On February 17, 2021 Pfizer Inc. (NYSE:PFE) reported that the first participant has been dosed in the registration-enabling Phase 2 MagnetisMM-3 study (NCT04649359) of elranatamab (PF-06863135), an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody, in patients with relapsed/refractory multiple myeloma (Press release, Pfizer, FEB 17, 2021, View Source [SID1234575209]). The study evaluates the efficacy and safety of elranatamab, administered subcutaneously, in patients with disease that is refractory to at least one agent in each of three major classes of medications approved for multiple myeloma. The study’s estimated primary completion date is June 2022.

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Elranatamab has also been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). Fast Track is a process designed to facilitate the development, and expedite the review, of new drugs and vaccines that are intended to treat or prevent serious conditions that have the potential to address an unmet medical need.1

"The initiation of MagnetisMM-3, our pivotal trial, is an important step in our robust and accelerated development program for elranatamab," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "Bispecific antibodies hold promise as the next potential breakthrough in the treatment of multiple myeloma. We are highly encouraged by early data with subcutaneous elranatamab, which was discovered and developed at Pfizer and designed to enhance safety and convenience."

At the Virtual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2020, Pfizer presented encouraging data from an ongoing Phase 1 trial of elranatamab (MagnetisMM-1) demonstrating manageable safety and high response rates in patients with relapsed/refractory multiple myeloma including three patients whose disease relapsed on or progressed after prior BCMA-targeted therapies. At the highest dose level, which informed the dose selected for the Phase 2 study, 83% of patients achieved a clinical response. Safety was manageable across all subcutaneous dose levels with no dose-limiting toxicities observed.

Bispecific antibodies are a novel type of cancer immunotherapy that bind to and engage two different targets at once. One arm binds directly to specific antigens on cancer cells and the other activates and brings a person’s own T-cells from the immune system closer to kill the cancer cells.

Elranatamab is a bispecific antibody designed to bind to BCMA which is highly expressed on the surface of multiple myeloma cells, and the CD3 receptor found on the surface of cancer-fighting T-cells, bridging them together to activate an immune response. Binding affinity to BCMA and CD3 has been optimized, to potentially elicit more potent T-cell-mediated anti-myeloma activity. Subcutaneous administration of elranatamab is intended to allow higher doses than intravenous administration without increasing adverse events. In addition to MagnetisMM-3, other trials of elranatamab in multiple myeloma are planned both as monotherapy and in combination with standard or novel therapies.

"Second and later relapses are unfortunately all too common in multiple myeloma and can be devastating to patients as remissions tend to be shorter and the disease may be more aggressive,2" said Alexander M. Lesokhin, M.D., lead investigator and hematologic oncologist at Memorial Sloan Kettering Cancer Center. "Targeting BCMA is a promising area of innovation in multiple myeloma."

"Living with multiple myeloma can often be a roller coaster, of both hope and disappointment. It can be so up and down and nerve wracking as it’s often the case that a new treatment gets started, only to end in another relapse," said Susie Novis Durie, Founder & President of the International Myeloma Foundation. "Continued research to develop new treatments with novel mechanisms of action is essential to improve outcomes for these patients."

About the MagnetisMM-3 Phase 2 Trial

MagnetisMM-3 is an open-label, multicenter, nonrandomized Phase 2 study of elranatamab monotherapy enrolling approximately 150 people with multiple myeloma who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody. This study will enroll two cohorts of participants: one with (n=90) and one without (n=60) prior treatment with a BCMA-directed ADC or CAR-T therapy (n=60). Participants will receive a weekly 76 mg subcutaneous injection of elranatamab following a priming dose of 44 mg. The primary endpoint is objective response rate as assessed by blinded independent central review. Key secondary endpoints include: duration of response, progression-free survival, minimal residual disease negativity rate, overall survival and safety. For more information about the trial, visit www.clinicaltrials.gov.

About Multiple Myeloma

Multiple myeloma is a blood cancer that affects plasma cells made in the bone marrow. Healthy plasma cells make antibodies that help the body fight infection. According to the latest figures available, there are approximately 32,270 new cases of multiple myeloma diagnosed annually in the U.S and 176,000 globally.3,4 Despite treatment advances, multiple myeloma remains incurable. The median survival is just over 5 years, and most patients receive four or more lines of therapy.5

About Pfizer Oncology

At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.

On February 17, 2021 Ultimovacs ASA ("Ultimovacs", ticker ULTI), a pharmaceutical company developing novel immunotherapies against cancer, reported its fourth quarter 2021 results today (Press release, Ultimovacs, FEB 17, 2021, View Source [SID1234575208]). A presentation by the company’s management team will take place today on a webcast at 09:00 CET.

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The presentation can be followed as a live webcast, which will also be available on our corporate website.

Highlights for the fourth quarter of 2020:

Ultimovacs provided details about the DOVACC trial in January 2021. Ultimovacs will participate in this randomized Phase II collaboration study, together with the Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU), the European Network of Gynaecological Oncological Trial Groups (ENGOT) and AstraZeneca, to evaluate Ultimovacs’ proprietary universal cancer vaccine, UV1, in combination with AstraZeneca’s durvalumab and olaparib in patients with relapsed ovarian cancer. The trial will include 184 patients in approximately 10 European countries at more than 40 sites. (Announced post balance sheet date)
In December 2020, Ultimovacs announced the FOCUS study, a Phase II randomized clinical trial that will evaluate Ultimovacs’ proprietary universal cancer vaccine, UV1, in 75 patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy pembrolizumab. The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle, Germany.
In the INITIUM trial, 24 patients have been enrolled as per the reporting date as compared to twelve patients reported in the previous quarterly report. INITIUM is a randomized, multi-center Phase II trial evaluating UV1 in combination with ipilimumab and nivolumab as first-line treatment for patients with metastatic malignant melanoma.
In the NIPU trial, 18 patients have been enrolled as per the reporting date compared to six patients reported in the previous quarterly report. NIPU is a randomized, multi-center Phase II trial in which UV1 is being investigated in combination with ipilimumab and nivolumab as a second-line treatment in mesothelioma.
The Company is actively monitoring the COVID-19 pandemic regarding patient enrollment in its Phase II clinical trials and continues to implement activities to minimize the impact. The longer-term effect of the pandemic on the biotech industry and the general ability to conduct clinical trials is still uncertain.
Ultimovacs reported five-year overall survival data from the Phase I trial evaluating UV1 in combination with the checkpoint inhibitor, ipilimumab, in patients with metastatic malignant melanoma in December 2020. The results confirmed achievement of the primary endpoints of safety and tolerability and indicated encouraging initial signals of long-term survival benefit. At five years, the Overall Survival (OS) rate was 50% and median Progression-Free Survival (mPFS) was 6.7 months.
The Company also announced five-year overall survival data from the Phase I trial evaluating UV1 as maintenance therapy in patients with non-small cell lung cancer in October 2020. The results confirmed achievement of the primary endpoints of safety and tolerability and indicated encouraging initial signals of long-term survival benefit. At five years of follow-up, the OS rate was 33% and mPFS was 10.7 months. (Also reported in the Q3 2020 report)
Ton Berkien joined Ultimovacs’ management team as Chief Business Officer in December 2020. At Ultimovacs he will lead all business and corporate development efforts and maintain and foster connections with leading biotechnology and pharmaceutical companies.
In November 2020, a paper was published in "Frontiers in Immunology" outlining the positive long-term follow-up data from the Company’s Phase I trial evaluating UV1 in non-small cell lung cancer.
Ultimovacs has secured public grants totaling MNOK 26 to support the execution of the DOVACC and FOCUS trials. Innovation Norway has granted Ultimovacs MNOK 10 to support the Phase II DOVACC study, and the FOCUS Phase II trial is supported through an innovation grant of up to MNOK 16 from the Norwegian Research Council.
Total operating expenses amounted to MNOK 25.6 in Q4-20 and MNOK 124.1 in FY20.
Cash flow from operations was MNOK -13.1 in Q4-20. Total cash and cash equivalents were reduced by MNOK 12.5 during Q4-20, amounting to MNOK 440.9 as per 31 December 2020.
The report and presentation are also available on the company website: www.ultimovacs.com/investors/reports-and-presentations

On February 17, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it has enrolled the final patient in the recurrent arm of its ongoing Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson) (Press release, Kintara Therapeutics, FEB 17, 2021, View Source [SID1234575207]). The recurrent arm of the study addresses patients suffering from glioblastoma multiforme (GBM) who have been pre-treated with temozolomide (TMZ) prior to disease recurrence. The trial was designed to enroll up to 83 patients (35 patients at 40 mg/m2/day and 48 patients at 30mg/m2/day) to determine whether treatment with VAL-083 improves overall survival.

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"Given the urgent need for improved treatment options for this deadly disease, we are pleased to have reached the very important milestone of full enrollment in the recurrent arm of this Phase 2 clinical study," commented Saiid Zarrabian, Kintara’s Chief Executive Officer. "We would like to thank our patients, their families, and MD Anderson for their participation and continued support for this arm of the trial and of course, for our adjuvant study arm as well. Moving forward, we anticipate reporting topline results from the recurrent arm in the second quarter of calendar 2021."

The Phase 2 trial is an open-label, two-arm, biomarker-driven study testing VAL-083 in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. Efficacy is being measured based on overall survival and progression-free survival. In addition to the recurrent arm, there is a second trial arm that is enrolling up to 36 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ, and who are receiving VAL-083 in place of standard of care TMZ for adjuvant therapy. In November 2020, the Company provided a clinical update on both arms of the study. For the recurrent arm, median overall survival (mOS) for the 77 efficacy evaluable patients who completed at least one cycle of treatment was 7.6 months (confidence interval: CI 6.4-10.6 months). Additionally, for the 43 efficacy evaluable patients initially receiving the 30 mg/m2/day dose that is being evaluated in the Global Coalition for Adaptive Research (GCAR) GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) registrational study, mOS was 8.5 months (CI 6.8-13.7 months). In the adjuvant therapy arm of the study, median progression-free survival (PFS) was 10.0 months (CI 7.6-10.8). Consistent with prior studies, myelosuppression was the most common adverse event with VAL-083 in both the recurrent GBM and adjuvant treatment setting. In the 30 mg/m2/day starting dose cohort (the planned dose for the GBM AGILE pivotal study) three subjects experienced a serious adverse event (SAE) possibly related to VAL-083 in the recurrent group and one patient experienced a possibly drug-related SAE in the adjuvant group.

VAL-083 is a "first-in-class," small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

On February 17, 2021 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported that Gerald McMahon, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the SVB Leerink 10th Annual Global Healthcare Conference (Press release, Harpoon Therapeutics, FEB 17, 2021, View Source [SID1234575206]). The discussion will take place on Wednesday, February 24, 2021 at 4:20 p.m. ET (1:20 p.m. PT).

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A live audio webcast of the fireside chat will be available in the Investors section of Harpoon Therapeutics’ website at www.harpoontx.com with an archived replay available following the event.

On February 17, 2021 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported that Michel Detheux, PhD, President and Chief Executive Officer, will host a fireside chat at the virtual 10th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 24, 2021 at 3:00 p.m. ET (Press release, iTeos Therapeutics, FEB 17, 2021, View Source [SID1234575205]).

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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

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A live webcast of the presentation will be available on the Investors section of the company’s website at View Source An archived replay will be available for approximately 30 days following the presentation.