On July 5, 2023 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for P-CD19CD20-ALLO1, the Company’s first allogeneic dual CAR-T cell product candidate, which targets both CD19 and CD20 antigens for the treatment of relapsed or refractory B-cell malignancies and is being developed in partnership with Roche (Press release, Poseida Therapeutics, JUL 5, 2023, View Source [SID1234633058]).

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"We are pleased to receive IND clearance for P-CD19CD20-ALLO1, our third fully allogeneic CAR-T cell product candidate and the second therapy in our partnership with Roche for hematological malignancies that will enter the clinic. We believe this represents the FDA’s first known IND clearance of an allogeneic dual CAR-T therapy targeting CD19 and CD20," said Kristin Yarema, Ph.D., President, Cell Therapy at Poseida. "The dual-targeting approach leverages our proprietary non-viral piggyBac DNA Delivery System, which enables expression of two fully functional CAR molecules into T cells from healthy donors for the treatment of B-cell malignancies that may have heterogeneous antigen expression. We believe that targeting both CD19 and CD20 has the potential to overcome the limitations of currently available CD19-directed CAR-T products where antigen escape has been observed as an important resistance mechanism. It has been estimated that up to 40% of cases where B-cell malignancies relapse or are refractory to CD19 targeting autologous CAR-T therapy may involve antigen escape. We look forward to dosing the first patients in this study."

P-CD19CD20-ALLO1 will be evaluated in a Phase 1 multi-center, open-label, dose-escalation study that will enroll up to 70 adult patients with relapsed or refractory B-cell malignancies. The study will evaluate the safety, tolerability, and preliminary efficacy of P-CD19CD20-ALLO1. After enrollment, patients will receive a chemotherapy-based lymphodepletion regimen followed by administration of P-CD19CD20-ALLO1 allogeneic CAR-T cells. With the P-CD19CD20-ALLO1 IND now cleared, the Company is actively focused on opening clinical sites.

About P-CD19CD20-ALLO1

P-CD19CD20-ALLO1 is an allogeneic CAR-T cell therapy product candidate being developed for relapsed or refractory B-cell malignancies in partnership with Roche. P-CD19CD20-ALLO1 expresses two fully functional CAR molecules to target cells that express either CD19 or CD20. The dual targeting approach employed in P-CD19CD20-ALLO1 aims to overcome the antigen escape limitations of CD19-only targeted CAR-T therapies by simultaneously targeting both CD19 and CD20. In addition to the dual targeting, P-CD19CD20-ALLO1 uses a novel CD19 binder that showed greater potency in in vivo preclinical models when compared to the canonical FMC63 Single-chain variable fragment (scFv) binder. P-CD19CD20-ALLO1 is an off-the-shelf CAR-T therapy for which patients do not have to undergo apheresis and wait for the cells to be manufactured, which can potentially overcome the limitation of autologous CAR-T therapies associated with significant manufacturing times. P-CD19CD20-ALLO1 will be studied in multiple B-cell malignancies.

On July 5, 2023 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat oncology indications, reported that Jeffrey Eisenberg, Chief Executive Officer and Curtis A. Lockshin, PhD, Chief Scientific Officer of Xenetic Biosciences will participate in the Virtual Investor Summer Spotlight Series on Wednesday, July 12, 2023 at 10:00 AM ET (Press release, Xenetic Biosciences, JUL 5, 2023, View Source [SID1234633057]).

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A live video webcast of the presentation will be available on the Events page in the Investors section of the Company’s website (www.XeneticBio.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

On July 5, 2023 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI" or the "Company"), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that it has commenced an underwritten public offering and a registered direct offering of its common shares and accompanying common warrants to purchase its common shares. VBI also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of common shares and/or common warrants offered in the public offering (Press release, VBI Vaccines, JUL 5, 2023, View Source [SID1234633056]). Both offerings are subject to market and other conditions and there can be no assurance as to whether or when the offerings may be completed, or as to the actual size or terms of the offerings. All of the securities to be sold in the offerings are being offered by VBI.

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Raymond James & Associates, Inc. is acting as the sole book-running manager for the underwritten public offering. Newbridge Securities Corporation is acting as the lead manager for the underwritten public offering. The registered direct offering is being made without an underwriter or a placement agent.

VBI intends to use the net proceeds from both offerings for the commercialization activities for PreHevbrio [Hepatitis B Vaccine (Recombinant)] in the United States, Europe, and Canada; manufacturing of PreHevbrio and clinical materials for its pipeline programs; and ongoing activities related to its development stage candidates, including VBI-1901 (glioblastoma) and VBI-2901 (coronaviruses). The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement on Form S-3 (File No. 333-267109) relating to these securities was previously filed with the Securities and Exchange Commission ("SEC") on August 26, 2022 and declared effective on September 6, 2022. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement (when available) and accompanying prospectus may be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

About PreHevbrio

PreHevbrio is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. The brand names for this vaccine are: PreHevbrio (US/Canada), PreHevbri (EU/EEA/UK), and Sci-B-Vac (Israel).

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

U.S. Indication

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

U.S. Important Safety Information (ISI)

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.=

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

On July 5, 2023 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported the grant of a restricted stock unit (RSU) award for 9,000 shares of Syros common stock to one newly hired employee in connection with commencing employment with Syros (Press release, Syros Pharmaceuticals, JUL 5, 2023, View Source [SID1234633055]). This RSU was granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

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The award was granted on June 30, 2023, and vests as to one-quarter of the shares on June 30, 2024, and as to an additional one-quarter of the shares at the end of each successive year thereafter, subject to the employee’s continued service with Syros. This award is subject to the terms and conditions of a restricted stock unit agreement covering the award and Syros’ 2022 Inducement Stock Incentive Plan.

On July 5, 2023 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that synthetic recombinant proenzymes trypsinogen and chymotrypsinogen were successfully produced via the Proenzyme Optimization Project 1 (POP1) joint research and drug discovery program with the Universities of Jaén and Granada, Spain (Press release, Propanc, JUL 5, 2023, View Source [SID1234633054]). The POP1 project is led by Mr. Aitor González, whose doctoral thesis is focused on the "synthetic development of PRP and its subsequent biological validation," conducted at the laboratory of Professor Macarena Perán, PhD, University of Jaén, Granada, Spain, and in collaboration with Professor Diethard Mattanovich at the Institute of Microbiology and Microbial Biotechnology, University of Natural Resources and Life Sciences, Vienna, Austria. The program is designed to produce a backup clinical compound to the Company’s lead product candidate, PRP, which is from bovine origin, targeting metastatic cancer from solid tumors. According to Emergen Research, the global metastatic cancer market is projected to be worth over $111 Billion by 2027.

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Key findings from the research conducted by Mr. González determined that it is possible to scale up production of both proenzymes trypsinogen and chymotrypsinogen using recombinant technology, resulting in stable, purified proteins that are biologically active and have a similar anti-tumoral effect when compared with PRP. Furthermore, cell viability assays on pancreatic cancer stem cells (Bx PC3-CSCs) suggest that recombinant proenzymes may possess an even stronger anti-tumor effect than pancreatic proenzymes from bovine origin.

Dr Julian Kenyon, MD, MB, ChB, Propanc’s Chief Scientific Officer, said, "The work undertaken by Aitor is masterfully brilliant. I read his thorough work producing recombinant proenzymes in detail. It started with a comprehensive assessment of our current level of understanding of proenzymes and then describes in detail recombinant technology, culminating in the successful production of a completely synthetic recombinant product. As a result, we now have a viable way forward to developing a recombinant product, ultimately into the clinic."

The recombinant proenzyme product candidate, designated the label, rec-PRP, is set to enter preclinical pharmacology and safety toxicology studies to compare the safety and efficacy profile to the naturally derived formula in 2023 and 2024 calendar years.

A recombinant version of PRP could have additional benefits to the global healthcare system that could further capitalize on a new therapeutic approach to treating cancer that the Company’s lead product candidate offers sufferers. For example, both proenzymes are synthesized by an in vivo (living organism) system to produce crystallized proteins that could be maintained for long periods without suffering degradation in the absence of refrigeration. This will be useful for a longer shelf life as well as global distribution of the product, particularly in warmer climates and developing regions where refrigeration may not be available.

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include pancreatic, ovarian, kidney, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers. Orphan Drug Designation status of PRP has been granted from the US Food and Drug Administration (US FDA) for treatment of pancreatic cancer.