On April 13, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that new preclinical findings of ALLO-316, an AlloCAR T therapy targeting CD70 for the treatment of renal cell carcinoma (RCC), were presented in a poster session of the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Allogene, APR 13, 2022, View Source [SID1234616272]). The findings were also published in Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

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ALLO-316 targets CD70, which is expressed in a number of malignancies ranging from solid tumors such as RCC, lung cancer and glioblastoma to hematologic cancers including acute myeloid leukemia (AML), diffuse large B-cell lymphoma, T-cell lymphomas, and multiple myeloma.

CD70 has previously been shown to be highly expressed in RCC and several hematological cancers with limited normal tissue expression. The current work illustrates that CAR T cells targeting CD70 could be generated in which expression of CD70 CARs was found to mask the cells own CD70 receptors in cis, providing protection from CAR T-mediated fratricide. Multiple CAR T cell constructs were evaluated for anti-tumor activity against RCC cell line and patient-derived mouse tumor models. Lead candidates were evaluated in preclinical safety studies which indicated limited potential for off-target binding. Lastly, highly functional CD70 allogeneic CAR T cells that were gene-edited with TALEN to eliminate TCR expression were produced at large scale. These preclinical data provide support for the ongoing clinical evaluation of ALLO-316 for the treatment of patients with RCC and other CD70 expressing hematological cancers and solid tumors.

"These results add to our strong interest in evaluating the potential of ALLO-316 to treat patients with CD70 expressing malignancies, including RCC and other cancers," said Rafael G. Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "Coupled with previously published preclinical data on ALLO-316 in a variety of tumors, these findings reinforce our belief that CD70 is an important target across a broad spectrum of cancers."

In March, Allogene announced that the FDA granted ALLO-316 Fast Track Designation (FTD) based on its potential to address the unmet need for patients with difficult to treat RCC who have failed standard RCC therapies. RCC is a disease in need of innovation as current therapies are limited to a few mechanistic targets and complete response rates are low. The five-year survival rate for patients with metastatic kidney cancer is less than 15%. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC.

On April 13, 2022 Juniper Biologics, a science-led healthcare company focused on researching, developing and commercializing novel therapies reported that it has gained the licensing rights to develop and commercialize TG-C LD (TissueGene-C low dose) for the treatment of knee osteoarthritis (Press release, Juniper Biologics, APR 13, 2022, View Source [SID1234615016]).

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The $600 million USD licensing deal which covers Asia Pacific, Middle East and Africa was signed withKolon Life Science, and is Juniper Biologics’ second acquisition in as many months. Under the terms of the partnership, Juniper Biologics will be responsible for developing and commercializing TG-C LD to medical professionals and hospitals within these regions. Kolon Life Science will be responsible for supporting the development as well as supplying TG-C LD.

TG-C LD is a non-surgical investigational treatment that has been hailed as the world’s first cell-mediated gene therapy for osteoarthritis of the knee,[i] which is the most common form of arthritis.[ii] According to research, osteoarthritis is estimated to be the eleventh[1] leading cause of disability worldwide with an estimated 300 million patients in Asia Pacific and Middle East and Africa alone, suffering from the debilitating effects of the degenerative joint disease. It is one of the biggest unmet medical needs among musculoskeletal conditions with the risk demonstrated to increase with age[iii] .

A first-in-class cell-mediated gene therapy, TG-C LD targets knee osteoarthritis through a single intra-articular injection. Kolon TissueGene, the license holder for TG-C in the United States (not TG-C LD), has already completed a phase 2 clinical trial in the United States, with initial data demonstrating sustained pain relief and mobility improvement following a single injection in the knee joint, for possibly up to 2 years. Phase 3 clinical trials in the United States comprising 1,020 patients are currently ongoing to confirm the safety and efficacy of TG-C. In addition to confirm the statistically significant pain reduction and function improvements observed from the US Phase 2 clinical trial, the trials are designed to show the delay of disease progression to achieve a DMOAD (Disease Modifying Osteoarthritis Drug) designation.

Juniper Biologics CEO, Raman Singh, said: "We are always looking to identify areas in which we can make the most difference and TG-C LD offers substantial relief for knee osteoarthritis patients who would otherwise be in need of surgery or other treatment options. We are committed to providing innovative treatments to treat osteoarthritis of the knee through the regeneration of cartilage and we believe this innovative investigational treatment will bring relief to millions of patients across the region."

"We are excited to work with Juniper Biologics to establish new avenues for patients to access this innovative investigational cell therapy. This would be a validation of our technology and its market value." said Woosok Lee President and CEO, Kolon Life Science. "We believe patients in Asia Pacific, Middle East and Africa will be able to benefit from TG-C LD as we go through the rigor of establishing it as a global standard treatment option."

On April 13, 2022 Oncocyte Corporation (Nasdaq: OCX), ("Oncocyte" or the "Company"), reported that it has commenced an underwritten public offering of shares of its common stock, together with warrants to purchase additional shares of its common stock (Press release, Oncocyte, APR 13, 2022, View Source [SID1234612492]). The Company expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock and/or additional warrants to purchase shares of common stock to be issued and sold in the public offering, in any combination thereof, on the same terms and conditions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering, the offering price of the common stock and warrants, or the exercise price of the warrants.

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BTIG and Needham & Company are acting as joint book-running managers for the offering.

The Company intends to use the net proceeds from the offering primarily to promote commercialization of DetermaRx, including sales and marketing efforts and by conducting additional clinical studies to support clinical adoption of the test; to complete development of DetermaIO; complete the development and begin commercialization of TheraSure; for development of other future tests in our pipeline, including DetermaCNI, DetermaTx and DetermaMx. The Company also expects to use net proceeds to pay for development costs associated with its activities under the Collaboration Agreement with Life Technologies Corporation ("LTC"), a subsidiary of Thermo Fisher Scientific, pursuant to which the Company has agreed to undertake certain development efforts with LTC and to collaborate with LTC in the commercialization of Thermo Fisher Scientific’s existing Oncomine Comprehensive Assay Plus, and the Company’s DetermaIO assay for use with LTC’s Ion TorrentTM Genexus Integrated Sequencer and LTC’s Ion Torrent Genexus Purification System, in order to obtain in vitro diagnostic regulatory approval of those tests. We may use net proceeds to make certain future milestone and other payments to former shareholders of companies that we have acquired, including Chronix Biomedical, Inc. and Insight Genetics, Inc. if the applicable milestones requiring such payments are met.

A shelf registration statement on Form S-3 (Registration No. 333-256650) relating to the securities being offered was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 8, 2021. The offering will be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source When available, electronic copies of the preliminary prospectus supplement and accompanying prospectus relating to the proposed public offering may be obtained by contacting BTIG, LLC, 65 East 55th Street, New York, NY, 10022, or by telephone at (212) 593-7555 or by e-mail at [email protected]; or from Needham & Company, LLC, Attention: Syndicate Prospectus Department, 250 Park Avenue, 10th Floor, New York, New York 10177, or by telephone at 800-903-3268 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On April 13, 2022 Statera Biopharma (Nasdaq: STAB) (the "Company"), a biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported that the Company has agreed to enter into a strategic agreement with Coeptis Therapeutics, Inc. (OTC PINK: COEP), a biopharmaceutical company developing innovative cell therapy platforms for cancer, to sell Statera’s rights to Entolimod and other related toll-like receptor 5 (TLR5) agonists (Press release, Cleveland BioLabs, APR 13, 2022, View Source [SID1234612445]). The consummation of the transaction is contingent upon negotiation of a definitive agreement and satisfaction of a number of closing conditions, including a contingency on Coeptis financing.

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"Coeptis’ commitment to cancer therapies makes it a natural choice for the further development of Entolimod, which has demonstrated potential in multiple preclinical disease models," said Michael K. Handley, President and Chief Executive Officer of Statera Biopharma. "With this announcement, we expect to improve our financial standing and enable the execution of a number of upcoming catalysts in advancing our programs and progressing toward our goal of changing the way people think about immunotherapy."

Under the terms of the definitive agreement, Statera will receive a $6 million upfront payment and revenue-based milestone payments from Coeptis in exchange for Statera’s rights to any product containing Entolimod as an active ingredient and all other related TLR5 agonists. Coeptis will also assume responsibility for associated licenses, as well as Statera’s interest in Genome Protection, Inc.

"We believe that Entolimod has significant clinical and commercial potential as the first in a new generation of immunotherapies that may improve outcomes for patients with cancer and other serious medical conditions. We are excited to undertake this strategic investment to help develop innovative therapeutics that offer improved patient outcomes," said Dave Mehalick, Chairman, President and Chief Executive Officer of Coeptis.

On April 13, 2022 Bayer reported that the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved larotrectinib, under the brand name Vitrakvi, for the treatment of adult and pediatric patients with advanced solid tumors that harbor a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion (Press release, Bayer, APR 13, 2022, View Source;ref=irrefndcd [SID1234612317]). NTRK gene fusions should be identified by a sufficiently validated test. Larotrectinib is a first-in-class, highly selective TRK inhibitor exclusively designed to treat solid tumors that have an NTRK gene fusion, also known as TRK fusion solid tumors. This precision oncology treatment has demonstrated high response rates, durable responses and a favorable safety profile in adults and children with TRK fusion solid tumors. Vitrakvi is already approved in the U.S., Japan, countries of the European Union (EU), the UK and other markets around the world.

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"These clinically meaningful high response rates and durable responses as well as the favorable safety profile seen in larotrectinib trials involving patients from China and worldwide, support its efficacy and safety in adults and children," said Prof. Xu Ruihua, MD, PhD, President of Sun Yat-sen University Cancer Center. "A high unmet need remains for new and innovative cancer treatments in China. Advancements in precision therapies, like larotrectinib, demonstrate the importance of comprehensive genomic testing to uncover actionable oncogenic drivers and identify patients most likely to benefit from a targeted treatment approach."

"The approval of larotrectinib in China represents a meaningful advancement in cancer care with a highly innovative treatment option that addresses the genomic alteration driving solid tumor growth, regardless of the location where the tumor originates," said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Bayer’s Oncology Strategic Business Unit. "This approval further demonstrates Bayer’s commitment to delivering next-generation precision medicines to appropriate patients and clinicians."

The approval of larotrectinib in China is based on data from the Phase I trial of adult patients, the Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II pediatric SCOUT trial. In these trials, larotrectinib was investigated across more than 20 different histologies of solid tumors including lung cancer, thyroid cancer and colorectal cancer as well as salivary gland cancer and soft tissue sarcomas including infantile fibrosarcoma and gastrointestinal stromal tumors. The compound has shown powerful efficacy with high response rates and durable responses as well as a favorable safety profile across tumor types in adults and children with TRK fusion solid tumors. The clinical activity has been shown across multiple tumor types including primary central nervous system (CNS) tumors and brain metastases.

TRK fusion cancer is rare overall. It affects both children and adults and occurs in varying frequencies across various tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing a chimeric TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering the activation of an intercellular signaling cascade leading to tumor growth and spread.

Larotrectinib will be available in China in oral capsules for adults and children. The CDE of China’s NMPA is currently reviewing its regulatory application as a liquid formulation.

About Vitrakvi (larotrectinib)
Vitrakvi (larotrectinib), a first-in-class oral TRK inhibitor, was exclusively designed to treat tumors that have an NTRK gene fusion. The compound has demonstrated high response rates and highly durable responses of over four years in adults and children with TRK fusion cancer, including central nervous system (CNS) tumors. To date, it has the largest dataset and longest follow-up data of any TRK inhibitor. The trials are still ongoing, with the latest dataset presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 and additional updates planned to be presented at upcoming scientific meetings.

Larotrectinib is approved under the brand name Vitrakvi in more than 40 countries around the world, including the U.S., countries of the European Union (EU), and most recently in China. Filings in other regions are underway or planned. In the EU, the product is approved for the treatment of adult and pediatric patients with solid tumors that harbor a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.

About TRK Fusion Cancer
TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing a chimeric TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering a signaling cascade. These TRK fusion proteins are oncogenic drivers promoting cell growth and survival, leading to TRK fusion cancer. TRK fusion cancer is not limited to certain types of tissues and can occur in any part of the body. TRK fusion cancer occurs in various adult and pediatric solid tumors with varying frequency, including lung, thyroid, gastrointestinal (GI) cancers (colon, cholangiocarcinoma, pancreatic and appendiceal), sarcoma, CNS cancers (glioma and glioblastoma), salivary gland cancers (including secretory carcinoma of the salivary gland) and pediatric cancers (infantile fibrosarcoma and other soft tissue sarcomas).

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes six marketed products across various indications and several compounds in different stages of clinical development. Bayer focuses its research activities on first-in-class innovations across the following scientific platforms: Precision Molecular Oncology, Targeted Alpha Therapies, and Immuno-Oncology. Across the areas of focus, we have several prostate cancer treatments on the market or in development, with the goal of extending survival while limiting side effects of treatment throughout the different stages of the disease. Another key focus at Bayer is on innovative precision oncology treatments, with an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread. The company’s approach to research prioritizes targets and pathways with the potential to impact the way that cancer is treated.