TC BioPharm and the NIPRO Corporation Announce Strategic Programme Co-Developing a Novel Gamma-Delta CAR-T Product to Treat Cancer

On February 7, 2018 The NIPRO Corporation (TSE: 8086) and TC BioPharm Ltd (TCB), reported that they have formed a strategic collaboration to co-develop a novel immunotherapy product using TCB’s safe CAR-T platform, based on unique properties of modified gamma delta (γδ) T cells to selectively target cancer whilst leaving healthy cells untouched (Press release, TC Biopharm, FEB 7, 2018, http://www.tcbiopharm.com/index.php/component/content/article/96 [SID1234524275]). TCB intends to use this novel platform to develop new CAR-based immunotherapies, with the aim of treating a broad range of cancers and major viral disease.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"TCB’s world-class GMP-compliant manufacturing facility and experienced in-house clinical team will allow us to leverage patient treatment at established cancer therapy centers throughout Europe", said TCB’s Chief Operating Officer, Angela Scott, "since commencing operations in 2014, we have treated numerous cancer patients successfully with unmodified gamma-delta T cells and built sufficient infrastructure to progress our innovative proprietary next-generation CAR-T towards phase I studies during 2018."

The NIPRO Corporation will provide non-dilutive funds in the form of up-front fees, milestone payments and research-support to progress elements of TCB’s CAR-T program to clinical studies. NIPRO cash will provide the Osaka-based company with an exclusive right to sell, and distribute CAR-T product worldwide.

TCB and NIPRO will co-develop an autologous gamma-delta CAR-T therapy directed against CD19, which is expressed in several B cell tumors such as multiple myeloma and lymphoma. Preclinical studies developing the product will be supported by a Scottish Enterprise ‘seek-and-solve’ grant which will provide £2.7m of additional non-dilutive funding. Commenting on both the grant and collaboration, Jim Watson, director of Innovation & Enterprise Services at Scottish Enterprise, said, "This particular grant is designed to encourage investment in R&D and inspire Scottish companies to partner with international players to expand market reach, it’s fantastic to see a pre-revenue company like TCB collaborating with NIPRO. TCB’s strong international mindset will help the company reap benefits of this collaboration – both in terms of financial support and the market knowledge that NIPRO brings to the table. The Seek and Solve project will allow TCB to accelerate route to market, meaning potentially quicker returns for the Scottish economy, helping establish TCB as a global leader in cancer-specific cell therapies."

TCB’s proprietary ImmuniCAR platform uses the innate ability of gamma-delta T cells to target cancer, this has allowed the Company develop a wide-range of innovative safe therapies designed to treat a variety of tumours without toxic side-effects seen in many current CAR-T products. NIPRO’s Managing Director, Toshiaki Masuda, said, "The collaboration with TC Biopharm – who has stand-alone technology in developing CAR-T products; and NIPRO – an experienced company in manufacturing cell culture products, will establish the safe and innovative cancer therapeutics for practical use in the global market."

Head of the Department of Oncology at the University of Oxford, Professor Mark Middleton noted that, "the combination of gamma delta and CAR T cell therapy gives us the opportunity to test this promising new treatment in patients for the first time.’ He added that, ‘those of us who treat solid tumors have followed use of CAR T cells in hematological malignancy with great interest, this exciting collaboration between TCB and NIPRO has potential to overcome safety challenges when developing such treatments in patients with solid tumors".

The collaboration with NIPRO is TCB’s first major pharma deal centred in Asia, and represents a strong endorsement of the therapeutic approach. Remarking on this significant milestone for the Company, Chief Executive Dr Michael Leek iterated that, "This commercial collaboration represents the cutting-edge of cell-based immunotherapy, providing clinicians and cancer patients access to next-generation, safe, innovative oncology products, we are privileged to be working alongside the NIPRO Corporation as they continue to build a formidable presence in the regenerative medicine sector ".

Chief Business Officer Dr Artin Moussavi added, "TCB has been very active over the last 12 months raising over $35m cash, sealing long-term commercial relationships with a potential combined pre-market income over $1bn. The NIPRO collaboration is our latest such deal, representing a joint-effort to build a significant immune-oncology business in Japan and Asia".

Cellular Biomedicine Group Announces $30.6 million Investment from Sailing Capital Overseas Investment Ltd.

On February 5, 2018 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the development of immunotherapies for cancer, reported the receipt of a $30.6 million investment from Sailing Capital Overseas Investment Ltd. and its affiliates (collectively "Sailing"), a global private equity firm focused on China cross-border investments in disruptive global companies in the healthcare, technology and consumer sectors (Press release, Cellular Biomedicine Group, FEB 7, 2018, View Source [SID1234523793]). As part of the transaction, Sailing will appoint a representative to the Company’s Board of Directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Sailing is a highly-regarded growth equity investor which leverages its unique commercial and government relationships to enhance its portfolio companies’ businesses in China and internationally. Sailing’s investment in the Company further validates our proprietary technology platform and independently affirms our prospects for CFDA approval and commercialization in China. We are proud of the demonstrated clinical proof-of-concept of our Chimeric Antigen Receptor ("CAR") T-cell immuno-oncology platform, and Sailing’s investment will enable further clinical development by funding our multiple clinical programs for progressive malignant lymphoma, Acute B lymphocytic leukemia and Hodgkin’s lymphoma, as well as development in novel T Cell Receptor (TCR) therapies to redirect T cells for solid tumors," said Tony (Bizuo) Liu, Chief Executive Officer of CBMG.

"With the recent regulatory approvals and commercialization of CAR-T in the US and the CFDA’s issuance of final guidance for the approval of CAR-T in China, we believe an investment in CBMG is timely as the China market opportunity for cell and gene therapy is substantial. We have conducted a deep dive on the cell and gene therapy industry and found CBMG to be not only a leader in China, but also globally, of vertically integrated cell and gene therapy manufacturing know-how, as evidenced by the Company’s strategic and joint development partnerships with both GE and Thermo Fisher. GMP quality manufacturing, market leading capacity (for 10,000 patients) and a focus on GCP standards in China are critical success factors in developing cutting-edge cancer immunotherapies for the global markets. Further, we have found CBMG to have strong innovation and translation medicine sophistication, which is reflected in a strong pipeline of multiple CAR-T and TCR constructs. We also see tremendous opportunity for leading cell and gene therapy companies based outside of China to partner with CBMG, leveraging the Company’s manufacturing expertise and the favorable regulatory environment in China, to rapidly advance development programs into the clinic. We look forward to supporting CBMG’s continued clinical success and believe the Company will emerge as a leader in the cancer medicine fields," said James Xiaodong Liu, Chairman of Sailing Capital.

Cellectar Receives USPTO Notice of Allowance for Patent Covering Use of CLR 131 in Multiple Myeloma

On February 7, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the United States Patent and Trademark Office has issued a notice of allowance for U.S. Patent Application No. 15/095,641, entitled "Alkylphosphocholine Analogs for Multiple Myeloma Imaging and Therapy," which covers a method of use for CLR 131, the company’s lead radiotherapeutic Phospholipid Drug Conjugate (PDC) in multiple myeloma (MM) (Press release, Cellectar Biosciences, FEB 7, 2018, View Source [SID1234523792]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CLR 131 is Cellectar’s investigational compound under development for a range of orphan designated cancers. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver the cytotoxic radioisotope iodine-131 directly to tumor cells. CLR 131 is currently being evaluated in a Phase 1 clinical trial in patients with relapse or refractory MM, as well as in a Phase 2 clinical trial for relapsed or refractory MM and select relapsed or refractory lymphomas. The U.S. Food and Drug Administration has granted orphan drug designation for CLR 131 in the treatment of MM.

"This patent allowance enhances our intellectual property estate and underscores the novelty of CLR 131 for the treatment of multiple myeloma, a life-threatening disease with high unmet medical need," said James Caruso, chief executive officer of Cellectar Biosciences. "Importantly, upon issuance, this patent will extend our coverage into the mid-2030s."

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized phospholipid ether-drug conjugates (PDCs) to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

Diffusion Pharmaceuticals to Present at the 2018 BIO CEO & Investor Conference

On February 6, 2018 Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) ("Diffusion" or "the Company"), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, reported that David Kalergis, Chairman and Chief Executive Officer, will present an overview of the Company and recent advancements of its lead product candidate, trans sodium crocetinate (TSC), at the BIO CEO & Investor Conference to be held on February 12 – 13, 2018 at the New York Marriott Marquis (Press release, Diffusion Pharmaceuticals, FEB 7, 2018, View Source [SID1234523794]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Mr. Kalergis is scheduled to present on Tuesday, February 13, 2018 at 2:45 p.m. Eastern time.

To listen to the presentation live, investors may visit the investor relations section of Diffusion Pharmaceuticals’ website at www.diffusionpharma.com. An archived webcast of the presentation will also be available on the Company’s website for 90 days.

Moleculin Announces Activity with Pancreatic Cancer Drug

On February 7, 2018 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported it has been able to show promising tumor suppression activity with its inhibitor of glycolysis, WP1122 (Press release, Moleculin, FEB 7, 2018, View Source [SID1234523798]).

"We have previously announced that our glycolysis inhibitors have shown a remarkable affinity for concentrating in the pancreas," commented Walter Klemp, Chairman and CEO of Moleculin. "And, we know that pancreatic cancer is highly glycolytic. Now, we have solid data showing the ability of WP1122 to inhibit pancreatic tumor growth in mice."

Mr. Klemp continued, "This is the indicator we were looking for to support our going after pancreatic cancer as a primary target for the WP1122 portfolio. We couldn’t be more excited given the intense unmet need in pancreatic cancer."