On May 11, 2020 AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) reported that Lynparza (olaparib) in combination with bevacizumab has been approved in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability (Press release, AstraZeneca, MAY 11, 2020, View Source [SID1234557439]). Patients will be selected for therapy based on an FDA-approved companion diagnostic test.

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The approval by the US Food and Drug Administration (FDA) was based on a biomarker subgroup analysis of the Phase III PAOLA-1 trial which showed that Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% (equal to a hazard ratio of 0.33). The addition of Lynparza improved progression-free survival (PFS) to a median of 37.2 months versus 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.

Approximately one in two women with advanced ovarian cancer has an HRD-positive tumour. For patients with advanced ovarian cancer, the primary aim of 1st-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission.

Isabelle Ray-Coquard, principal investigator of the PAOLA-1 trial and medical oncologist, Centre Léon Bérard and President of the GINECO group, said: "Ovarian cancer is a devastating disease. The magnitude of benefit in HRD-positive patients in the PAOLA-1 trial is impactful. The combination of Lynparza and bevacizumab now provides women with HRD-positive advanced ovarian cancer with a new standard of care and I look forward to seeing this translate into clinical practice."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "This approval represents another milestone for Lynparza in patients with ovarian cancer. The median progression-free survival of more than three years offers new hope for more women to delay relapse in this difficult-to-treat disease. These results further establish that HRD-positive is a distinct subset of ovarian cancer, and HRD testing is now a critical component for the diagnosis and tailoring of treatment for women with advanced ovarian cancer."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: "Advances in understanding the role of biomarkers and PARP inhibition have fundamentally changed how physicians treat this aggressive type of cancer. Today’s approval based on the PAOLA-1 trial highlights the importance of HRD testing at diagnosis to identify those who may benefit from Lynparza in combination with bevacizumab as a 1st-line maintenance treatment."

The full results from the Phase III PAOLA-1 trial were published in The New England Journal of Medicine.

Regulatory reviews are currently underway in the EU, Japan and other countries for Lynparza based on results from the PAOLA-1 trial. As part of a broad development programme, Lynparza is being tested as a monotherapy and in combination across multiple tumour types including as a potential adjuvant treatment of patients with germline BRCA-mutated high-risk HER2-negative primary breast cancer in the Phase III OlympiA trial.

Financial considerations

Following this approval for Lynparza in the US, AstraZeneca will receive from MSD $100m in Collaboration Revenue, anticipated to be booked by the Company during the second quarter of 2020.

Ovarian cancer

Ovarian cancer is the eighth most common cause of death from cancer in women worldwide.1 In 2018, there were nearly 300,000 new cases diagnosed and around 185,000 deaths.2 Most women are diagnosed with advanced (Stage III or IV) ovarian cancer and have a five-year survival rate of approximately 30%.3 Approximately 50% of ovarian cancers are HRD-positive including BRCA1/2 mutation. 4,5 Some 22% of ovarian cancers have a BRCA1/2 mutation.5

For patients with advanced ovarian cancer, the primary aim of 1st-line treatment is to delay progression of the disease for as long as possible and maintain the patient’s quality of life with the intent of achieving complete remission.6,7,8,9

In the US, bevacizumab was approved for use in combination with chemotherapy for the 1st-line treatment of advanced ovarian cancer in 2018. Within two years nearly half of all patients with advanced ovarian cancer are receiving this combination treatment.10

PAOLA-1

PAOLA-1 is a double-blind Phase III trial testing the efficacy and safety of Lynparza in combination with bevacizumab vs. bevacizumab alone, as a 1st-line maintenance treatment for newly diagnosed advanced FIGO Stage III-IV high-grade serous or endometroid ovarian, fallopian tube, or peritoneal cancer patients who had a complete or partial response to 1st-line treatment with platinum-based chemotherapy and bevacizumab. AstraZeneca and MSD announced in August 2019 that the trial met its primary endpoint of PFS.

Simultaneously, the Myriad Genetics myChoice CDx test has been approved in the US as a companion diagnostic for Lynparza in this new indication.

Homologous recombination deficiency

HRD, which defines a sub-group of ovarian cancer, encompasses a wide range of genetic abnormalities, including BRCA mutations and beyond. As with BRCA gene mutations, HRD interferes with normal cell DNA repair mechanisms and confers sensitivity to PARP inhibitors including Lynparza.5

Lynparza

Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair, such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.

Lynparza is currently approved in a number of countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer. It is approved in the US, the EU, Japan, China, and several other countries as 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in the US, Japan, and a number of other countries for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer. Lynparza is approved in the US and several other countries for the treatment of germline BRCA-mutated metastatic pancreatic cancer. Regulatory reviews are underway in several jurisdictions for ovarian, breast, pancreatic and prostate cancers.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, has been used to treat over 30,000 patients worldwide. Lynparza has the broadest and most advanced clinical trial development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells

The AstraZeneca and MSD strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and Koselugo (selumetinib), a MEK inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investment that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

On May 10, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that latest clinical data of the company’s drug candidates, including the MDM2-p53 inhibitor APG-115, novel Bcl-2/Bcl-xL dual inhibitor APG-1252, and IAP inhibitor APG-1387, will be presented in three poster discussions and a poster at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Ascentage Pharma, MAY 10, 2020, View Source [SID1234557437]). Because of concerns about the current coronavirus (COVID-19) pandemic, this year’s annual meeting will be held in a virtual format from May 29 through May 31, 2020.

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The ASCO (Free ASCO Whitepaper) Annual Meeting is the most authoritative meeting in the oncology space. The purpose of this meeting is to disseminate premier scientific research and cutting-edge treatment approaches in oncology to the world.

"We are excited to present the clinical advances of three of our drug candidates," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "Through these results, Ascentage Pharma is demonstrating its capabilities of global clinical development in apoptosis. We are striving to offer more treatment options for patients with unmet medical needs."

Four posters will be presented at ASCO (Free ASCO Whitepaper)20, including:

Poster Discussion Sessions

Phase Ib study of a novel, small-molecule MDM2 inhibitor APG-115 combined with pembrolizumab in U.S. patients with metastatic solid tumors
Time: May 29th, 8:00–11:00am, EST

Abstract: #3512

Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

First-in-human study of palcitoclax (APG-1252), a novel dual Bcl-2/Bcl-xL inhibitor, demonstrated advantages in platelet safety while maintaining anticancer effect in U.S. patients with metastatic solid tumors
Time: May 29th, 8:00–11:00am, EST

Abstract: #3509

Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Phase Ib study of a novel bivalent IAP antagonist APG-1387 in combination of pembrolizumab for patients with advanced solid tumors
Time: May 29th, 8:00–11:00am, EST

Abstract: #3508

Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Poster Session

Phase I study results of APG-115, a MDM2-p53 antagonist, in Chinese patients with advanced liposarcoma and other solid tumors
Time: May 29th, 8:00–11:00am, EST

Abstract: #11542

Session: Sarcoma

On May 10, 2020 Hummingbird Bioscience, an innovative biotherapeutics company focused on the discovery and development of new breakthrough therapies, reported that it has closed an extended Series B funding round of US$25 million (Press release, Hummingbird Bioscience, MAY 10, 2020, View Source [SID1234557436]). This brings the total capital raised through financing activities and strategic partnerships to more than US$65 million to date.

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Leading the Series B extension is new investor SK Holdings, with participation from existing shareholders including Heritas Capital and SEEDS Capital, the investment arm of Enterprise Singapore.

The Series B round was extended to US$25 million due to significant over-subscription, with the addition of select quality and value-add investors. Hummingbird will use the new funds to accelerate development of new candidates into clinical trials and strengthen its scientific and research and development capabilities.

"We are delighted to have SK Holdings join our investor base. Hummingbird is building a strong portfolio of promising new therapies that we believe can deliver very meaningful benefit for patients across a broad spectrum of disease. These new funds give us further resources to develop our early stage pipeline, and support the clinical development of our lead programs," said Dr Piers Ingram, Chief Executive Officer and co-founder, Hummingbird Bioscience.

"Heritas Capital is pleased to continue our backing of the Hummingbird team since leading its Series A extended round," commented Chik Wai Chiew, Executive Director and Chief Executive Officer, Heritas Capital Management. "Even as the COVID-19 pandemic has resulted in a slow-down in investing, we are mindful that backing leading innovative biotech companies, especially players such as Hummingbird, to develop cures for addressing patients’ needs remains our priority."

Earlier this year Hummingbird announced publication of positive data on its lead candidate, HMBD-001, a first-in-class HER3 antibody; and manufacturing of HMBD-002, a first-in-class VISTA antibody. Regulatory submissions to initiate Phase I studies for these two candidates are expected in the second half of 2020.

On May 9, 2020 Avalon GloboCare Corp. (NASDAQ: AVCO), a clinical-stage global developer of cell-based technologies and therapeutics, reported that it has achieved significant milestones, advancing its next generation immune cell therapy using FLASH-CAR technology co-developed with the Company’s strategic partner Arbele Limited (Press release, Avalon, MAY 9, 2020, View Source [SID1234609546]). The adaptable FLASH-CAR platform can be used to create personalized cell therapy from a patient’s own cells, as well as off-the-shelf cell therapy from a universal donor.
Currently available Chimeric Antigen Receptor T (CAR-T) cellular immunotherapy involves a patient’s own T-cells—a type of white blood cell that protects against infections and other diseases including cancer—that are turned into personalized cancer fighting cells. The T-cells are removed from the patient, reprogrammed in the lab using a viral vector to target cancer cells, and infused back into the patient as a cancer immunotherapy.

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In contrast to these existing therapies, Avalon’s FLASH-CAR uses next generation CAR technology to modify patients’ T-cells and natural killer (NK) cells using a ribonucleic acid (RNA)-based platform rather than a viral vector. Similar to T-cells, NK cells are a type of white blood cell, also able to attack cancer cells, but utilize different mechanisms. By using RNA molecules rather than a viral vector, Avalon’s RNA-based CAR technology is designed to rapidly create personalized CAR therapies in 1 to 2 days compared to the 10- to 14-day bio-manufacturing time necessary to generate currently available CAR-T cellular immunotherapy. Avalon’s FLASH-CAR technology is also designed to reprogram the immune cells to hone in on multiple crucial cancer cell targets, called tumor antigens, to potentially achieve superior therapeutic effect. Avoiding the use of viral vectors and complicated bio-processing procedures significantly reduces manufacturing costs, resulting in a more affordable and potentially breakthrough therapy for cancer patients. The FLASH-CAR technology can also be used to generate "off-the-shelf", universal cell therapy that has the potential to reach even more patients.

Avalon’s first FLASH-CAR platform candidate, AVA-011, targets both CD19 and CD22 tumor antigens on cancer cells. Pre-clinical research on AVA-011, including tumor cytotoxicity studies, has been successfully completed and Avalon is immediately entering the process development stage to generate clinical-grade CAR-T and CAR-NK cells for use in human clinical trials. Avalon and Arbele have jointly filed for USPTO provisional and PCT patents for this RNA-based CAR platform cellular therapy and for other applications.

Avalon expects to begin a first-in-human clinical trial with AVA-011 for the treatment of relapsed or refractory B-cell lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma in the first quarter of 2021. The goal is to use AVA-011 as a bridge to bone marrow stem cell transplant therapy, currently the only curative approach for patients with these blood cancers.

"Avalon GloboCare is committed to decreasing the time it takes to deliver cellular immunotherapies to cancer patients, as well as lowering the cost of manufacturing by building on our unique RNA-based CAR platform that does not require using a viral vector," stated David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon GloboCare. "We are accelerating our innovative discovery and development plan, as well as delivering precise clinical execution and leadership in cellular immunotherapy. Our pre-clinical studies are encouraging and we are excited for AVA-011 to enter the clinical development stage, including multi-center clinical trials following completion of process development to generate the cell therapy," said Dr. Jin.

"Through this strategic partnership with Avalon GloboCare, we envision an accelerated scientific and clinical development of the RNA-based FLASH-CAR technology platform with great potential to generate "off-the-shelf" immune effector cell therapies to treat both hematologic and solid malignancies," said John Luk, Ph.D., EMBA, President and Chief Executive Officer of Arbele Limited.

On May 9, 2020 Cinda Biopharmaceutical (Hong Kong Stock Exchange: 01801), an innovative drug dedicated to the development, production and sale of major diseases such as cancer, autoimmunity, metabolic diseases, etc. The biopharmaceutical company, and Eli Lilly (NYSE: LLY) reported : A randomized, innovative, and innovative PD-1 inhibitor Daboshu (Sindilimumab Injection) jointly developed by the two parties (Press release, Innovent Biologics, MAY 9, 2020, View Source [SID1234557375]). Double-blind, phase III controlled clinical study (ORIENT-12)-Daboshu (sindilimumab injection, hereinafter referred to as sinidiumab) combined with Gemcitabine (gemcitabine for injection, hereinafter referred to as gemcitabine) Platinum-based chemotherapy is used in the first-line treatment of advanced or metastatic squamous non-small cell lung cancer (NSCLC) to reach the primary study endpoint. This is the world ’s first randomized, double-blind, phase III clinical study evaluating PD-1 antibody combined with Gemcitabine (gemcitabine) and platinum for first-line treatment of squamous NSCLC.

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Studies have shown that Sindilimum combined with gemcitabine and platinum compared with placebo combined with gemcitabine and platinum, significantly prolonged progression-free survival (PFS), reached the preset study endpoint, PFS significantly benefited, safety characteristics and previous reports The research results of xindilimumab were consistent and there was no new safety signal. Detailed research results will be announced in subsequent academic conferences.

Cinda and Eli Lilly plan to communicate with the Drug Evaluation Center (CDE) of the State Drug Administration on the submission of a new indication for the application of cindilimumab combined with gemcitabine and platinum for first-line treatment of squamous NSCLC.

Professor Zhou Caicun, director of the Department of Oncology, Shanghai Pulmonary Hospital, said: "Lung cancer accounts for the first cause (25.2%) of all cancer deaths, of which NSCLC accounts for approximately 80% to 85%. About 35% of NSCLC are squamous NSCLC. Over the past two decades, the development of drugs for the treatment of NSCLC has mainly focused on non-squamous NSCLC. Due to the lack of driver genes and special tumor biological characteristics, drug development has been slow. The emergence of anti-PD-1 antibodies is This type of patient brings a new treatment. We see that the study of Sindilimum reached the preset primary study end point. The ORIENT-12 study compared with the KEYNOTE-407 study of pabolizumab Using different combination chemotherapy regimens, it is the first randomized controlled study in the world to confirm that PD-1 antibody combined with gemcitabine and platinum can significantly improve the benefit of progression-free survival in patients with first-line squamous NSCLC. "

Dr. Hui Zhou, Vice President of the Medical Science and Strategic Oncology Department of Cinda Biopharmaceutical Group, said: "Currently Cindylimumab is the only anti-PD-1 monoclonal antibody drug listed in the National Medical Insurance List. It was awarded the National Drug Administration in 2018 Approved by the Administration for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after at least second-line chemotherapy. We are currently conducting a number of phase III randomized controlled studies on Sindrinimab. ORIENT-12 The results of the study are encouraging, and we foresee the potential of Sindilimumab to benefit more lung cancer patients. This is also the main study of Cinda Biological following ORIENT-11 (first-line non-squamous NSCLC randomized, double-blind, phase III study, NCT03607539) After the end point, the second successful randomized controlled study of lung cancer. "

Dr. Li Wang, senior vice president of Eli Lilly China and head of the Center for Drug Development and Medical Affairs, said, "Not long ago, the Drug Evaluation Center (CDE) of the State Drug Administration accepted Cindilimum for non-squamous non-small The application of new indications for first-line treatment of cell lung cancer (nsqNSCLC). And the exciting research results of ORIENT-12 have reflected the potential of Sindilimumab in the treatment of squamous non-small cell lung cancer. Here we think Thanks to all the patients and their families, researchers and clinical trial centers, and Cinda colleagues who participated in the study. We look forward to bringing this new treatment to lung cancer patients in China as soon as possible. "

About ORIENT-12 research

The ORIENT-12 study is a randomized evaluation of the efficacy and safety of Daboshu (sintilimab) or placebo in combination with Gemcitabine (gemcitabine) and platinum for first-line treatment of advanced or metastatic squamous NSCLC , Double-blind, Phase III controlled clinical study (ClinicalTrials.gov, NCT03629925). The primary study endpoint was progression-free survival (PFS) assessed by the Independent Imaging Review Committee (IRRC) according to the RECIST v1.1 standard. Secondary study endpoints include overall survival (OS) and safety.

A total of 357 subjects were enrolled in this study. They were randomized 1: 1 and received Daboshu (Sintilimab injection) 200 mg or placebo in combination with Gemcitabine (gemcitabine for injection) and platinum Treatment, given once every 3 weeks, after completing 4 or 6 cycles of combination therapy, enter Daboshu (sindilimumab injection) or placebo for maintenance therapy until disease progression, toxicity intolerance or other Circumstances where treatment needs to be terminated. After the disease progresses in the control group, it can be conditionally crossed to monotherapy of daboshu (sintilimab injection).

About squamous non-small cell lung cancer (sqNSCLC)

Lung cancer is the first malignant tumor in China that ranks first in both morbidity and mortality. NSCLC accounts for about 80% to 85% of all lung cancers, and about 70% of NSCLC patients are diagnosed as locally advanced or metastatic tumors that are not suitable for radical surgery. At the same time, a considerable proportion of early-stage NSCLC patients undergoing surgery will have recurrence or distant metastasis, and then die due to disease progression. About 35% of Chinese patients with NSCLC are squamous NSCLC. Squamous NSCLC lacks driver genes, and the effectiveness of first-line chemotherapy is about 30%. At present, only paclizumab combined with carboplatin and paclitaxel has been approved by the FDA and the National Drug Administration (NMPA) for this population. Treatment is still limited, and there are huge unmet medical needs.

About Daboshu (Sintilimab Injection)

Daboshu (Sintilimab Injection) is an innovative biopharmaceutical of international quality jointly developed by Cinda Biopharma and Eli Lilly in China. The first indication for its approval is relapsed / refractory classic Hodgkin’s lymphoma, which was included in the 2019 edition of the Chinese Society of Clinical Oncology (CSCO) lymphoma diagnosis and treatment guidelines. In April 2020, the National Drug Administration (NMPA) formally accepted the application for indications for the first-line treatment of non-squamous non-small cell lung cancer (nsqNSCLC) with dabershu (sintilimab injection). In the medical insurance country talks in 2019, Dabex (Sintilimab Injection) is the only PD-1 inhibitor that enters the National Health Insurance.

Dabshu (Sindilimumab Injection) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thereby blocking tumor immune tolerance The PD-1 / Programmed Death Receptor Ligand 1 (Programmed Death-Ligand 1, PD-L1) pathway reactivates the anti-tumor activity of lymphocytes to achieve the purpose of treating tumors. There are currently more than twenty clinical studies (of which more than 10 are registered clinical trials) are underway to explore the anti-tumor effect of sundilimumab on other solid tumors. Cinda Biotech is also conducting clinical research work on Cindylimumab injections worldwide.