgery, Thomas Jefferson University, US
Location: Exhibit Hall A, Poster Board #399

On May 24, 2024 Mabwell (688062.SH), an innovation-driven biopharmaceutical company, reported data and latest progress of the Phase I/II clinical study of 9MW2821, a novel Nectin-4-targeting ADC for multiple advanced solid tumors, which will be reported as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Mabwell Biotech, MAY 24, 2024, View Source [SID1234643693]).

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As of April 1, 2024, among 240 patients in the 1.25 mg/kg dose group in the Phase II clinical trial:

>> Urothelial Carcinoma (UC)
Of the 37 patients evaluable for efficacy assessment, the objective response rate (ORR) and disease control rate (DCR) were 62.2% and 91.9%, respectively, with median progression-free survival (mPFS) was 8.8 months and median overall survival (mOS) was 14.2 months.

>> Cervical Cancer (CC)
Of the 53 patients evaluable for efficacy assessment, 51% were previously treated with platinum-based doublet chemotherapy and bevacizumab, and 58% received platinum-based doublet chemotherapy and immune checkpoint inhibitor, with ORR and DCR were 35.8% and 81.1%, respectively. The mPFS was 3.9 months, with mOS not reached. Of the patients with Nectin-4 tumor cell staining intensity 3+, the ORR was 43.6% among the 39 evaluable patients.

>> Esophageal Cancer (EC)
Of the 39 patients evaluable for efficacy assessment, ORR and DCR were 23.1% and 69.2%, respectively, with mPFS of 3.9 months and mOS of 8.2 months; 37 of them were treated with platinum-based chemotherapy and immunotherapy previously.

>> Triple-negative Breast Cancer (TNBC)
Of the 20 patients with locally advanced or metastatic triple-negative breast cancer and evaluable for efficacy assessment, the ORR and DCR were 50.0% and 80.0% respectively. The mPFS was 5.9 months, and the mOS was not yet reached, with one patient achieved complete response (CR) and had been in CR for 20 months and is currently sustained to be CR.

>> Safety Profile
To date, the most common treatment-related adverse events (all grade, ≥grade 3) in the 240 patients in the 1.25 mg/kg dose group were white blood cell count decreased (50.8%, 23.3%), neutrophil count decreased (46.3%, 27.9%), anemia (43.8%, 8.3%), aspartate aminotransferase increased (42.1%, 2.9%), alanine aminotransferase increased (35.4%, 2.1%), asthenia (32.1%, 2.9%), rash (30.0%, 5.0%), decreased appetite (28.8%, 1.3%), nausea (26.7%, 0%), hyperglycemia (25.4%, 2.1%), platelet count decreased (24.2%, 4.6%), alopecia (24.2%, 0%), hypoaesthesia (22.5%, 1.7%), constipation (21.3%, 0%), vomiting (20.9%, 1.3%), hypertriglyceridemia (20.4%, 2.1%), and gamma glutamyl aminotransferase increased (15.8%, 5.4%). The data suggest that 9MW2821 has a manageable safety profile.

About 9MW2821
9MW2821 is the first site-specific conjugated novel Nectin-4-targeting ADC developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies, and the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data of cervical cancer, esophageal cancer and breast cancer. 9MW2821 has been granted Fast Track Designation (FTD) and Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma and esophageal cancer in Feb. 2024 and May 2024, respectively.

9MW2821 achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.

On May 24, 2024 xCures, a leading-edge healthcare technology company, reported the presentation of two abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024, to be held May 31 – June 4, at McCormick Place, Chicago, IL, USA (Press release, xCures, MAY 24, 2024, View Source [SID1234643686]).

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The two abstracts illustrate the value of xCures’ real-time healthcare data platform. The platform’s enhanced longitudinal nationwide data goes beyond traditional retrospective real-world data, allowing for analysis of electronic medical records from partnerships with sites of care nationwide. Through its platform and patient- and observation-driven real-time datasets, xCures helps partners learn from complex and multidisciplinary therapeutic approaches to provide valuable insights to improve outcomes.

"Access to real-time, longitudinal, uninterrupted clinical data offers an unparalleled capacity to extract insights from patient medical records," said Tim Stuhlmiller, Vice President of Scientific and Medical Affairs at xCures. "These abstracts showcase the importance of our partnerships and our platform’s incredible power to analyze outcomes and support evidence-based decisions, resulting in improved patient care."

In one work, xCures and their partner Genome Medical, a nationwide telehealth provider of genetic services, analyzed data from patients with germline genetic testing followed by genetic counseling, including cancer risk assessment. The platform generated structured clinical data from multiple care sites to determine the percentage of patients who underwent bilateral mastectomies after receiving genetic testing and genetic counseling from Genome Medical. This is one of the first studies to use multi-institution real-world data to assess the impact of genetic counseling and genetic testing.

Half of the patients with a genetic test result that indicated bilateral mastectomy elected to have a mastectomy done after discussing this guideline-based care option with a Genome Medical genetic counselor. As evidenced in prior research, bilateral mastectomy markedly reduces the risk of breast cancer.

"Access to longitudinal records across multiple care sites allowed us to more thoroughly assess how genetic counseling and genetic testing increase the uptake of guideline-recommended cancer prevention services," said Colleen Caleshu, Senior Director of Clinical Research at Genome Medical. "Our goal is to make genetics clinically actionable so patients can make more informed decisions about their health. By working with xCures, we are able to gain better insights into those decisions and the impact they have on the patients we serve."

In the other abstract, xCures partnered with the FibroFighters Foundation to better understand the landscape of real-world treatments for Fibrolamellar carcinoma (FLC) by tracking treatments, molecular profiling, and outcomes. This is essential for such a rare form of liver cancer without an established standard of care.

Patients with FLC undergo extensive molecular profiling with multiple novel therapeutic regimens employed in real-world practice. Raw imaging scans are being aggregated for central radiological review to measure the depth and duration of response offered by the recorded therapeutic strategies. This dataset is a rich resource for academic and government researchers to fuel research and define optimal treatment modalities. Topline statistics for the dataset are available at View Source

"xCures has done what no one else has been able to do for rare diseases, specifically for Fibrolamellar Carcinoma," said Paul Kent, MD, Medical Director of the FibroFighters Foundation. "We have the largest interactive, real-time scientific database of FLC ever collected, allowing doctors from 15 countries and 27 institutions to discuss their cases with expert FLC panelists of oncologists, surgeons, radiation oncologists, interventional radiologists, and patient advocates. xCures has driven the most important advances in clinical research for FLC ever."

Attendees of the ASCO (Free ASCO Whitepaper) Annual Meeting are encouraged to find Mika Newton, Max Goldstein, Tim Stuhlmiller, or Artem Petrov from xCures, who can provide in-depth insights, discuss potential collaborations, and showcase case studies from the platform’s implementation.

The abstracts presented:

Use of a nationwide, patient-powered observational platform to define the landscape of treatment, molecular profiling, and outcomes for fibrolamellar carcinoma.
Authors: Paul Kent, Alaa Awawda, Hiba Kouser, Alanis Sabates, Zachariah Cole, Mark Shapiro, Tom Stockwell, Timothy Stuhlmiller

View Source

and,

Leveraging real-world data from multiple institutions to assess the rate of bilateral mastectomy after cancer genetics evaluations with genetic counselors.
Authors: Ashley Daley, Callan Russell, Timothy Stuhlmiller, Zachary Kaufman, Jill Davies, Colleen Caleshu

View Source

On May 23, 2024 – Rakovina Therapeutics Inc. (TSX-V: RKV, the "Company" or "Rakovina Therapeutics") a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies reported the undertaking of a non-brokered Private Placement (the "Offering") for gross proceeds of up to $1.5 million at a purchase price of $0.10 per Unit (Press release, Rakovina Therapeutics, MAY 24, 2024, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-announces-1-5-million-non-brokered-private-placement [SID1234643685]). This includes lead orders totalling approximately $1.25 million from two new investors.

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Each Unit will be comprised of one (1) common share of Rakovina Therapeutics common share stock and one (1) share purchase warrant at a purchase price of $0.20 for a period of three years (36 months) after the closing date of the Offering. If the closing price for the Common Shares on the TSX Venture Exchange (the "TSXV") is $0.25 or greater for five consecutive trading days, the expiry date of the Warrant shall be accelerated to the date that is 30 days following the last day of the five-trading day period.

The Company plans to use the proceeds primarily to support research and development activities related to its recently announced Artificial Intelligence (AI) collaboration that provides exclusive access to the proprietary Deep Docking platform for DNA-damage response targets. Over the next 12 to16 weeks, Rakovina Therapeutics aims to screen over five billion potential drug candidates using this platform. The most promising lead candidates will be further validated in the Company’s laboratories at the University of British Columbia. Rakovina Therapeutics intends to advance these validated drug candidates to clinical trials in collaboration with pharmaceutical partners.

The Units will be sold on a non-brokered "private placement" basis in accordance with applicable Canadian securities laws and under applicable exemptions from prospectus and registration requirements and the securities will be subject to resale restrictions for a period of four months plus one day from the date of issue.

On May 24, 2024 Philogen reported that Prof. Dr. Axel Hauschild, on behalf of Philogen, is giving a presentation about the Phase III PIVOTAL study on May 31st, entitled "Phase 3 study (PIVOTAL) of neoadjuvant intralesional Daromun versus immediate surgery in fully resectable melanoma with regional skin and/or nodal metastases" (Press release, Philogen, MAY 24, 2024, View Source [SID1234643684]).

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Prof. Dr. Lukas Flatz, on behallf of Philogen, is presenting a poster about Philogen’s DUNCAN study on June 1st, entitled "Intralesional administration of L19IL2/L19TNF in high-risk locally advanced basal cell carcinoma or cutaneous squamous cell carcinoma"