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.

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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)".

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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

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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]).

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"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.

Gritstone Oncology Advances into Phase 2 Expansion Cohorts for its Personalized Neoantigen Immunotherapy GRANITE and its Off-the-Shelf Neoantigen Immunotherapy SLATE

On November 2, 2020 Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, reported that it has begun dosing patients in the Phase 2 expansion cohorts of the Phase 1/2 clinical studies for GRANITE and SLATE, its neoantigen-based immunotherapies (Press release, Gritstone Oncology, NOV 2, 2020, View Source [SID1234573683]).

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"We are excited to advance the highest doses of GRANITE and SLATE tested in the Phase 1 studies into Phase 2 clinical cohorts and interrogate the ability of our immunotherapies at full dose to elicit robust immune responses against historically cold (or non-immunogenic) tumor types such as metastatic colorectal cancer," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. "We have seen promising data in our Phase 1 study, which is still ongoing, including in gastro-esophageal and colorectal cancers, and we look forward to presenting the full dataset by mid-2021. Additionally, we continue to remain highly interested in the adjuvant setting where immunotherapy is likely to have the greatest impact and where diagnostic blood tests such as circulating tumor DNA (ctDNA) can be employed to run efficient trials in patients in need."

Daniel Catenacci, M.D., director of the Gastrointestinal Oncology Program at the University of Chicago Medicine and principal investigator on the studies, added, "The early Phase 1 data clearly show robust induction of neoantigen-specific CD8+ T cells, expansion of those cells in the tumor microenvironment, and early evidence of benefit to our patients. Delivering effective immunotherapy to patients with cold tumors would change the landscape of cancer treatment and expand the role of immunotherapy significantly."

The Phase 2 portion of the GRANITE Phase 1/2 study (GO-004) includes a cohort for patients with microsatellite stable colorectal cancer (MSS CRC) who have progressed on FOLFOX/FOLFIRI therapy and a second cohort for patients with gastro-esophageal cancer (GEA) who have progressed on chemotherapy. GRANITE was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS CRC.

In the Phase 2 part of the SLATE Phase 1/2 study (GO-005), the company has begun enrolling non-small cell lung cancer patients with relevant KRAS mutations who have progressed on prior immunotherapy, and patients with tumors where a relevant TP53 mutation exists.

Raphaël Rousseau, M.D., Ph.D., executive vice president and chief medical officer of Gritstone Oncology, added, "These expansion cohorts are designed to rapidly and unambiguously identify efficacy signals by studying patients in whom checkpoint inhibitor therapy is essentially inactive (MSS CRC) or has low activity (GEA). Furthermore, and related to the low activity of immunotherapy observed to date, patients with metastatic colorectal or gastro-esophageal cancers have poor prognoses, with estimated 12-month survival figures of only 56% and 30% respectively (SEER18 data). Registrational studies in these contexts can be consequently fast, particularly if observed treatment effects are strong."

About GRANITE and SLATE
Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens, or TSNA, that are identified by the company using its proprietary Gritstone EDGETM artificial intelligence platform and tumor HLA peptide sequencing. Data demonstrating the neoantigen identification capabilities of EDGE were published in Nature Biotechnology.

GRANITE is Gritstone’s personalized immunotherapy that consists of two components: first, a priming adenoviral vector is used to deliver a cassette of 20 patient-specific TSNA derived from the patient’s own tumor; and second, the same personalized TSNA cassette is delivered using a self-amplifying RNA vector in a repeated boost sequence. GRANITE is being evaluated in combination with immune checkpoint blockade in a Phase 1/2 clinical study, referred to as GO-004. GRANITE was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS CRC.

SLATE is Gritstone’s "off-the-shelf" immunotherapy. It uses the priming adenoviral vector and self-amplifying RNA vector to deliver a cassette of 20 shared TSNA, representing mutated gene sequences that are shared across patients (such as TP53 and K-RAS mutations). SLATE is being evaluated in combination with immune checkpoint blockade in a Phase 1/2 clinical study called GO-005.