On December 31, 2020 ImmVira Group Company ("the Company"), a biotechnology platform dedicated to the development of oncolytic virus("OV") and vector type approaches to create more effective and safer therapies against cancer, reported the signing of Series C financing (Press release, Immvira, DEC 31, 2020, View Source [SID1234573361]).

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!

The Company’s rapidly advancing OV programs with Best-in-class potential have drawn broad interest from renowned international and domestic institutional investors. Lead investor for Series C was Greater Bay Area Homeland Development Fund ("GBA Fund"), and Octagon Capital, China Merchants Capital (through Hui Kang Equity Fund), WinDigital Capital, LanTing Capital, and OrbiMed were co-investors. The Company’s existing investor GL Ventures, the venture capital arm of Hillhouse Capital, who invested in Series A Plus and Series B financings, also participated in this Series C round. O’Melveny & Myers acted as Company counsel with UBS and CICC as Financial Advisors.

The proceeds from the Transaction would be primarily used to fund international multi-center trial for MVR-T3011-IT, IND filing and swift initiation of clinical trials for two additional pipeline candidates, as well as the discovery and validation of new product candidates developed on the OvPENS platform.

Remarks from the executive management team, "We appreciate our new and existing investors for supporting what the company has achieved and trust in where it is heading. This group of new investors will bring tremendous resources to accelerate clinical and commercialization of our lead candidates while expanding the possibilities and viability of new pipelines developed on the OvPENS platform. We are grateful existing investors have also kindly supported in every way to make this Series C possible."

"Reflecting on 2020, ImmVira made leaps and bounds in building a solid foundation to ensure our OV programs will be successful. For MVR-T3011 intratumoural program, a landmark license program was achieved with Shanghai Pharma along with a validating strategic investment. As company’s first clinical effort, the intratumoral program expanded quickly from a single center trial in China to multiple sites in China with Australia and US multiple sites activated and synced to be a truly international trial, a first for oncolytic virus globally. For our near clinical candidates such as MVR-T3011 intravenous delivery and C5252 targeting brain tumors, we continue to accelerate our timetable for IND filing and look forward to having both candidates in clinical well before the end of second quarter of 2021."

"Our platform and corporate development also made great progress in the second half of 2020. The OvPENS platform team supported our manufacturing partner to scale and meet regulatory compliance such that production for all pre-clinical and clinical requirements ahead are secured. The OvPENS team also made several novel drug discoveries with the target to enable CAR T-cell, ADC and BiTE effective on solid tumors using an OV based vector-receptor approach. These breakthroughs will provide exciting candidate pipelines well into 2022 and beyond. For the company, the joining of highly experienced CMO and CFO would ensure our clinical and financing functions operate at the world class level. 2020 was a challenging year yet we are pleased to close the year with a new class of investors to welcome the New Year ahead."

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.

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!

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]).

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!

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.

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!

"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).

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!

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".