On December 15, 2022 AnHeart Therapeutics, a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, reported that the U.S. Food & Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to proceed with a global Phase 2 study of safusidenib for the treatment of patients with IDH1 mutant glioma (Press release, AnHeart Therapeutics, DEC 15, 2022, View Source [SID1234625339]). Glioma is a type of cancer that develops in the glial cells of the brain.

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"Receiving IND clearance from US FDA to advance safusidenib into a global Phase 2 trial in glioma represents an important milestone, as we continue to advance our clinical pipeline of precision oncology therapeutics," said Bing Yan, M.D., Co-Founder and Global Chief Medical Officer, AnHeart Therapeutics. "We are excited about the prospects of our mIDH1 inhibitor and how it can address the unmet medical need for patients with glioma, one of the most common type of primary brain tumors."

"Current standard of care treatment for IDH mutant glioma is far from satisfying, and no targeted therapy or immuno-therapy has been approved to treat lower grade glioma patients with IDH1 mutations. We look forward to working with AnHeart Therapeutics to further develop safusidenib in the clinical setting for IDH1 mutant glioma patients who desperately need therapies with a better efficacy and safety profile," said David A. Reardon, M.D., Dana-Farber Cancer Institute and Harvard Medical School.

Safusidenib is a potent, small molecule mIDH1 inhibitor. Mutations in IDH1 are frequently found in various tumor types such as glioma, cholangiocarcinoma, and chondrosarcoma. Safusidenib has also shown high blood brain barrier penetration from prior studies.

A Phase 1 clinical trial of safusidenib in glioma patients demonstrated a promising efficacy and safety profile in 12 non-enhancing and 35 enhancing glioma patients. The objective response rate (ORR) was 33% and 17% in non-enhancing and enhancing patients, respectively.

The Phase 2, multicenter, open label, clinical study will evaluate the efficacy and safety of safusidenib in patients with WHO Grade II or Grade III glioma.

About Glioma

Glioma is a type of cancer that develops in the glial cells of the brain. Gliomas are classified into Grades I, II, III or IV. Mutations in IDH1 are present in the majority of adult Grade II and Grade III gliomas (together categorized as lower grade glioma). IDH1 mutations are observed in about 75% of lower-grade gliomas, where no approved targeted therapy is available. Approximately 30,000 patients are newly diagnosed with mIDH1+ lower-grade glioma in the US, Europe and China annually.

On December 15, 2022 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors, reported the acceptance of four clinical data abstracts supporting its lead oncology product candidate, RenovoGem, and its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform to be presented at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) (Press release, Renovorx, DEC 15, 2022, View Source [SID1234625338]). The Symposium is to be held on January 19-21, 2023 in San Francisco, California and online.

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RenovoGem (gemcitabine, an FDA-approved chemotherapy, delivered via the Company’s proprietary delivery system) utilizes pressure mediated delivery of drug across the arterial wall to bathe tumor tissue in chemotherapy via RenovoTAMP. RenovoGem is currently being evaluated in a Phase III clinical trial in Locally Advanced Pancreatic Cancer (LAPC) patients and the Company plans to investigate RenovoGem in extrahepatic Cholangiocarcinoma (eCCA), beginning in the first half of 2023.

"These research presentations will mark the beginning of a significant year at RenovoRx," said Shaun Bagai, CEO of RenovoRx. "We anticipate continued strong progress on the TIGeR-PaC study with our most significant milestone to date: the first prospective interim analysis of TIGeR-PaC. We also plan to launch a clinical program in extrahepatic Cholangiocarcinoma (bile duct cancer), the second clinical indication for RenovoGem and the RenovoTAMP platform."

"We are excited to present clinical research data generated by some of our investigators of the TIGeR-PaC study at ASCO (Free ASCO Whitepaper) GI," said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. "These abstracts cover topics relevant to treatment of patients participating in the TIGeR-PaC study. Furthermore, we will also share data regarding the difference in systemic level of gemcitabine using our therapy platform versus the conventional treatment approach for LAPC which is central to our goal of presumed increased efficacy for RenovoTAMP with less systemic side effects."

Poster Presentations Details:

Title: Incidence and Clinical Characteristics of Patients with Locally Advanced Pancreatic Cancer (LAPC) and Mesenteric Vein thrombosis and Current Treatment Paradigm
Authors: Amer H. Zureikat, MD, et al.
Abstract ID: 392418

Title: Intra-arterial Gemcitabine vs IV Gemcitabine PK Sub-study in Patients with Locally Advanced Pancreatic Cancer
Authors: Amer H. Zureikat, MD, et al.
Abstract ID: 394254

Title: Toxicity and Efficacy of Stereotactic Body Radiation Therapy vs. Intensity-modulated Radiation Therapy for the Treatment of Locally Advanced Pancreatic Cancer in a Phase III Trial
Authors: Karyn A. Goodman, MD, et al.
Abstract ID: 392402

Title: Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-paclitaxel Following Induction with Sequential IV gemcitabine Plus Nab-paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer (TIGeR-PaC): A Randomized Phase III Multi-Center Study (Clinical Trials in Progress)
Authors: Michael J. Pishvaian, MD, et al.
Abstract ID: 393234

About the Phase III TIGeR-PaC Clinical Trial
TIGeR-PaC is a randomized multi-center Phase III study using RenovoRx’s innovative therapy platform, RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion). The study is evaluating the Company’s first product candidate, RenovoGem, to treat locally advanced pancreatic cancer (LAPC) through the intra-arterial delivery of gemcitabine (FDA-approved chemotherapy). The study has a primary endpoint of overall survival and several secondary endpoints, including quality of life.

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit View Source

On December 15, 2022 TRANSGENE (Paris:TNG) reported that Management will participate in several investor events in January and February 2023, as set out below (Press release, Transgene, DEC 15, 2022, View Source [SID1234625337]).

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Transgene will meet institutional investors at the 12th Annual LifeSci Advisors Corporate Access Event and at BIO Partnering at JPM in San Francisco from January 9 to 12, 2023, in conjunction with the J.P. Morgan Healthcare conference.

The Company will also attend:

26th ODDO BHF Forum (virtual): January 9-10, 2023;
Invest Securities Biomed Forum: January 24, 2023;
Degroof Petercam’s Virtual Healthcare Conference: January 27, 2023;
BIO CEO & Investor Forum (New York): February 6-9, 2023.

On December 15, 2022 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that China National Medical Products Administration (NMPA) has accepted the new drug application (NDA) from Juventas Cell Therapy, Ltd., (Juventas) for CNCT19 (Inaticabtagene Autoleucel), an investigational CD-19 directed CAR-T therapy, for the treatment of adult patients with relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL) (Press release, CASI Pharmaceuticals, DEC 15, 2022, View Source [SID1234625336]).

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CNCT19 is the first CAR-T cell therapy for the treatment of B-ALL submitted for NDA and has the potential to be the first approved domestic developed CD19 directed CAR-T therapy in China. Owing to the unique CD19 scFv（HI19a）structure and the leading CMC manufacturing techniques, CNCT19 indicated an 100% success rate of drug production from r/r B-ALL patients in the registrational trial. It has been granted the Orphan Drug Designation from the FDA and the Breakthrough Designation status by the China Center of Drug Evaluation (CDE).

The r/r B-ALL NDA submission for CNCT19 contains the initial data from study NCT04684147, a Phase II, single-arm, open-label, single-dose, multicenter clinical trial. The study results reveal that CNCT19 has demonstrated a high level of efficacy, durable remissions, and substantially reduced CAR-T related toxicity for the treatment of adults with r/r B-ALL. Professor Wang Jianxiang, the Principal Investigator of CNCT19 from the Institute of Hematology and Blood Diseases Hospital, and his team presented the study results at the 64th Annual Meeting of American Hematology (2022 ASH (Free ASH Whitepaper)) on December 12th, 2022.

CNCT19 CAR-T cell therapy achieved outstanding ORRs with high rates of MRD-negative complete remission in adult patients with r/r B-ALL within three months and by the end of the third month. Of the 39 evaluable patients, 32 (82.1%) patients reached CR/CRi within three months and 25 (64.1%) patients remained CR/CRi by the end of the third months. The CR rates were 66.7% (26/39) and 51.3% (20/39) respectively. The MRD-negative rate was 100% (32/32) within three months and persisted at 92% (23/25) by the end of the third month. Median duration of response (DOR) has not been reached.

The most common CNCT19 related adverse events (AEs) were cytokine release syndrome (CRS) and neuro toxicity (NT). There were 4 cases of Grade ≥3 CRS (n=4, 10.3%) and 3 cases of Grade ≥ 3 NT (n=3, 7.7%). Following CNCT19 infusion, all the patients recovered without any unexpected AEs reported.

Dr. Wei-Wu He, CASI’s Chairman and CEO commented, "CNCT19 NDA acceptance by NMPA represents a significant milestone. We are in preparation for the anticipated CNCT-19 commercial launch. This product is truly exciting as it proved to have significant clinical benefits for unmet medical needs. CASI and Juventas will work side by side to deliver CNCT19 to patients in China, and eventually worldwide."

On December 15, 2022 ImpediMed Limited (ASX: IPD) reported a poster showing that breast cancer patients receiving early detection of lymphedema using ImpediMed’s L-Dex technology and intervention had statistically higher rates of lymphedema progression-free survival through three years compared to using tape measure was presented at the 2022 San Antonio Breast Cancer Symposium on December 6-10, 2022 in San Antonio, Texas (Press release, ImpediMed, DEC 15, 2022, View Source [SID1234625335]).

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L-Dex monitoring with intervention translated into lower risk of chronic breast cancer-related lymphedema

New Data Presented at the 2022 San Antonio Breast Cancer Symposium Shows Early Detection using L-Dex and Intervention Improves Lymphedema Progression-Free Survival
New Data Presented at the 2022 San Antonio Breast Cancer Symposium Shows Early Detection using L-Dex and Intervention Improves Lymphedema Progression-Free Survival
The poster, titled "Bioimpedance spectroscopy monitoring reduces long-term clinical lymphedema risk" includes a Kaplan-Meier analysis of data from the PREVENT Trial to assess lymphedema progression-free survival in breast cancer patients who triggered for subclinical lymphedema and received intervention (n=209). The analysis showed that there were statistically higher rates of lymphedema progression-free survival in patients screened for subclinical lymphedema using L-Dex compared to using tape measure, p = 0.021.

"L-Dex monitoring for subclinical lymphedema with subsequent intervention translated into significantly lower risk of chronic lymphedema in breast cancer patients compared to monitoring with tape measure and intervention," commented Dr. Chirag Shah, Director of Breast Radiation Oncology and Director of Clinical Research in the Department of Radiation Oncology at Cleveland Clinic, co-investigator of the PREVENT Trial, lead author on the poster, and scientific adviser to ImpediMed.

He continued, "Chronic lymphedema is a serious side effect of breast cancer treatment that dramatically impacts patients’ quality of life in survivorship. The results of this poster further reinforce the need for long-term monitoring of breast cancer patients for subclinical lymphedema following cancer treatment since progression to chronic lymphedema occurred throughout the three-year follow-up period."

The primary aim of the PREVENT Trial was published in January 2022 and demonstrated that patients with early detection using L-Dex and at-home intervention with compression garments resulted in a 7.9% rate of chronic lymphedema compared to a 19.2% rate of chronic lymphedema using tape measure. The difference is statistically significant (p=0.016) as well as being clinically significant for patients and clinicians. This represents an absolute reduction of 11.3% and relative reduction of 59% in lymphedema progression at three years.

The primary aim paper also included a risk-adjusted analysis, which showed a significantly consistent benefit of L-Dex monitoring in a large group of patients with key risk factors for breast cancer-related lymphedema including body weight, stage of cancer, type of cancer surgery, lymph node dissection, chemotherapy, and radiation (odds ratios: 0.23-0.39). Today, L-Dex is the only non-invasive, reliable, validated tool to help clinicians identify subclinical lymphedema. Monitoring L-Dex scores allows clinicians across multiple specialties to provide individualized, proactive care that can help improve patient outcomes.

To learn more about the PREVENT Trial, visit www.impedimed.com/stopping-lymphedema-starts-with-prevent/.

About Lymphedema
Lymphedema is a side effect of cancer treatment. It currently affects about 1-in-3 patients who have undergone surgery, radiation, or chemotherapy, each of which may compromise the lymphatic system. Lymphedema is characterized by abnormal swelling that generally occurs in one of the arms or legs, and sometimes both arms and both legs. Patients with lymphedema also have a greater risk of getting infections. Cuts or small breaks in the skin can lead to serious complications and hospitalizations. Currently, no cure for lymphedema exists. By the time patients experience swelling, the condition is typically irreversible. However, extensive research indicates that prevention is possible if lymphedema is caught early and ImpediMed’s L-Dex technology, which is available on the SOZO Digital Health Platform, has the most extensive evidence of efficacy for early detection.