On September 10, 2019 DelveInsight reported that it has launched Hormone Receptor positive/ Human Epidermal Receptor 2 negative Breast Cancer Market Insights, Epidemiology and Market Forecast- 2028 (Press release, Delve Insight, SEP 10, 2019, View Source [SID1234539424])

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HR+/ HER2- Breast Cancer market report covers a detailed overview and comprehensive insight of the HR+ / HER2- breast cancer Epidemiology and HR+/ HER2- breast cancer market in the 7 MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan.)
HR positive/ HER2 negative breast cancer market report provides insights into the current and emerging HR positive/ HER2 negative breast cancer therapies.
HR positive/ HER2 negative breast cancer market report offers a global historical and forecasted market covering drug outreach in 7 MM.
HR positive/ HER2 negative breast cancer market report provides an edge that will help in developing business strategies, by understanding trends shaping and driving the Human Epidermal Receptor 2 negative Breast Cancer market.
"Among the 7MM countries, the United States had the highest HER2 negative breast cancer market size in 2017 that accounts for approximately 83.96% of the total market."

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At present, the growth of HR positive breast cancer market size is attributed to drugs that have been approved for Hormone Receptor positive breast cancer by the US FDA

Among the EU-5 countries, Germany had the highest HR-positive/HER2-negative breast cancer market size in 2017, which accounts for approximately 25.51% of the total market. Of the therapies prescribed as first-line breast cancer treatment, CDK4/6 inhibitors occupy the largest market share, of which Ibrance contributed the majority of the share, followed by Kisqali and Verzenio. The second position in the first-line treatment options is occupied by SERD class (Faslodex). Among the second and higher lines of therapy, CDK4/6 inhibitors occupy the largest breast cancer market share.

As the HR positive breast cancer mostly affects women. The treatment management of this specific cancer is complex and patient-centric, as treatment and outcomes differ significantly according to biomarker status among other patient characteristics, indicating a trend towards higher personalized medicine based upon patient biomarkers and physiologic characteristics.

Current treatment landscape is well-provided with treatment management. However, there is a lack of treatment and diagnostic guidelines specific to the ER-Positive breast cancer required for the management and diagnosis of ER-positive breast cancer. In recent years, there are many advancements in early detection, prevention, risk stratification, and therapeutic strategies, as well as supportive care for patients with breast cancer, and these have resulted in essential improvements in morbidity and mortality. There is a myriad of companies that are developing drugs for breast cancer treatment.

The expected launch of breast cancer emerging therapies is believed to create a positive impact on the HR positive/ HER2 negative breast cancer market size in the upcoming years.

SHR6390
TESETAXEL
RAD1901
IMMU-132
RG7440
Entinostat
MK-3475
EGL-5385-C-1701
MM-121
GSK525762 (Molibresib)
SAPANISERTIB (TAK-228)
Radium-223 dichloride
and many others
Some of the HR positive/ HER2 negative breast cancer companies are:-

Jiangsu HengRui Medicine Co.
Odonate Therapeutics
Radius Pharmaceuticals
Immunomedics
Roche Group
Syndax Pharmaceuticals
Merck Sharp & Dohme Corp
Eagle Pharmaceuticals
Merrimack Pharmaceuticals
GlaxoSmithKline
Millennium Pharmaceuticals
Bayer
and many others
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Table of contents

1. Key Insights

2. Hormone Receptor positive Breast Cancer Market Overview at a Glance

3. Human Epidermal Receptor 2 negative breast cancer Disease Background and Overview

4. HR 2 positive Epidemiology and Patient Population

5. Hormone Receptor of Positive Breast Cancer Country Wise-Epidemiology

5.1. United States

5.2. EU5 Countries

5.3. Germany

5.4. France

5.5. Italy

5.6. Spain

5.7. United Kingdom

5.8. Japan

6. Estrogen-Receptor Positive Breast Cancer Treatment

7. HER 2 negative Marketed Products

7.1. Ibrance (Palbociclib): Pfizer

7.2. PIQRAY (Alpelisib; BYL719): Novartis

7.3. Lynparza (olaparib): AstraZeneca Pharmaceuticals

7.4. Verzenio (Abemaciclib): Eli Lilly

7.5. Kisqali (Ribociclib; LEE011): Novartis Pharmaceuticals

7.6. Afinitor (Everolimus): Novartis

7.7. Faslodex (Fulvestrant) Injection: AstraZeneca

7.8. Arimidex (Anastrozole): AstraZeneca

7.9. Aromasin (Exemestane): Pharmacia and Upjohn Company

7.10. Femara (Letrozole): Novartis Pharmaceuticals

8. Unmet Needs

9. HR positive/ HER2 negative breast cancer breast cancer Emerging Drugs

9.1. Key Cross Competition

9.2. SHR6390: Jiangsu HengRui Medicine Co.

9.3. TESETAXEL: Odonate Therapeutics

9.4. RAD1901: Radius Pharmaceuticals

9.5. IMMU-132 (Sacituzumab Govitecan): Immunomedics

9.6. Ipatasertib (RG7440): Roche Group

9.7. Venclexta: Roche Group

9.8. Entinostat: Syndax Pharmaceuticals

9.9. Pembrolizumab (MK-3475): Merck Sharp and Dohme

9.10. Eribulin Mesylate: Merck Sharp & Dohme Corp.

9.11. MM-121: Merrimack Pharmaceuticals

9.12. GSK525762 (Molibresib): GlaxoSmithKline

9.13. SAPANISERTIB (TAK-228): Millennium Pharmaceuticals

9.14. Radium-223 dichloride: Bayer

9.15. EGL-5385-C-1701(fulvestrant): Eagle Pharmaceuticals

10. HR+/HER2- Post Menopause Breast Cancer Market Analysis (7MM)

11. The United States HR positive/ HER2 negative breast cancer Market Analysis

11.1. The United States HR positive/ HER2 negative breast cancer Market Outlook

11.2. United States HR positive/ HER2 negative breast cancer Market Size

12. EU-5 HR positive/ HER2 negative breast cancer Market Analysis

12.1. EU-5 HR positive/ HER2 negative breast cancer Market Outlook

12.2. Germany HR positive/ HER2 negative breast cancer Market Size

12.3. France HR positive/ HER2 negative breast cancer Market Size

12.4. Italy HR positive/ HER2 negative breast cancer Market Size

12.5. Spain HR positive/ HER2 negative breast cancer Market Size

12.6. The United Kingdom HR positive/ HER2 negative breast cancer Market Size

13. Japan Market Outlook

14. Market Drivers

15. Market Barriers

16. Appendix

17. DelveInsight Capabilities

18. Disclaimer

On September 9, 2019 Genmab A/S (Nasdaq: GMAB) reported that it has entered into a strategic collaboration agreement with Tempus, a privately-owned technology company advancing precision medicine through the practical application of artificial intelligence in healthcare (Press release, Genmab, SEP 9, 2019, View Source [SID1234539371]). The multi-year collaboration will combine Tempus’ sequencing capabilities and industry-leading platform of integrated clinical and molecular data with Genmab’s state-of-the-art translational, biomarker and target discovery expertise. The companies will work together, based upon novel insights identified by Genmab, to advance new disease targets and biomarkers that may have the potential to generate new treatments in oncology.

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This new strategic collaboration builds upon existing service agreements between the companies. Under the terms of the collaboration agreement, the companies will jointly work on research projects that are identified by Genmab to explore novel product concepts and biomarkers. For any resulting products, Genmab will lead all development and commercial activities. Tempus will be eligible for undisclosed milestones and royalties from Genmab and will also have the option to fund part of product development programs in exchange for increased royalty payments due to Tempus under the agreement.

"Tempus has built the world’s largest library of clinical and molecular data, is a leader in the field of personalized medicine and like Genmab, Tempus has a mission to improve the lives of cancer patients. We are looking forward to expanding our exciting partnership with them and to the possibility of discovering important new oncology targets and biomarkers," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Today’s news does not impact Genmab’s 2019 Financial Guidance.

On September 9, 2019 Jubilant Life Sciences Limited has reported that Dr. Syed Kazmi, PhD, MBA, will join its new innovative biopharmaceutical company in the U.S., Jubilant Therapeutics Inc., as President and Chief Executive Officer (Press release, Jubilant Life Sciences, SEP 9, 2019, View Source;jubilant-therapeutics-inc-300914090.html [SID1234539387]).

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Dr. Kazmi joins from Novartis Pharmaceuticals Corporation where he was Vice President, Global Head of Business Development & Licensing for Oncology.

Earlier this year, Jubilant Life Sciences spun off select proprietary innovation assets that are in various stages of discovery and development into Jubilant Therapeutics. The new company has a unique business model with a combination of semi-virtual set up and significant synergies with rest of Jubilant Life Sciences including strategic partnership with Jubilant Biosys, a world-class preclinical CRO.

Jubilant Therapeutics’ strategy is to discover and develop novel small molecule modulators of important and previously undruggable targets primarily in oncology and establish creative partnerships to bring innovative therapeutics to patients in need.

The Company’s current pipeline includes a novel dual epigenetic inhibitor of LSD1/HDAC6 to address unmet needs in liquid cancers like acute myeloid leukemia (AML), a small molecule PDL-1 therapy with comparable efficacy to large molecules and lower side effects, a small molecule PAD4 inhibitor with potential to address unmet needs in multiple auto-immune disorders and a PRMT5 inhibitor for lymphoma.

"We extend a warm welcome to Syed as the CEO of Jubilant Therapeutics," said Shyam Bhartia and Hari Bhartia, Chairman and Co-Chairman of Jubilant Life Sciences. "Syed has had an accomplished career of over 25 years in M&A, licensing, strategic collaborations, and R&D in both specialty biotech and large pharma companies. We are confident that his extensive experience will help make Jubilant Therapeutics a successful global clinical stage biopharmaceutical company with the mission of transforming the lives of patients with serious diseases."

"I am honored to join as CEO to continue building the pipeline assets and collaborations to fast-track new innovative drugs to market. I look forward to growing Jubilant Therapeutics into a first-in-class biopharma company," said Syed Kazmi.

On September 9, 2019 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported newly released proof-of-concept data showing evidence of NT-219 mechanism of action in reversing cancer drug resistance in PDX models (Press release, Kitov Pharmaceuticals , SEP 9, 2019, View Source [SID1234539372]). The data was presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s (AACR) (Free AACR Whitepaper) Pancreatic Cancer: Advances in Science and Clinical Care conference in Boston on September 8, 2019.

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NT-219 is a first-in-class small molecule bi-specific inhibitor of two key cancer resistance pathways STAT3 and IRS1/2. As previously disclosed, the preclinical study initially evaluated the efficacy of NT-219 in combination with the approved chemotherapy agent gemcitabine on four PDX models of mutated KRAS pancreatic cancer. Data demonstrated reversal of gemcitabine-resistant tumors in all PDX models following treatment with NT-219 and gemcitabine. One of these models demonstrated complete response in about half of the animal group upon addition of NT-219 to gemcitabine. The study was then extended to define an optimal dose regimen and future clinical protocol.

Newly released data from the NT-219 poster showed:

●The combination of NT-219 with the targeted therapies trametinib (MEK inhibitor) or folfirinox (chemotherapy) reversed tumor resistance to the treatments.

●Administering NT-219 prior to chemotherapy suppressed activation of two key cancer survival pathways, STAT3 and IRS. The sequence of administering the therapies had a remarkable impact on the efficacy of NT-219 in reversing resistance.

●Gene expression analysis of the tumors in a PDX model of KRAS mutated pancreatic cancer revealed an average 80% reduction in IRS1 levels compared to the control group following a single treatment with NT-219 and gemcitabine combined therapy. Similar reductions were observed in the expression of STAT3-regulated genes and the proliferation marker Ki67, confirming NT-219 mechanism of action.

●A dose-dependent therapeutic effect of NT-219 was demonstrated on tumor-growth and correlated with NT-219 levels in plasma.

"STAT3 and IRS play an important role in KRAS-induced pancreatic tumorigenesis and drug resistance. Demonstrating efficacy of NT-219 in pancreatic cancer models is in line with previous results in other cancer types. We believe that targeting IRS and STAT3 may be a tumor-agnostic solution to combat resistance to multiple oncology drugs," said Hadas Reuveni, PhD, VP Research and Development of Kitov. "NT-219 is a first-in-class small molecule which suppresses both targets using a unique mechanism of action, and is crucial for overcoming cancer drug resistance."

"We are encouraged by the results of the study which demonstrate the potential of NT-219 to reverse resistance to oncology therapies in a wide range of PDX models. We plan to clinically explore its efficacy in multiple hard-to-treat oncology indications including squamous cell carcinoma of the head and neck in a planned clinical study to be launched soon. We are also exploring its potential in pancreatic cancer," said Isaac Israel, CEO of Kitov. "Resistance to chemotherapy and targeted therapies is a major problem facing oncology patients. Kitov is now strategically focused on developing first-in-class oncology therapies, including such which are targeted to overcome drug resistance and tumor immune evasion, and to ultimately provide patients long-lasting treatment alternatives."

Kitov plans to submit an Investigational New Drug Application (IND) to the U.S Food and Drug Authority (FDA) for a clinical study on NT-219 in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck before the end of 2019, and to initiate the trial immediately following FDA’s clearance.

The poster is available on the "Investor Relations" section on the Kitov website: View Source

On September 9, 2019 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported that the Company will present at the upcoming Annual CAR-TCR Summit in Boston, MA September 10-13, 2019 (Press release, Cellular Biomedicine Group, SEP 9, 2019, View Source [SID1234539388]).

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Wednesday, September 11, 2:47pm
Yihong Yao, PhD, Chief Scientific Officer
"Meeting the Challenge of Delivering Cell & Gene Therapy Products to Patients in China"

Medical digitalization will fundamentally transform research, clinical, and healthcare as a whole
How China can advance the progress in novel therapy modalities
De-risking clinical trials by leveraging fast-track clinical studies
A copy of the presentation will be made available on the Company’s website following the presentation.