On February 13, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune and other major diseases, reported that the first patient has been dosed in a Phase I clinical trial of IBI101, a recombinant fully human anti-tumor necrosis factor receptor superfamily member 4 (anti-OX40) monoclonal antibody (Press release, Innovent Biologics, FEB 13, 2019, View Source [SID1234533290]).

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!

In this Phase I clinical study, the tolerance, safety and primary efficacy of IBI101, either as monotherapy or in combination with Tyvyt (sintilimab injection), an anti-programmed cell death protein 1 (PD-1) antibody, will be evaluated. The study comprises two parts, namely a Phase Ia study with IBI101 as monotherapy and a Phase Ib study with IBI101 in combination with Tyvyt. Patients with advanced solid tumors who have failed standard treatments will be enrolled in the study.

"The Investigational New Drug (IND) application of IBI101, indicated for patients with advanced solid tumors, was approved by the U.S. Food & Drug Administration (FDA) on 5 Dec, 2018. The mechanism of IBI101 is different from that of anti-PD-1 antibodies. IBI101 stimulates the OX40 pathway so as to activate effector T cells, thus enhancing the anti-tumor immune reaction," commented Professor XU Ruihua, Director of Sun Yat-Sen University Cancer Hospital. "Worldwide clinical research on anti-OX40 antibodies is limited so far. We are looking forward to the study results of IBI101."

"Innovent, a China-based company, was established with an ambition to serve global patient needs. We are dedicated to exploring the most advanced research areas in cancer immunotherapy and providing innovative medicines that improve lives around the world. The initiation of Phase I study of IBI101 and dosing of first patient have again demonstrated our efforts and commitment. We truly anticipate further breakthroughs so that more patients will potentially benefit in the future," said Michael Yu, Founder, Chief Executive Officer and Chairman.

About IBI101

IBI101 is a recombinant fully human anti-OX40 monoclonal antibody developed by Innovent with independent intellectual property rights. Pre-clinical data confirms that IBI101 has a clear mechanism of action that enhances the activation of effector T cells and mediates the clearance of regulatory T cells, thus inhibiting the growth of tumor cells. The IND application of IBI101 was approved by the U.S. FDA on 5 Dec, 2018. Agonistic OX40 candidates are expected to be used in combination with our anti-PD-1 monoclonal antibody, Tyvyt (sintilimab injection), and other immunomodulating agents in our R&D pipeline to meet the unmet medical needs of cancer patients. At present, there are no approved monoclonal antibody therapeutics against the same target across the world.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is currently conducting the clinical studies of sintilimab injection in the United States. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been approved by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL). Currently, more than twenty clinical studies of sintilimab injection, including seven registration studies, are ongoing to evaluate the efficacy of sintilimab injection on other solid tumors.

On February 13, 2019 Cerus Corporation (Nasdaq:CERS) reported that its fourth quarter and full-year 2018 results will be released on Tuesday, February 26, 2019, after the close of the stock market (Press release, Cerus, FEB 13, 2019, View Source [SID1234533312]). The company will host a conference call and webcast at 4:30 P.M. EDT that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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!

To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 2392137. The replay will be available approximately three hours after the call through March 12, 2019.

On February 13, 2019 Doer Biologics reported in January 2019, Doer Biologics has closed tens of millions RMB in its first financing (Press release, Doer Biologics, FEB 13, 2019, View Source [SID1234656201]). The Series A round was led by Kaitai Capital, with participation from Hangzhou Bairui Investment Company. Doer Biologics devotes to the development of multi-domain innovative biopharmaceutics, focusing on unmet clinical needs. Based on its MultipleBody and XLong long acting technology platforms, Doer biologics has developed DR10619, DR30121 and other products, which are significantly competitive in the field of NASH and AMD. Its first financing will certainly facilitate the progress of its products to IND application.

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!

On February 13, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that the first patient has been dosed in a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-402 (loncastuximab tesirine) plus AstraZeneca’s IMFINZI (durvalumab) in patients with advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL) (Press release, ADC Therapeutics, FEB 13, 2019, View Source [SID1234596065]).

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!

ADCT-402, an ADC designed to target and kill CD19-expressing malignant B-cells, is also being evaluated in an ongoing pivotal Phase II clinical trial in patients with relapsed or refractory (R/R) DLBCL. Durvalumab is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "Data from our 183-patient first-in-human clinical trial of ADCT-402, which were presented at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, demonstrated its acceptable safety profile and promising anti-tumor activity as a single agent in patients with relapsed or refractory B-cell non-Hodgkin lymphomas. We are now excited to explore the possible impact of ADCT-402 plus durvalumab in patient populations that would greatly benefit from new treatment options."

Craig Moskowitz, MD, Physician in Chief for the Cancer Service Line of the Sylvester Comprehensive Cancer Center, Professor of Medicine in the Miller School of Medicine at University of Miami Health System, and an investigator for the trial, said, "While the majority of patients with non-Hodgkin lymphoma typically respond to initial treatment, many patients relapse and face a poor prognosis. I look forward to evaluating this combination therapy of ADCT-402 and a PD-L1 blocker to determine its safety and potential anti-tumor activity in patients with relapsed or refractory diffuse large B-cell lymphoma, mantle cell lymphoma and follicular lymphoma who have failed or are intolerant to established therapies, or who don’t have other available treatment options."

The open-label, single-arm trial will include a dose-escalation part, followed by a dose-expansion part. The dose-expansion part will consist of up to three expansion cohorts – one for DLBCL, one for MCL and one for FL – to obtain additional safety and preliminary anti-tumor activity information at the maximum tolerated dose. Approximately 75 patients will be enrolled in the trial. For more information, please visit www.clinicaltrials.gov (identifier NCT03685344).

ADCT-402 Interim First-in-Human Data

Updated data from the ongoing 183-patient Phase I clinical trial of ADCT-402 were presented at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In a subpopulation of 139 evaluable patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had failed or were intolerant to established therapies, ADCT-402 demonstrated manageable toxicity. At doses >120 μg/kg, the overall response rate (ORR) was 43.3 percent (55/127 patients with DLBCL), comprising 23.6 percent complete responses and 19.7 percent partial responses. In a subgroup of 15 patients with R/R mantle cell lymphoma (MCL) and 14 patients with R/R follicular lymphoma (FL), ADCT-402 demonstrated manageable toxicity. In MCL patients, ORR was 46.7 percent (7/15) and median duration of response (DoR) was not reached after a median follow-up time of 8.7 months. In FL patients, ORR was 78.6 percent (11/14) and median DoR was not reached after a median follow-up time of 11.6 months.

About ADCT-402

ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD19-expressing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. ADCT-402 is being evaluated in a pivotal Phase II clinical trial in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (NCT03589469) and a Phase I clinical trial in combination with IMFINZI (durvalumab) in patients with R/R DLBCL, mantle cell lymphoma or follicular lymphoma (NCT03685344). The U.S. Food and Drug Administration granted orphan drug designation to ADCT-402 for the treatment of DLBCL and MCL.

On February 13, 2019 Biocure Technology Corp. (CSE: CURE) (OTCQB: BICTF)("CURE" or the "Company") reported that it has arranged a non-brokered private placement of 6,976,745 million units at 43 cents per unit for gross proceeds of $3 Million or more, depending on investor interest (Press release, Biocure Technology, FEB 13, 2019, View Source [SID1234628757]). Each Unit will entitle the holder to receive one common share of the Company (each a "Common Share") and one Full Warrant ("Warrants") exercisable for 24 Months for CDN$0.86. Each warrant is subject to accelerated expiry provisions, such that if at any time after the expiry of any resale restriction governing the subscribed shares, the corporation’s common shares trade on the Canadian Securities Exchange at or above a volume-weighted average trading price of $1.29 per common share for 10 consecutive trading days, the company may give notice to the holders that each warrant will expire 30 days from the date of providing such notice.

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!

Finder’s fees or commissions may be payable by the Company in connection with this Private Placement.

The net proceeds from the non-brokered private placement are intended to be used for general working capital and research and development.