On April 19, 2021 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the first quarter of 2021 after the market closes on Thursday, April 29, 2021 (Press release, MacroGenics, APR 19, 2021, View Source [SID1234578186]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, April 29, 2021 at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID# 5257004.

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The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On April 19, 2021 Incyte (Nasdaq:INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) reported the first patient has been dosed in the placebo-controlled Phase 3 inMIND study evaluating the efficacy and safety of tafasitamab or placebo in combination with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL) (Press release, Incyte, APR 19, 2021, View Source [SID1234578185]).

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"Despite improvements in treatment for patients with relapsed or refractory FL and MZL, there continues to be a significant medical need for additional therapies with improved outcomes," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "We are pleased to have initiated the inMIND study as we seek meaningful, new options for patients with relapsed or refractory FL or MZL."

FL and MZL are the most common indolent, or slow growing, forms of B-Cell non-Hodgkin lymphomas (NHLs). FL and MZL account for approximately 20-25% and 7% of adult NHL cases, respectively.1 There are limited treatment options for the more than 17,000 new cases of relapsed or refractory FL treated every year in the United States, Europe and Japan.2

"We are looking forward to building on previous, exploratory data in FL, and the results seen with tafasitamab and lenalidomide in relapsed or refractory diffuse large B-cell lymphoma, to evaluate the potential benefit of adding tafasitamab to the current lenalidomide and rituximab combination regimen in patients with indolent lymphomas," said Mike Akimov, M.D., Ph.D., Head of Global Drug Development, MorphoSys.

On January 7, 2021, the U.S. Food and Drug Administration granted orphan drug designation to tafasitamab for the treatment of FL.

About inMIND

inMIND (NCT04680052), a global, double-blind, placebo-controlled, randomized Phase 3 study, is evaluating whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide alone as an add-on to rituximab in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study is expected to enroll over 600 adult (age ≥18 years) patients with relapsed or refractory FL or MZL.

The primary endpoint of the study is progression-free survival (PFS) in the FL population, and the key secondary endpoints are PFS and overall survival (OS) in the overall population as well as positron emission tomography complete response (PET-CR) at the end of treatment (EOT) in the FL population.

For more information about the study, please visit: View Source

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi is a registered trademark of MorphoSys AG.

XmAb is a registered trademark of Xencor, Inc.

Important Safety Information

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:

Feeling tired or weak
Diarrhea
Cough
Fever
Swelling of lower legs or hands
Respiratory tract infection
Decreased appetite
These are not all the possible side effects of MONJUVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

Have an active infection or have had one recently.
Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

On April 19, 2021 Amgen (NASDAQ:AMGN) reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for investigational bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin), based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b (Press release, Amgen, APR 19, 2021, View Source [SID1234578184]).

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"The FIGHT trial is the first study to evaluate targeting the overexpression of FGFR2b in cancer. Bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or gastroesophageal cancer as a frontline therapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Amgen looks forward to further investigating the role of FGFR2b and will continue to work with regulatory agencies on next steps to bring this potential first-in-class, frontline therapy to patients."

More than one million new gastric cancer cases are diagnosed annually, and gastric cancer is particularly prevalent in Asia.1,2 Approximately 80 to 85% of patients with advanced gastric and GEJ cancers are HER2-negative, and approximately 30% of these patients present with FGFR2b overexpression.3,4

Following sotorasib, bemarituzumab is the second asset in Amgen’s oncology portfolio to receive Breakthrough Therapy Designation in the past six months. A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial improvement on a clinically significant endpoint over available medicines.5

The FIGHT trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b+, non-HER2 positive frontline advanced gastric or GEJ cancer. In the study, treatment with bemarituzumab plus chemotherapy demonstrated clinically significant and substantial improvements in the primary endpoint of progression-free survival (PFS) and secondary endpoint of overall survival (OS) in the patient population in which at least 10% of tumor cells overexpressed FGFR2b. Additional analysis showed a positive correlation between benefit and the prevalence of FGFR2b+ tumor cells, affirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target. The Breakthrough Therapy Designation was granted based upon this subset of patients who showed at least 10% of tumor cells overexpressing FGFR2b.

Amgen acquired Five Prime Therapeutics on April 16, 2021. In addition to bemarituzumab, Five Prime’s pipeline complements Amgen’s efforts to bring innovative therapies to oncology patients.

About Bemarituzumab
Bemarituzumab (anti-FGFR2b) is a potential first-in-class investigational targeted antibody that is designed to block fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. The company is also evaluating the potential for bemarituzumab in other cancers that overexpress FGFR2b.

Zai Lab (Shanghai) Co. Ltd. was granted an exclusive license to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.

On April 19, 2021 Oncocyte Corporation (NASDAQ: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported that it has completed its acquisition of Chronix Biomedical, a privately held molecular diagnostics company developing blood tests for use in cancer treatment and organ transplants (Press release, Oncocyte, APR 19, 2021, View Source [SID1234578183]). The acquisition includes the intellectual property and technology for Chronix’s TheraSure-Copy Number Instability (CNI) Monitor test for immune therapy monitoring. The Chronix CNI test is a patented, novel blood-based test that is differentiated from current methods because it requires no upfront tumor tissue sample. With the acquisition, Oncocyte also gains the organ transplant technology and the associated patent portfolio developed by Chronix.

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"We believe the acquisition of Chronix will provide Oncocyte a distinct competitive advantage as the first and only company to potentially offer a continuum of tests, from selecting patients for immune therapy treatment, to monitoring the effectiveness of the treatment," said Ron Andrews, President and Chief Executive Officer of Oncocyte. "Once available, we believe the CNI test will allow physicians to begin monitoring patients for treatment efficacy more quickly given the CNI test requires only a blood sample. In contrast, getting a result from the emerging tests for monitoring can take significantly longer as these tests start with the time consuming and costly genetic sequencing of a patient’s tissue sample. According to our voice of customer work, many later stage cancer biopsies do not provide enough tissue available to complete the analysis. These challenges are particularly amplified in lung cancer, where most later stage patients have very limited tissue from a fine needle biopsy sample and thus, quite often, have too little sample to perform tissue-based testing, including personalized MRD testing. Even in cases where sufficient tissue is available, preserving precious sample to enable other tests will be an added benefit of Oncocyte’s fully blood-based approach. Assuming the data published to date continues to be validated in future studies, the CNI test will be able to deliver timely results on progression using blood only, with no need for tissue biopsies, at the second treatment cycle. This time frame will deliver valuable information to physicians much faster than currently seen with imaging or tissue-informed technologies."

The addition of the CNI test to Oncocyte’s portfolio of diagnostic products marks the Company’s entry into blood-based immune-therapy monitoring, a market that is estimated at $3 billion in the United States alone. Ownership of Chronix’s intellectual property portfolio helps establish the foundation for Oncocyte to potentially build additional applications to address an estimated $6 billion U.S. recurrence monitoring market. Further, as approximately 40%-60% of patients fail to see a sustained response to immune checkpoint inhibitors, it is estimated that by 2025, more than $60 billion a year could be misspent on treatments that may never benefit patients.

The acquisition, which includes Chronix’s lab in Germany and its EU-based development and business team, establishes a footprint for the continued development and potential commercial launch of Oncocyte’s proprietary tests in the European market. The Company expects to launch the CNI test as a pharma service in Europe from Germany by the end of the current quarter. After the tech transfer to its U.S. facilities, Oncocyte plans to launch the test for research use only in domestic immune therapy clinical trials during the fourth quarter of this year. The anticipated first indication for use will be in lung cancer, followed by expansion to other cancer types. Further, as the path to reimbursement is already established, Oncocyte plans to demonstrate the comparability of the CNI test to existing reimbursed tests.

Also included in the acquisition are tests and a patent estate for the use of digital PCR to detect transplant rejection in recipients as well as enabling the absolute amount of tumor or donor cell-free DNA, which eliminates the influence of changes in cell-free DNA caused by unrelated reasons making the technique more specific for monitoring. The Company plans to explore the use of the patented methodologies and combine with digital PCR for development of super-sensitive detection of tumor-derived DNA in blood to monitor for long-term recurrence as well as explore licensing this technology and patent estate for transplant to potential partners.

Dr. Ekkehard Schuetz, former CEO and Chief Medical Officer of Chronix and now General Manager and CMO of Oncocyte Europe said, "By becoming part of Oncocyte, we believe our CNI monitoring test, together with DetermaIO, has the potential to become a much more powerful tool for oncologists as they will have a comprehensive solution for two of the biggest challenges in immune therapy: better identifying patients who are most likely to respond to treatment, and then monitoring for treatment efficacy and the development of resistance. The combination of Oncocyte’s proprietary immune therapy selection test and their commercial experience with Chronix’s rich portfolio of tests and IP make the deal clearly a case of the sum of the parts being greater than the whole."

More about CNI and the CNI Monitor Test

Cancer modifies the normal genome of cells by accumulating mutations and variation in the number of copies of genes in the genome.
Chronix’s CNI test measures the collective burden of tumor derived copy number variation (CNV) across the genome in blood as a sensitive, specific and quantifiable measure of tumor burden, i.e., response to therapy or prognosis of cancer.
CNI is a novel approach to measuring cell-free tumor DNA in blood that does not rely upon sequencing the tumor biopsy specimen (tumor naive vs. tumor informed).
The proprietary CNI test quantitatively measures the amount of CNV present in blood that has been shed by dying tumor cells.
The CNI Monitor test monitors the change in CNI over time and is suitable for monitoring patients being treated with chemotherapy, targeted therapy or immunotherapy.
Multiple publications have demonstrated the accuracy of CNI in identifying response or resistance to therapy prior to the second or third cycle of treatment, including a study in Clinical Cancer Research, and the value to assess the prognosis of cancer published for Head & Neck Cancer.
About the Merger and Principal Transaction Terms

Under the amended merger agreement, Oncocyte delivered closing consideration and paid off assumed liabilities approximating $4.25 million in cash and $3 million of Oncocyte common stock (or approximately 591,000 shares) and agreed to pay an additional $2.5 million of liabilities by July 2022. The agreement also provides for Oncocyte to pay a revenue share on the net collected revenues for certain tests and services for specific periods, and to pay a combination of cash or Oncocyte common stock of up to $14 million if certain milestones are achieved over a ten-year timeframe, subject to offset by Oncocyte for liabilities paid in excess of $8.25 million. Oncocyte issued the shares in a private transaction and intends to register the resale of the shares. Additional information regarding the terms of the transaction will be provided in Oncocyte’s Current Report on Form 8-K expected to be filed with the Securities and Exchange Commission on or about April 19, 2021.

On April 19, 2021 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of Quality, Affordable Self-Care Products, reported that its Board of Directors declared a quarterly dividend of $0.24 per share, payable on June 22, 2021 to shareholders of record on June 4, 2021 (Press release, Perrigo Company, APR 19, 2021, View Source [SID1234578182]).

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