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.

On February 6, 2023 Presage Biosciences, a biotechnology company whose mission is understanding the complexity of drug response in the tumor microenvironment, reported that it has entered into a new research collaboration with Poland-based biopharmaceutical company Pure Biologics to evaluate two of Pure Biologics’ very early stage assets in a Phase 0 intratumoral microdosing study (Press release, Presage Biosciences, FEB 6, 2023, View Source [SID1234626894]). Presage’s CIVO platform will be used to evaluate drug mechanism of action, potential indicators of efficacy, and drug combinations.

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"We are excited to work with a forward-thinking partner who grasps the power of Phase 0 for cancer drug development and the insights we can gain from drug-exposed areas of the human tumor microenvironment," said Rich Klinghoffer, PhD, Presage CEO. "We see this partnership as a tremendous opportunity for Presage to continue innovating and delivering key pharmacodynamic insights into a partner’s early-stage oncology assets."

"The tumor microenvironment is complex and we are enthusiastic about Presage’s innovative approach to obtain information about the effectiveness of our compounds faster than traditional Phase I and Phase II trials," said Dr. Filip Jelen, Pure Biologics Co-Founder and President of the Management Board. "Their CIVO platform will allow us to introduce our novel agents directly into patient tumors and provide the first real clues about drug efficacy."

The collaboration with Pure Biologics comes on the heels of Presage’s recently completed Phase 0 clinical trials (NCT04065555 and NCT04541108) with Takeda Pharmaceutical Company evaluating immune-oncology drugs alone and in combination in head and neck cancer patients. The trials demonstrated that CIVO is able to deliver key spatial biology and mechanistic insights. Presage expects to publish the results from both studies later this year.

About CIVO
Comparative In Vivo Oncology (CIVO) is Presage’s patented platform that enables multiplexed intratumoral microdosing and generation of detailed tumor profiling. Presage’s CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with molecular profiling technologies in both preclinical and Phase 0 trials in order to inform and de-risk oncology drug development.

On February 6, 2023 Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, reported that it now owns all rights to develop DF6002, its novel interleukin-12 (IL-12) cytokine investigational immunotherapy program, which is in Phase 1 clinical development, with dose escalation progressing successfully in monotherapy and in combination with nivolumab, in the U.S. and in Europe (Press release, Dragonfly Therapeutics, FEB 6, 2023, View Source [SID1234626893]). Clinical development is currently being carried out by Bristol Myers Squibb, but will be transferred to Dragonfly over the coming weeks.

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"We are very excited to have the Dragonfly developed IL12 asset back," said Joseph Eid, MD, Dragonfly’s President of Research and Development, who previously led the pioneering clinical development of KEYTRUDA. "Given the encouraging profile we have seen both in preclinical models and in the clinic to date, we are accelerating DF6002’s development across a range of indications and combinations."

"We have great respect for Bristol Myers Squibb, whose broad range of oncology agents and talented, experienced and committed team have made it a strong partner," said Bill Haney, Co-founder and CEO of Dragonfly Therapeutics.

Since an original 2017 collaboration focusing on hematology malignancies, BMS and Dragonfly have entered multiple additional collaborations which include both oncology and neuroinflammation targets. BMS has licensed six Dragonfly TriNKET drug candidates and has two of them presently in the clinic. BMS licensed a TriNKET from Dragonfly for neuroinflammation in January 2023.

"We appreciate the BMS team’s hard work on the development of DF6002, the most advanced drug in Dragonfly’s rich cytokine pipeline," said Bill Haney. "And we are excited that Dr. Eid, who has had such an extraordinary career rapidly and effectively advancing drugs in oncology, will now take charge of accelerating DF6002 in the clinic."

About DF6002
DF6002, Dragonfly’s extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated alone and in combination with nivolumab in participants with locally advanced or metastatic solid tumors [NCT04423029]. DF6002 is a monovalent IL12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002 is the most advanced in a pipeline of cytokines that Dragonfly is developing to address the high unmet need in patients with advanced cancer.

On February 6, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes for Health (NIH), to develop Actimab-A for the treatment of patients with acute myeloid leukemia (AML) and other hematologic malignancies (Press release, US NCI, FEB 6, 2023, View Source [SID1234626892]). Under the terms of the CRADA, the NCI will serve as the regulatory sponsor for any clinical trials mutually approved by both parties to study Actimab-A while Actinium will be responsible for supplying and distributing Actimab-A to participating clinical sites and providing additional support as needed. The CRADA will provide broad support for the development of Actimab-A alone or in combination with chemotherapy, immunotherapy, targeted agents and other novel combinations, in line with Actinium’s strategy of leveraging Actimab-A’s targeted radiotherapy mechanism to elicit synergistic effects.

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The CRADA studies will be overseen by NCI in collaboration with Actinium’s clinical development team. Through the CRADA, Actimab-A will be available at over 2,000 clinical trial sites under the Experimental Therapeutics Clinical Trials Network (ETCTN) and the National Clinical Trials Network (NCTN) that includes leading oncology network groups such as Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network (ECOG-ACRIN), Southwest Oncology Group (SWOG) and the Alliance for Clinical Trials in Oncology. Actimab-A studies may also be conducted through NCI’s MyeloMATCH program. NCI Cancer Therapy Evaluation Program (CTEP), which sponsors approximately two thirds of all combination cancer studies, will be accepting Letters of Intent (LOIs) or concepts for Phase 1, 2 or 3 studies of Actimab-A in AML and other hematological malignancies.

Sandesh Seth, Actinium’s Chairman and CEO, said, "We are incredibly honored to be collaborating with NCI and excited that they share our vision for Actimab-A’s potential for the treatment of AML and other blood cancers. The CRADA will allow Actimab-A’s broad applicability to be fully studied and developed by leading oncology network groups as well as NCI’s leading-edge MyeloMATCH program in ways Actinium could not do independently. NCI’s sponsorship will also allow us to accelerate novel Actimab-A combinations and broaden its use in AML and other hematological indications, while the collaboration with NCI, who funds and maintains the largest centralized clinical trial support systems in the United States, will help preserve our balance sheet for additional corporate priorities."

Dr. Avinash Desai, Chief Medical Officer of Actinium Pharmaceuticals, commented, "NCI’s broad support under the CRADA is a strong encouragement for us to together explore Actimab-A’s potential for the treatment of AML and other hematologic malignancies. As the only CD33 targeting radiotherapy in development, Actimab-A is uniquely positioned to address the challenges in treating relapsed or refractory AML patients who do not respond well to front line therapies and those whose disease stops responding to traditional cytotoxic or available targeted therapies. We are highly encouraged by the high rates of responses, minimal residual disease negativity and strong survival benefit at 1 and 2 years in heavily treated patients, including prior Venetoclax treatment and/or transplant, and those with adverse cytogenetics, including TP53 mutations, recently reported from the Actimab-A CLAG-M combination study. We look forward to working collaboratively with the NCI and all investigators through this CRADA to complete multiple clinical trials to further realize Actimab-A’s therapeutic potential."