On November 22, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTX110, its wholly-owned allogeneic CAR-T cell therapy targeting CD19+ B-cell malignancies (Press release, CRISPR Therapeutics, NOV 22, 2021, View Source [SID1234595889]).

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"This RMAT designation is based on the encouraging clinical data we have presented thus far, and it is an important milestone that recognizes the transformative potential of CTX110 for the treatment of hematological malignancies," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "We look forward to working closely with the FDA as we continue our efforts to bring this important new therapeutic modality to patients."

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline products, including genetic therapies. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such disease or condition. Similar to Breakthrough Therapy designation, RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the biologics license application (BLA) and other opportunities to expedite development and review.

About CTX110
CTX110, a wholly owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting Cluster of Differentiation 19, or CD19. CTX110 is being investigated in the ongoing CARBON trial.

About CARBON
The ongoing Phase 1 single-arm, multi-center, open label clinical trial, CARBON, is designed to assess the safety and efficacy of several dose levels of CTX110 for the treatment of relapsed or refractory B-cell malignancies.

On November 22, 2021 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will host an inaugural Spatial Day on December 15, 2021 at 12 p.m. ET. The program will feature Akoya speakers and experts at the forefront of this new field who will discuss how spatial biology is uniquely positioned to address challenges in discovery, translational and clinical research, where the field is headed, and Akoya’s vision for the future (Press release, Akoya Biosciences, NOV 22, 2021, View Source [SID1234595888]).

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Akoya is a pioneer in the rapidly emerging field of spatial phenotyping, a transformational new application that is giving unprecedented context to cell-cell interactions within tissue biology. Understanding spatial biomarker signatures within the framework of spatial phenotyping has the potential to unlock an explosion of new applications in medicine and research, such as the ability to segment patient populations based on immune interactions, development of spatial diagnostic assays, drug discovery, and design or identification of personalized therapeutic interventions. Biomarkers that predict response or resistance to drugs, based on understanding specific types and subtypes of immune cells and the ability to map their spatial distribution, are among the most advanced opportunities with spatial phenotyping.

The agenda and speakers are as follows:

Welcome & Introduction, Brian McKelligon, CEO, Akoya
Revolutionizing Our Understanding of Disease Biology, Kai Kessenbrock, PhD, Principal Investigator, Human Cell Atlas Initiative, University of California, Irvine, CA, and Robert Schreiber, PhD, Professor of Pathology, Washington University, St. Louis, MO
Q&A Roundtable, hosted by Niro Ramachandran, PhD, CBO, Akoya
Changing the Standard of Care Using Spatial Biomarkers, Carl Barrett, PhD, VP, Translational Medicine, AstraZeneca plc, and Kurt Schalper, MD, PhD, Professor of Pathology and Oncology, Yale University, New Haven, CT
Q&A Roundtable, hosted by Pascal Bamford, PhD, SVP, R&D, Akoya
The Future Direction of Akoya, Niro Ramachandran, PhD, CBO, Akoya
Closing remarks, Brian McKelligon, CEO, Akoya
Audience Q&A

On November 22, 2021 Keros Therapeutics, Inc. ("Keros") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, reported that Keros’ President and Chief Executive Officer Jasbir S. Seehra, Ph.D. will present at the Piper Sandler 33rd Annual Virtual Healthcare Conference (Press release, Keros Therapeutics, NOV 22, 2021, View Source [SID1234595887]).

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A recording of the fireside chat presentation will be available starting on Monday, November 22, 2021 at 10:00 a.m. ET., and will be archived in the Investors section of the Keros website at View Source A replay will be available for 90 days following the conclusion of the event.

On November 22, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS"), a clinical-stage biopharmaceutical company developing transformational therapeutics for serious diseases with significant unmet medical need, reported it has entered into securities purchase agreements with certain institutional investors in connection with a private placement priced at-the-market under Nasdaq rules of 3,000,000 shares of common stock, series A additional investment options (the "Series A AIOs") to purchase up to 1,500,000 shares of common stock, and series B additional investment options (the "Series B AIOs", together with the Series A AIOs, the "AIOs") to purchase up to 1,500,000 shares of common stock at a purchase price of $3.25 per share and associated AIOs for gross proceeds of $9.75 million, before deducting placement agent fees and other estimated offering expenses payable by the Company (Press release, Scopus BioPharma, NOV 22, 2021, View Source(Nasdaq%3A%20%E2%80%9CSCPS%E2%80%9D),private%20placement%20priced%20at%2Dthe%2D [SID1234595886]). The offering is expected to close on or about November 22, 2021, subject to satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

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The Series A AIOs are exercisable immediately with a term of five years following the authorized share increase date and have an exercise price of $3.125 per share. The Series B AIOs are exercisable upon the authorized share increase date with a term of five years following the authorized share increase date and have an exercise price of $3.125 per share.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

Under an agreement with the investors, the Company is required to file an initial registration statement with the Securities and Exchange Commission (the "SEC") covering the resale of the shares of the Company’s common stock and the shares of common stock underlying the AIOs no later than January 4, 2022 and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than the later of (i) February 15, 2022 and (ii) 30 days after the authorized share increase date.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

On November 22, 2021 Athenex (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that an abstract for a subgroup analysis of its Phase 3 study of oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of metastatic breast cancer has been accepted for poster presentation at the 2021 San Antonio Breast Cancer Symposium (SABCS), to be held from December 7 to December 10, 2021 (Press release, Athenex, NOV 22, 2021, View Source [SID1234595885]).

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The abstract and poster provide data from a post hoc, subgroup analysis of safety, progression free survival and overall survival of patients with elevated liver enzymes (AST or bilirubin) from study KX-ORAX-001, a Phase 3 study of weekly Oral Paclitaxel plus Encequidar vs IV Paclitaxel 175mg/m2 every three weeks. 402 subjects were randomized in a 2:1 ratio to Oral Paclitaxel and Encequidar vs IV Paclitaxel.

Prior to treatment, 122 patients out of 402 total study patients (30.3%) had elevated AST or bilirubin, primarily mild hepatic dysfunction. For patients with elevated liver enzymes receiving Oral Paclitaxel, the median survival was 18.9 months compared to 10.1 months for patients receiving IV Paclitaxel: with a hazard ratio of 0.593 (95.5% CI 0.382 – 0.921) favoring Oral Paclitaxel. Although metastatic breast cancer patients with mild hepatic dysfunction at baseline are at increased risk of early serious neutropenic and infectious/septic complications this risk may be counterbalanced by a potential increase in efficacy after treatment with Oral Paclitaxel.

Details of the poster presentation is as follows:

Abstract Title: Oraxol + Encequidar (OPac+E) vs IV paclitaxel (IVPac) in the treatment of patients with metastatic breast cancer (mBC) (Study KX-ORAX-001): Subgroup survival analysis of patients with hepatic dysfunction
Session: 1
Program Number: P1-16-05
Date and Time: Wednesday, December 8, 2021. 7:00 am CT