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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.

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.

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]).

"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.