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 Veracyte, Inc. (Nasdaq: VCYT) reported that new data demonstrating the clinical capability of the Percepta Genomic Atlas for informing lung cancer treatment decisions, as well as the technical feasibility of enabling the company’s Envisia Genomic Classifier on the nCounter Analysis System, will be presented at the American Thoracic Society (ATS) 2021 International Conference (Press release, Veracyte, APR 19, 2021, View Source [SID1234578201]). Multiple posters reinforcing the Envisia classifier’s diagnostic performance will also be presented at the meeting, which will be held virtually May 14-19, 2021.

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"We’re also very excited about the new data demonstrating that we can successfully enable the Envisia classifier on the nCounter system, maintaining the test’s clinical performance while enabling access for patients globally through local labs."

"The data being presented at ATS suggest that the Percepta Genomic Atlas can provide information that will accelerate appropriate treatment for patients following a lung cancer diagnosis and, importantly, that the test provides this information regardless of disease stage," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "We’re also very excited about the new data demonstrating that we can successfully enable the Envisia classifier on the nCounter system, maintaining the test’s clinical performance while enabling access for patients globally through local labs."

The Percepta Genomic Atlas provides comprehensive genomic profiling information on cancerous lung nodules, utilizing small samples from the same biopsy used for diagnosis. Data to be shared at ATS show that the in-development test accurately detects known gene variants in lung cancer using bronchoscopy samples, potentially enabling earlier and more appropriate treatment with currently available and in-development targeted therapies.

The Envisia Genomic Classifier is a genomic test that detects a genomic pattern of usual interstitial pneumonia (UIP) to improve interstitial lung disease (ILD) diagnostic and prognostic confidence. The classifier is performed in Veracyte’s U.S.-based CLIA laboratory. In December 2019, Veracyte acquired the exclusive global diagnostics rights to the nCounter Analysis System, a CE-marked and FDA-cleared decentralized molecular testing platform. The company plans to make the Envisia classifier available on the nCounter platform in international markets by the end of this year.

Following are details of the Percepta Genomic Atlas and Envisia classifier posters accepted for presentation at ATS. These posters will be available to meeting registrants on demand beginning May 14 through July 2, 2021:

Title:

Identification of Driver Mutations in Transbronchial Needle Aspirates of Suspicious Lung Nodules Concurrent with Diagnostic Bronchoscopy, Abstract #A4825

First Author:

Joshua Babiarz, Ph.D., Veracyte

Title:

Envisia Genomic Classifier Demonstrates Consistent Performance Across Gender, Age Group, and Smoking Status. Abstract #A1839

First Author:

Luca Richeldi, M.D., Ph.D., Università Cattolica del Sacro Cuore, Rome, Italy

Title:

Envisia Genomic Classifier Helps Improve Multidisciplinary Diagnoses of Complex Interstitial Lung Diseases, Abstract #A1877

First Author:

Lisa H. Lancaster, M.D., Vanderbilt University Medical Center

Title:

Cryobiopsy and Genomic Classifier (Envisia) in the Diagnosis of Usual Interstitial Pneumonia, Abstract #A4236

First Author:

R. Ronaghi, M.D., University of California, Los Angeles

Title:

Role of the Envisia Genomic Classifier in Establishing a Diagnosis of Idiopathic Pulmonary Fibrosis, Abstract #1837

First Author:

M. Abdalla, M.D., Pulmonary and Critical Care Medicine, Medical College of Wisconsin

Title:

Bridging the Envisia Genomic Classifier to the nCounter Platform: A Proof-of-Concept Study, Abstract #A4352

First Author:

Huimin Jiang, Ph.D., Veracyte

On April 19, 2021 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an oncology-focused drug development company, reported that it has entered into a worldwide exclusive licensing agreement and a master services agreement with Evotec SE (FRA: EVT), a leading European drug discovery and development company, for EVT801, a small-molecule, first-in-class oncology drug candidate. Kazia expects to launch a phase I clinical trial of EVT801 in CY2021 (Press release, Kazia Therapeutics, APR 19, 2021, View Source [SID1234578160]).

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Key Points

Evotec has granted Kazia an exclusive global worldwide license to develop, manufacture, and commercialise EVT801 in all territories and indications.
Under the terms of the agreement, Kazia will pay an immediate upfront of €1 million (AU$ 1.6 million), contingent milestones of up to €308 million (AU$ 480 million) related to achievement of clinical, regulatory, and commercial outcomes over the lifetime of the drug, and a tiered single-digit royalty on net sales.
Evotec is a leading drug discovery and development company, headquartered in Hamburg, Germany, and listed on the Frankfurt Stock Exchange.
EVT801 is a small-molecule inhibitor of VEGFR3. Its primary activity is to inhibit lymphangiogenesis, the formation of new lymphatic vessels around a growing tumour. By doing so, EVT801 is expected to starve the tumour of vital nutrients and to reduce metastasis. EVT801 also has marked activity on the immune system within the tumour and may therefore enhance the activity of immuno-oncology therapies.
Kazia and Evotec have also entered into a master services agreement, under which the two companies will collaborate closely on the further development of EVT801.
EVT801 was originally discovered by Sanofi (NASDAQ: SNY), the largest pharmaceutical company in France and among the five largest in the world and was developed through a partnership between Sanofi and Evotec.
Kazia expects to launch a phase I clinical trial in CY2021. The initial exploratory indications for EVT801 include renal cell carcinoma (kidney cancer), hepatocellular carcinoma (liver cancer), and soft tissue sarcoma.
Kazia CEO, Dr James Garner, commented, "We are delighted to add this tremendously exciting new compound to the Kazia pipeline. Evotec have done first-class work in the early development of EVT801, and the preclinical data package is exceptionally strong. We intend to fast track a phase I clinical trial of the drug, which we expect to commence in CY2021."

He added, "As we have built Kazia over the past five years, our strategy has been to assemble a portfolio of world-class development candidates through in-licensing. The EVT801 transaction is wholly consistent with that strategy. We have demonstrated, through the paxalisib program, our ability to add value to a development candidate, and we intend to similarly accelerate EVT801 via a rich and innovative development program."

Evotec CEO, Dr Werner Lanthaler, commented, "we are very pleased to partner with Kazia for this promising asset, for which we have high hopes. Our corporate strategy does not provide for Evotec to take EVT801 through clinical trials itself, so we have sought to identify a partner who can do justice to the drug’s potential. We recognise Kazia’s track record and look forward to working together to make EVT801 available to patients and clinicians."

EVT801

EVT801 is a small molecule inhibitor of vascular endothelial growth factor receptor 3 (VEGFR3). It is orally available, and so can be administered to patients by mouth.

For more than two decades, one of the most successful approaches in the treatment of cancer has been to target angiogenesis, the formation of new blood vessels. Drugs which inhibit angiogenesis, such as Avastin (bevacizumab), starve the growing tumour of nutrients. However, inhibiting angiogenesis also results in hypoxia (low levels of oxygen) around the tumour, and this is thought to generate resistance to treatment. Almost all cancers treated with current anti-angiogenic drugs will eventually develop resistance.

An alternative approach, which may avoid this problem, is to target lymphangiogenesis, which is the formation of new lymphatic vessels. Doing so achieves many of the same objectives as targeting angiogenesis but may avoid the problem of resistance induced by hypoxia. Moreover, the lymphatic system is a common route by which tumours spread (metastasise) throughout the body, and so inhibiting lymphangiogenesis may help to limit the ability of the tumour to spread.

In recent years, several new drug candidates have attempted to inhibit lymphangiogenesis. For example, Nexavar (sorafenib) inhibits several forms of VEGFR, as well as other targets, and is approved for the treatment of renal cell carcinoma and hepatocellular carcinoma. Several drugs described as angiokinase inhibitors are in development, and some of these inhibit VEGFR3. However, each of these drugs has multiple targets, leading in many cases to significant side effects. The distinguishing feature of EVT801 is a high degree of specificity for VEGFR3, which should allow it to minimise toxicity.

In addition, EVT801 has shown powerful evidence in the laboratory of an ability to change the balance of immune cells within the tumour. Many tumours are resistant to the newest generation of immuno-oncology therapies because they do not contain the right immune cells for the drugs to act upon. It is hoped that administration of EVT801 may help to sensitise these tumours to immuno-oncology therapies such as Keytruda (pembrolizumab) and Opdivo (nivolumab) and thereby extend their use.

Kazia expects to explore all these potential uses of EVT801 during the clinical program. The initial focus will be on a phase I study, which is expected to be conducted at one or more leading hospitals in France and to commence in CY2021.

Master Services Agreement

In parallel with the license agreement, Kazia and Evotec have entered into a Master Services Agreement (MSA), under which they will collaborate on the further development of EVT801. Kazia intends to utilise Evotec’s substantial capabilities and expertise in research, clinical trial management, biomarker development, and manufacturing, to expedite the development of EVT801.

Investor Conference Call

Kazia is pleased to invite investors to attend a conference call to further discuss the EVT801 in-licensing.

The call will be held on Tuesday 20 April 2021 at 8:00am, Sydney time (AET), which is 6pm on Monday 19 April in New York (ET) and 3pm on Monday 19 April in San Francisco (PT).

Participants will need to pre-register for the call via the following link:

Registration Link: View Source

Click the ‘Register Now’ button and follow the prompts to complete pre-registration. You will then receive a calendar invite with dial in numbers, a passcode and a PIN to dial into the conference call.

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 ImmVira reported the preclinical study results of MVR-T3011 via intravenous administration through publication in a virtual poster at the AACR (Free AACR Whitepaper) annual meeting (Press release, Immvira, APR 19, 2021, View Source [SID1234578202]). MVR-T3011 is a replication competent and genetically modified oncolytic herpes simplex virus-1 expressing human interleukin-12 and anti-PD-1 antibody. ImmVira owns the global right for development and commercialization of MVR-T3011 via intravenous administration.

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Oncolytic virus(OV) has been proven to inhibit tumor growth in a number of superficial tumors through intratumoral injection. From clinical studies, intratumoral injection of OV has been proved to provide effective treatment against tumor via its abscopal effect, transitions from immunologically cold to hot tumor and combination with other cancer therapies. However, to advanced tumors, especially the lesions of multiple metastasis are ideally treated via a systemic route. At present, common types of viruses that have been studied clinically for intravenous administration are Vaccinia virus, Coxsackie virus and Reovirus etc. However, for various reasons, most virus types used in developing oncolytic viruses including HSV-1 and adenoviruses, have not been fully studied for intravenous administration preclinically and clinically.

In the preclinical study conducted by ImmVira, intravenous administration of MVR-T3011 demonstrated enrichment of viral DNA in tumor tissue. MVR-T3855, the surrogate of MVR-T3011 for mouse, was shown to significantly extend the survival time of several mouse with orthotopic tumors including primary and metastatic lung cancer and primary liver cancer, and repeated dose via intravenous administration has clearly enhanced antitumor effect. Furthermore, intravenous administration or intra-cavity of MVR-T3855 significantly delayed or prevented the formation of malignant ascites in mouse liver model. In terms of safety, the three-month pre-clinical study showed that the intravenous administration of MVR-T3011 and MVR-T3855 did not cause significant adverse reactions and had clinical significance. After administration, no histopathological change was found in non-target organs.

ImmVira submitted an IND application for MVR-T3011 intravenous administration to the U.S. FDA in January 2021 and expects to recruit patients in five leading U.S. research cancer centers within the next few weeks.