On June 16, 2021 ImmunoGenesis, a clinical-stage biotechnology company developing therapeutics to catalyze effective immune responses in immunologically cold cancers, reported the publication in Clinical Cancer Research of results from a Phase 1 trial of evofosfamide, the only known reducer of solid tumor hypoxia, combined with an immune checkpoint inhibitor, ipilimumab, in patients with advanced cancer (Press release, ImmunoGenesis, JUN 16, 2021, View Source [SID1234584081]). The journal article, "A Phase 1 Dose Escalation Study to Evaluate the Safety and Tolerability of Evofosfamide in Combination with Ipilimumab in Advanced Solid Malignancies," highlights an overall response rate of 17% and a disease control rate of 83% across four dose levels in 21 heavily pre-treated patients. In addition, a clear biomarker picture emerged with pre-existing immune gene signatures correlating with response to therapy and hypermetabolic signatures predicting progression. Responders also showed improved cellular signatures of anti-tumor immunity.

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!

"A hostile tumor metabolism is a major source of immune resistance in certain tumors," said James Barlow, ImmunoGenesis President and CEO. "Evofosfamide, with the demonstrated ability to reduce tumor hypoxia, can be a critical component of facilitating immunotherapy efficacy in these tumors. With these compelling results in hand, we look forward to advancing our development pipeline."

"Along with others in the field, I had identified tumor hypoxia as a barrier to effective tumor immunity in certain tumors," said Michael Curran, PhD, founder of ImmunoGenesis. "These exciting Phase 1 data support preclinical observations in which evofosfamide reversed tumor hypoxia and facilitated the efficacy of checkpoint inhibition. The efficacy of the combination in these heavily pre-treated patients appears superior to checkpoint monotherapy and provides strong rationale for the use of evofosfamide as a tumor conditioning agent."

The study was led at The University of Texas MD Anderson Cancer Center by Curran, Associate Professor of Immunology and David S. Hong, M.D., Professor of Investigational Cancer Therapeutics. Dr. Curran has a personal financial relationship with ImmunoGenesis, which is managed and monitored by the MD Anderson Conflict of Interest Committee.

About the Phase 1 Study
The Phase 1 (NCT03098160), dose-escalation study tested evofosfamide in combination with ipilimumab administered in four three-week cycles in heavily pre-treated patients with castration-resistant prostate cancer, advanced pancreatic cancer, immunotherapy-resistant melanoma, and advanced HPV-negative head and neck cancer. The combination regimen was well-tolerated, with most drug–related-adverse events being grade 1–2. There were no unexpected safety signals.

About Evofosfamide
Evofosfamide is a 2-nitroimidazole prodrug of the cytotoxin bromo-isophosphoramide mustard (Br-IPM) originally developed as a hypoxia-activated prodrug. Through his research, Dr. Curran discovered that evofosfamide can reduce hypoxia in solid tumors. In pre-clinical models, evofosfamide restored T cell function and synergized with checkpoint inhibition. ImmunoGenesis is developing evofosfamide as a hypoxia-reversal agent that can condition tumors to respond to checkpoint inhibition.

On June 16, 2021 Harbour BioMed (HKEX: 02142) reported that it has entered into a multi-year, multifaceted research collaboration agreement with Dana-Farber Cancer Institute to co-develop novel biotherapies in cancer treatment(Press release, Harbour BioMed, JUN 16, 2021, View Source [SID1234584080]).

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!

Harbour BioMed scientists and Dana-Farber researchers will be working together to develop novel oncologic drugs, including bispecific antibodies and CAR-T cell products. In recent years, bispecific antibodies and CAR-T cell therapies are both considered as the next-generation solutions in the tumor immunology field. For their ability to engage two different targets, bispecific antibodies are expected to extend the possibilities of monoclonal antibody (mAb) therapeutics, and CAR-T cell therapy is an innovative immunotherapy that uses specially altered T-cells to redirect them to target cancer cells.

This strategic collaboration will leverage Harbour BioMed’s transgenic Harbour Mice platform with Dana-Farber’s expertise in CAR-T cell development and basic oncology research to generate novel biotherapies.

Harbour BioMed’s antibody technology platforms – Harbour Mice, which is based on two proprietary transgenic mouse platforms will be utilized to generate human therapeutic antibodies. The platforms have broad potential for generating both conventional as well as next-generation biologics, such as bi- and multi-specifics, CAR-Ts or VH domain-derived products that are fully human, affinity matured with excellent solubility and developability.

"We are delighted to initiate this collaboration with Harbour BioMed. The complementary technology and expertise between Harbour and DFCI will dramatically shorten the interval from novel discovery to developing optimized antibody and cellular therapies for clinical translation," said Dr. Eric Smith, Laboratory Principal Investigator & Director of Translational Research for Immune Effector Cell Therapies at Dana-Farber Cancer Institute.

"The collaboration with world renowned Dana-Farber Cancer Institute demonstrates HBM’s commitment to developing novel medicines and fostering fast-track innovative research. I believe this collaboration will be ultimately translated into better treatments for cancer patients," said Jingsong Wang, Founder, Chairman & Chief Executive Officer of HBM.

On June 16, 2021 Marker Therapeutics, a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that its Chief Financial Officer, Anthony H. Kim, will present at the upcoming virtual Raymond James Human Health Innovation Conference on Monday, June 21, 2021 at 9:20 a.m. ET (Press release, Marker Therapeutics, JUN 16, 2021, View Source [SID1234584079]).

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!

A live webcast of the presentation will be accessible from the Investors section of the company’s website at markertherapeutics.com and will be available for replay following the event.

On June 16, 2021 A1 Medical Imaging’s Chief Operating Officer, Marilyn Radakovic, applauded recent research that indicates magnetic resonance imaging (MRI) is effective in detecting interval breast cancers in women with a prior history of the disease (Press release, A1 Medical Imaging, JUN 16, 2021, View Source [SID1234584078]).

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!

The research that was published June 8, 2021, in the Radiology journal concluded that breast MRI has been shown to improve the early detection of recurrent breast cancers that may be missed by mammography.

The study took place between January 2008 and March 2019 and involved 2,809 women with a median age of 47 years who had undergone surgery because of breast cancer. In all, 6,603 MRI examinations were conducted.

"According to the report, the purpose of the research was to evaluate the screening of breast MRI in women with a personal history of breast cancer who might be at more risk for what’s known as interval breast cancers or IBC," Radakovic stated. "IBC is the cancer detected after a normal screening mammogram, but before the next scheduled mammogram."

Mammograms are low-dose X-rays of the breast. Regular mammograms are recommended to find breast cancer early, when treatment is most successful. However, mammograms may not be the best option for women who are at high risk.

A breast MRI is a noninvasive technology that uses strong magnets instead of radiation to make very detailed, cross-sectional pictures of the breast. It is much more sensitive than mammography and can find invasive breast cancers sooner than mammograms. It can also rule out abnormalities that appear suspicious on a mammogram.

Peter Solodko, A1 Medical Imaging’s Chief Executive Officer, commented, "This research indicates that breast MRIs can detect early stages of cancer better than mammography in women with a past history of breast cancer."

Radakovic added, "This research confirms the effectiveness of breast MRIs and provides encouraging hope for women who are at high risk of recurring cancer."

A1 Medical Imaging has open MRI centers throughout Florida and in Georgia and provides breast MRI screenings at its Aventura, Pembroke Pines, Plantation and Orange Park locations in Florida. Visit www.A1mri.com to learn more.

On June 16, 2021 The Pancreatic Cancer Action Network (PanCAN), a leading pancreatic cancer advocacy organization, reported that the latest update to its novel clinical trial platform, Precision PromiseSM, with the addition of a new treatment arm by biopharmaceutical company, FibroGen, Inc(Press release, PanCAN, JUN 16, 2021, View Source [SID1234584077]).

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!

Pancreatic cancer is currently the third leading cause of cancer-related death in the U.S., with an overall five-year survival rate of just 10 percent. Roughly 63 percent of patients die within the first year of a pancreatic cancer diagnosis, underscoring the urgent need for new and more effective treatment options.

The new experimental treatment arm tests FibroGen’s pamrevlumab in combination with standard of care chemotherapy treatments for pancreatic cancer, Gemcitabine and Abraxane. The combination therapy is offered to patients with metastatic pancreatic cancer as either a first- or second-line treatment option, marking the first experimental treatment arm to be offered as a first-line treatment in PanCAN’s innovative Precision Promise trial. With this addition, a newly diagnosed patient enrolling in Precision Promise has the opportunity to be randomized onto an experimental therapy as their first-line treatment, and then onto another experimental therapy as their second-line treatment if they maintain eligibility when the first treatment becomes no longer effective.

"By partnering with FibroGen to bring a first-line experimental treatment arm into Precision Promise, we are expanding options for the patients enrolling in this trial," said Anne-Marie Duliege, MD, PanCAN’s Chief Medical Officer. "It is one of PanCAN’s major objectives to continue to bring innovative, experimental drugs like FibroGen’s pamrevlumab into this study in order to accelerate drug development and hopefully bring new therapies to market faster. Pancreatic cancer patients can’t afford to wait."

FibroGen’s pamrevlumab is a first-in-class antibody that inhibits the activity of connective tissue growth factor (CTGF), which, in cancer, is characterized by promotion of tumor growth. Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC).

"We are inspired by the mission of the Pancreatic Cancer Action Network and are excited to partner with them," said Mark Eisner, M.D, M.P.H, Chief Medical Officer, FibroGen. "We share PanCAN’s goal of accelerating the development of new treatment options for pancreatic cancer patients."

PanCAN’s Precision Promise aims to revolutionize the clinical development paradigm in pancreatic cancer by enabling a faster, more efficient, and patient-centric approach to developing new treatment options and improving outcomes for pancreatic cancer patients.The novel clinical trial platform requires fewer patients to understand if a potential new therapy is working and can accelerate late stage development by up to two years. The statistical design of Precision Promise was led by renowned statistician Dr. Donald Berry (Berry Consulting), designer of the I-SPY breast cancer trials.

Precision Promise is currently open and enrolling at 15 Clinical Trial Consortium sites nationwide and PanCAN expects to add five additional sites in early 2022. In selecting the additional sites, PanCAN has set strict criteria to identify not only institutions with strong pancreatic cancer programs, but also institutions that represent new geographic areas and serve a diverse patient population in order to expand access for typically underserved communities.

To learn more about Precision Promise and PanCAN’s commitment to research, visit pancan.org. Pancreatic cancer patients and caregivers can receive personalized support and resources, and more information about Precision Promise, through PanCAN’s Patient Services or by calling 877-2-PANCAN.