On December 31, 2020 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported that it has completed the previously announced 1-for-6 reverse stock split of its outstanding and authorized shares of common stock (Press release, Acorda Therapeutics, DEC 31, 2020, View Source [SID1234573360]). The reverse stock split became effective at 4:01 p.m. Eastern Time today, and the Company’s common stock will begin trading on a split-adjusted basis at the market open on January 4, 2021.

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The reverse stock split was effected in accordance with the authorization adopted by Acorda’s stockholders at the Company’s Special Meeting of Stockholders held on July 31, 2020. The reverse stock split is intended to enable the Company to regain compliance with the $1.00 per share minimum bid price required for continued listing on The Nasdaq Global Select Market.

Pursuant to the reverse stock split, every six shares of Acorda’s issued and outstanding common stock were automatically combined and converted into one issued and outstanding share of common stock, and there was a proportionate reduction in the number of shares of the Company’s authorized common stock, from 370,000,000 to 61,666,666. Fractional shares resulting from the reverse stock split were rounded up to the next whole number. The reverse stock split applied equally to all outstanding shares of the common stock, and each stockholder held the same percentage of common stock outstanding immediately following the reverse stock split as that stockholder held immediately prior to the reverse stock split, except for adjustments resulting from the treatment of fractional shares.

Acorda’s common stock will continue to trade on The Nasdaq Global Select Market under the symbol "ACOR," and the new CUSIP number is 00484M601.

Acorda has appointed its transfer agent, Computershare Trust Company, N.A. ("Computershare"), to act as exchange agent for the reverse stock split. Stockholders owning shares of common stock via a bank, broker or other nominee will have their positions automatically adjusted to reflect the reverse stock split and will not be required to take further action in connection with the reverse stock split, subject to brokers’ particular processes. Computershare will provide instructions to stockholders with physical certificates regarding the optional process for exchanging their pre-split stock certificates for post-split stock certificates.

On December 31, 2020 NETRIS Pharma, a clinical-stage biopharmaceutical company developing therapeutics based on dependence receptor biology, reported that the first patient has been dosed in its GYNet Phase 1b/II clinical study (Press release, Netris Pharma, DEC 31, 2020, View Source [SID1234573345]).

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GYNet is a randomized, multicenter, open label Phase Ib/II study that will enroll up to 240 patients with locally advanced/metastatic endometrial carcinoma or cervix carcinoma progressing/relapsing after at least one prior systemic chemotherapy. In the Phase1b part, the study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NP137 administered in combination with KEYTRUDA and/or chemotherapeutic agents. The Phase 2 part will assess the clinical activity of the combination in both tumor types. More information on GYNet study can be found at View Source (NCT04652076).

NP137 is a monoclonal antibody that targets netrin-1, which is a protein overexpressed in over 80% of uterine tumors. In early clinical studies, NP137 monotherapy demonstrated encouraging clinical signs of efficacy as measured by objective response and prolonged stable disease. In addition, preclinical data confirmed that netrin-1 interference via NP137 alleviates resistance to chemotherapy and immune checkpoint inhibitors, reinforcing the strong scientific rationale of this combination trial.

"We look forward to seeing the first clinical result of the GYNet trial, given the anti-tumor activity as single agent observed in the Phase 1a trial and unique mode of action of NP137," said Professor Isabelle Ray Coquard, MD, Ph.D. from the Centre Leon Bérard in Lyon, France and Principal Investigator of the trial.

Patrick Mehlen, CEO and Founder of NETRIS Pharma added: "The inclusion of the first patient in this phase 1b/2 clinical trial is a new milestone in the development of Netris. We look forward to seeing the results of this study as well as additional clinical advances in the near future."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About NP137

NP137, a humanized monoclonal antibody of isotype IgG1 directed against netrin-1, is the first drug candidate developed by NETRIS Pharma. Most types of tumors produce an abnormal amount of dependence receptors’ ligands, which prevents cells from dying. Netrin-1 is overexpressed in a large percentage of human cancers, including over two thirds of gynecologic cancers.

In preclinical studies, NP137 inhibited tumor growth and had a significant impact on tumoral plasticity, which potentiates the efficacy of chemotherapies and immune checkpoint inhibitors. In the phase 1 dose-escalation study, NP137 was found to be safe and very well tolerated up to 20mg/kg, with no dose limiting toxicity (DLT). In addition, patients with advanced uterine cancers exhibited encouraging signs of anti-tumor activity, including prolonged stable disease and objective responses.

On December 31, 2020 Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, reported that it has regained the worldwide rights to its HPK1 inhibitor program from Bristol Myers Squibb (Press release, Nimbus Therapeutics, DEC 31, 2020, View Source [SID1234573335]). Under Nimbus’ agreement with Celgene, now a Bristol Myers Squibb company, Celgene held an option to acquire the HPK1 inhibitor program. As part of its Celgene integration process, Bristol Myers Squibb is streamlining and prioritizing its portfolio and as a result, made the decision to decline this option.

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"We’re excited to continue progressing our small molecule HPK1 inhibitors within Nimbus’ wholly owned pipeline. Preclinical data we presented this year at prominent oncology conferences show that our potent HPK1 inhibitor has a high degree of selectivity, demonstrates in vitro effects on T cells, B cells and dendritic cells, and shows significant in vivo tumor growth inhibition across multiple animal models," said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. "We look forward to progressing this promising immuno-oncology program into a first-in-human clinical study in 2021."

On December 30, 2020 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) reported that it has received positive preliminary results from a bioavailability study in healthy volunteers with an improved HyNap-Dasa version of the reference drug Sprycel, demonstrating that absorption of HyNap-Dasa is not dependent on the gastric pH level (Press release, Xspray, DEC 30, 2020, View Source [SID1234649571]). HyNap-Dasa is being developed both as a generic and improved version of the marketed drug Sprycel (dasatinib).

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The preliminary results from the bioavailability study demonstrates that solubility and absorption of Xspray Pharma’s amorphous version of dasatinib, HyNap-Dasa, is not dependent on the gastric acidity (pH level). Xspray Pharma has earlier announced positive preliminary data for a sub-group of the subjects in the study.

As disclosed in Sprycel US labelling, the uptake is dependent on the patient’s gastric acidity. Increased pH dramatically decreases dasatinib´s solubility and absorption. The results from Xspray Pharma’s clinical study show that HyNap-Dasa is not affected during omeprazol treatment which increases the gastric pH. The results from the current conducted study shows a minor absorbtion increase of 8%, measured as area under the curve (AUC) after treatment with 40 mg of omeprazole (proton pump inhibitor) daily for five days. This can be compared to publiced data for Sprycel where AUC was reduced by 43% in combination with omeprazole. In 2019, Sprycel was the leading drug for the treatment of chronic myeloid leukaemia (CML) in sales, with global and US sales of 2,11 and 1,19 billion dollar, respectively.

"We have now demonstrated that our amorphous HyNap-Dasa formulation, produced in our commercial supply chain, can eliminate the pH dependent absorption seen in the crystalline reference product. This will allow for long-lasting acid suppressing medication also for CML patients treated with dasatinib. There are also patients with no production of hydrochloric acid in the stomach (achlorhydria) resulting in high gastric pH. These patients will have the chance to get a better dasatinib product for their cancer therapy," says Per Andersson, CEO of Xspray Pharma. "For many of the amorphous drug candidates we decide to develop, we will have the possibility to develop either a generic or an improved version, or both where we see a clinical and commercial rationale. This makes multiple registration pathways also for our lead product candidate possible and will not only increase Xspray Pharma’s value proposition to potential partners, but also broaden the commercial possibilities for Xspray Pharma as a company".

On December 30, 2020 Biocure Technology Corp. ("CURE" or the "Company") (CSE:CURE; OTCQB: BICTF) BiocurePharm, Korea ("BPK"), a subsidiary of Biocure Technology Inc. ("CURE") reported that BiocurePharm Korea ("BPK") and Pharos Vaccine Inc. ("PVI") have jointly submitted an Investigational New Drug ("IND") application to the Korean Ministry of Food and Drug Safety ("KFDS") to proceed with clinical trial Phase 1 for CD19 CAR-T therapy to treat Acute Lymphocyte Leukemia ("ALL") (Press release, Biocure Technology, DEC 30, 2020, View Source [SID1234628750]).

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CD19 CAR-T is an immune cell therapy for relapse and refractory B-cell precursor acute lymphoblastic leukemia, demonstrating a significantly high CR ("Complete Remission") rate as an individual medical prescription for a custom-made product for an individual patient.

BPK plans to conduct a clinical trial at two renowned hospitals in Korea, Seoul A-San Medical Center and Seoul St. Mary`s Hospital upon the approval of the IND application by KFDS. BPK anticipates the completion of the Phase 2 clinical trial no later than the first half of 2023. Once completed and pending positive results in the clinical trials, the drug would be released for commercialization in Korea and potentially internationally.

Dr. Sang Mok Lee, CEO and President of Biocure and BPK, states "This is an important milestone for the Company to advance its CAR T technology. We are about to start a clinical trial in Korea and are confident that if we have positive outcomes from the Korean clinical trial, this should enable the therapy to be readily available and offer affordable CAR T Therapy to save more lives."