On December 17, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that the first patient has been dosed in the Company’s Phase 1 dose-escalation study of VIP152 in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or Richter Syndrome (RS) (Press release, Vincerx Pharma, DEC 17, 2021, View Source [SID1234597377]).

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"The dosing of the first patient in Vincerx’s Phase 1 dose-escalation study of VIP152 in R/R CLL or RS marks the initiation of the second Vincerx-sponsored clinical trial this year, less than one year after becoming a publicly-listed company," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "Our data recently disclosed through an oral presentation at ASH (Free ASH Whitepaper) demonstrated increased selectivity and potency of VIP152 when compared with other CDK9 inhibitors currently in development, leading to cytotoxic activity in primary CLL samples as well as improved survival in a mouse model of CLL. With this compelling preclinical proof-of-concept data in hand, we are focused on advancing VIP152 across challenging indications like R/R CLL and RS, where targeted CDK9 inhibition has the potential to bring meaningful patient benefit. We are continuing our momentum in the clinic and remain on-track to initiate Phase 2 studies of VIP152 in the second half of 2022."

The Phase 1 study will evaluate VIP152 in patients with relapsed/refractory CLL who have failed a Bruton tyrosine kinase inhibitor (BTKi) and venetoclax and in patients with RS who have relapsed after, or been refractory to, at least one prior line of therapy for DLBCL and have MYC overexpression/amplification/translocation. A dose-escalation arm will be performed in R/R CLL before enrolling 20 additional patients in each of the CLL and RS cohorts.

The Phase 1 dose-escalation in CLL and RS builds upon Vincerx’s ongoing first-in-human (FIH) study (NCT04978779) in patients with advanced cancer, which consists of two expansion arms. Arm 1 will enroll up to 40 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, patients with mantle cell lymphoma who have failed a BTKi, as well as patients with any other type of lymphoma characterized by a MYC aberration. Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration. All patients must have confirmed MYC overexpression or translocation.

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.