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"

On May 24, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported the company will presented two abstracts at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Philogen, MAY 24, 2024, View Source [SID1234643683]). One is a trial-in-progress abstract discussing cohort 5 of the GOBLET study, which will evaluate the combination of pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. The second describes pelareorep’s ability to induce the expansion of tumor-infiltrating lymphocytes (TILs) across multiple cancers and the correlation between TIL expansion and tumor response. The ASCO (Free ASCO Whitepaper) annual meeting will take place from May 31 – June 4, 2024, in Chicago, Illinois.

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"The two abstracts that we are sharing at ASCO (Free ASCO Whitepaper) this year are in synch with our mission of advancing pelareorep towards registrational trials. The first abstract outlines the design of a new GOBLET PDAC cohort that could significantly expand the potential of the company’s pancreatic cancer program," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "The chemotherapy regimens of mFOLFIRINOX and gemcitabine/nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates nearly triple historical results. Should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy. This cohort is being funded by a US$5 million grant in the form of the Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN). We anticipate enrollment in this cohort will begin this quarter."

Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics stated, "Pelareorep stimulates a proinflammatory response that primes tumors for immunologic killing and also activates both innate and adaptive immune responses. Our second ASCO (Free ASCO Whitepaper) abstract provides additional support for pelareorep’s immunotherapeutic mechanism of action by describing its ability to stimulate the expansion of pre-existing and new TIL clones in the blood, which correlate with treatment response. These results build upon previously reported data from the AWARE-1 study in breast cancer to expand our understanding of pelareorep’s immune-based mechanism of action, and it supports further investigation of TIL expansion as a potential biomarker of clinical activity in patients treated with pelareorep."

Details on the abstracts and poster presentation are shown below.

Title: Phase 1/2 randomized, open-label, multicenter, Simon two-stage study of pelareorep combined with modified FOLFIRINOX +/- atezolizumab in patients with metastatic pancreatic ductal adenocarcinoma.
Presentation Type: Poster
Abstract Number: TPS4203
Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: June 1, 2024, 1:30 – 4:30 p.m. CT

A copy of the ASCO (Free ASCO Whitepaper) presentation will be available on the Media page of Oncolytics’ website (LINK) following the conclusion of the meeting.

Highlights from the GOBLET cohort 5 abstract and poster include:
•The study utilizes a Simon two-stage design to evaluate patients with newly diagnosed metastatic PDAC.
•In Stage 1, 15 evaluable patients per arm will be randomized to receive either: 1) pelareorep + mFOLFIRINOX, or 2) pelareorep + mFOLFIRINOX + atezolizumab.
•The co-primary endpoints are objective response rate and safety. Secondary and exploratory endpoints include additional efficacy assessments (e.g., progression-free and overall survival), and biomarker evaluations.
•If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled.
•Blood and tumor samples are being collected for translational evaluations.

Title: Pelareorep driven blood TIL expansion in patients with pancreatic, breast and colon cancer.
Presentation Type: Online abstract
Abstract Number: e14625

Highlights from the abstract include:
•The presence and expansion of TILs are associated with a better prognosis and response to treatment in cancer patients.
•Pelareorep treatment increased TIL expansion in the blood in all pancreatic, breast, and colorectal cancer patients evaluated after one cycle of treatment.
•Pre-existing TIL clonal expansion in the blood appears to correlate with tumor responses in pancreatic cancer patients.
•The addition of the PD-L1 inhibitor avelumab, unlike atezolizumab, eliminated pre-existing TIL expansion in the blood and reduced pelareorep’s clinical activity.
•These data suggest that pelareorep offers a simple, reliable way to expand TILs to provide clinical benefit.

About GOBLET Cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising five treatment groups:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients;

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.