Celsion Corporation Announces Closing of $7.0 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

On April 8, 2022 Celsion Corporation (NASDAQ: CLSN) ("Celsion" or the "Company"), reported the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules, of 1,328,274 shares of common stock at a purchase price of $5.27 per share, resulting in net proceeds of $6.4 million, after deducting placement agent fees and expenses payable by the Company (Press release, Celsion, APR 8, 2022, View Source [SID1234611709]).

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A.G.P./Alliance Global Partners acted as sole placement agent for the offering.

Celsion intends to use the net proceeds for general corporate purposes, including research and development activities, capital expenditures and working capital.

This offering was made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-254515) previously filed with the U.S. Securities and Exchange Commission (the "SEC") under the Securities Act of 1933, as amended, which was declared effective by the SEC on March 30, 2021. The offering of the shares of common stock were made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC’s website at View Source or by contacting A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, 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 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.

Cellectis Presents Preclinical Data from its First Allogeneic Dual CAR T-cell Product Candidate UCART20x22 for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma at the American Association for Cancer Research (AACR) 2022 Annual Meeting

On April 8, 2022 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that preclinical data on its product candidate UCART20x22 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Cellectis, APR 8, 2022, View Source [SID1234611708]). The data showed robust pre-clinical proof of concept with the potential to overcome common mechanisms of resistance to CAR T-cell therapies in relapsed or refractory Non-Hodgkin Lymphoma (r/r NHL), such as single-antigen escape or tumor heterogeneity.

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UCART20x22 is Cellectis’ first allogeneic dual CAR T-cell product candidate being developed for patients with r/r NHL. It features TALEN-mediated disruptions of the TRAC gene (to reduce the risk of graft-versus-host disease) and of the CD52 gene (to permit use of a CD52-directed monoclonal antibody in patients’ preconditioning) to enhance CAR T engraftment, expansion and persistence.

Dual targeting of CD20 and CD22, both validated targets in B-cell malignancies, is designed to enhanced tumor cell killing and to prevent immune escape due to single-antigen targeting. UCART20x22 has the potential to offer an alternative to CD19-directed therapies and CD19 negative relapses.

The poster presentation at AACR (Free AACR Whitepaper) highlighted the following preclinical data:

UCART20x22 showed strong activity against tumor cell lines expressing either a single antigen, CD20 or CD22, or both simultaneously.
In vivo pre-clinical models demonstrate that UCART20x22 efficiently eradicates tumors expressing both or either antigen, and sustained presence of UCART20x22 cells was observed in the bone marrow after tumor clearance.
In vitro assays against primary cells from Non-Hodgkin Lymphoma patients with diverse CD22 and CD20 antigen levels demonstrate that UCART20x22 has potent and specific cytotoxic activity.
"We are very excited to share these encouraging preclinical data at AACR (Free AACR Whitepaper) that support the transition of UCART20x22 into the clinic. Cellectis’ UCART20x22 further validates CD20 and CD22 targets in B-cell malignancies, provides an opportunity to overcome some of the current challenges, and represents a potential therapeutic alternative to CD19-directed therapies. Moreover, manufacturing UCART20x22 from healthy donors holds the potential of an allogeneic CAR T-cell option for r/r NHL patients with enhanced activity." said Beatriz Aranda Orgilles, Ph.D., Team Leader, Immuno-Oncology at Cellectis.

UCART20x22 is expected to be Cellectis’ first product candidate fully designed, developed and manufactured in-house, showcasing the Company’s transformation into an end-to-end cell and gene therapy platform from discovery, product development, GMP manufacturing, to clinical development.

An Investigational New Drug application (IND) for UCART20x22 is expected to be filed this year.

Title: UCART20x22: First allogeneic dual CAR T-cell therapy for the treatment of B-cell malignancies

Date: April 10, 2022 at 1:30 p.m. ET

Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 36

Session Title: Adoptive Cell Therapy 1

Poster Board Number: 5

Abstract Number: 551

E-posters will be available on the AACR (Free AACR Whitepaper) website to registrants of the AACR (Free AACR Whitepaper) Annual Meeting at 1:00 p.m. EDT on Friday, April 8, linked here.

2seventy bio Presents New Preclinical Data on bbT369, an Investigational Dual-Targeting Gene-Edited CAR T Cell Therapy, at the AACR Annual Meeting

On April 8, 2022 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported that it will present preclinical data on bbT369, an investigational novel CD79a/CD20 dual-targeting CBLB gene edited CAR T cell therapy at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans, LA (Press release, 2seventy bio, APR 8, 2022, View Source [SID1234611707]). These data will be presented in a poster session (poster #581) on Sunday, April 10, 1:30-5:30 PM CT.

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"While anti-CD19 CAR T cell therapies have improved outcomes for relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL) patients, 60-70% of those treated with currently available CAR T cell therapies do not achieve a long-term remission, highlighting the need for more treatment options," said Philip Gregory, D.Phil., chief scientific officer at 2seventy bio. "bbT369 was purposefully designed to potentially address known mechanisms of anti-CD19 CAR T cell therapy failure. We are excited to present the results of preclinical studies that demonstrate the anti-lymphoma activity of bbT369 and suggest that bbT369 has the potential to overcome failure modes of anti-CD19 CAR therapies, supporting a first-in-human trial (CRC-403) to evaluate initial safety and efficacy in B-NHL patients."

bbT369 is an innovative therapeutic approach designed to address known limitations of anti-CD19 CAR T cell therapy

Emerging data1-2 suggests several failure modes for anti-CD19 CAR T cell therapies, including loss or down-regulation of CD19 antigen, loss of co-stimulatory ligands on tumor cells, exhaustion of CAR T cells, and immunosuppressive microenvironments.

bbT369 was purposely designed with three layers of innovation to address the potential mechanisms of anti-CD19 CAR T cell therapy failure:

First, bbT369 targets a novel combination of antigens highly expressed in B cell lymphomas, CD79a and CD20. CD79a, a novel target, is a critical signaling component of the B cell receptor and CD20 is a known clinical target for lymphoma. The dual targeting of bbT369 may limit antigen escape as a mechanism of lymphoma relapse.
Second, bbT369 is designed with a combination of a traditional 2nd generation CAR and an investigative "chimeric co-stimulatory" architecture (CCR-CAR), a split co-stimulation signaling technology intended to drive more robust T cell activation in response to either antigen compared with dual CAR designs.
Third, cells are gene-edited with megaTAL technology to remove the function of CBLB, a known negative regulator of T cells. Removal of CBLB function may enable robust antigen-dependent CAR T cell expansion and allow cells to resist anergy and maintain activity in sub-optimal conditions for T cell activation.
bbT369 demonstrates increased anti-lymphoma activity and duration of response in preclinical models

Increased tumor control was seen with bbT369’s CCR-CAR design compared to dual CAR designs, and cell killing was observed when bbT369 encountered either antigen.
Compared with non-gene edited cells in different in vitro model systems, bbT369 demonstrated a lower threshold for stimulation, retained activity in the presence of the immunosuppressive factor TGFβ, reduced reliance on tumor cell co-stimulation, and exhibited increased capacity for multiple rounds of tumor cell killing.
bbT369 resulted in three-fold increased cell expansion and prevention of late relapses in B-NHL mouse models compared with a non-gene edited control.
bbT369 outperformed CD19 CAR T cells in cell-based and mouse models, with increased IL-2 secretion and prolonged duration of tumor remission, suggesting bbT369 may have enhanced functionality compared with the other constructs.
Results are detailed in an E-Poster here, available to registered attendees on the AACR (Free AACR Whitepaper) website through Wednesday, July 13.

Infusion of first patients in Phase 1/2 study of bbT369 in B-NHL is anticipated in 2022

CRC-403 (NCT05169489), an open-label, multi-site Phase 1/2 dose-escalation study, is currently enrolling patients, and will assess the safety and potential efficacy of bbT369 in patients with relapsed and/or refractory B-NHL, including patients who relapsed after CD19 CAR T cell therapy as well as patients who are CAR-naïve. Initial assessment of feasibility of bbT369 drug product manufacturing and patient safety is expected in 2H 2022.

The study will also serve as a proof-of-concept assessment of 2seventy bio’s proprietary megaTAL gene editing platform, dual-targeting strategies and split co-stimulation signaling technology.

About bbT369

bbT369 is an investigational dual-targeting CAR T cell therapy with a gene edit for patients with relapsed and/or refractory B-NHL.

bbT369 has three layers of innovation, purposely designed to address the potential mechanisms of anti-CD19 CAR T cell therapy failure: dual targeting (CD79a/CD20), split co-stimulation signaling technology, and a gene edit to remove the function of CBLB.

In December 2021, the FDA cleared the Investigational New Drug (IND) application for bbT369.

The clinical development program for bbT369 includes the Phase 1/2 CRC-403 study (NCT05169489). Safety and potential efficacy of bbT369 in patients with specific subtypes of relapsed and/or refractory B-NHL will be assessed, including patients who relapsed after CD19 CAR T cell therapy as well as patients who are CAR-naïve.

bbT369 is not approved for any indication in any geography.

About megaTAL technology

megaTALs are single-chain enzymes that combine the natural DNA recognition and cleavage processes of Homing Endonucleases (HEs) with the modular DNA binding properties of transcription activator-like (TAL) effectors. This protein fusion architecture allows the generation of highly specific and active nucleases in a compact format compatible with all current viral and non-viral cell delivery methods.

Kiromic BioPharma Reports Fourth Quarter and Full-Year 2021 Financial Results and Recent Corporate Highlights

On April 8, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence (AI) and big data mining platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology, reported financial results for the fourth quarter and fiscal year ended December 31, 2021 (Press release, Kiromic, APR 8, 2022, View Source [SID1234611706]).

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"We are extremely encouraged by the progress the Company demonstrated in the fourth quarter. Our team’s unified efforts are strictly focused on achieving our goal of beginning the activation of the clinical trial for our first oncology cell therapy candidate by the end of the fourth quarter of 2022," stated Pietro Bersani, Kiromic BioPharma’s Interim Chief Executive Officer. "We have been intensely preparing for this milestone, ensuring we have the right team, the right capabilities, and the right processes in place to achieve this objective. Our team has been executing critical advancements – occurring simultaneously – across our research and development, clinical trial preparation, facility expansion, and manufacturing operations, among other functions. We look forward to more opportunities to communicate with our shareholders as we demonstrate the Company’s overall progress."

Fiscal Year Ended 2021 Financial Highlights:

Cash Position: Cash and cash equivalents were $25,353,900 as of December 31, 2021, compared to $10,150,500 as of December 31, 2020. The difference is attributable to cash outflows of $20,321,500, and $1,810,800 for operating activities, and investing activities, respectively. There were cash inflows of $37,335,700 from financing activities.
R&D Expenses: Our research and development expenses increased by $6,314,900, or 124.98%, to $11,367,800 for the year ended December 31, 2021 from $5,052,900 for the year ended December 31, 2020. The increase was attributable to increased headcount, manufacturing, and experimentation costs for the development of our ALEXIS clinical platform.
G&A Expenses: Our general and administrative expenses decreased by $206,100, or 1.46%, to $13,937,900 for the year ended December 31, 2021 from $14,144,000 for the year ended December 31, 2020. This decrease was primarily due to reduced stock compensation expenses, offset by increases in professional services fees, personnel, and recruiting costs.
Net Loss: Our net loss increased to $25,588,700 during the year ended December 31, 2021 compared to $19,200,200 during the year ended December 31, 2020.
Recent Business Highlights:

ALEXIS (Gamma Delta CAR-T cell Platform) Research & Development:

Developed an innovative and highly efficient process that improves the manufacturing of our cell therapy candidates, making it more space-efficient and cost-effective. We believe that this will significantly reduce the costs of CAR-T cell manufacturing, providing a competitive market advantage.
Successfully tested a prototype variant of the ALEXIS manufacturing process that leverages the potential of pooled donors’ cells. This is a necessary step to building a proprietary bank of precursor cells for the manufacturing of our ALEXIS product line. A donor cell bank is expected to ensure a high degree of homogeneity and consistency of our drug products, and at the same time to improve the resilience of our supply chain.
Continued progress towards a scalable and retrovirus-free process for the delivery of recombinant genes into T cells. This is an important step towards the deployment of our proprietary non-viral cell engineering system.
Key Hires in Research & Development, Clinical Translational Medicine and Clinical Trial Preparation:

The Company added new hires across the organization, specifically augmenting research & development, clinical translational medicine and clinical trial preparation capabilities. This represents a headcount total of nearly 60 employees, which is an increase from 19 as of December 31, 2020.
cGMP Manufacturing:

We have completed approximately 90% of our in-house current Good Manufacturing Practices (cGMP) facility expansion and redesign.
DIAMONDAI 2.0 Platform for Drug Discovery and Development is Completed:

The Company developed and made operational a completely revised version of its proprietary platform for identification and vetting of immunotherapy targets. Diamond AI 2.0 was developed by Kiromic’s in-house bioinformatics team and includes:
Enhanced and updated existing models to provide more accurate predictions of therapy target efficacy;
A modular, containerized architecture to support rapid addition of new algorithms, scientific methods, and therapy designs;
Integrated data mining components to provide a seamless workflow from identification of cancer-specific surface protein regions through to vetted immunotherapy targets;
Proteomic validation of transcript targets;
An additional 300+ million data points were added to the DIAMOND database in Q4 2021, which included proteomic data covering and extending the range of cancer types; and
Approximately 600 million data points were added in 2021, representing a 50% data point increase from 2020.

Plus Therapeutics Announces Poster Presentation at the American Association for Cancer Research (AACR) Annual Meeting

On April 8, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that the company will present a poster at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting, which is being held April 8-13, 2022, in New Orleans, La., and virtually (Press release, Cytori Therapeutics, APR 8, 2022, View Source [SID1234611705]).

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Details of the poster presentation

Title: A biology-based, mathematical model to predict the response of recurrent glioblastoma to treatment with 186Re-labeled nanoliposomes

Session Title: Mathematical Models

Session Date and Time: Tuesday, April 12, 2022, 9:00 a.m. – 12:30 p.m. CT

Location: New Orleans Convention Center, Exhibit Halls D – H, Poster Section 29

Poster Board Number: 13

Permanent Abstract Number: 2742

Link to Abstract: View Source!/10517/presentation/18391

A copy of the poster presentation will be made available under the Presentations tab of the For Investors section of the Company’s website following the meeting at www.plustherapeutics.com.