On November 27, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that Dan Shoemaker, Ph.D., Chief Scientific Officer, will present at the 31st Annual Piper Jaffray Healthcare Conference in New York on Wednesday, December 4, 2019, at 4:00 p.m. EST (Press release, Fate Therapeutics, NOV 27, 2019, View Source [SID1234551747]).

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!

A live webcast of the presentation will be available through the investor relations section of the Company’s website at www.fatetherapeutics.com. Following the live webcast, an archived replay will be available on the Company’s website.

On November 27, 2019 Arvinas Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, reported that Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the 31st Annual Piper Jaffray Healthcare Conference on Thursday, December 5 at 12:00 p.m. ET in New York, NY (Press release, Arvinas, NOV 27, 2019, View Source [SID1234551746]).

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!

A live audio webcast of the presentation will be available on the Company’s website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

On November 27, 2019 Nerviano Medical Sciences, the NMS Group company leader in the discovery and development of oncology drugs, reported the enrollment and treatment of the first patient with the PARP inhibitor NMS-293 in a phase 1 study aimed at patients with advanced solid tumors (Press release, Nerviano Medical Sciences, NOV 27, 2019, View Source [SID1234551736]).

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 treatment of the first patient in our Phase 1 study represents a turning point in the process of developing a new, safe and effective treatment for patients who need alternative care compared to what is available today and we are very happy about this. proud, "said Gregory Wu, Ph.D., CEO of Nerviano Medical Sciences. "Thanks to the unique preclinical characteristics of NMS-293, we are confident that we can expect important clinical developments, both as a single agent and in combination with other drugs, and we look forward to sharing positive results over the next year."

NMS-293 is a "small molecule" with oral administration, inhibitor of the poly (ADP-ribose) polymerase-1 enzyme (PARP-1) that has shown high anti-tumor efficacy in preclinical models lacking some repair mechanisms, such as mutated tumors in the BRCA1 and BRCA2 genes. These mutations are particularly common in breast, ovarian, pancreatic and prostate cancers.

NMS-293 has unique characteristics compared to other PARP inhibitors that have been approved or under development, such as its selectivity for the PARP-1 vs PARP-2 isoenzyme and the lack of "entrapment" effects, which could lead to a better tolerability in terms of lower hematological effects, in particular when administered together with chemotherapy. Furthermore, the high cerebral penetration of the compound offers a potential for the treatment of brain tumors and brain metastases.

This clinical study will be conducted in two parts and involves enrollment of up to 100 patients in China, Europe and the United States. The first part will consist in the evaluation of tolerability and pharmacokinetics and in the determination of the recommended dose for phase 2. The second part of the study will allow to have a preliminary evaluation of the efficacy of NMS-293 administered at the recommended dose to patients with different types of mutated tumors in BRCA genes.

On November 27, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that an anticancer agent/anti-PD-L1 (Programmed Death-Ligand 1) monoclonal antibody Tecentriq Intravenous Infusion 840 mg [generic name: atezolizumab (recombinant)] has been listed on the National Health Insurance (NHI) reimbursement price list and launched (Press release, Chugai, NOV 27, 2019, View Source [SID1234551735]). Tecentriq 840 mg is an optimal formulation to be dosed every two weeks for the treatment of PD-L1-positive hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer. This additional indication and dosage were approved on September 20, 2019.

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!

"Immune checkpoint inhibitor has been changing the treatment paradigm among various types of cancers in recent years. We are very pleased that we can now deliver Tecentriq to patients with PD-L1 positive TNBC as the first approved immune checkpoint inhibitor in the breast cancer field," said Dr. Osamu Okuda, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. "TNBC is an aggressive and rapidly progressing disease with limited treatment options, and there are high unmet medical needs. We would engage in providing information, aiming at contributing to patients thorough offering this cancer immunotherapy-based treatment for TNBC as a new treatment option."

Tecentriq is an immune checkpoint inhibitor targeting PD-L1 which is a protein expressed on tumor cells and tumor-infiltrating immune cells. PD-L1 blocks T-cell activity by binding with PD-1 and B7.1 receptors on T-cell surface. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells and boost immune response against cancer cells. The efficacy and safety of Tecentriq were investigated in the phase III IMpassion130 study.

As a top pharmaceutical company in the field of oncology in Japan, Chugai is committed to contribute to patients and medical professionals by offering Tecentriq as a new treatment option and accordingly, to improve access to medications and appropriate use.

About the IMpassion130 study
The IMpassion130 study is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel (albumin-bound) compared with nab-paclitaxel (albumin-bound) in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer. The co-primary endpoints are PFS per investigator assessment (RECIST 1.1) and OS in the ITT population and in the PD-L1-positive population.

[Reference]
Chugai Obtains Approval for Additional Indication and Formulation for Tecentriq in PD-L1-Positive Triple Negative Breast Cancer (Press release issued on September 20, 2019)
View Source

Termination of free offering of Tecentriq 840 mg prior to the listing on the NHI reimbursement price list
Under the system for healthcare services combining insurance-covered and non-covered services provided by the Ministry of Health, Labour and Welfare, Chugai has been offering Tecentriq 840 mg for free to respond to requests for emergency use from patients with PD-L1-positive, hormone receptor-negative and HER2-negative inoperable or metastatic breast cancer with very limited treatment options since its approval dated on September 20, 2019. Chugai announced the termination of free offering of Tecentriq 840 mg with the listing on the NHI reimbursement price list as of today.

Prescribing Information

Product name Tecentriq Intravenous Infusion 840 mg
Generic name atezolizumab (genetical recombination)
Indications Tecentriq Intravenous Infusion 840 mg
PD-L1-positive, hormone receptor-negative and HER2-negative inoperable or metastatic breast cancer
Dosage and administration
In case of patients with PD-L1-positive, hormone receptor-negative and HER2-negative inoperable or metastatic breast cancer.
The usual adult dosage is 840 mg atezolizumab (genetical recombination) in combination with nab-paclitaxel (albumin-bound) administered by intravenous infusion over 60 minutes once every 2 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.
Drug price Tecentriq Intravenous Infusion 840 mg JPY 448,853/vial
Conditions for approval
A risk management plan should be created and appropriately implemented.
About Triple-Negative Breast Cancer
In Japan, 86,500 women (2018 predicted value) are estimated to be afflicted with breast cancer each year. 14,800 women in Japan (2018 predicted value) die as a result of the disease.1) Triple-negative breast cancer accounts for 15% of all breast cancer cases and, is more common in women under the age of 50, compared with other forms of breast cancer.2-4) Triple-negative breast cancer is defined by the lack of expression of hormone receptors (estrogen and progesterone receptors) and the overexpression of human epidermal growth factor receptor 2 (HER2). In general, triple-negative breast cancer has a high tumor-proliferative capacity and shorter overall survival, compared with other forms of breast cancer.3, 5)

Trademarks used or mentioned in this release are protected by law.

Sources

Cancer Registry and Statistics. Cancer Information Service, National Cancer Center, Japan. [Internet; cited October, 2019] Available from: View Source

Yao H et al. Triple-negative breast cancer: is there a treatment on the horizon? Oncotarget. 2017;8(1):1913–1924.
BreastCancer.org. What is Triple-Negative Breast Cancer? [Internet; October, 2019] Available from: View Source
Cancer Treatment Centers of America. Triple negative breast cancer risk factors. [Internet; cited October, 2019]
View Source
Pal SK et al. Triple negative breast cancer: unmet medical needs. Breast Cancer Res Treat. 2011;125(3):627-636.

On November 27, 2019 Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, reported that it has completed its most recent round of seed financing, resulting in a total raised to date of $12M (Press release, PhoenixMD, NOV 27, 2019, View Source [SID1234551550]). The primary use of funds continues to be on the preclinical and clinical advancement of its lead product candidate, PMD-026, a proprietary first-in-class orally-available RSK (kinase) inhibitor. PMD-026 is being developed as a platform technology to treat resistant forms of cancer, such as metastatic breast cancer and, more specifically, triple-negative breast cancer (TNBC).

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!

Investors in the financing round included Pallasite Ventures and World Changing Ventures.

"We are proud to help fund the PhoenixMD team in their mission to develop better therapeutic options for women with breast cancer," said Dr. Christopher Bissonnette, Managing Partner of Pallasite Ventures. "We believe PMD-026 is a promising new approach to treat advanced breast cancer, both as a monotherapy or in combination with chemotherapy. We are looking forward to working with the team and fellow investors to advance this important product into the clinic."

The company’s Phase 1/1b clinical trial is being conducted at leading medical centers across United States and it will evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of PMD-026 in patients with metastatic breast cancer as well as a sub-group of women with TNBC. Importantly, this trial will include a College of American Pathologists/Clinical Laboratory Improvement Amendments (CAP/CLIA) certified companion diagnostic (CDx) designed to detect RSK2 activation in breast tumors and to then correlate it with response to PMD-026. Activated RSK2 is highly prevalent in breast cancer as it is expressed in approximately 89 percent of primary tumors. It is also detected in metastatic breast cancers, indicating that this drug target is retained in cancer cells that have moved to other parts of the body. The targeting of RSK2 by PMD-026, together with a validated CDx detecting activated RSK2 in tumors, create a distinct precision medicine approach to treating breast cancer.

"As a company in a challenging disease space, we appreciate the vote of confidence from our investors who join us in the pursuit of new medicines for patients with metastatic breast cancer," said Sandra Dunn, Ph.D., chief executive officer of Phoenix Molecular Designs. "Our seed funding has supported the early development of our lead product candidate, PMD-026, and we are delighted to have opened our Phase 1/1b clinical trial."

The advancement of PMD-026 in the company’s clinical trial is underscored by their teams’ impressive track record of market success in developing targeted therapies for breast cancer. Previously, this team has brought forward FDA-approved CDK4/6, PARP, ER and PIK3CA oral selective small molecule inhibitors. PhoenixMD looks forward to building upon this momentum in the pursuit of additional treatment options for individuals living with TNBC.

About PMD-026
PhoenixMD’s lead candidate, PMD-026, is the first RSK inhibitor being developed for the treatment of TNBC. PMD-026 was precisely designed for TNBC because RSK2 was specifically identified as the key kinase, out of 519 kinases, that drives the growth of this breast cancer subtype. Preclinical data shows the potential for PMD-026 to be effective alone or in combination with conventional chemotherapies. It has the potential to be a platform technology for chemotherapy, hormone therapy and/or immunotherapy sensitization for a wide range of refractory cancers in the future. PMD-026 has begun Phase 1/1b clinical trials in the United States with the first site initiated at the end of October 2019.