1stOncology™: Cancer Intelligence Service – Page 13345 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Cantargia and BioWa Extend Ongoing Collaboration around the POTELLIGENT® Technology

On August 23, 2019 Cantargia AB and BioWa Inc. reported that they have signed an extension of the license agreement around the BioWa proprietary POTELLIGENT Technology for production of Cantargia’s antibody drug candidate CAN04, which gives Cantargia broader rights to use the technology (Press release, Cantargia, AUG 23, 2019, View Source [SID1234538962]). Since the original agreement allowing use of POTELLIGENT Technology was signed in 2015, Cantargia has advanced CAN04 to phase IIa clinical development for potential use in the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer (PDAC).

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!

Cantargia develops antibody-based pharmaceuticals against the interleukin 1 receptor accessory protein (IL1RAP). The POTELLIGENT technology generates antibodies with enhanced antibody dependent cellular cytotoxicity (ADCC). The investigational antibody CAN04 binds IL1RAP with high affinity and functions through both ADCC and blockade of interleukin 1 signaling. CAN04 is currently produced in a Chinese Hamster Ovary (CHO) cell line provided by BioWa which has been engineered using POTELLIGENT Technology. The extended agreement enables Cantargia to create and use additional CHO cell lines engineered using POTELLIGENT Technology and develop and commercialize CAN04 made through such CHO cell line.

With CAN04 having reached phase IIa clinical development, the next step in the production development is to further reduce production costs using various process improvements as well as scaling up, and Cantargia and BioWa have agreed to extend the current license to include additional opportunities.

"We are extremely pleased with our collaboration with BioWa and the amended agreement is a logical step in our long-term relationship. Given the successful advances of CAN04, optimization of the production process to reduce cost is part of the CAN04 development plan", Göran Forsberg, Cantargia’s CEO says.

"We believe that this extension of the license agreement would add benefits into the fruitful collaboration between Cantargia and BioWa." said Takeshi Masuda, BioWa’s President and CEO. "We are very pleased that this amended agreement could support the innovative program going forward".

This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on August 23, 2019.

Medtronic Announces Cash Dividend for Second Quarter of Fiscal Year 2020

On August 23, 2019 The board of directors of Medtronic plc (NYSE:MDT) reported the fiscal year 2020 second quarter cash dividend of $0.54 per ordinary share, representing an 8 percent increase over the prior year (Press release, Medtronic, AUG 23, 2019, View Source;p=RssLanding&cat=news&id=2407089 [SID1234538961]). This quarterly declaration is consistent with the dividend announcement made by the company in June 2019. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 42 consecutive years. The dividend is payable on October 18, 2019, to shareholders of record at the close of business on September 27, 2019.

GSK announces positive headline results from the pivotal DREAMM-2 study for multiple myeloma

On August 23, 2019 GlaxoSmithKline plc (LSE/NYSE: GSK) reported positive headline results from the pivotal DREAMM-2 open-label, randomised study of two doses of belantamab mafodotin (GSK2857916) (Press release, GlaxoSmithKline, AUG 23, 2019, View Source [SID1234538956]).

The 196 patients in the trial had relapsed multiple myeloma, were refractory to an immunomodulatory drug, a proteasome inhibitor, and to treatment with an anti-CD38 antibody. The two-arm study met its primary objective and demonstrated a clinically meaningful overall response rate with belantamab mafodotin in the patient population. The safety and tolerability profile was consistent with that observed in DREAMM-1, the first time in human study of belantamab mafodotin.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK said: "I am pleased with the results of the DREAMM-2 study and excited about what these data could mean for patients with multiple myeloma who have exhausted other lines of treatment. We are on track to file belantamab mafodotin later this year and continue to investigate how it could help even more patients with this disease."

Data from the DREAMM-2 study will be the basis for regulatory filings starting later this year.

Multiple myeloma is the second most common blood cancer and is generally considered treatable, but not curable[i]. Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.

Safety and efficacy results from the DREAMM-2 study will be submitted for presentation at an upcoming scientific meeting. Additional ongoing studies are testing the effect of belantamab mafodotin as third-line monotherapy in relapsed/refractory multiple myeloma and as a combination treatment in the first and second line setting as part of the broader DREAMM clinical development programme.

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines[ii].

About the DREAMM clinical trial programme for belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an immuno-conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using technology licensed from BioWa.

Belantamab mafodotin is currently being investigated in patients with multiple myeloma.

Trial Name

GSK ID/NCT ID

Status

Design

DREAMM-1

117159/ NCT02064387

Active, not recruiting

A Phase I Open-label Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of Belantamab Mafodotin (GSK285791) in Subjects with Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA

DREAMM-2

205678/ NCT03525678

Active, not recruiting

A Study to Investigate the Efficacy and Safety of Two Doses of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma Who are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed Prior Treatment with an Anti-CD38 Antibody

DREAMM-3

207495

Planned

A Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) Compared to Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-4

205207/ NCT03848845

Recruiting

A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-5

208887

Planned

A Phase I/II, Randomized, Open-label Platform Study of Belantamab Mafodotin (GSK2857916) with Innovative Combination Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-6

207497/ NCT03544281

Recruiting

A Phase I/II Randomized Study to Evaluate Safety, Tolerability and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Lenalidomide plus Dexamethasone (Arm A), or in Combination with Bortezomib plus Dexamethasone (Arm B) in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-7

207503

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Dexamethasone versus Daratumumab, Bortezomib, and Dexamethasone in participants with relapsed/refractory multiple myeloma

DREAMM-8

207499

Planned

A Phase III, Multicentre, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) in Combination with Pomalidomide plus Low-Dose Dexamethasone (BPd) versus Pomalidomide plus Bortezomib and Low-Dose Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-9

209664

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Lenalidomide and Low-Dose Dexamethasone (VRd) vs. VRd in Participants with Newly Diagnosed Multiple Myeloma who are Ineligible for Transplant

DREAMM-10

207500

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with a Novel Agent versus SoC

ISS / GSK Co-Sponsored Study

209418

Recruiting

A Phase I/II Dose-escalation and Dose-expansion Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pomalidomide plus Low-dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Who Have Received Two or More Prior Lines of Therapy That Must Have Included Lenalidomide and a Proteasome Inhibitor

Belantamab mafodotin is not currently approved for use anywhere in the world.

GSK in Oncology
GSK is focused on maximizing patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

Immunowake raises $3M in Financing

On August 22, 2019 Immunowake reported the company has raised $3M in financing, led by Changchun High-tech Industries Group Inc (SZSE: 000661) (Press release, Immunowake, AUG 22, 2019, View Source [SID1234656118]). This investment will be used to accelerate the research, development, and commercialization of Immunowake’s portfolio.

Immunowake is a pre-clinical company focused on the development of antibody-based therapeutics against cancer. Immunowake’s CEO and founder Xiaoyun Wu said, "This financing will allow us to advance our pipeline and further improve our antibody platform, which will be critical in identifying and developing future products. This investment symbolizes a high level of confidence in our technology."

CStone completes registration filing for the Phase I trial of CDK4/6 inhibitor CS3002 in Australia and will soon initiate the study

On August 22, 2019 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that the Company has recently received ethics approval from the Human Research Ethics Committee in Australia for the Phase I clinical trial of CS3002, and Australia’s Therapeutic Goods Administration (TGA) has acknowledged the electronic Clinical Trial Notification (eCTN) the Company submitted for the trial (Press release, CStone Pharmaceauticals, AUG 22, 2019, View Source [SID1234551374]). This clinical trial is an open-label, multi-dose, dose-escalation, and dose-expansion Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of CS3002 in patients with advanced solid tumors.

Being developed by CStone, CS3002 is a selective inhibitor of the cyclin-dependent kinases 4 and 6 (CDK4/6). Inducing cell cycle arrest of tumor cells through the selective inhibition of CDK4/6, CS3002 has demonstrated high therapeutic potential for combination with endocrine therapy or immune checkpoint inhibitor therapy in various solid tumors. At present, three CDK4/6 inhibitors have been approved by the U.S. FDA. However, in China, palbociclib is the only approved CDK4/6 inhibitor, indicated for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women.

Preclinical studies have revealed that CS3002’s in vivo and in vitro activities are comparable to that of palbociclib’s. In mouse models, CS3002 combined with PD-1 monoclonal antibody therapy or endocrine therapy has shown improved tumor suppressing activities compared to monotherapies. In addition, CS3002 has also demonstrated potentially favorable safety and tolerability profiles.

Dr. Frank Jiang, Chairman and CEO of CStone, commented: "Currently, there are several CDK4/6 inhibitors that are either approved or in clinical development in the world. However, options in this class of therapies available to Chinese patients remain very limited and no domestically developed CDK4/6 inhibitor has been approved. I am pleased that we are about to initiate the Phase I trial on CS3002 in Australia. We will accelerate our work in obtaining its clinical trial approval in China and actively explore CS3002’s application in the treatment of various tumor types and different combination therapies. We hope CS3002 will become a new effective treatment option benefiting Chinese patients."

Dr. Jon Wang, CStone’s Chief Scientific Officer, noted: "The aberrant activation CDK4/6 was observed across various tumor types, suggesting CS3002’s potential utility in the treatment of breast cancer and a variety of other solid tumors. Recent studies have shown that, in addition to inducing cell cycle arrests, CDK4/6 inhibitors also have the effects of strengthening anti-tumor immunity and modulating the tumor microenvironment. These discoveries provide the foundation for a new approach in cancer treatment, which is the combination of CDK4/6 inhibitors and immunotherapies. We are hopeful that the clinical trial on CS3002 in Australia will be carried out successfully."

About CS3002

CS3002 is a new generation of well-tolerated and highly selective CDK4/6 inhibitor developed by CStone.

CDK4/6 inhibitors are the cyclin-dependent kinases that play a crucial role in the regulation of cell cycle progression from the first Growth phase (G1 phase) to the Synthesis phase (S phase). Upon activation of the cell proliferation signal, cyclin D protein binds to CDK4/6. The cyclin D–CDK4/6 complex then phosphorylates downstream retinoblastoma (Rb) protein, resulting in the aberrant proliferative signaling in the CDK4/6 pathway that drives the cell cycle progression from the G1 phase to the S phase. Aberrant CDK activity is a common feature of most cancer types. CDK4/6 inhibitors could suppress the activities of CDK4/6 and the phosphorylation of Rb protein, thereby achieving the suppression of tumor cell growth by interrupting the cell cycle transition from the G1 phase to the S phase. The commonality of aberrant cyclin D–CDK4/6–INK4–Rb pathway signaling in a tumor cells suggests CDK4/6 inhibitors’ potential application in strengthening anti-tumor immunity, and CDK4/6 inhibitors’ promising potential for the treatment of various solid tumors and synergistic combination with immuno-oncology therapies.