On February 6, 2023 Kezar Life Sciences, Inc., (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported that the Compensation Committee of the company’s Board of Directors granted five employees nonqualified stock options to purchase 131,000 shares of its common stock with an exercise price of $7.10 per share, which is equal to the closing price of Kezar’s common stock on February 3, 2023, the grant date of the awards (Press release, Kezar Life Sciences, FEB 6, 2023, View Source [SID1234626899]). The stock options were granted as an inducement award material to the individuals entering into employment with Kezar, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options will vest over a four-year period, with 25% of each option vesting on the first anniversary of the employee’s start date, and 1/48th of the total shares vesting monthly thereafter, subject to continued employment on each vesting date. The options are subject to the terms and conditions of Kezar’s 2022 Inducement Plan and the stock option agreement covering the grants.

On February 6, 2023 InnoCare reported American Journal of Hematology recently published the phase 2 study result of BTK (Bruton Tyrosine Kinase) inhibitor orelabrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) patients (Press release, InnoCare Pharma, FEB 6, 2023, View Source [SID1234626898]). The journal concluded that monotherapy of orelabrutinib demonstrated compelling efficacy and a well-tolerated safety profile, with a significant number of patients achieving CR in R/R CLL/SLL.

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In the study, 80 eligible patients were enrolled. IRC-assessed overall response rate (ORR) and complete response (CR) was 92.5% and 21.3% respectively. Based on the investigator evaluation, the ORR and CR was 93.8% and 26.3% respectively. The median progression-free survival (PFS) had not been reached, and the 30-month PFS rate and overall survival (OS) rate was 70.9% and 81.3% respectively. Orelabrutinib also revealed substantial response in patients with high prognostic risks: the ORR of patients with del(17p) or TP53 mutation, del(11q), and unmutated immunoglobulin heavy-chain variable region gene (IGHV) was 100%, 94.7%, and 93.9%, respectively.

Patients achieved a quick and sustained response. The median time to first response was 1.9 months. The response rate increased with treatment time. Compared with the data at a median follow-up of 8.7 months, the CR/CRi rate increased from 3.8% to 21.3% and ORR increased from 88.8% to 92.5% at median follow-up of 32.3 months.

Orelabrutinib demonstrated a well-tolerated safety profile. Most adverse events (AEs) were Grade 1 or 2. Similar to the observation in other studies with orelabrutinib, atrial fibrillation/flutter was not observed in this study.

Professor Jianyong Li, Department of Hematology, Pukou CLL Center, The First Affiliated Hospital of Nanjing Medical University, said, "This study confirmed that orelabrutinib was efficacious in treating R/R CLL/SLL patients, with durable responses and an improved safety profile. As a selective BTK inhibitor with favorable pharmacokinetic and pharmacodynamic properties, orelabrutinib provides an alternative therapeutic option for patients with R/R CLL/SLL.

Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), one of the most common types of leukemia, is an indolent malignancy of B lymphocytes, mainly affecting the elderly population. Although CLL/SLL is indolent, some patients will progress over time. There are 191,000 newly diagnosed CLL cases and 61,000 deaths every year globally. Long-term treatment for CLL/SLL is very important, since early discontinuation will compromise the efficacy. A new generation of BTK inhibitors with higher selectivity and improved safety profiles is in urgent need.

The American Journal of Hematology is an academic journal focusing on hematology, which was founded in 1976 and published monthly by WILEY publisher. The journal has been included in SCIE and SCI databases, with an impact factor of 13.268 in 2022.

Note: In addition to background information, the content of this press release is derived from this published article. Full text can be found in View Source

About Orelabrutinib

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On Dec. 25 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.

The supplemental New Drug Applications of orelabrutinib for the treatment of R/R WM and R/R Marginal Zone Lymphoma were accepted in China.

In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies, such as first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).

In addition, orelabrutinib is also being evaluated in global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.

On February 6, 2023 RNAimmune, Inc. (the "Company" or "RNAimmune"), a biopharmaceutical company specializing in discovery and development of mRNA-based therapeutics and vaccines, reported that its RNAimmune mRNA cancer vaccine program has been accepted for oral presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2023 (Press release, RNAimmune, FEB 6, 2023, View Source [SID1234626897]). The AACR (Free AACR Whitepaper) Annual Meeting will take place April 14-19 in Orlando, Florida.

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Title: A pan-ras mRNA vaccine elicits specific immune responses and inhibits tumor growth in the mouse model of colon cancer

Presenter: Dong Shen, MD PhD, RNAimmune founder and President

Session Category: Experimental and Molecular Therapeutics

Session Title: New Tricks for Known Targets: Novel Approaches to Inhibit Oncogenic Signaling

Session Date/Time: Tuesday, Apr 18, 2023, 2:30 PM – 4:30 PM ET

Note: The presentation will also be published in the online Proceedings of the AACR (Free AACR Whitepaper).

Venue: Orange County Convention Center, Orlando, Florida

RNAimmune will present a pre-clinical study showing the most recent mRNA cancer vaccine progress. The study shows immunization of the mRNA vaccine can elicit T and B cell responses, which are crucial in anti-cancer immunotherapy, and inhibit tumor growth in the mouse model of colon cancer, prolonging survival. Notably, the anti-tumor effect is further enhanced in the combination of anti-PD1 antibody.

RAS is one of the most common mutated oncogenes in human cancer. Unfortunately, there is still a lack of specifically effective medication for most RAS-mutated cancer patients. For G12C-mutated patients, drug resistance frequently appears soon after targeted therapy. The reported Pan RAS mRNA cancer vaccine was designed and screened by RNAimmune, which owns its proprietary independent intellectual property rights. Its anti-tumor effects have been validated both in vitro and in vivo. The current program yielded outstanding antitumor activity, and the Company plans to submit to the U.S. Food and Drug Administration an Investigational New Drug application after completion of the current dose titration study.

Found in 1907, AACR (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to fighting against cancer. The annual meeting of AACR (Free AACR Whitepaper) is one of the biggest meetings in the global cancer research community, and it highlights the latest advances in anti-cancer research and development from all over the world.

On February 6, 2023 Aethlon Medical, Inc. (NASDAQ: AEMD), a company developing medical therapeutics to treat cancer and life-threatening infectious disease, reported that it will issue financial results for its third quarter ended December 31, 2022, at 4:15 p.m. EST on Monday, February 13, 2023 (Press release, Aethlon Medical, FEB 6, 2023, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-third-quarter-financial-results-and-host-conference-call-on-february-13-2023-301738635.html [SID1234626896]).

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Management will host a conference call on Monday, February 13, 2023 at 4:30 p.m. EST to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:
PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442
All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through March 13, 2023. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 4716809.

On February 6, 2023 J INTS BIO announced that the preclinical results of "JIN-A04," a novel oral tyrosine kinase inhibitor (TKI) targeting HER2 Exon20 insertion mutation in NSCLC, will be presented at the upcoming 2023 American Cancer Research Association meeting in Orlando, U.S. from April 14 to 19 (Press release, J INTS BIO, FEB 6, 2023, View Source [SID1234626895]).

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HER2 Exon20 insertion mutation accounts for 2-3% of NSCLC and there is currently no approved oral targeted therapy.

"JIN-A04" showed potent efficacy against HER2 Exon20 insertion mutant NSCLC cell lines, and in-vivo mouse models using HER2 Exon20 insertion mutant cell lines significant tumor regression was demonstrated.

J INTS BIO completed the application for designation of ‘JIN-A04’ as an orphan drug with the US FDA in August last year and said that the procedure for designation as an orphan drug is in progress. As a result, the company said, "If JIN-A04 is approved for designation as an orphan drug, it will be possible for it to be used in patients after the completion of Phase 1 and Phase 2 clinical trials." To this end, the company plans to submit an IND to the US and Korea in the first half of this year, allowing us to enter Phase 1 clinical study in the US and Korea simultaneously.