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Patient treatments commence with Clarity’s copper-64/copper-67 SARTATEin neuroblastoma clinical trial

On November 3, 2020 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that treatment has commenced in a 64/67Cu-SARTATETM theranostic trial of paediatric patients with neuroblastoma at Memorial Sloan Kettering Cancer Center (MSK) in New York City (Press release, Clarity Pharmaceuticals, NOV 3, 2020, View Source [SID1234569699]).

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The first patient was treated with 67Cu-SARTATE therapy following a positive diagnostic scan with 64Cu-SARTATE and is progressing through the study assessments as planned. Patient recruitment continues at MSK and will be expanding to other clinical sites across the United States (U.S.) in the coming months (ClinicalTrials.gov Identifier: NCT04023331)1.

"We are very excited to commence the treatment of neuroblastoma patients with SARTATE, especially given the great promise of both the diagnostic and therapeutic products in changing the treatment outcomes in these children," commented Dr Alan Taylor, Clarity’s Executive Chairman. "We are looking forward to building more data as we expand the trial to include additional clinical sites and recruit more patients with high-risk neuroblastoma into the study. We are very hopeful that 64/67Cu-SARTATE will save and improve lives of children with this insidious disease."

The SARTATE neuroblastoma trial uses the next-generation radiopharmaceutical pair of 64Cu-SARTATE and 67Cu-SARTATE to assess and treat paediatric patients with high-risk neuroblastoma. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a theranostic clinical trial being conducted in the U.S. Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.2 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.3

Dr Taylor continued: "Our team is pleased to have received very strong support from our numerous collaborators in the clinical development of 64/67Cu-SARTATE in neuroblastoma. We have also recently been granted Orphan Drug Designation as well as two Rare Paediatric Disease Designations for the diagnostic and therapeutic application of SARTATE in neuroblastoma by the U.S. Food and Drug Administration (FDA). These regulatory milestones will enable us to progress SARTATE through clinical development in a swift and cost-effective manner and make Clarity eligible for two Priority Review Vouchers (PRV) upon FDA marketing approval of the diagnostic and therapeutic products. PRVs, which allow for the faster processing of new drug applications through the FDA, are tradable and currently have a market value of approximately USD100 million each. The awarding of these two PRVs will underpin our extensive theranostic development pipeline as we look to progress treatments in other cancers including prostate and breast, as well as neuroendocrine tumours.

"From all the support and positive feedback from the industry that we have received to date, it is clear that the development of next-generation diagnostic and therapeutic tools as well as novel treatment strategies are imperative to improving treatment outcomes for children with high risk neuroblastoma who currently have very poor prognosis and few treatment options. Clarity and our collaborators remain focused on the important goal of developing better treatments for children with cancer and we look forward to further progressing the development of SARTATE together," Dr Taylor said.

Doer Biologics Received nearly 100 millions of RMB in A+ round of financing to promote the research of multispecific innovative biologics

On November 2, 2020 Zhejiang Doer Biologics Corporation (hereinafter referred to as "Doer "), which focuses on the development of innovative multispecific protein drugs based on multi-domains, reported the completion of nearly 100 millions of RMB in A+ round of financing (Press release, Doer Biologics, NOV 2, 2020, View Source [SID1234656202]). The financing was led by Huarui Investment, followed by Haiyue Asset Management, and the old shareholders Kaitai Capitaland Hangzhou Bairui made additional investments. The funds raised will be used to promote the company’s clinical applications of three first-class innovative drugs and follow-ups in R&D and preclinical research.

Doer Biologics was founded by Dr. Yanshan Huang in 2014, who is a domestic biopharmaceutical research expert and serial entrepreneur. Dr. Huang has nearly 30 years of experience in biomedicine research, development and industrialization . Two biopharmaceutical marketing authorizations were achieved under his leadership in Hangzhou Jiuyuan Gene (the first recombinant rhG-CSF and rhIL-11 to be marketed in China) . He promoted the entry of multiple biological drugs into clinical research, and at the same time he presided over the completion of the clinical development of the first domestic long-acting biological drug based on albumin fusion technology and China’s first biological drug production based on Pichia Pastoris expression system. Dr. Huang later co-founded Jiangsu Taikang Biology in 2008. He was responsible for establishing the technology platform and he promoted four improved antibody/long-acting protein drugs (Bio-better) into clinical research. Finally, he dominated the Mergers and acquisitions of Taikang Biology which brought nearly 10 times the return on investment within 6 years for investors. Dr. Huang founded Doer Biologics in 2014 and completed round A financing of tens of millions of RMB jointly funded by Kaitai Capital and Hangzhou Bairui in 2019.

Doer has developed 4 technology platforms with independent intellectual property rights: xLONGylation, MultipleBody, AccuBody and SMART-VHHBody. It has developed a number of innovative multispecific protein drugs based on multiple domains using these platforms to address unmet clinical needs. At present, Doer has more than 10 innovative protein drugs under development. The research focuses on three important therapeutic areas: Metabolic disease(cardiovascular disease, diabetes, obesity, NASH), oncology and ophthalmology. And there are 3 first-class innovative drugs ready for clinical application. Among them, DR10624 is the world’s first (first-in-class) long-acting tri-agonist. It has excellent hypoglycemic, lipid-lowering, weight-loss and liver-protecting activities. DR10624 is expected for the treatment of metabolic diseases such as diabetes, obesity and nonalcoholic fatty liver (NASH). DR10627 is a potential best-in-class dual-agonist, with good activities in lowering bloodglucose, lowering lipids, and protecting liver. The clinical indications are diabetes and NASH. DR30303 is the world’s first therapeutic antibody against Claudin 18.2 developed based on the single domain antibody. It has extremely high anti-tumor activity and clinical indications are gastric cancer and pancreatic cancer.

Regarding for the successful completion of this round A+ financing, Dr. Huang, founder and CEO of Doer, said: "Thank you very much for the support of the inventors. Doer will continue to work hard to contribute to human health."

Yuding Wu, Investment Director of Huarui Investment, said: "Doer is the first domestic company to deploy multispecific biologics, and it is also an important partner of Huarui Investment in the field of biotechnology. Huarui Investment will accompany Dr. Huang steadily for a long time, assist Doer to promote the research and development of new drugs, solve unmet clinical needs, and make contributions to human health."

Nannan Chang, Chief Executive Officer of Kaitai Capital, said: "Doer has been deeply involved in the field of multi-domain biopharmaceuticals for many years, and has developed a number of globally competitive products. We are fortunate to participate in Doer and I believe that under the leadership of Dr. Huang, the team has the ability to bring more and better biological drugs to patients continuously.

Zhen Qin, Chairman of Haiyue Asset Management, said: "Doer has gathered excellent teams to overcome difficulties on the new track and develops rapidly. It will surely grow into an excellent star enterprise. Haiyue Asset Management has always been a loyal partner of excellent enterprises and we will accompany Doer to develop together in the future.

NIH Federal Grant Awarded to Wildflower Biopharma

On November 2, 2022 Wildflower Biopharma reported the National Institute of Health rewarded a grant this fall to the company (Press release, Wildflower Biopharma, NOV 2, 2020, View Source [SID1234632139]). The work/research is explained in the Grant Title: "Efficacy of a novel small-molecule splicing modulator in chronic lymphocytic leukemia (CLL)".

The Wildflower Team is excited to announce that the Grant work will be performed at BioLabs San Diego and in collaboration with Huidong Shi at the Department of Biochemistry and Molecular Biology at Augusta University, Georgia.

ABL Bio and LegoChem Biosciences Expand ADC Technology Cooperation

On November 2, 2020 ABL Bio and LegoChem Biociences have reported the signing of a memorandum of understanding(MOU) to expand their partnership on ADC technology (Press release, ABL Bio, NOV 2, 2020, View Source [SID1234628153]). The agreement draws attention as it comes shortly after ABL202(LCB71), an ADC co-developed by the two companies, was licensed out to CStone Pharmaceuticals

Under the agreement, the two companies will cooperate on two additional projects, totaling their joint projects to four. While their previous focus was on treatments that combine monoclonal antibodies with LCB’s platform technology, such as ABL202(LCB71), their new projects will center on bispecific antibody ADCs that global pharmaceutical companies are increasingly viewing as a promising sector

This new agreement by ABL Bio and LCB reflect the growing interest in ADC technology. Gilead Sciences recently announced its decision to acquire Immunomedics for approximately $21 billion, at $88 per share in cash. MSD signed a $1.6 billion deal with Seattle Genetics on two new oncology projects. AstraZeneca and Daiichi Sankyo also entered collaboration for the global development and commercialization of another ADC

ABL Bio has the knowledge and proven experience of bispecific antibodies, having acquired a set of bispecific antibody platforms. Combining the company’s BsAb specialty with LCB’s linker and ConjuAllTM Site-specific conjugation technology is anticipated to create a synergy effect in developing next-generation ADCs

Yong-Zu Kim, CEO of LCB said ""Four years of joint research have allowed ABL Bio and LegoChem Biosciences to understand each other’s strengths and build trust. Our long-standing relationship will lead to a much more accelerated and efficient research collaboration

Sang Hoon Lee, CEO of ABL Bio said "We are happy to announce our two companies’ expanded cooperation in ADC technology. On the backdrop of the recent success of achieving a licensing deal for ABL202, ABL Bio and LCB will work closely together to continue this momentum."

Rexahn Pharmaceuticals Announces Stockholder Approval of All Proposals Required for Merger with Ocuphire Pharma

On November 2, 2020 Rexahn Pharmaceuticals, Inc. (NASDAQ:REXN) ("Rexahn") reported that at its special meeting of stockholders held on November 2, 2020, Rexahn’s stockholders approved all of the proposals presented, including: (i) the issuance of shares of Rexahn common stock pursuant to the Agreement and Plan of Merger and Reorganization, dated June 17, 2020, as amended, by and among Rexahn, Razor Merger Sub, Inc. and Ocuphire Pharma, Inc. ("Ocuphire") and the change of control of Rexahn resulting from the merger; (ii) a reverse stock split of Rexahn common stock, at a ratio of one new share for every 3 to 5 shares outstanding, with such final ratio to be approved by Rexahn’s board of directors; (iii) changing the name of Rexahn from "Rexahn Pharmaceuticals, Inc." to "Ocuphire Pharma, Inc."; (iv) the adoption of the Ocuphire Pharma, Inc. 2020 Equity Incentive Plan; and (v) the issuance of shares of Rexahn common stock upon the exercise of warrants to be issued in the pre-merger financing and the issuance of additional shares of Rexahn common stock that may be issued following the closing of the pre-merger financing (Press release, Rexahn, NOV 2, 2020, View Source [SID1234584259]).

"We appreciate the participation and support from our stockholders regarding the upcoming merger transaction with Ocuphire," commented Douglas Swirsky, President and CEO of Rexahn. "Ocuphire’s Board of Directors and President and CEO Mina Sooch are well positioned to guide the combined company forward with an exciting late-stage pipeline of ophthalmic therapeutic candidates and multiple potential value inflection points in 2021."

With the recent approvals by the stockholders of both Rexahn and Ocuphire, and as previously announced, the unanimous approval by the Boards of Directors of both Rexahn and Ocuphire, the merger is expected to be consummated on or about November 5, 2020, subject to the satisfaction of certain closing conditions. In connection with the closing of the merger, Rexahn will change its name to Ocuphire Pharma, Inc. and the combined company’s shares are expected to commence trading on the Nasdaq Capital Market under the symbol "OCUP".

The final voting results for Rexahn’s special meeting of stockholders will be filed with the Securities and Exchange Commission (the "SEC") in a Current Report on Form 8-K.