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ARTMS Inc. Submits Drug Master File for the First Ever Multi-Curie Production of Gallium-68 with ARTMS’ Solid Target Solution on Medical Cyclotrons

On March 31, 2021 ARTMS Inc. (ARTMS) reported the submission of a Drug Master File (DMF) to the FDA for the high-volume production of Gallium-68 (68Ga) with ARTMS’ solid target technology in combination with a medical cyclotron (Press release, ARTMS Products, MAR 31, 2021, View Source [SID1234577464]). ARTMS’ proprietary QUANTM Irradiation system (QISTM) demonstrated world record production of over 10 Ci 68Ga in 2019 on a low energy cyclotron. These low energy cyclotrons are installed in hundreds of sites globally where the QIS can be installed for daily use.

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"This submission to the FDA demonstrates how the team at ARTMS is executing our strategy. The molecular imaging community has and will continue to develop a number of innovative agents that are labeled with 68Ga. Unfortunately, the current supply chain of germanium/gallium generators is not robust enough to meet projected demand for these products. The action taken today by ARTMS marks a significant step toward solving the forthcoming supply issues for this critical isotope. ARTMS has spent the last 18 months solidifying partnerships with drug developers and building a network of cyclotron operators with the intention of changing the way isotopes are delivered to patients in greatest need of these imaging studies. The ARTMS platform goes far beyond 68Ga production, expanding our client’s reach to other high demand diagnostic and therapeutic isotopes. I am extremely excited about the opportunity that is in front of ARTMS and our partners," says Charles S. Conroy, Chief Executive Officer of ARTMS.

The use of 68Ga labelled products is among the most important innovations in the history of nuclear medicine. Currently, 68Ga radiopharmaceuticals are used to identify and stage a variety of oncology conditions, including neuroendocrine tumors and prostate cancer. This isotope has been traditionally supplied by generators which have limited output capabilities and are logistically and economically burdensome. While generators will continue to be a part of the 68Ga supply chain, ARTMS’ technology will alleviate widespread shortages as demand increases for 68Ga labelled diagnostic agents.

"It is our strategy to work alongside the radiopharmaceutical innovator community to allow the ARTMS solution and associated regulatory filings to be included in the innovator’s investigational new drug and new drug applications," said Dr. Michael Cross, Chief Operating Officer and project lead at ARTMS. "Moving forward, ARTMS will continue to expand collaboration efforts with the radiopharmaceutical innovators to validate ARTMS’ 68Ga with these important medical products."

With a focus on optimizing production potential, ARTMS will continue the development of cyclotron-produced 68Ga and other vitally important medical isotopes, while also pursuing multiple regulatory approvals. ARTMS has a variety of solid targets commercially available used in combination with ARTMS’ QUANTM Irradiation System (QIS).

Gracell Biotechnologies Announces Enrollment of First Patient in Registrational Phase 1/2 Clinical Study for GC007g, an Allogeneic CAR-T Cell Therapy for the Treatment of Relapsed or Refractory B-ALL

On March 31, 2021 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that they have enrolled the first patient in their pivotal Phase 1/2 clinical study of GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy for the treatment of B-cell acute lymphoblastic leukemia (B-ALL) (Press release, Gracell Biotechnologies, MAR 31, 2021, View Source [SID1234577463]).

GC007g is an allogeneic HLA (human leukocyte antigen)-matched donor-derived CAR-T therapy. Gracell obtained IND approval for GC007g for the treatment of B-ALL from China’s National Medical Products Administration (NMPA) and the approval for the pivotal Phase 1/2 clinical study in December 2020. The open-label, single-arm Phase 1/2 study is evaluating the safety and efficacy of GC007g in r/r B-ALL patients.

"We are thrilled to announce the enrollment of the first patient into our registrational Phase 1/2 trial for the allogeneic donor-derived CD19-targeted CAR-T therapy, GC007g, for the treatment of patients with B-ALL," said Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell. "GC007g is a unique treatment approach for B-ALL patients who relapse after allogeneic stem cell transplantation and are not eligible for standard-of-care. With Gracell’s innovative portfolio, we are excited to bring novel CAR-T therapies to more patients with high unmet medical need."

About GC007g

GC007g is a donor-derived CD19-directed allogeneic CAR-T cell therapy that has been studied for the treatment of r/r B-ALL in a completed investigator-initiated Phase 1 trial in China, where CAR-T cells were manufactured using T cells from an HLA-matched healthy donor.

About B-ALL

B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50.[1] In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide.[2] It is also the most common cause of cancer and death from cancer among children.

Gracell Biotechnologies Signs Agreement with Lonza to Manufacture Gracell’s FasTCAR Product Candidates in the U.S.

On March 31, 2021 Gracell Biotechnologies Inc. (NASDAQ:GRCL)("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the company has entered into a Manufacturing Service Agreement (MSA) with Lonza (SIX:LONN) for clinical manufacturing of Gracell’s FasTCAR-enabled CAR-T cell product candidates in the U.S (Press release, Gracell Biotechnologies, MAR 31, 2021, View Source [SID1234577462]).

Gracell is advancing its innovative CAR-T pipeline globally for difficult-to-treat cancers, including its lead program for GC012F, a BCMA/CD19 dual-targeting CAR-T therapy for multiple myeloma. This autologous CAR-T product candidate is manufactured on Gracell’s proprietary FasTCAR technology platform, which significantly reduces the manufacturing time from an industry norm of two to six weeks down to next day. Gracell will leverage Lonza’s integrated services in CAR-T manufacturing and establish state of the art cGMP process, a critical component of Gracell’s IND enabling clinical development programs.

"Gracell has developed some highly innovative CAR-T manufacturing platforms, including our FasTCAR platform enabling next day manufacturing of autologous CAR-T products. With Lonza’s experience in CAR-T therapy manufacturing and excellent reputation, they are an ideal strategic collaborator for advancing our pioneering, proprietary FasTCAR platform globally," stated Dr. William Wei Cao, Chief Executive Officer of Gracell. Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell, added, "We are pleased to enter into this collaboration with Lonza and are currently building our international presence, including clinical operations to advance our product candidates and bring them to more patients globally. We are hoping to expand our programs in close collaboration with Lonza’s capabilities. In addition, we look forward to a strategic relationship with Lonza to support IND-filing and clinical manufacturing in the U.S."

About FasTCAR

CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

Cannabics Pharmaceuticals to Initiate in-vivo Dose Response Study on Proprietary Colorectal Cancer Drug Candidate RCC-33

On March 31, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported it is initiating a Dose Response in-vivo Study in mice; results to be included as part of the Product Package to be submitted to the U.S. Food and Drug Administration along with a Pre-IND meeting request (Press release, Cannabics Pharmaceuticals, MAR 31, 2021, View Source [SID1234577461]).

The Dose Response Study comes in light of previously reported results indicating a 33% reduction in tumor volume and a 35% prolonged survival rate in mice inoculated with human colorectal cancer cells and exposed to Cannabics RCC-33.

Eyal Barad Cannabics Pharmaceuticals co-founder and CEO said: "the entire Cannabics team is filled with enthusiasm as we see our own formula having such promising results on animals. Our priority and attention is in advancing RCC-33 down the clinical and regulatory pathway in a timely and efficient manner to be potentially become a part of the standard of care and treatment regimen for colorectal cancer patients."

CTI BioPharma Corp. Announces Proposed Public Offering of Common Stock and Preferred Stock

On March 31, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) ("CTI"), a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers, reported that it intends to offer and sell shares of its common stock and series X1 preferred stock (the "Series X1 Preferred") in an underwritten registered public offering (Press release, CTI BioPharma, MAR 31, 2021, View Source [SID1234577460]). All of the securities in the proposed offering are to be sold by CTI. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Each share of Series X1 Preferred will be convertible into 10,000 shares of common stock at the election of the holder, subject to beneficial ownership conversion limits applicable to the Series X1 Preferred.

CTI intends to use the proceeds from the proposed sale of its shares of common stock and Series X1 Preferred Stock for commercialization activities for pacritinib, general working capital and corporate purposes.

Stifel and JMP Securities are acting as joint book-running managers for the offering. BTIG is acting as lead manager for the offering.

The offering is being made pursuant to a registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and subsequently was declared effective by the SEC. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC. Copies of the preliminary prospectus supplement and accompanying prospectus relating to these securities may also be obtained by sending a request to Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery St, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected], or JMP Securities LLC, 600 Montgomery St, Suite 1100, San Francisco, CA 94111, Attn: Prospectus Department, telephone: 415-835-8900.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will 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 the registration or qualification under the securities laws of any such state or other jurisdiction.