1stOncology™: Cancer Intelligence Service – Page 11718 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

CHMP Issues Positive Opinion Recommending Subcutaneous Formulation of Daratumumab for the Treatment of Patients with Multiple Myeloma

On April 30, 2020 Genmab A/S (Nasdaq: GMAB) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending the use of the subcutaneous formulation of daratumumab for the treatment of adult patients with multiple myeloma in frontline and relapsed / refractory settings (Press release, Genmab, APR 30, 2020, View Source [SID1234556831]). The CHMP’s Positive Opinion for the subcutaneous formulation of daratumumab applies to all currently approved daratumumab indications in frontline and relapsed / refractory multiple myeloma settings. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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!

"We are very pleased with this Positive Opinion from the CHMP as it potentially brings the convenient dosing of subcutaneous daratumumab closer to becoming available for multiple myeloma patients in Europe," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The Marketing Authorization Application for this formulation was submitted to the EMA by Janssen Pharmaceutica NV in July 2019 based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the subcutaneous formulation of daratumumab to the intravenous formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which is evaluating subcutaneous daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA data were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2019.

About the COLUMBA (MMY3012) study
The Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that included 522 adults diagnosed with relapsed and refractory multiple myeloma. Patients were randomized to receive either: subcutaneous (SC) daratumumab, as 1800 mg daratumumab with rHuPH20 2000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study; or 16 mg/kg IV daratumumab once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The co-primary endpoints of the study are overall response rate and Maximum trough concentration of daratumumab (Ctrough; defined as the serum pre-dose concentration of daratumumab on Cycle 3 Day 1).

About the PLEIADES (MMY2040) study
The Phase II trial (NCT03412565) is a non-randomized, open-label, parallel assignment study that includes 265 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma are being treated with 1,800 mg SC daratumumab in combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan and prednisone (D-VMP). Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg SC daratumumab plus lenalidomide and dexamethasone (D-Rd). An additional cohort of patients with relapsed and refractory multiple myeloma treated with daratumumab plus carfilzomib and dexamethasone (D-Kd) was subsequently added to the study. The primary endpoint for the D-VMP, D-Kd and D-Rd cohorts is overall response rate. The primary endpoint for the D-VRd cohort is very good partial response or better rate.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; 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.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; 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 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 therapy2. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma; 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 for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. 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).1,2,3,4,5,6

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 refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

IMV ANNOUNCES PROPOSED $22.3 MILLION PRIVATE PLACEMENT

On April 30, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company, reported its intention to complete a private placement (the "Private Placement") of 7,797,203 units of the Company (each, a "Unit") at the market price of Cdn$2.86 per Unit based on the volume-weighted average price calculated over the 5 days ending Friday, April 24, 2020 (Press release, IMV, APR 30, 2020, View Source [SID1234556830]).

With aggregate gross proceeds of approximately Cdn$22.3 million this non-brokered private placement is being co-led by Fonds de Solidarité FTQ, an existing investor, and Lumira Ventures, a new investor in the Company, along with participation by Altium Capital, also a new investor in IMV and including other institutional investors. The Company intends to use the net proceeds from the Private Placement for the clinical development of its lead candidate, DPX-Survivac, currently being assessed in advanced ovarian cancer, as well as in multiple clinical studies in combination with Merck’s Keytruda. The balance of the net proceeds will be used for general corporate purposes, including funding research and development, preclinical and clinical expenses, and corporate costs.

Each Unit will consist of one common share of the Company ("Common Share") and 0.35 of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant will have an exercise price of Cdn$3.72 and will be exercisable until 24 months after its issuance.

The Company anticipates that the Private Placement will close on or about May 7, 2020. The Private Placement is conditional upon the Company receiving the conditional approval of the Toronto Stock Exchange (the "TSX") to list the Common Shares underlying the Units and the Warrants on the TSX. Listing will be subject to satisfying all of the requirements of the TSX. The Private Placement is also subject to the requirements of the NASDAQ Stock Market ("NASDAQ").

All securities issued pursuant to the Private Placement will be subject to a four month and one day hold period in Canada in accordance with applicable securities laws.

Notable and MDS Foundation Announce Partnership to Collaborate on Clinical MDS Trials and Advance Drug Therapies for MDS Patients

On April 30, 2020 Notable, which is redefining cancer treatment with its scientific technology platform to rapidly advance drug development, reported a partnership with the MDS Foundation (Press release, Notable Labs, APR 30, 2020, View Source [SID1234556829]). MDS Foundation (MDSF) provides insight and information to families on upcoming clinical trials for myelodysplastic syndrome (MDS).

As part of the partnership, Notable is providing a grant to support MDSF’s critical education and advocacy efforts on behalf of MDS patients and their support network. Notable and MDSF will work closely together to engage physicians, biopharmaceutical companies, health authorities, and clinical trial organizations to collaborate on novel clinical trial designs. The goal of this effort is to match patients to effective drug therapies, and get those therapies approved faster for the benefit of all MDS patients.

The MDS Foundation is a non-profit organization dedicated to providing an ongoing exchange of information about MDS with patients and families. For clinical trials, the organization acts as an important conduit providing information, and translating technical jargon and medical terms and procedures for patients to better understand what each trial is about and what their participation will involve.

This partnership marks the MDS Foundation’s first time working with a scientific technology platform like Notable.
"Notable has breakthrough technology for accelerating drug development and precision medicine, matching patients with effective therapies," said Tracey Iraca, Executive Director of the MDS Foundation. "We are excited to work closely with Notable to continue to learn more about what its platform will mean for MDS research and help translate important information about MDS developments and trials to our community."

About the Collaboration
Educational patient-facing information highlighting key details about the trials in easy to understand descriptions will be communicated in various formats including social media, email, print, video and on the MDS Foundation’s website.

Furthermore, the MDS Foundation will also help connect the Notable team with MDS research through its Centers of Excellence network on available clinical trials, new research and treatment options.

"The MDS Foundation is paramount for communicating and educating the MDS community about groundbreaking research and treatments in this field," said Laurie Heilmann, CEO of Notable. "The combination of our scientific technology platform and the MDS Foundation’s charter will help advance functional precision medicine while educating patients and families about the latest clinical trials available."

Notable’s automated technology platform is built to help predict patient responses to cancer treatment therapies. As a precision oncology company, Notable matches patients with effective therapies and accelerates the drug development process for novel therapeutics. The company is developing the testing capability that will help physicians make better-informed decisions about which treatments and clinical trials might be most beneficial for their patients. A feasibility study conducted at the Stanford University School of Medicine demonstrated that Notable achieved an 84 percent overall accuracy rate in retrospectively predicting patient therapeutic responses. The most recent data from this collaboration was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December of 2019.

Magenta Therapeutics to Host Business Update Conference Call

On April 30, 2020 Magenta Therapeutics (NASDAQ:MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune reset to more patients, reported it will host a conference call on Thursday, May 7, 2020 at 8:00am ET to discuss recent business updates (Press release, Magenta Therapeutics, APR 30, 2020, View Source [SID1234556825]). The call will also feature a discussion of current stem cell transplant practices by a transplant key opinion leader.

To access the call, please reference the dial-in details below. A playback of the call will be available on the Magenta Therapeutics website at View Source for 90 days following the call.

Conference ID number: 9594495
U.S./CANADA: (866) 688-5232; (409) 217-8328
UK (London): 08000288438
Switzerland: 0225803283
Australia: 1800005989

Genocea Provides First Quarter 2020 Corporate Update

On April 30, 2020 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported its operating and financial results for the first quarter ended March 31, 2020 (Press release, Genocea Biosciences, APR 30, 2020, View Source [SID1234556824]).

Genocea remains on track with its two differentiated clinical stage programs – GEN-009 (neoantigen vaccine) and GEN-011 (neoantigen cell therapy). The GEN-009 phase 1/2a clinical trial has reached sufficient enrollment for Part B of the study, which evaluates GEN-009 in combination with standard-of-care ICI therapy. The company anticipates preliminary clinical results in Q3 2020. Genocea also intends to file an Investigational New Drug Application (IND) for GEN-011 later this quarter with preliminary clinical results expected in 1H 2021.

Genocea will host a GEN-011 virtual symposium on May 12th at 12 p.m. EDT with Eric Tran, PhD, who generated transformational data showing the potential of TIL therapy as a National Cancer Institute (NCI) fellow. Dr. Tran will provide a brief overview of the current T cell therapy landscape – including the evolution of adoptive cell therapy and the need for new approaches to improve patient outcomes. Genocea will provide an in-depth profile of GEN-011 – a potential best-in-class adoptive T cell therapy -targeting an unprecedented breadth of relevant neoantigens, avoiding unwanted expansion of deleterious T cells and employing peripheral blood in a rapidly scalable manufacturing process to treat large cancer patient populations.

"Over the last quarter, we have conducted our GEN-009 clinical program and prepared GEN-011 for IND filing as planned," said Chip Clark, President and Chief Executive Officer, Genocea. "We remain focused on the opportunity to create life-changing medicines for cancer patients during these uncertain and challenging times."

First Quarter 2020 Financial Results
•
Cash position: As of March 31, 2020, cash and cash equivalents were $26.5 million versus $40.1 million as of December 31, 2019.
•
Research and Development (R&D) expenses: R&D expenses were $10.0 million for the quarter ended March 31, 2020, compared to $6.5 million for the same period in 2019.
•
General and Administrative (G&A) expenses: G&A expenses were $3.4 million for the quarter ended March 31, 2020, compared to $3.0 million for the same period in 2019.
•
Net loss: Net loss was $12.9 million for the quarter ended March 31, 2020, compared to $15.6 million for the same period in 2019.

Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations into the first quarter of 2021.

Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. EDT. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 4855738. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.