On April 26, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it will release its first quarter 2021 financial results and operational highlights before open of U.S. markets on Thursday, May 6, 2021 (Press release, Autolus, APR 26, 2021, View Source [SID1234578494]).

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Management will host a conference call and webcast at 8:30 am ET/1:30 pm GMT to discuss the company’s financial results and provide a general business update. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 7756178. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 7756178.

On April 26, 2021 Biond Biologics Ltd. ("Biond" or the "Company"), a private clinical-stage biopharmaceutical company, developing novel immunotherapies for cancer and a platform enabling the intracellular delivery of biologics, reported that the first patient has been dosed in the first-in-human, phase 1 clinical trial of BND-22 (SAR444881), an Ig-Like Transcript 2 (ILT2) receptor blocking antibody (Press release, Biond Biologics, APR 26, 2021, View Source [SID1234578511]).

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The first patient was administered BND-22 at the Oncology Research Unit of the Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, one of the six US and Israel trial sites planned to initially participate in the phase 1, open-label, dose escalation study exploring the safety, tolerability, pharmacokinetics (PK), anti-tumor activity, and exploratory biomarkers for BND-22 activity in patients with select advanced solid tumors.

"BND-22 represents a novel approach to cancer immunotherapy targeting both adaptive and innate immune cells," said Ravit Geva, M.D., Research Unit Head and Deputy Director, Division of Oncology at the Tel Aviv Sourasky Medical Center, and a clinical investigator in the trial. "There continues to be an urgent need to develop new treatments for patients with cancers refractory to standard of care therapy. BND-22 has demonstrated compelling preclinical activity, and we look forward to further investigate the potential of ILT2 blockade in this Phase 1 study."

"The entry of BND-22 into the clinic is a significant milestone for Biond as it represents the achievement of an important aspect of the company’s vision to progress our novel medicines into clinical evaluation while using our drug discovery, development, and translation capabilities," said Tehila Ben Moshe, Ph.D., Co-Founder and Chief Executive Officer of Biond. "BND-22, a multi-cell checkpoint inhibitor, was studied extensively by our scientific team for several years and was found to have the potential to improve upon current treatment paradigms, either as a monotherapy or in combination. Based on in-depth translational studies of real-world patient samples we have designed the Phase 1 trial to focus on patient populations we believe are most likely to respond to ILT2 blockade. We look forward to the results of the BND-22-001 trial as we strive to improve the treatment of cancer patients with dire needs for new therapies."

Biond announced on January 12th, 2021 an exclusive worldwide license agreement with Sanofi, for the development and commercialization of BND-22. Under the terms of the agreement, Biond will lead the first-in-human, phase 1 study of BND-22, evaluating its safety and tolerability as a single agent and in combination with approved cancer therapeutics as well as exploring the association between BND-22 anti-tumor activity and select tumor and blood-based biomarkers; Sanofi will assume clinical development and commercialization responsibilities thereafter.

About BND-22

BND-22 is a humanized IgG4, antagonist antibody targeting the ILT2 receptor in development for the treatment of solid tumors. ILT2, a member of the ILT family of immuno-modulating receptors, is an inhibitory receptor expressed on both innate and adaptive immune cells that binds major histocompatibility complex (MHC) class I molecules including HLA-G, an immunosuppressive protein expressed by multiple tumor types.

BND-22 has been shown in preclinical studies to have a broad anti-tumor effect by targeting ILT2-mediated "do not eat me" signals in macrophages and by activating NK and CD8+ lymphocytes. The program is supported by a comprehensive biomarker strategy designed to guide patient enrollment in advanced clinical trials.

BND-22-001 is the first-in-human clinical trial of BND-22. It is a Phase 1/2 multicenter, open-label, dose escalation and expansion study enrolling advanced cancer patients with solid tumor types known to express HLA-G. Following dose escalation and determination of BND-22′ recommended Phase 2 dose, the study design allows for the expansion of patient cohorts to evaluate the anti-tumor activity of BND-22 in specific tumor types. BND-22-001 is planned to be expanded to also evaluate the safety and anti-tumor activity of BND-22 in combination with other therapies. For more information about the trial, including participating medical centers, please visit View Source (Trial Identifier: NCT04717375).

On April 26, 2021 Applied Cells, a commercial provider of cell preparation and isolation solutions for tumor biology research, reported that it will further its research collaboration on rare cell isolation of breast cancer disseminated tumor cells in bone marrow with the Perelman School of Medicine at the University of Pennsylvania (Penn)(Press release, Applied Cells, APR 26, 2021, View Source;utm_medium=rss&utm_campaign=applied-cells-inc-enters-collaborative-research-agreement-for-the-development-of-rare-cell-isolation-in-minimum-residual-disease [SID1234584031]). Applied Cells MARS technologies will be used in a multi-center trial as part of the 2-PREVENT (Secondary PREvention through SurVEillance and iNTervention) Translational Center of Excellence to evaluate their potential role in the detection of breast cancer minimum residual disease.

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Penn’s 2-PREVENT program focuses on the collaboration of clinical and basic science researchers with the goal of improving the surveillance, prevention, and treatment of recurrent breast cancer. Applied Cells MARS technologies will be evaluated in clinical trials to determine whether they will successfully pre-enrich extremely low frequency cancer cells in bone marrow samples that might result in high recovery. Applied Cells MARS workflow reduces human factors and ensures standardized operation, which are required for the trial.

"I am glad our MARS technologies will have the opportunity to be tested for ability to provide simplicity and desired performance," said Dr. Yuchen Zhou, CEO of Applied Cells. "We are very excited to further our collaboration with Penn Medicine to utilize MARS to investigate whether this technology can advance the detection of rare cancer cells in a multi-center breast cancer trial."

"If successful, it will allow us to refine and extend our efforts to detect ultra-rare disseminated tumor cells in breast cancer patients with early stage disease," said Dr. Lewis Chodosh, Chairman of the Department of Cancer Biology in the Perelman School of Medicine at the University of Pennsylvania. "We believe this approach has the potential to markedly improve the sensitivity with which this critical reservoir of cancer cells can be detected and characterized in patients – which will need to be confirmed in clinical trials.

On April 26, 2021 Nmune Bio, Inc. (NASDAQ: INMB) (the "Company" or "INmune"), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported that Raymond J. Tesi, MD, President and CEO, will participate in a fireside chat at the B Riley Neuroscience Conference on Wednesday, April 28 (Press release, INmune Bio, APR 26, 2021, View Source [SID1234578468]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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B Riley Neurosciences Conference
Fireside Chat Date: Wednesday, April 28, 2021
Presentation Time: 1:00 PM Eastern Time
Webcast: View Source

Please contact your representative at B Riley to schedule a virtual one-on-one meeting with INmune Bio during the respective conference.

On April 26, 2021 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform oncology drug discovery and development, reported a manuscript describing the efficacy profile of LP-184 in a variety of non-small cell lung cancer models was published in Oncotarget (Press release, Lantern Pharma, APR 26, 2021, View Source [SID1234578495]). The manuscript is titled ‘The acylfulvene alkylating agent, LP-184, retains nanomolar potency in non-small cell lung cancer carrying otherwise therapy-refractory mutations’. LP-184 is being developed by Lantern for the potential treatment of non-small cell lung cancer (NSCLC) among several other targeted indications in solid tumors including pancreatic and CNS cancers.

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The unmet clinical need where LP-184-based therapy could potentially be valuable is for those non-small cell lung cancer patients that are ineligible for targeted therapy options or have developed resistance to other forms of therapy. Existing targeted therapies, such as EGFR or ALK inhibitors, only work in specific, genetically defined patient subsets. There’s a sizable fraction of lung cancers — 30 to 40 percent — that do not have those targetable alterations, or have developed resistance to the current standard of care therapies which can often leave lung cancer patients without additional therapeutic options. According to Panna Sharma, CEO of Lantern Pharma, "More people continue to die of lung cancer every year than any other type of cancer, and significant improvements have been made in the era of targeted and combination therapies; however, many lung cancers rapidly evolve and form resistance to both targeted agents and chemotherapy combinations, and there is a major clinical need for new options and potentially extending patient lives further." Mr. Sharma continued, "With this additional indication for our DNA-damaging agent, LP-184, we continue to invest in the development of therapeutic options for increasing the personalization of therapy for lung cancer patients."

This publication in Oncotarget highlights LP-184’s nanomolar in vitro potency in primary and metastatic NSCLC models. It also demonstrates that LP-184 is generally more potent in vitro than commonly prescribed platin and taxane based chemotherapeutics. Based on the research conducted, the activity profile of LP-184 is not influenced by the presence of mutations in key oncogenes such as KRAS or KEAP1 and tumor suppressors such as TP53 and STK11, that otherwise underlie resistance to other drugs. LP-184 is believed to be a promising drug candidate that can address the treatment of KEAP1 mutant NSCLC, because the mutations up-regulate expression of PTGR1, and increased PTGR1 in turn makes tumor cells increasingly sensitive to LP-184.

Additionally, LP-184 showed tumor growth inhibition in a mouse xenograft model of KRAS/KEAP1 mutant lung cancer. Co-occurring KRAS and KEAP1 mutations occur in about 17 percent of lung adenocarcinoma cases and are believed to represent an aggressive form of lung cancer that is believed to be "undruggable". Lantern Pharma has developed a genomic signature that is believed to predict response in tumors that will be responsive to LP-184. This correlation and pinpointing of clinical need were supported by further TCGA analysis of 517 lung adenocarcinoma patients, out of which 35% showed elevated PTGR1, and 40% of those further displayed statistically significant co-occurrence of KEAP1 mutations. Considering an overlap between LP-184-specific response biomarkers and NSCLC-related genomic groups, we believe that the clinical data analyses reveal patient subgroups with distinct molecular backgrounds that are likely to be responders to LP-184 and benefit from this drug candidate.

According to Mr. Sharma, "Using our data-driven approach we have shown that not only can we find unique biomarkers that link to drug response and mechanism, but we can also rapidly uncover clinically meaningful patient subgroups that can benefit from our portfolio of therapies." Mr. Sharma continued, "By understanding the genomic and biomarker characteristics driving a compound’s activity in various sub types of cancer, we can rapidly develop new meaningful indications that have the potential to deliver life changing therapy options for cancer patients — and we can do this faster and with better insights as a result or our RADR platform. We will continue to invest into increasing the data, scope and functionality of the A.I. platform and expect that it will be able to play a wider role in cancer therapy development.

Lantern is continuing to validate LP-184 sensitivity in advanced lung tumor models both as monotherapy and in combination with drugs prioritized by Lantern’s RADR models, to increase the potential future benefit to patients with tumors that are or have become otherwise "undruggable" or non-responsive to existing approved therapies.