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 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."

On December 30, 2020 Cancer Research UK reported that scientists have finally found a way to target the KRAS mutation – a common mutation found in several hard-to-treat cancers (Press release, Cancer Research UK, DEC 30, 2020, View Source [SID1234573621]).

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By targeting two components of the KRAS signalling pathway, a new drug was much better at stopping the growth of pancreatic tumours with a KRAS mutation in mice compared to standard KRAS inhibitors, which only block one component of the pathway.

The drug, which has already shown promise in one sarcoma patient whose tumour had a KRAS mutation, will next be tested in patients with a variety of cancers in a larger Phase II clinical trial. The results are published in Annals of Oncology(link is external) today (Wednesday).

Changes to the KRAS gene, which is important in controlling cell growth, can lead to cells growing and dividing out of control to form tumours. Mutations in KRAS are found across 25% of cancers and are commonly found in several hard-to-treat cancers, including pancreatic, lung and colorectal tumours*.

Despite the prominent role of KRAS mutations in cancers and clear need for new treatments, scientists have been working for decades trying to find ways to target this pathway. Researchers say the main issue is because current KRAS inhibitors only target one component of the signalling pathway.

Now, a team of researchers led by Professors Caroline Springer and Richard Marais at the Cancer Research UK Manchester Institute have developed a new drug called CCT3833, which blocks two pathways in the KRAS signalling pathway called RAF and SRC.

The scientists tested CCT3833 in pancreatic, colorectal and lung cancer cell lines that had KRAS gene changes, as well as pancreatic tumours in mice, and compared the new drug with other standard KRAS inhibitors**.

Results showed that CCT3833 was able to restrict the growth of the cancer cells. It was also more effective in killing the cancer cells compared with other KRAS inhibitors. This was even more apparent when using 3D spherical tumour models, or ‘mini tumours’, which bridge the environment of cells grown in the lab and tumours in the body.

When tested in mouse models of pancreatic cancer with KRAS mutations, CCT3833 was more effective than other drugs in preventing cancer growth. CCT3833 also reduced tumour size.­

The study also describes the results of an early phase clinical trial of the drug tested in 31 patients with solid tumours. Whilst primarily designed to test safety, one patient in the trial who had a KRAS-mutant tumour that was growing larger after failing to respond to standard treatment had their tumour reduce in size for 8 months after receiving CCT3833.

The team is now planning to investigate the drug in further clinical trials.

Professor Caroline Springer, director of the drug discovery unit at the Cancer Research UK Manchester Institute, said: "Faulty KRAS signalling in cancer was identified over 35 years ago and yet, we still cannot block this pathway effectively. Our new drug stops the function of two critical growth pathways in KRAS-driven cells and has shown to be more effective than current drugs that only block one part of the pathway. We now need to run broader clinical trials to see how many cancer patients could benefit from this drug."

Professor Richard Marais, director of the Cancer Research UK Manchester Institute, said: "Cancers with a KRAS gene change have been notoriously difficult to treat. Because current drugs that target KRAS are only able to block one part of the pathway, cancer cells can easily outmanoeuvre treatments. It’s extremely encouraging to see that the impressive effects of the drug in the lab are already also showing promise in early-stage trials that include hard-to-treat cancers."

Michelle Mitchell, chief executive of Cancer Research UK, said: "This study has built upon almost 20 years of Cancer Research UK-funded research, and shows the importance of investing in basic research in the lab, which unpicks the biology of cancer. Breakthroughs in science are all about small steps that can lead to great change, and these results have brought us closer to a potential new option for people with these difficult-to-treat cancers."

On December 30, 2020 Histogen Inc. (Nasdaq: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported that it has it has priced a public offering of an aggregate of 14,000,000 shares of common stock (or common stock equivalents offered through the issuance of pre-funded warrants), together with accompanying warrants to purchase up to an aggregate of 14,000,000 shares of common stock, at an effective public offering price of $1.00 per share and accompanying warrant. Each share of common stock (or common stock equivalent offered through the issuance of a pre-funded warrant) will be sold in the offering with one warrant to purchase one share of common stock (Press release, Conatus Pharmaceuticals, DEC 30, 2020, View Source [SID1234573478]). The warrants have an exercise price of $1.00 per share, are immediately exercisable, and expire five years following the date of issuance.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds of the offering are expected to be $14.0 million, prior to deducting placement agent’s fees and other estimated offering expenses payable by Histogen and assuming none of the warrants issued in the public offering are exercised for cash. The offering is expected to close on or about January 5, 2021, subject to the satisfaction of customary closing conditions.

Histogen intends to use the net proceeds from the offering for working capital and general corporate purposes, which may include continued development of products for our CCM, hECM and HSC programs, further research and development, capital expenditures and general and administrative expenses.

The securities described above are being offered by Histogen pursuant to a registration statement on Form S-1 (File No. 333-251491) previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC") on December 30, 2020, and an additional registration statement on Form S-1 filed pursuant to Rule 462(b), which became automatically effective on December 30, 2020. The offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, electronic copies of the final prospectus relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at [email protected] or by telephone at 646-975-6996.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction