On April 26, 2021 NeuBase Therapeutics, Inc. (Nasdaq: NBSE), ("NeuBase"), a biotechnology company accelerating the genetic revolution with a new class of precision genetic medicines, reported the closing of its previously announced underwritten public offering of 9,200,000 shares of its common stock (inclusive of 1,200,000 shares that were sold pursuant to the underwriters’ full exercise of their option to purchase additional shares of NeuBase’s common stock), at a price to the public of $5.00 per share, generating gross proceeds of $46.0 million before deducting the underwriting discounts and commissions and offering expenses payable by NeuBase (Press release, NeuBase Therapeutics, APR 26, 2021, View Source [SID1234578571]). NeuBase intends to use the net proceeds from the offering for general corporate purposes, working capital and development of its product candidates and pipeline expansion.

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RBC Capital Markets, Oppenheimer & Co. Inc. and Chardan acted as the joint book-running managers for the offering, and National Securities Corporation acted as co-manager for the offering.

The securities described above were offered by NeuBase pursuant to a shelf registration statement on Form S-3 (File No. 333-254980) previously filed with the Securities and Exchange Commission (the "SEC") on April 1, 2021 and declared effective by the SEC on April 14, 2021. A final prospectus supplement and the accompanying prospectus relating to and describing the offering was filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting RBC Capital Markets, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281, or by telephone at (877) 822-4089 or by e-mail at [email protected], Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055 or by e-mail at [email protected], or Chardan, 17 State Street, 21st floor, New York, New York 10004, by telephone at (646) 465-9032 or by e-mail at [email protected].

This press release does 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On April 26, 2021 OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), reported that the U.S.-based SWOG Cancer Research Network has started patient enrollment for a Phase I/II study of OBI-3424, a first-in-class (small-molecule prodrug) DNA alkylating agent that targets cancers expressing the aldo-keto reductase 1C3 (AKR1C3) enzyme (Press release, OBI Pharma, APR 26, 2021, View Source [SID1234578513]).

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The study, S1905 (ClinicalTrials.gov Identifier: NCT04315324), is titled "A Phase 1/2 Study of AKR1C3-Activated Prodrug OBI-3424 in Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)." SWOG is a member of the National Cancer Institute’s (NCI) National Clinical Trials Network (NCTN), America’s largest publicly funded cancer research network. In the NCTN, cancer trials are designed by some of the nation’s leading cancer experts, funded by tax dollars, and powered by patient volunteers.

OBI Pharma’s Chief Medical Officer, Tillman Pearce, M.D., noted, "This clinical trial intends to verify whether the potent efficacy that OBI-3424 demonstrated against T-ALL patient-derived xenografts in mice (Evans et al. Clin Ca Res 2019) can be observed in T-ALL and T-LBL patients. The initial xenograft experiments were conducted by the NCI Pediatric Preclinical Study Group, so it is very fitting that SWOG is the first to evaluate the concept in patients. This study in an unmet population of patients with T cell acute leukemias and lymphomas is complementary to OBI Pharma’s ongoing phase 1/2 study evaluating OBI-3424 in solid tumors (ClinicalTrials.gov Identifier: NCT03592264)."

Anjali S. Advani, MD, director of the Inpatient Leukemia Unit at Cleveland Clinic Taussig Cancer Institute and professor of medicine at Cleveland Clinic Lerner College of Medicine in Cleveland, OH is the lead investigator of the OBI-3424 T-ALL/T-LBL SWOG trial.

"Although the treatments in B-ALL have advanced significantly, we have lagged behind in T-ALL," said Dr. Advani. "We are hopeful that targeting AKR1C3 in T-ALL will represent a promising treatment strategy."

About OBI-3424

OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.

AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including hepatocellular carcinomas (HCC), castrate-resistant prostate cancer (CRPC), and T-cell acute lymphoblastic leukemia (T-ALL). AKR1C3 is highly expressed in up to 15 solid and liquid tumors.

Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed based on tumor biopsies or circulating tumor cells to identify patients with other tumor types most likely to respond to treatment with OBI-3424, and thus offering the possibility for a streamlined clinical development strategy.

On April 26, 2021 Seneca Biopharma, Inc. (Nasdaq: SNCA) ("Seneca" or the "Company"), reported the passing of the final proposal required for approval of the proposed merger between Seneca and Leading Biosciences, Inc. ("LBS") (Press release, Seneca Biopharma, APR 26, 2021, View Source [SID1234578512]). The Merger is expected to close on or about April 27, 2021 and the new combined company, Palisades Bio, is expected to begin trading on the Nasdaq Capital Market on or about April 28, 2021 under the ticker "PALI".

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Seneca and LBS will announce the final exchange ratio prior to the common stock commencing trading on or about Wednesday, April 28, 2021.

On April 26, 2021 Biond Biologics Ltd. ("Biond" or the "Company"), a private clinical-stage biopharmaceutical company, developing novel immunotherapies for cancer and a platform enabling the intracellular delivery of biologics, reported that the first patient has been dosed in the first-in-human, phase 1 clinical trial of BND-22 (SAR444881), an Ig-Like Transcript 2 (ILT2) receptor blocking antibody (Press release, Biond Biologics, APR 26, 2021, View Source [SID1234578511]).

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The first patient was administered BND-22 at the Oncology Research Unit of the Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, one of the six US and Israel trial sites planned to initially participate in the phase 1, open-label, dose escalation study exploring the safety, tolerability, pharmacokinetics (PK), anti-tumor activity, and exploratory biomarkers for BND-22 activity in patients with select advanced solid tumors.

"BND-22 represents a novel approach to cancer immunotherapy targeting both adaptive and innate immune cells," said Ravit Geva, M.D., Research Unit Head and Deputy Director, Division of Oncology at the Tel Aviv Sourasky Medical Center, and a clinical investigator in the trial. "There continues to be an urgent need to develop new treatments for patients with cancers refractory to standard of care therapy. BND-22 has demonstrated compelling preclinical activity, and we look forward to further investigate the potential of ILT2 blockade in this Phase 1 study."

"The entry of BND-22 into the clinic is a significant milestone for Biond as it represents the achievement of an important aspect of the company’s vision to progress our novel medicines into clinical evaluation while using our drug discovery, development, and translation capabilities," said Tehila Ben Moshe, Ph.D., Co-Founder and Chief Executive Officer of Biond. "BND-22, a multi-cell checkpoint inhibitor, was studied extensively by our scientific team for several years and was found to have the potential to improve upon current treatment paradigms, either as a monotherapy or in combination. Based on in-depth translational studies of real-world patient samples we have designed the Phase 1 trial to focus on patient populations we believe are most likely to respond to ILT2 blockade. We look forward to the results of the BND-22-001 trial as we strive to improve the treatment of cancer patients with dire needs for new therapies."

Biond announced on January 12th, 2021 an exclusive worldwide license agreement with Sanofi, for the development and commercialization of BND-22. Under the terms of the agreement, Biond will lead the first-in-human, phase 1 study of BND-22, evaluating its safety and tolerability as a single agent and in combination with approved cancer therapeutics as well as exploring the association between BND-22 anti-tumor activity and select tumor and blood-based biomarkers; Sanofi will assume clinical development and commercialization responsibilities thereafter.

About BND-22

BND-22 is a humanized IgG4, antagonist antibody targeting the ILT2 receptor in development for the treatment of solid tumors. ILT2, a member of the ILT family of immuno-modulating receptors, is an inhibitory receptor expressed on both innate and adaptive immune cells that binds major histocompatibility complex (MHC) class I molecules including HLA-G, an immunosuppressive protein expressed by multiple tumor types.

BND-22 has been shown in preclinical studies to have a broad anti-tumor effect by targeting ILT2-mediated "do not eat me" signals in macrophages and by activating NK and CD8+ lymphocytes. The program is supported by a comprehensive biomarker strategy designed to guide patient enrollment in advanced clinical trials.

BND-22-001 is the first-in-human clinical trial of BND-22. It is a Phase 1/2 multicenter, open-label, dose escalation and expansion study enrolling advanced cancer patients with solid tumor types known to express HLA-G. Following dose escalation and determination of BND-22′ recommended Phase 2 dose, the study design allows for the expansion of patient cohorts to evaluate the anti-tumor activity of BND-22 in specific tumor types. BND-22-001 is planned to be expanded to also evaluate the safety and anti-tumor activity of BND-22 in combination with other therapies. For more information about the trial, including participating medical centers, please visit View Source (Trial Identifier: NCT04717375).

On April 26, 2021 CARISMA Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported it has established a multi-year scientific collaboration with Bruce Blazar, MD, Regents Professor of Pediatrics, Division of Blood and Marrow Transplantation and Cellular Therapy at the University of Minnesota to investigate and develop allogeneic macrophage therapies (Press release, Carisma Therapeutics, APR 26, 2021, View Source [SID1234578510]).

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Allogeneic macrophage therapies may prove successful in providing a solution forged in cell therapy to a broader population of patients, further extending the potential benefits of CARISMA’s CAR-Macrophage (CAR-M) platform beyond oncology and into other disease states with unmet clinical needs.

"The collaboration with Dr. Blazar marks the initiation of the development of allogeneic, universal donor derived monocyte and macrophage cell therapies at CARISMA," said Michael Klichinsky, PharmD, PhD, Scientific Co-Founder and Senior Vice President of Research at CARISMA Therapeutics. "The focus of this multi-year collaboration will be optimizing and developing iPSC derived allogeneic chimeric antigen receptor macrophages, further expanding the potential of macrophage-based cell therapy for cancer and other diseases."

The announcement follows the recent dosing of the first patient in CARISMA’s Phase 1 multi-center clinical trial for CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted CAR-M. It is the first time CAR-engineered macrophages are being studied in humans.

"For more than 35 years, I have focused on transplantation immunobiology in my lab in order to develop new therapies that may improve patient health," said Dr. Blazar. "I look forward to working with the company to develop allogeneic CAR-Ms to help patients with hard-to-treat cancers and other severe diseases."