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I-Mab Reports Multiple Positive Clinical Updates of Differentiated CD47 Antibody Lemzoparlimab

On September 30, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported multiple clinical advancements of its anti-CD47 monoclonal antibody lemzoparlimab (also known as TJC4) (Press release, I-Mab Biopharma, SEP 30, 2021, View Source [SID1234590606]).

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I-Mab has initiated a phase 2 expansion trial (NCT03934814) of lemzoparlimab in combination with rituximab (Rituxan) in non-Hodgkin’s lymphoma (NHL) patients in China. The expanded trial is part of the ongoing international multi-center trial (IMCT) that is being conducted in the U.S. and now also in China. The study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamic (PD) and determine the recommended phase 2 dose (RP2D) of lemzoparlimab in combination with rituximab in patients with lymphomas. On September 28, 2021, the first patient in the expanded trial was dosed. Patient enrollment for the trial is expected to be completed in a few months.

Progress in clinical trials of lemzoparlimab in NHL and AML/MDS:

In the U.S. clinical trial of lemzoparlimab in combination with rituximab for NHL patients, the preliminary efficacy and safety data have been summarized and submitted for presentation at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The expanded clinical trial is on track and expected, pending approval by the NMPA, to lead to a registrational trial in patients with NHL in 2022 in China.
In the China clinical trial of lemzoparlimab in combination with azacitidine (AZA) in patients with myelodysplastic syndrome (MDS), preliminary clinical response data is being evaluated, and patient enrollment is on track for completion in Q4 2021, the complete data set will be analyzed and reported at a later time. The Company plans to initiate another registrational trial in patients with MDS in 2022 in China based on the efficacy and safety data from this study, pending approval by the NMPA.
Progress in clinical trials of lemzoparlimab in patients with solid tumors:

I-Mab is currently investigating lemzoparlimab in combination with pembrolizumab (Keytruda) in advanced solid tumors in U.S. Data readout is expected in early 2022. Further, on September 16, the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) approved the Company’s IND application to advance to a phase 2 clinical trial of lemzoparlimab in combination with toripalimab (TUOYI) in patients with advanced solid tumors. The combined clinical results will potentially support a registrational trial later in China.

In all clinical trials conducted so far by the Company, including NHL, AML/MDS and solid tumors, lemzoparlimab have been evaluated without the need of a priming dose.

"Accumulative data from the ongoing lemzoparlimab clinical trials further increase our understanding of its safety, PK and efficacy profile," said Dr. Joan Shen, CEO of I-Mab. "We are encouraged by the clinical data of lemzoparlimab obtained so far and are rapidly advancing the clinical development of lemzoparlimab towards multiple registrational trials, with the goal of becoming the first CD47 antibody drug in China."

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at I-Mab have discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.

I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for solid tumors in the U.S. and with Rituxan for lymphoma in the U.S. and China, in addition to an on-going clinical trial in patients with AML in China.

In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. AbbVie has assumed sponsorship of the U.S. study as of April 2021.

CNS Pharmaceuticals Doses First Group of Patients with Berubicin, an FDA-Designated Fast Track Drug Candidate, in the Potentially Pivotal Study for the Treatment of Glioblastoma Multiforme (GBM)

On September 30, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported the dosing of the first patients in its Berubicin clinical development program for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer (Press release, CNS Pharmaceuticals, SEP 30, 2021, View Source [SID1234590605]). Further patient enrollment, randomization and dosing is currently underway as well as a robust lineup of clinical sites located globally which are advancing toward activation and enrollment.

"As one of the most aggressive, deadly and treatment-resistant cancers that forms in the brain where current standard of care remains ineffective in ~60% of patients, the treatment landscape for GBM is in desperate need of a better treatment option. We continue to be encouraged by the data seen from Berubicin to date and are excited to now have patient dosing underway in this potentially pivotal trial. Our team is committed to expeditiously advancing the study and look forward to further understanding the full potential of Berubicin to offer improvement and overall survival in this devastating disease," stated Erin Dunbar, M.D., founding physician of the Brain Tumor Center and Director of Neuro-Oncology at Piedmont Atlanta Hospital, and Principal Investigator for the study.

Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a global potentially pivotal study evaluating its efficacy and safety. The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. Approximately 243 patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine for the evaluation of Overall Survival, the primary endpoint of the study. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration (FDA) has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.

In the Phase 1 clinical trial previously conducted evaluating Berubicin in patients with previously treated disease, 44% of the patients showed clinical benefit (49% of the Avastin-naïve patient population), with the demonstration that it was effective based on this patient population with a dismal median survival rate of only 14.6 months from diagnosis. One patient in the Phase 1 study had a durable Complete Response (CR, a demonstrated lack of detectable cancer cells) that has continued for 14 years, and another patient had a durable partial response, with others showing substantial stabilization of disease. Additionally, the novel anthracycline agent Berubicin appears to have a toxicity profile consistent with that of other anthracyclines and demonstrates activity as monotherapy for recurrent glioblastoma multiforme. Berubicin has side effects that are able to be effectively treated and managed.

"I am extremely pleased with the progress made to-date in this potentially pivotal trial. Our team has been working intensely to open sites in the U.S. and in Europe, understanding where we can best advance this important study. With hundreds of potentially competing GBM trials currently enrolling patients, the fact that we’ve been able to bring these initial sites on-line and get patients enrolled and dosed not only supports our strategic evaluation and selection, but also allows our data demonstrating Berubicin’s potential effectiveness to continue to convince the medical community that we have a new drug with impressive potential. With the de-risked profile of Berubicin, its mechanism of action, history of development, encouraging Phase 1 data, and safety in study design, I am personally more optimistic about our work than at any time since joining the Company," commented John Climaco, CEO of CNS Pharmaceuticals.

"The investigator dedication to advance the science and development of Berubicin we’re seeing here is meaningful to these patients that are out of options. Berubicin provides an innovative option for treatment in GBM as a safe and potentially effective therapy. We look forward to providing data at the interim analysis of the study," added Sandra L. Silberman, M.D., Ph.D. Chief Medical Officer of CNS Pharmaceuticals.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA. Taken together the Company believes these important designations can be seen as a recognition of the significance of not only the unmet clinical need in GBM, but of our Berubicin program.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

Jubilant Therapeutics Announces Successful Completion of Pre-IND Meeting with FDA for its Novel Dual LSD1 and HDAC6 Inhibitor JB1-802

On September 30, 2021 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan, clinical study design and dosing strategy for the Phase I/II trial of JB1-802, a dual inhibitor of LSD1 and HDAC6, for the treatment of small cell lung cancer, treatment-induced neuro-endocrine prostate cancer and other mutation-defined neuroendocrine tumors (Press release, Jubilant Therapeutics, SEP 30, 2021, View Source [SID1234590604]).

A pre-IND meeting provides the drug development sponsor an opportunity for an open communication with the FDA to discuss the IND development plan and to obtain the agency’s guidance regarding planned clinical evaluation of the sponsor’s new drug candidate. After reviewing the preclinical data provided, plans for additional data generation and the Phase I/II clinical trial protocol, the FDA addressed Jubilant Therapeutics’ questions, provided guidance and aligned with the sponsor on the proposed development plan for JBI-802.

"We appreciate the FDA’s guidance as we endeavor to find an innovative new treatment for high unmet-need tumors with devastatingly low survival rates," said Hari S Bhartia, Chairman, Jubilant Therapeutics Inc.

"We are pleased with the outcome of the pre-IND meeting with the FDA and plan to submit the IND application by the end of 2021," said Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc.

BridGene Biosciences Announces Titles and Authors of Five Abstracts Accepted for Poster Presentations at the 2021 AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics

On September 30, 2021 BridGene Biosciences, Inc., a biotechnology company using a unique chemoproteomic technology to discover and develop small molecules for high value, traditionally undruggable targets, reported the titles of the abstracts accepted by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) for poster presentations during the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Press release, Bridgene Biosciences, SEP 30, 2021, View Source [SID1234590603]). BridGene submitted five abstracts detailing the company’s proprietary small molecule discovery platform, IMTAC (Isobaric Mass Tagged Affinity Characterization), BridGene’s latest discovery of therapeutic candidates, and the identification of new targets for approved small molecule drugs. The conference will take place virtually October 7–10, 2021.

The titles of the abstracts are currently available on the AACR (Free AACR Whitepaper) web site, with full abstracts, including the dates and times of presentations, scheduled for publication at 9:00 a.m. ET on October 7, 2021. The titles of the presentations are as follows:

Abstract Title: A chemoproteomic platform for identifying small-molecule modulators of protein-protein interactions, discovering new cancer targets, and revealing previously unknown targets for well-known drugs
Authors:
Cindy Huang, Ph.D., Senior Research Scientist, BridGene Biosciences
Vivian Zhang, Ph.D., Research Scientist, BridGene Biosciences
Ning Deng, Ph.D., Senior Research Scientist, BridGene Biosciences
Irene Yuan, Executive Vice President, BridGene Biosciences
Linda Pullan, Ph.D., Head of Business Development, BridGene Biosciences
C. Glenn Begley, Ph.D., Head of Biology, BridGene Biosciences
Ping Cao, Ph.D., CEO, BridGene Biosciences

Abstract Title: Identification of previously unknown targets for approved small-molecule drugs using chemoproteomic platform IMTAC
Authors:
Vivian Zhang, Ph.D., Research Scientist, BridGene Biosciences
Cindy Huang, Ph.D., Senior Research Scientist, BridGene Biosciences
Chao Zhang, Ph.D., Associate Professor of Chemistry, University of Southern California
Ping Cao, Ph.D., CEO, BridGene Biosciences

Abstract Title: Discovery of novel small-molecule inhibitors for an epigenetic modulator WDR5
Authors:
Cindy Huang, Ph.D., Senior Research Scientist, BridGene Biosciences
Shirley Guo, Ph.D., Principal Scientist, BridGene Biosciences
Ping Cao, Ph.D., CEO, BridGene Biosciences

Abstract Title: Discovery and development of novel covalent inhibitors of the YAP-TEAD transcription activity
Authors:
Shirley Guo, Ph.D., Principal Scientist, BridGene Biosciences
Cindy Huang, Ph.D., Senior Research Scientist, BridGene Biosciences
C. Glenn Begley, Ph.D., Head of Biology, BridGene Biosciences
Michael J. Bishop, Ph.D., Head of Chemistry, BridGene Biosciences
Ping Cao, Ph.D., CEO, BridGene Biosciences

Abstract Title: Discovery of a covalent inhibitor for an oncogenic mutant RhoAY42C
Authors:
Shirley Guo, Ph.D., Principal Scientist, BridGene Biosciences
Ping Cao, Ph.D., CEO, BridGene Biosciences

"We are excited to have all five of our abstracts accepted for poster presentations during this year’s AACR (Free AACR Whitepaper)-NCI-EORTC, which is among the most prominent scientific gatherings addressing drug discovery and molecular targets," stated Ping Cao, Ph.D., Co-Founder and CEO of BridGene Biosciences. "Our posters will illustrate how the work at BridGene has the potential to address multiple therapeutic areas and bring game-changing capabilities to drug discovery and development. Overall, the posters describe our IMTAC platform technology and its capabilities, the discovery of novel small molecule inhibitors for undruggable targets, and the identification of previously unknown targets for approved small molecule drugs. We look forward to having this opportunity to showcase the potential of BridGene’s technology."

Information about the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC conference may be accessed here.

About AACR (Free AACR Whitepaper)
The American Association for Cancer Research (AACR) (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer. Through its programs and services, the AACR (Free AACR Whitepaper) fosters research in cancer and related biomedical science; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer etiology, prevention, diagnosis, and treatment throughout the world.

Curaleaf to Report Third Quarter 2021 Financial and Operational Results

On September 30, 2021 Curaleaf Holdings, Inc. (CSE: CURA /OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer products in cannabis, reported that it will report its financial and operating results for the third quarter ended September 30, 2021 after market close on November 8, 2021 (Press release, Curaleaf Holdings, SEP 30, 2021, View Source [SID1234590602]).

Management will host a conference call and audio webcast that evening at 5:00 p.m. ET consisting of prepared remarks followed by a question and answer session related to the Company’s operational and financial highlights.

Event:

Curaleaf Third Quarter 2021 Financial Results Conference Call

Date:

Monday, November 8, 2021

Time:

5:00 p.m. ET

Live Call:

+1-888-317-6003 (U.S.), +1-866-284-3684 (Canada) or +1-412-317-6061 (International)

Passcode:

2599473

Webcast:

View Source

For interested individuals unable to join the conference call, a dial-in replay of the call will be available until November 15, 2021 and can be accessed by dialing +1-877-344-7529 (U.S.), +1-855-669-9658 (Canada) or +1-412-317-0088 (International) and entering replay pin number: 10160750.