On July 8, 2019 MorphoSys and Vivoryon Therapeutics reported that it enter Agreement on Small Molecule Inhibitors of CD47-SIRP alpha Signaling in Immuno-Oncology (Press release, MorphoSys, JUL 8, 2019, View Source [SID1234537398]).

MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) and Vivoryon Therapeutics AG (Euronext Amsterdam: VVY) reported that they have entered into an agreement under the terms of which MorphoSys has obtained an exclusive option to license Vivoryon’s small molecule QPCTL inhibitors in the field of oncology. The option covers worldwide development and commercialization for cancer of Vivoryon’s family of inhibitors of the glutaminyl-peptide cyclotransferase-like (QPCTL) protein, including its lead compound PQ912. In exchange, MorphoSys has committed to investing up to EUR 15 million in a minority stake in Vivoryon Therapeutics as part of a capital raise planned for later this year.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

While Vivoryon’s lead drug candidate PQ912 has already completed a phase 2a clinical trial in Alzheimer’s disease, recent preclinical data strongly suggest that the compound could represent a novel approach for cancer therapy. Vivoryon’s orally available compounds target the QPCTL enzyme, which has been shown to be a modulator of the CD47-SIRP alpha interaction. Left unchecked, this interaction, known as the "don’t eat me" signal, allows cancer cells to escape the body’s innate immune defense through inhibition of the phagocytic activity of macrophages. During the option period, MorphoSys will conduct preclinical validation experiments on Vivoryon’s family of QPCTL inhibitors, including an assessment of the potential benefits of combining them with MorphoSys’s proprietary program tafasitamab (MOR208), which is currently in late-stage development for the treatment of relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL).

"This deal gives us access to a unique set of drug candidates with exciting potential in cancer", said Dr. Simon Moroney, CEO of MorphoSys. "A number of studies suggests that the CD47-SIRP alpha interaction may be of central importance to the activity of some anti-cancer antibodies. In this regard, securing rights to Vivoryon’s estate of compounds in oncology makes strong strategic sense for us. In particular, we are looking forward to exploring the potential for synergy with tafasitamab (MOR208), our most advanced drug candidate. If successful, the use of these orally formulated QPCTL inhibitors may open the way to combinations with other anti-cancer antibodies aiming at boosting their cell killing activity."

"Our small molecule inhibitors represent a novel and innovative therapeutic approach to silence the critical CD47-SIRP alpha checkpoint signal in cancer immunotherapy," said Dr. Ulrich Dauer, CEO of Vivoryon Therapeutics. "As a leading company for antibody and protein technologies with a strong oncology focus, MorphoSys is the ideal partner for us. For Vivoryon this is a strategic alliance to exploit the potential of our first-in-class, highly specific and potent small molecules in combination with therapeutic antibodies for a targeted range of cancer indications. While remaining strongly committed to our development plans in Alzheimer’s disease, we are delivering on our strategy to extend the potential of our technology to immuno-oncology."

If MorphoSys chooses to exercise the option, Vivoryon Therapeutics will receive an option fee, and is eligible for milestone payments and royalties.

On July 8, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that topline data from the Phase II GRIFFIN (MMY2004) study of newly diagnosed patients with multiple myeloma eligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT), who were treated with daratumumab in combination with lenalidomide, bortezomib, and dexamethasone (VRd), met its primary endpoint, demonstrating a higher percentage of stringent complete responses (sCR) than patients who received VRd alone (Press release, Genmab, JUL 8, 2019, View Source [SID1234537397]). Specifically, the topline data showed that 42.4% of patients treated with daratumumab in combination with VRd achieved a sCR, compared to 32.0% of patients who received VRd alone, with an odds ratio of 1.57 (95% CI: 0.87 – 2.82, p=0.1359, exceeding the statistical significance at the pre-set 2-sided alpha level of 0.2). Secondary endpoints, including the results of the minimal residual disease (MRD) analysis, supported the primary endpoint favoring daratumumab in combination with VRd.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Overall, the safety profile of daratumumab in combination with VRd was consistent with the safety profile for each therapy separately, which has been reported from previous studies with the VRd regimen as well as previous studies with daratumumab.

Further analysis of the safety and efficacy data is ongoing, and Janssen Biotech, Inc., which licensed daratumumab from Genmab in 2012, plans to submit additional data for presentation at an upcoming medical conference.

"The data from the Phase II GRIFFIN trial underlines the potential of daratumumab when used in combination with VRd and supports Janssen’s decision to start the PERSEUS and CEPHEUS Phase III studies of daratumumab in combination with VRd for certain frontline multiple myeloma indications," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "This data also builds on the efficacy and safety data for daratumumab as a frontline treatment for transplant-eligible multiple myeloma patients as seen in the CASSIOPEIA Phase III study in which newly diagnosed patients with multiple myeloma who were candidates for ASCT were treated with daratumumab combined with an immune-modulatory drug and a proteasome inhibitor."

About the GRIFFIN (MMY2004) study
This Phase II trial (NCT02874742) is a randomized, open label, parallel assignment study that included 223 patients with newly diagnosed multiple myeloma who were eligible for high-dose chemotherapy and autologous stem cell treatment. Patients were randomized to receive either daratumumab plus lenalidomide, bortezomib and dexamethasone, or lenalidomide, bortezomib and dexamethasone alone. The primary endpoint of the study is the number of patients who achieve sCR by the end of the consolidation treatment.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were expected to be diagnosed with multiple myeloma and approximately 13,650 people were expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the United States. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,7,8,9,10

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases, such as NKT-cell lymphoma, B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.

On July 8, 2019 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), reported that UDENYCA preliminary unaudited net sales for the quarter that ended June 30, 2019 are expected to be in the range of $79.0 million to $84.0 million Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), reported that UDENYCA preliminary unaudited net sales for the quarter that ended June 30, 2019 are expected to be in the range of $79.0 million to $84.0 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Coherus will not disclose topline gross sales, discounts, or gross-to-net data until these data are reported in its Form 10-Q for the quarter ended June 30, 2019.

As announced, Coherus will provide additional financial updates and business highlights on August 1, 2019 at 4:30 p.m. Eastern Time.

.

Coherus will not disclose topline gross sales, discounts, or gross-to-net data until these data are reported in its Form 10-Q for the quarter ended June 30, 2019.

As announced, Coherus will provide additional financial updates and business highlights on August 1, 2019 at 4:30 p.m. Eastern Time.

On July 8, 2019 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), reported that its second quarter 2019 financial results will be released after market close on Thursday, August 1, 2019. Starting at 4:30 p.m. ET, Coherus’ management team will host a conference call to discuss financial results and provide a general business update (Press release, Coherus Biosciences, JUL 8, 2019, View Source/news-releases/news-release-details/coherus-biosciences-report-second-quarter-financial-results" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-second-quarter-financial-results" rel="nofollow">View Source [SID1234537395]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

After releasing second quarter 2019 financial results, the company will post them on the Coherus website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information

When: Thursday, August 1, 2019 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 9268814
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On July 8, 2019 ArcherDX, Inc., a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine and Ayala Pharmaceuticals, a clinical stage precision oncology company dedicated to developing targeted therapies for genomically defined, clinically underserved cancers, reported a strategic collaboration to develop companion diagnostic (CDx) tests targeting cancers bearing Notch activating mutations and fusions (Press release, ArcherDX, JUL 8, 2019, View Source [SID1234537393]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As we continue our work to bring pan-Notch inhibitors to those living with cancers bearing Notch-activating mutations and fusions, we are excited to enter into this collaboration with ArcherDX, a leader in molecular technology," said Roni Mamluk, Ph.D., Chief Executive Officer at Ayala Pharmaceuticals. "We believe that through this partnership we’ll have additional tools to identify those patients most likely to respond to the Notch inhibitors that Ayala is developing."

"Working closely with biopharma partners to help bring biomarker-driven therapies to individuals diagnosed with cancer is central to our mission to improve access to genomic-based medicine. Partnerships with progressive companies such as Ayala who can leverage our unique ability to provide companion diagnostic solutions from both tissue and blood-based specimens and deploy them at scale as in-vitro diagnostics to laboratories around the world is essential to achieving this mission," said Jason Myers, Co-Founder and Chief Executive Officer of ArcherDX. "We’re proud to support Ayala in their pursuit of meaningful new precision oncology treatment options."