On March 31, 2021 Edison Oncology Holding Corp. ("Edison Oncology"), a company established to develop and commercialize new therapies targeting the fight against cancer, reported that it has transferred certain worldwide rights to novel DNA-damage response (DDR) inhibitors, including its EO2000 series PARP Inhibitor Program Technology, to Rakovina Therapeutics Inc. ("Rakovina", TSX-V: RKV) (Press release, Edison Oncology, MAR 31, 2021, View Source [SID1234577472]).

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In exchange for transferring these rights, Edison Oncology has been issued common shares representing approximately 43% of the outstanding shares of Rakovina. Edison Oncology’s ownership in Rakovina is held by NewGen Therapeutics, Inc. a wholly-owned subsidiary of Edison Oncology.

"We are pleased to work with the Rakovina Therapeutics team to establish this new company that will seek to develop new cancer treatments based on novel DNA-damage response technologies", said Mr. Jeffrey Bacha, Edison Oncology’s chief executive officer. "Edison Oncology and its shareholders will benefit by virtue of our substantial ownership, which will provide opportunities for significant value creation as Rakovina advances its pipeline toward human clinical trials."

As a result of this transaction, Dennis Brown, Ph.D., Edison Oncology’s chairman and Jeffrey Bacha, Edison Oncology’s chief executive officer have been appointed to Rakovina’s Board of Directors. Mr. Bacha has been appointed Rakovina’s executive chairman.

Rakovina was capitalized through a private placement financing and will conduct lead optimization research under a collaboration agreement with the University of British Columbia. Rakovina’s common shares are expected to begin trading as a Tier 2 Issuer on the TSX Venture Exchange under the symbol "RKV" on or about Thursday, April 1, 2021.

On March 31, 2021 The nonprofit Pennsylvania Biotechnology Center (PABC), one of the nation’s most successful life sciences incubators, reported a new collaboration that includes a pledge by Daiichi Sankyo to become an investor in the fund managed by Hatch Biofund Management LLC (Press release, Daiichi Sankyo, MAR 31, 2021, https://www.businesswire.com/news/home/20210331005113/en/Pennsylvania-Biotechnology-Center-PABC-announces-new-collaboration-and-10-million-investment-pledge-from-Daiichi-Sankyo-Inc. [SID1234577465]).

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An investment of $10 million has been committed by Daiichi Sankyo to Hatch Biofund 1, which was created by the Baruch S. Blumberg Institute as a companion to their Incubator and BioAccelerator. The PABC is managed by the Blumberg Institute. Hatch Biofund is currently in a fundraising mode with plans to raise $50 million with a first close within months.

Louis P. Kassa, the PABC’s executive vice president and chief operating officer, said, "Having Daiichi Sankyo join our innovation ecosystem is a big win for the PABC and our nearly 80 member companies, and it’s a win for Bucks County, the Philadelphia region and the Commonwealth of Pennsylvania as well."

Daiichi Sankyo’s interests in oncology and cell and gene therapy align well with the current PABC incubator.

"This collaboration provides Daiichi Sankyo with access to the new therapeutics under development in the incubators as well as a front row seat at the birth of the new cell and gene therapy industry here in our region," Vlad Walko, CEO of Hatch, said. "The lead investment in Hatch reflects Daiichi Sankyo’s confidence in the PABC model and in the Philadelphia region as a major biotech hub."

Daiichi Sankyo, one of the largest pharmaceutical companies in Japan with sales of more than $9 billion, has its U.S. headquarters in Basking Ridge, N.J. "At Daiichi Sankyo, we are committed to exploring and investing in a variety of avenues to improve health and extend lives," said Stu Mackey, Global Head of Business Development, Daiichi Sankyo. "We are proud to partner with the Pennsylvania Biotechnology Center to support the advancement of companies that share our goals for better global human health."

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).

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]).

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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.

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]).

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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.