On December 16, 2021 Cothera Bioscience, the parent company of Percans Oncology, reported that it had successfully completed the first administration for the first patient in the Phase 1/2 clinical trial of CTB-02 for the treatment of pan-KRAS/BRAF mutant colorectal cancer in Australia (Press release, Cothera Bioscience, DEC 16, 2021, View Source [SID1234618850]).

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CTB-02 is a first-in-class targeted combination therapy discovered by the i-CR technology platform that has been independently developed by Cothera Bioscience and clinically verified for the treatment of KRAS/BRAF mutant colorectal cancer. CTB-02 has demonstrated strong inhibitory activity against KRAS/BRAF mutant colorectal cancer in multiple animal models, especially those based on patient transplanted tumor PDX. Colorectal cancer (CRC) is a common malignant tumor disease. According to the statistics, there were nearly two million new cases and one million deaths from this disease worldwide in 2020, among which there were about 560,000 new cases and 290,000 deaths in China. The incidence of colorectal cancer has been significantly increasing in China. KRAS mutation is the most important genetic variation in colorectal cancer, and has been detected in 40% of patients with metastatic colorectal cancer (mCRC). KRAS mutations may lead to sustained activation of the RAS-RAF-MEK pathway, resulting in tumor resistance to EGFR monoclonal antibodies. In CRC, KRAS mutations are significantly associated with resistance to EGFR-targeted drugs such as cetuximab. BRAF is a component of the RAS-RAF-MEK signaling pathway. About 10% of mCRC patients have BRAF activation mutations that are mutually exclusive with KRAS mutations. BRAF mutations, mostly the V600E subtype, have been demonstrated to be associated with a poor overall prognosis in studies.

"This is the first clinical trial of CTB-02," said Dr. Chun Jiang, cofounder of Cothera Bioscience and the executive vice president leading product development. "KRAS mutant colorectal cancer currently has no approved targeted therapies and there is a huge unmet clinical need. CTB-02 has presented an effect not only on KRAS G12C mutant colorectal cancer, but also on other KRAS mutations in cells as well as CDX and PDX animal experiments. We are fully committed to advancing this clinical trial and expect CTB-02 to lead to a breakthrough in the treatment of patients with KRAS/BRAF mutant colorectal cancer."

On December 16, 2021 Allergan Aesthetics, an AbbVie company (NYSE: ABBV), reported the successful completion of its acquisition of Soliton, Inc. (NASDAQ: SOLY) (Press release, AbbVie, DEC 16, 2021, View Source [SID1234597283]). The addition of Soliton and its technology complements Allergan Aesthetics’ portfolio of non-invasive body contouring treatments to now include a proven treatment for the appearance of cellulite.

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The RESONIC device initially received U.S. Food and Drug Administration (FDA) 510(k) clearance for the short-term improvement in the appearance of cellulite, and that clearance has now been expanded to long-term improvement up to one year. In recent clinical data submitted to the FDA, RESONIC demonstrated significant improvement in the appearance of cellulite and 97.6% of participants (n=67) found there was good improvement in the appearance of cellulite at 52-weeks post-treatment.

"We welcome the Soliton team to Allergan Aesthetics and the opportunity to offer health care providers and their patients a new, non-invasive option to reduce the appearance of cellulite," said Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "In a recent survey of aesthetics consumers, cellulite was cited as a top 5 aesthetic concern, and this technology offers a new approach to treatment."

RESONIC has also received FDA 510(k) clearance for use in conjunction with laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. For full safety information, please visit www.RESONIC.com/ISI.

On December 16, 2021 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to NKX101 for treatment of acute myeloid leukemia (AML) (Press release, Nkarta, DEC 16, 2021, View Source [SID1234597307]).

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NKX101 is a novel investigational NK cell therapy, engineered to augment the innate anti-tumor biology of NKG2D. NKG2D is an activating receptor found on naturally occurring NK cells that triggers the targeted killing of stressed and cancerous cells.

AML is a blood cancer that disrupts the production of normal blood cells in the bone marrow. In patients with AML, the five-year survival rate is 26%. While frontline therapy induces remission, most patients will relapse within 3 years. No standard of care is currently available for patients with relapsed/refractory (r/r) AML. These patients may be treated with various chemotherapeutic approaches, all of which have poor results. Clinical trials have resulted in complete response rates of 12% to 18% and a 3 to 9 month median overall survival in this challenging population.

"This orphan drug designation acknowledges the urgent need for new treatment options for patients with AML," said Kanya Rajangam, MD, PhD, Chief Medical Officer of Nkarta. "At Nkarta, we are committed to advancing our NK cell therapy platform to develop ground-breaking treatment options for cancer, and we look forward to working with the leukemia community and the FDA to deliver the unique benefits of off-the-shelf cell therapy to AML patients."

NKX101 is currently being studied in a first-in-human Phase 1 clinical trial in adults with r/r AML or myelodysplastic syndrome (MDS). As previously announced, Nkarta expects to announce initial data from the NKX101 clinical trial in the first half of 2022.

The FDA grants ODD to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. ODD may qualify the company developing the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.

About NKX101
NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-bound IL-15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.

On December 16, 2021 Epic Sciences, Inc. reported DefineMBC, a novel metastatic breast cancer (MBC) test that includes both cell-based and cell-free analysis from a single blood draw (Press release, Epic Sciences, DEC 16, 2021, View Source [SID1234597341]). DefineMBC provides comprehensive MBC profiling when a tissue biopsy result is not available.

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"Tissue biopsy to confirm metastatic breast cancer diagnosis and to subtype the cancer is the established standard of care, but can be highly invasive, expensive to payers, and due to sampling and access limitations, tissue biopsy may not provide physicians with the information needed to guide therapy. DefineMBC uses both cell-based and cell-free analysis from a simple blood draw and provides information for optimal treatment decision making," says Rick Wenstrup MD, Chief Medical Officer, Epic Sciences. DefineMBC also enables better therapeutic decision making in more advanced MBC where tissue biopsy is not routinely performed but patients’ cancers often evolve due to the impact of targeted therapies, ongoing clonal variations, and other known cancer dynamics."

DefineMBC combines several multi-analyte assay methods to perform comprehensive cancer profiling and has demonstrated impressive sensitivity, specificity, accuracy, and precision. The features of DefineMBC are described below:

Detection of circulating tumor cells (CTCs), and quantification of ER and HER2 protein expression on those cells, through immunofluorescent staining combined with image analysis by an algorithm developed through advanced machine learning.
Whole-genome sequencing of individual CTCs (called single-cell sequencing) to detect presence of amplified cancer-related genes through analysis of copy number variation provide Isolation and characterization of the copy number variation (CNV).
Analysis of cell-free DNA (cfDNA) by next-generation sequencing (NGS) of 56 genes, the detection of genomic alterations [single nucleotide variants (SNVs), fusions, CNVs, microsatellite instability (MSI), and tumor mutational burden (TMB)]. Expanded coverage of up to 500 genes is available for research and biopharma trials.
"DefineMBC delivers on the full potential of liquid biopsy, ensuring no information is left behind." says Lloyd Sanders, CEO and President at Epic Sciences. "We are excited about the positive impact this product can have on patient care as well as the opportunity to provide critical data to drug development efforts. We are now enrolling several community cancer centers into our Early Access Program for DefineMBC and expanding the menu of assays we offer to our pharmaceutical and research partners.

On December 16, 2021 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported that it intends to offer and sell shares of its common stock and warrants to purchase common stock in an underwritten public offering pursuant to an existing shelf registration statement (Press release, Abeona Therapeutics, DEC 16, 2021, View Source [SID1234597284]). All of the securities in the offering are to be sold by Abeona. 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.

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Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering, and A.G.P./Alliance Global Partners is acting as lead manager for the offering.

Abeona intends to use the net proceeds of the offering to fund continued clinical development of pipeline products, as well as for working capital and corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-256850) that was filed with the Securities and Exchange Commission (the "SEC") on June 7, 2021 and amended on August 27, 2021 and October 19, 2021, and was declared effective by the SEC on October 22, 2021. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. The preliminary prospectus supplement and the accompanying prospectus that form a part of the registration statement has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

The securities described above have not been qualified under any state blue sky laws. This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Abeona being offered, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.