On December 27, 2019 Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, reported the China National Medical Products Administration (NMPA) approved the New Drug Application (NDA) for ZEJULA (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor as maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy (Press release, Zai Laboratory, DEC 27, 2019, View Source [SID1234552618]). ZEJULA is a potent and highly selective PARP1/2 inhibitor that does not require BRCA mutation or other biomarker testing prior to administration.

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"The NMPA approval of ZEJULA, our first product to be approved in Mainland China, is a testament to the hard work and dedication of the entire Zai Lab team," said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. "We are grateful to all of the patients and investigators who contributed to the success of the ZEJULA clinical development program. Additionally, we appreciate the NMPA for their partnership through this rapid and thorough assessment of the ZEJULA application, recognizing the high unmet medical need it serves. As the first PARP inhibitor with Category 1 designation and manufactured in Mainland China, we are very excited to bring ZEJULA to Chinese patients following the successful launch in Hong Kong. With enrollment completed with 265 patients, we remain committed to finish our pivotal trial for maintenance therapy for Chinese patients with recurrent ovarian cancer (the NORA study) by third quarter of next year."

"The approval of ZEJULA in Mainland China is welcoming news for the ovarian cancer community, where advances in treatment have been very limited despite the clinical need," said Dr. Xiaohua Wu, Professor and Chair of Gynecologic Oncology Department of Fudan University Shanghai Cancer Centre. "The NOVA study shows that ZEJULA is a potential best-in-class PARP inhibitor for ovarian cancer patients, regardless of BRCA mutation or biomarker status, due to its compelling clinical data, convenience of once-daily dosing and attractive pharmacokinetic properties, including its ability to cross the blood brain barrier."

Mirza MR, Monk BJ, Herrstedt J, et al; ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164, and Supplementary Appendix.

The Committee of Gynecological Oncology, Chinese Anti-Cancer Association (CACA) has updated its clinical practice guidelines in Consensus of Chinese Experts on Recurrent Epithelial Ovarian Cancer to recommend ZEJULA (I/A category) as a maintenance treatment option for platinum sensitive recurrent ovarian cancer.

"Ovarian cancer is a devastating disease with a 5-year survival rate that hasn’t improved in a decade," said Dr. Lingying Wu, Director of the Department of Gynecologic Oncology of the Cancer Hospital of China Academy of Medical Sciences. "In addition to helping patients with recurrent ovarian cancer, ZEJULA’s recent PRIMA study demonstrated significant PFS improvement when given as monotherapy in women with first-line platinum responsive ovarian cancer, resulting in a 38% reduction in the risk of disease progression or death in the overall study population. Clinically meaningful reduction in risk of disease progression or death was further demonstrated with hazard ratios (HRs) of 0.40, 0.43 and 0.68 for BRCA mutant, HRD positive and HRD negative tumors, respectively. This study showed ZEJULA as the first PARP inhibitor to significantly improve PFS in this setting, regardless of biomarker status."

Zai Lab anticipates filing a supplemental NDA for ZEJULA (niraparib) with the NMPA as a first-line monotherapy maintenance treatment of platinum-responsive ovarian cancer patients soon after GlaxoSmithKline plc (GSK) files with the relevant global health authorities.

Ovarian cancer in China

Ovarian cancer is one of the most common gynecologic cancers in China with more than 52,000 newly diagnosed cases and 23,000 deaths in China each year. The 5-year overall survival rate of ovarian cancer patients is 46% across all stages, but only 29% in patients diagnosed with distant metastatic disease. While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. Effective treatment options for patients with platinum-sensitive recurrent ovarian cancer remain limited. New agents that prolong the duration of response following platinum-based treatment and delay the inevitable relapse of ovarian cancer will benefit patients with ovarian cancer in China.

About ZEJULA (niraparib)

ZEJULA (niraparib, ZL-2306) is a potential best-in-class PARP inhibitor for ovarian cancer patients due to its compelling clinical data2, once-daily dosing and pharmacokinetic properties, including its ability to cross the blood brain barrier. As maintenance therapy for recurrent ovarian cancer (the NOVA study), ZEJULA treatment reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations (HR 0.27) and by 55% in patients without germline BRCA mutations (HR 0.45).

Mirza MR, Monk BJ, Herrstedt J, et al; ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164, and Supplementary Appendix.

Zai Lab also conducted a Phase 1 pharmacokinetic (PK) study of niraparib in Chinese patients with ovarian cancer. This study was published in August 2019 in The Oncologist and demonstrated that the PK profile of niraparib in Chinese patients were comparable to that of patients evaluated in ZEJULA’s global PK study. Zai Lab in-licensed rights to ZEJULA from GSK for Mainland China, Hong Kong and Macau.

The NDA was accepted by the NMPA on December 12, 2018 and granted priority review status on January 29, 2019. Zai Lab has now obtained approvals for marketing ZEJULA in Mainland China, Hong Kong and Macau for maintenance therapy in patients with platinum-sensitive, recurrent ovarian cancer.

Since the Hong Kong launch of ZEJULA in October 2018, it has rapidly gained market share in the region despite being launched more than two years behind Lynparza. Based on IQVIA (formerly IMS) data, ZEJULA is now the market leading PARP inhibitor with market share in Hong Kong of 77% by value in the third quarter of 2019.

ZEJULA is also being evaluated in China in pivotal studies as first-line maintenance therapy in small-cell lung cancer.

IMPORTANT SAFETY INFORMATION

The most common side effects for patients taking ZEJULA include heart not beating regularly, nausea, constipation, vomiting, pain in the stomach area, mouth sores, diarrhea, indigestion or heartburn, dry mouth, tiredness, loss of appetite, urinary tract infection, shortness of breath, cough, rash, changes in liver function or other blood tests, pain in your joints, muscles, and back, headache, dizziness, change in the way food tastes, trouble sleeping, anxiety, sore throat and changes in the amount or color of your urine. Other potential serious side effects include bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of blood cancer called Acute Myeloid Leukemia (AML), symptoms of low blood cell counts (which can be a sign of serious bone marrow problems) and high blood pressures. Patients should take a few medical tests before they are treated with ZEJULA. Healthcare providers should periodically monitor their patients’ blood cell counts and blood pressures.

On December 27, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported that the first patient has been dosed in a phase 1b clinical study of MorphoSys’ proprietary human anti-CD19 antibody tafasitamab in newly diagnosed diffuse large B cell lymphoma (DLBCL) (Press release, MorphoSys, DEC 27, 2019, View Source [SID1234552617]). The phase 1b study is an open-label, randomized, multicenter study to evaluate safety and preliminary efficacy of tafasitamab in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristin, prednison) as well as tafasitamab and lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated DLBCL. Patients enrolled in each arm will receive six cycles of treatment. The primary endpoint is the incidence and severity of treatment-emergent adverse events (AEs), key secondary endpoints are objective response rate (ORR) and PET-negative complete response (CR) rate at the end of treatment.

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"It is a great opportunity for us to expand the clinical development of tafasitamab into firstline DLBCL," said Dr. Malte Peters, Chief Development Officer of MorphoSys. "Based on the encouraging results we have seen so far with tafasitamab in relapsed and refractory DLBCL, we are now looking forward to explore the potential of tafasitamab in addition to
R-CHOP or lenalidomide and R-CHOP in newly diagnosed DLBCL. This phase 1b study forms the basis for a subsequent pivotal phase 3 study in front line DLBCL. DLBCL is an aggressive and very challenging disease and we hope to improve the current R-CHOP standard of care by adding tafasitamab and lenalidomide to offer a potential new treatment option for these critically ill patients."

About tafasitamab (MOR208)
Tafasitamab (formerly MOR208) is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. Fc-modification of tafasitamab is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. Tafasitamab has been observed in preclinical models to induce direct apoptosis by binding to CD19, which is assumed to be involved in B cell receptor (BCR) signaling.
MorphoSys is clinically investigating tafasitamab as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Based on interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide in this patient population. B-MIND is a phase 3 study assessing the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being investigated in patients with relapsed/refractory CLL/SLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

On December 27, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that the first patient in a clinical phase 1b study in newly diagnosed diffuse large B-cell lymphoma (DLBCL) with the MorphoSys’s own human anti-CD19 antibody tafasitamab was dosed (Press release, MorphoSys, DEC 27, 2019, View Source [SID1234552617]). The Phase 1b study is an open, randomized, multicenter study to evaluate the safety and preliminary efficacy of tafasitamab in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) compared to tafasitamab and lenalidomide as well as R-CHOP adult patients with newly diagnosed, previously untreated DLBCL. The patients in each study arm receive six treatment cycles with a follow-up period of up to 24 months.

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"We are very excited to expand the clinical development of tafasitamab to include first-line DLBCL," said Dr. Malte Peters, MorphoSys’s Chief Development Officer. we are now excited to investigate the potential of our most important program in combination with R-CHOP or lenalidomide and R-CHOP in newly diagnosed DLBCL. This phase 1b study is the basis of a subsequent phase 3 approval study in first-line DLBCL. DLBCL is an aggressive and difficult to treat disease and we hope to improve the current standard R-CHOP therapy by adding tafasitamab and lenalidomide,

About Tafasitamab (MOR208)
Tafasitamab (MOR208) is a humanized Fc-modified monoclonal antibody to CD19. The Fc modification of tafasitamab is said to lead to a significant increase in the antibody-dependent cell-mediated cytotoxicity (ADCC) and the antibody-dependent cellular phagocytosis (ADCP) and thus improve a key mechanism of tumor cell killing. Tafasitamab has been studied in preclinical models to induce direct apoptosis by binding to CD19, which is considered a critical component for B cell receptor (BCR) signaling.
MorphoSys is investigating tafasitamab as a therapeutic option for B cell malignancies in a number of ongoing combination studies. The phase 2 combination study (L-MIND study) examined the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed / refractory DLBCL who were not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) come. Based on preliminary data from L-MIND, the FDA granted therapeutic breakthrough status for tafasitamab plus lenalidomide in this patient population in October 2017. B-MIND is a phase 3 study that investigates the combination of tafasitamab and bendamustine compared to rituximab and bendamustine in r / r DLBCL.

On December 26, 2019 GenScript reported that it signed a strategic collaboration agreement with Selecxine Inc., a Korean biotech company dedicated to novel therapeutics for immuno-oncology (Press release, GenScript, DEC 26, 2019, View Source [SID1234552615]). The parties have reached a partnership on innovative antibody drug development.

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According to the agreement, GenScript will be responsible for preclinical pharmacy research and IND filing in Selecxine’s project. This project is based on cytokine-antibody complexes. Compared with classic monoclonal antibody and protein drug, this project provides a new insight into new drug development.

It is said that the project is challenging, featuring novel design of the drug molecular form. As there are no drugs in the market for reference, this presents a great challenge to GenScript’s process development capability. After the comprehensive project evaluation, based upon its extensive experience in biologics process development, GenScript has provided development solutions in different hosts tailored to customers and provided the preparation and purification solutions for the final complex, which won recognition from customers. This project will further test and enhance the process development capability of GenScript CDMO team.

"We are delighted to reach strategic collaboration with Selecxine in the field of innovative drug development. In recent years, Korea’s biopharmaceutical industry has grown rapidly. Among outstanding innovative biotech companies in Korea, Selecxine has extensive experience in innovative therapeutics," Dr. Brian Min, CEO of GenScript BDBU said, "This collaboration once again demonstrates our superior process development capabilities. We would like to empower more innovative companies like Selecxine in the future to accelerate the development of innovative therapies and new drug approval."

Dr. Jun-Young Lee, CEO of Selecxine, said at the signing ceremony, "I am so glad to have a collaboration with global CDMO GenScript to develop our lead candidate SLC-3010. During last several years, we have experienced the capability of GenScript as global CDMO through successful performance on multiple sub-projects belong to SLC-3010. I believe that the newly updated agreement for closer partnership covering wide range of new medicine development processes from stable cell line development to GMP production of SLC-3010 will lead us to clinical trials. I hope to maintain this great business partnership as growing together for developing better out-comes in this promising field of drug development."

On December 26, 2019 OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OBI-999 for the treatment of Pancreatic Cancer (Press release, OBI Pharma, DEC 26, 2019, View Source [SID1234552614]). OBI-999 is a first-in-class antibody drug conjugate targeting Globo H, a glycolipid antigen.

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A Phase 1/2 clinical trial of OBI-999 has commenced enrollment at the University of Texas M.D. Anderson Cancer Center, with Dr. Apostolia M. Tsimberidou as the Principal Investigator, in patients with locally advanced or metastatic solid tumors, including Pancreatic, Gastric, Colorectal and Esophageal Cancers (ClinicalTrials.gov Identifier: NCT04084366). The objective of the trial is to verify the safety and preliminary efficacy profile of OBI-999 in these patient populations.

Tillman Pearce, MD, CMO, OBI Pharma noted, "We are very excited about the potential value that OBI-999 may provide to patients with pancreatic cancer given both the high potency we have observed using OBI-999 in pancreatic cancer xenograft models and because many pancreas cancers highly overexpress Globo H, the glycolipid target of OBI-999, using the validated IHC assay that will be available for selecting patients for the Phase 2 portion of this first-in-human clinical trial."

About Pancreatic Cancer

Pancreatic Cancer originates in the exocrine or endocrine pancreatic cells and is thought to be caused by poor diet, smoking, and genetic factors. Pancreatic Cancer is a deadly disease that currently affects 69,839 people in the US and has a survival rate of only 8.5% at five years. In addition, treatment options are limited to surgical resection for patients with early stages of the disease and these patients may only have a five-year survival rate of up to 34.3%. As Pancreatic Cancer is asymptomatic in early stages, a majority of patients are undiagnosed or misdiagnosed until advanced stages of the disease. Surgery is no longer effective at this stage of the disease, leaving a large population with limited treatment options.

About Orphan Drug Designation (ODD)

The orphan drug designation provides OBI Pharma with potential benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees, and tax credits for qualified clinical trials. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for rare diseases or conditions that affect fewer than 200,000 people in the U.S.

About OBI-999

OBI-999 is a novel first-in-class Antibody Drug Conjugate (ADC) with a proprietary linker technology that provides a consistent Drug-to-Antibody ratio (DAR) for cancer treatment that is based on Globo H, an antigen expressed in up to 15 epithelial cancers. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. OBI-999 is currently in a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT04084366) to test its safety and efficacy as an oncology ADC therapy. In pre-clinical xenograft animal models in multiple tumor types (pancreatic, lung, gastric, and breast), OBI-999 has demonstrated profound tumor shrinkage at various doses. In pre-clinical single and repeated dose toxicology studies, OBI-999 was well-tolerated, and achieved a favorable safety margin which warrants further clinical development. OBI Pharma owns global rights to OBI-999.