On December 30, 2019 MorphoSys (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that it has filed a biologics license application (BLA) for tafasitamab with the United States Food and Drug Administration (FDA) , Tafasitamab is MorphoSys anti-CD19 antibody, which is currently in clinical development for the treatment of therapy-resistant or recurrent diffuse large B-cell lymphoma (R / R DLBCL) (Press release, MorphoSys, DEC 30, 2019, View Source [SID1234552626]). The application for approval is based on the data from the primary analysis of the L-MIND study with tafasitamab in combination with lenalidomide in patients with R / R DLBCL as well as the data from the primary analysis of the retrospectively considered suitable control group (Re-MIND), which showed the effectiveness of a lenalidomide -Monotherapy in R / R DLBCL patients examined.

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"The submission of the BLA marks an important milestone in the history of MorphoSys and shows our commitment to address the high medical need for therapy-resistant or recurrent DLBCL," said Dr. Malte Peters, Chief Development Officer at MorphoSys. "If approved, tafasitamab and lenalidomide could be an alternative treatment for these critically ill patients."

The FDA has a 60-day period to review the application for completeness and as sufficient for an application for approval. MorphoSys will communicate the authority’s decision.

About L-MIND
L-MIND is a one-arm, open-label phase 2 study that examines the combination of tafasitamab and lenalidomide in patients with relapsed or refractory large cell B-cell lymphoma (R / R DLBCL) using up to two previous therapy lines, at least one have received anti-CD20-directed therapy (e.g. with rituximab) and are not suitable for high-dose chemotherapy and subsequent autologous stem cell transplantation. The primary endpoint of the study is the overall response rate (ORR). Secondary endpoints include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). The study reached its primary completion in May 2019. The primary analysis data (as of November 30, 2018) was based on 80 patients enrolled in the study, who had received tafasitamab and lenalidomide and had been observed for at least one year according to the study protocol. The efficacy results of this analysis were based on the response rates assessed by an independent review panel for all 80 patients. Based on previously reported interim results from the L-MIND study, the U.S. regulatory agency FDA granted treatment breakthrough status for tafasitamab plus lenalidomide in this patient population in October 2017. MorphoSys is working on completing an application for approval (BLA) with the US FDA based on L-MIND by the end of 2019. The efficacy results of this analysis were based on the response rates assessed by an independent review panel for all 80 patients. Based on previously reported interim results from the L-MIND study, the U.S. regulatory agency FDA granted treatment breakthrough status for tafasitamab plus lenalidomide in this patient population in October 2017. MorphoSys is working on completing an application for approval (BLA) with the US FDA based on L-MIND by the end of 2019. The efficacy results of this analysis were based on the response rates assessed by an independent review panel for all 80 patients. Based on previously reported interim results from the L-MIND study, the U.S. regulatory agency FDA granted treatment breakthrough status for tafasitamab plus lenalidomide in this patient population in October 2017. MorphoSys is working on completing an application for approval (BLA) with the US FDA based on L-MIND by the end of 2019.

About Re-MIND
Re-MIND, a retrospective observational study, was designed to isolate the contribution of tafasitamab to the combination with lenalidomide and to demonstrate the combinatorial effect. The study compared the real response data of patients with relapsed or refractory DLBCL who received lenalidomide monotherapy to the efficacy results of the tafasitamab-lenalidomide combination as examined in MorphoSys’s L-MIND study. Re-MIND collected efficacy data from 490 r / r DLBCL patients in the United States and the EU. Eligible patients were assigned 1: 1 to the L-MIND study population, based on important basic characteristics such as relevant prognostic factors, laboratory values ​​and patient demography.

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 to be a critical component for B cell receptor (BCR) signaling.
MorphoSys untersucht Tafasitamab als therapeutische Option bei B-Zell-Malignomen in einer Reihe von laufenden Kombinationsstudien. Die offene Phase-2-Kombinationsstudie (L-MIND-Studie) untersucht die Sicherheit und Wirksamkeit von Tafasitamab in Kombination mit Lenalidomid bei Patienten mit rezidivierender/refraktärer DLBCL, die nicht für eine Hochdosis-Chemotherapie (HDC) und autologe Stammzelltransplantation (ASCT) in Frage kommen. Basierend auf vorläufigen Daten von L-MIND hat die FDA im Oktober 2017 den Status Therapiedurchbruch für Tafasitamab plus Lenalidomid in dieser Patientenpopulation erteilt.
Re-MIND, the real world data study in a control group treated with lenalidomide monotherapy, reached its primary endpoint in October 2019 and demonstrated the clinical superiority of the tafasitamab / lenalidomide combination over lenalidomide alone. B-MIND is an ongoing phase 3 study that investigates the combination of tafasitamab and bendamustine in comparison with rituximab and bendamustine in r / r DLBCL. In addition, tafasitamab is currently being studied in patients with relapsed / refractory CLL / SLL after discontinuation of previous Bruton tyrosine kinase inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or Venetoclax.

On December 30, 2019 Boehringer Ingelheim reported its collaboration with BeiGene, Ltd. and the provision of manufacturing services for their monoclonal antibody tislelizumab, Boehringer Ingelheim Biopharmaceuticals China is the first company to successfully apply the adopted Marketing Authorization Holder (MAH) system within the revised Chinese Drug Administration Law (DAL) (Press release, Boehringer Ingelheim, DEC 30, 2019, View Source [SID1234552625]). The National Medical Products Administration of China (NMPA) recently approved the new monoclonal antibody tislelizumab as the first biopharmaceutical manufactured by a multinational contract manufacture service provider in China. It is also the first innovative biopharmaceutical commissioned under the new MAH model in China.

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"This is an important milestone, not only to ensure the supply of medicines for patients in China, but also for the rapidly emerging Chinese biopharmaceutical Research & Development landscape," states John Oyler, Chairman and CEO of BeiGene, Ltd. The collaboration between BeiGene and Boehringer Ingelheim Biopharmaceuticals China demonstrates that the country’s MAH trial project can be successfully applied in order to advance the life sciences industry in China.

In 2014, the process of reforming the local MAH/Contract Manufacturing model in order to enable a new regulatory pathway for authorizing third parties to manufacture biopharmaceutical products for drug authorization holders was initiated. In 2015, tislelizumab, where Boehringer Ingelheim Biopharmaceuticals China is the manufacturer, became the pilot project for the new regulatory approach and is now the first biologic approved under this new setup.

"We are very proud to become the first company starting commercial biopharmaceutical manufacturing under the MAH model in China." says Dr. Jiali Luo, General Manager and Site Head of Boehringer Ingelheim Biopharmaceuticals China. "The trial project was smoothly conducted and now proven successful. The newly established model can be of great benefit for the Chinese health care system and provide Chinese patients broader access to more innovative medicine."

BeiGene, a global commercial-stage biopharmaceutical company focused on developing and commercializing innovative drugs for the treatment of cancer, and Boehringer Ingelheim Biopharmaceuticals China started their collaboration in 2013. Boehringer Ingelheim’s biopharmaceutical contract manufacturing business, known as Boehringer Ingelheim BioXcellence, has been providing the chemistry, manufacturing, and control (CMC) services for tislelizumab.

"We congratulate BeiGene for reaching this very important milestone with the approval of their antibody in China. We are excited and set up to reliably supply this important innovative product according to international quality standards," stated Dr. Uwe Buecheler, Head of the Biopharmaceuticals Business Unit at Boehringer Ingelheim. "This is the first commercial biopharmaceutical manufactured in our facilities in China. By reaching this milestone, we are adding another important biopharmaceutical to our outstanding product track record of now 36 licensed biopharmaceuticals for patients worldwide."

On December 30, 2019 AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) reported that Lynparza (olaparib) has been approved in the US for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen (Press release, AstraZeneca, DEC 30, 2019, View Source [SID1234552624]). Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza.

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The approval follows the recommendation from the US FDA Oncologic Drugs Advisory Committee (ODAC) on 17 December for Lynparza in this indication, and was based on results from the pivotal Phase III POLO trial published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Results showed a statistically significant and clinically meaningful improvement in progression-free survival, where Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo. The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in prior clinical trials.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades. Lynparza is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: "Lynparza embodies MSD’s and AstraZeneca’s commitment to advance the treatment of challenging types of cancer, including metastatic pancreatic cancer. The expanded approval of Lynparza represents a significant milestone for patients and supports the value of germline BRCA testing in patients with this disease."

Hedy L. Kindler, Co-Principal Investigator of the POLO trial and Professor of Medicine, University of Chicago Medicine, said: "Today’s approval of olaparib based on the POLO results gives clinicians an important 1st-line maintenance treatment option which nearly doubled the progression-free survival benefit in patients with germline BRCA-mutated metastatic pancreatic cancer."

Julie Fleshman, President and CEO, Pancreatic Cancer Action Network, said: "Metastatic pancreatic cancer patients have been waiting a long time for new therapy options for their devastating disease. Today’s approval of Lynparza provides an exciting new treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer."

The Pancreatic Cancer Action Network (PanCAN) is a US-based organisation that supports and advocates on behalf of the patients, caregivers and communities affected by pancreatic cancer.

About pancreatic cancer

Pancreatic cancer is a deadly cancer with a high unmet medical need. It is the 12th most commonly occurring cancer2 and the 7th leading cause of cancer death globally.3 The disease has the lowest survival rate of the most common cancers4,5 and is the only major cancer with a single-digit five-year survival rate (2-9%) in nearly every country.5 There were approximately 460,000 new cases worldwide in 20186. As there are often no symptoms, or symptoms may be non-specific in the early stages7, it is most commonly diagnosed at an incurable stage.8 Around 80% of pancreatic cancer patients are diagnosed when the disease has metastasised and for these the average survival is less than a year.9 Despite advances in treatment10, few improvements have been made in diagnosis and treatment over the decades.11,12 Current treatment is surgery (for which approximately only 10-20% of patients are eligible), chemotherapy and radiotherapy, highlighting a critical unmet medical need for more effective treatment options.13

About POLO

POLO is a Phase III randomised, double-blinded, placebo-controlled, multi-centre trial of Lynparza tablets (300mg twice daily) as maintenance monotherapy vs. placebo. The trial randomised 154 patients with gBRCAm metastatic pancreatic cancer whose disease had not progressed on 1st-line platinum-based chemotherapy. Patients were randomised (3:2) to receive Lynparza or placebo until disease progression. The primary endpoint was PFS and key secondary endpoints included overall survival, time to second disease progression, overall response rate and health-related quality of life.1

The results showed a statistically significant and clinically meaningful improvement in progression-free survival, where Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo and reduced the risk of disease progression or death by 47% (HR 0.53 [95% CI, 0.35-0.81], p=0.0035). The benefit of maintenance with Lynparza was seen consistently across a range of clinically meaningful endpoints. In patients with measurable disease at baseline, 23% responded to Lynparza vs.12% on placebo (odds ratio, 2.30; 95% CI, 0.89 to 6.76) and had a median duration of treatment in excess of two years (24.9 months; 95% CI, 14.8 to could not be calculated) vs 3.7 months on placebo (95% CI, 2.1 to could not be calculated). Overall survival (OS), a secondary endpoint, at interim analysis was 18.9 months for Lynparza vs. 18.1 months for placebo but did not reach statistical significance (HR=0.90; p=0.68).

The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in prior clinical trials. The most common adverse reactions (ARs) ≥10% were fatigue (60%), nausea (45%), abdominal pain (34%), diarrhoea (29%), anaemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnoea (13%), nasopharyngitis (12%), neutropenia (12%), dysgeusia (11%) and stomatitis (10%). Grade 3 or above ARs were anaemia (11%), fatigue (5%), neutropenia (4%), decreased appetite (3%), thrombocytopenia (3%), abdominal pain (2%), vomiting (1%) and arthralgia (1%). ARs led to dose reduction in 23% of patients on Lynparza while 6% of patients discontinued treatment.

Based on the results of POLO, the National Comprehensive Cancer Network (NCCN) guidelines were updated in July 2019 to recommend Lynparza as maintenance treatment for gBRCAm pancreatic cancer.14

In the US, eligible metastatic pancreatic cancer patients will be selected for therapy based on the FDA-approved companion diagnostic, BRACAnalysis CDx, a genetic test that detects the presence of a BRCA1 or BRCA2 gene mutation. BRACAnalysis CDx is owned and commercialised by Myriad Genetics, Inc.

About BRCA mutations

BRCA1 and BRCA2 (breast cancer susceptibility genes 1/2) are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.

About 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 (HRR), 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 65 countries, including those in the EU, for the maintenance
treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status. 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 44 countries, including the US and Japan, for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer. Regulatory reviews are underway in other jurisdictions for ovarian, breast and pancreatic cancers.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, is approved for advanced ovarian cancer and metastatic breast cancer and has been used in over 25,000 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.

About the AstraZeneca and MSD strategic oncology collaboration

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

About 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 at least six new medicines to be 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 investments 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 December 29, 2019 Starpharma (ASX:SPL, OTCQX:SPHRY) reported that AstraZeneca (LSE/STO/NYSE:AZN) has commenced a phase 1 clinical trial of AZD0466 (DEP Bcl2/xL conjugate) and the first patient has been successfully dosed (Press release, Starpharma, DEC 29, 2019, View Source [SID1234552623]). The trial will recruit patients with a range of cancers and will be conducted at 4-5 US sites.

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The development of AZD0466, is being progressed under a multi-product license whereby Starpharma is eligible to receive development, launch and sales milestones of up to US$124 million, plus tiered royalties on net sales. The first dose of AZD0466 administered in the phase 1 trial has triggered a milestone payment to Starpharma of US$3 million. AstraZeneca also funds the development costs of DEP AstraZeneca products under the license.

AstraZeneca describes AZD0466 as having the potential to be a ‘best-in-class’ agent in this field with a broad opportunity in solid and haematological tumours (blood cancers) due to its ability to target both Bcl2 and Bcl/xL1.

Bcl2 is a clinically validated oncology target with the Bcl2 inhibitor, venetoclax (Venclexta – AbbVie/Genentech), being approved by the US FDA in 2016 with estimated peak global sales projected to be between US$2-3 billion2.

Dr Jackie Fairley, Starpharma CEO, commented: "It is really exciting to achieve this important milestone both for our collaboration with AstraZeneca and for Starpharma’s DEP platform. This is our first partnered DEP product to enter the clinic, alongside our three internal DEP products, DEP docetaxel, DEP cabazitaxel and DEP irinotecan. AZD0466 is a great illustration of the benefits that can be created for novel agents using Starpharma’s DEP platform and we look forward to further updates as the trial progresses."

On December 28, 2019 Elpiscience Biopharma reported the completion of Series B financing of 100 million USD (Press release, Elpiscience, DEC 28, 2019, View Source;id=1336 [SID1234552621]). The round was led by Hyfinity Investments, with participation from Tencent, GTJA Investment Group, Dyee Capital, Oriza Holdings, Ming Bioventures, WisdoMont, Parkway Global and others. Existing investors, including Lilly Asia Ventures, Hillhouse Capital Group, and CDH Investments continued to invest in this round of financing. The proceeds from Series B will primarily be used to advance highly innovative immunotherapy candidates such as ES101, ES102 and ES002 through pre-clinical and clinical development. The Company will also use these funds to expand its innovative product pipeline through internal discovery and global partnering.

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Elpiscience is a biopharmaceutical research and development company that strives to lead the next revolution of cancer immunotherapies. Built on its deep understanding of tumor biology and immunology, and with its highly efficient execution capabilities, Elpiscience has developed a globally competitive pipeline of 12 products in just two years, which is highly recognized not only by institutional investors but also by the commercial banks. Two weeks ago in Suzhou, Elpiscience announced the signing of a 150 million RMB collaboration with two major banks, Bank of China and Agricultural Bank of China. The fund will be used to establish Elpiscience’s GMP manufacturing capabilities. This signifies a major milestone of Elpiscience towards late stage and commercial development of antibody therapeutics.

Dr. Darren Ji, Elpiscience’s co-founder and CEO, commented, "We are pleased to be recognized by top investors during this round of financing. Their trust is truly appreciated, especially in this challenging year of private investment. We are particularly grateful towards Hyfinity Capital for their leading role and warmly welcome many other seasoned investors who participated in this Series B round. The participation of these top-notch investors greatly empowers us to continuously pursue the exciting journey of developing innovative drugs. We will stay committed to carefully exploring new scientific discovery towards finding effective therapies for cancer patients."

Dr. Sylvia Xin He, Hyfinity Investments’ Managing Partner, commented, "Elpiscience has a deep understanding of immunotherapy and focuses on the truly global innovative targets. The team at Elpiscience excels in execution, international collaboration, and innovative drug discovery and research in the field of tumor immunology. The rapid progress from preclinical to clinical development, the establishment of an integrated R&D team and the system, and their global network and collaboration with leading academic institutions and industry partners testify to the team’s strength. Immunotherapy is one of the vertical foci for Hyfinity Investments, a field that we have already deeply cultivated for the last two years. We are honored to join and support Elpiscience in its pursuit of innovative cancer immunotherapy and Hyfinity is committed to assisting Elpiscience in its great endeavors."