Synaffix Announces Expansion of Mersana License Deal to a Total Potential Value Exceeding $1 Billion

On November 30, 2021 Synaffix B.V., a biotechnology company focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported the expansion of its license agreement with Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need (Press release, Synaffix, NOV 30, 2021, View Source [SID1234596265]).

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!

Under the expanded license agreement, Mersana will expand its access to Synaffix’s GlycoConnect site-specific ADC bioconjugation technology for six additional ADC targets. The license rights granted to Mersana are tied to specific ADC targets to be selected and provide non-exclusive access to deploy GlycoConnect site-specific ADC bioconjugation technology against the specified targets. Under the expanded deal, Synaffix is eligible to receive upfront and milestone payments on a per-target basis with a total potential deal value exceeding $1 billion plus royalties. This builds on the long-term relationship between the two companies announced in 2019.

Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics, said:

"Our collaboration with Synaffix and use of the GlycoConnect site-specific ADC bioconjugation technology has yielded highly innovative ADC products with superior characteristics. Based on the data that we generated to date across multiple programs, we have gained the confidence to significantly expand our collaboration with Synaffix and elect GlycoConnect as our preferred site-specific ADC bioconjugation technology."

Peter van de Sande, Chief Executive Officer of Synaffix, said:

"We are delighted to expand our collaboration with Mersana, a leader in ADC innovation, who will be utilizing our GlycoConnect platform to build out their pipeline with innovative ADC cancer therapeutics. We are honored to see the confidence that Mersana has placed in our platform, demonstrating once again the added value GlycoConnect can bring to innovative ADCs."

Mersana will continue to be responsible for the research, development, manufacturing and commercialization of any resulting ADC products.

This licensing agreement expansion follows three recent ADC technology out-licensing agreements with Kyowa Kirin, a global specialty pharmaceutical company; ProfoundBio, an emerging oncology biotherapeutics company; and Innovent Biologics, a leading biopharmaceutical company developing innovative medicines for the treatment of major diseases. Other collaborators include ADC Therapeutics and Shanghai Miracogen. Twelve ADCs using Synaffix’s technology are currently in development of which three are in clinical development.

Merck Announces First-Quarter 2022 Dividend

On November 30, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company’s common stock for the first quarter of 2022 (Press release, Merck & Co, NOV 30, 2021, View Source [SID1234596264]). Payment will be made on Jan. 7, 2022 to shareholders of record at the close of business on Dec. 15, 2021.

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!


ITI Announces Open Enrollment for RENEW Clinical Study for the Treatment of Newly-Diagnosed Glioblastoma Patients

On November 30, 2021 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy, reported the opening of a new clinical study in collaboration with Dr. Duane Mitchell at the University of Florida (Press release, Immunomic Therapeutics, NOV 30, 2021, View Source [SID1234596263]). RENEW (NCT04963413) is designed to evaluate the ability to generate pp65 Lysosomal Associated Mediated Protein (LAMP) RNA-pulsed dendritic cells in patients who have completed standard external beam radiation and concomitant temozolomide and who are receiving adjuvant temozolomide chemotherapy at the time of enrollment.

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!

This is an extension of the Phase 2 ATTAC-II study (NCT02465268) where eligibility is limited to those patients who have had surgery but have not yet received chemoradiation. The RENEW pilot study will enroll adult patients with newly diagnosed WHO Grade IV glioma (GBM) who have completed standard of care surgery and chemoradiation and who are currently receiving adjuvant temozolomide chemotherapy.

"The RENEW pilot study’s expansion of the eligibility criteria allow a number of untreated patients with GBM to participate in a clinical study that includes our novel dendritic cell vaccine," said Dr. Bill Hearl, Chief Executive Officer at Immunomic Therapeutics, Inc. "We look forward to continued evaluation of ITI’s platform in both the ongoing ATTAC-II and the RENEW studies in an effort to address this clear and pressing unmet medical need."

ITI is developing several dendritic cell vaccines for the treatment of cancer, including ITI-1000 for glioblastoma multiforme (GBM), with key opinion leaders in cancer immunotherapy for brain tumors, John Sampson, M.D., Ph.D. from Duke University and Duane Mitchell, M.D., Ph.D. from the University of Florida. ITI’s dendritic cell vaccine is designed to target the pp65 viral antigen of Cytomegalovirus (CMV) that is expressed in GBM, but not in normal brain cells. In the ATTAC studies, the GBM patients’ white blood cells are removed, matured into dendritic cells (DCs), and modified to generate a vaccine to the pp65 viral protein when fused to the Lysosomal Associated Membrane Protein 1 (LAMP1) protein for antigen presentation. This dendritic cell vaccine is then returned to the patient. As observed in the ATTAC studies (ATTAC-GM: NCT00693639), ITI believes this approach may harness the body’s immune system to recognize, attack and destroy tumor cells that express CMV in GBM and potentially other cancers.

About Glioblastoma (GBM)

According to the American Association of Neurological Surgeons, GBM is an aggressive brain cancer that often results in death within 15 months of diagnosis. GBM develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. GBM is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that GBM represents about 15% of all primary brain tumors and approximately 10,000 cases of GBM are diagnosed each year in the U.S.

About ITI-1000 and the Phase 2 (ATTAC-II) Study

ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase II clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was developed using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized, placebo-controlled clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 improves survival. This study is enrolling up to 120 subjects at three clinical sites in the United States. For more information on the ATTAC-II study, please visit (NCT02465268).

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1 (LAMP1), an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

HUYABIO International Receives Regulatory Approval for Hiyasta® Monotherapy of Peripheral T-Cell Lymphoma in Japan

On November 30, 2021 HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations, reported the regulatory approval of HBI-8000, brand name Hiyasta, monotherapy for the treatment of relapsed or refractory (R/R) PTCL by the Ministry of Health, Labour and Welfare in Japan (Press release, HUYA Bioscience, NOV 30, 2021, View Source [SID1234596262]).

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!

"Relapsed and/or refractory PTCL carries a grim prognosis with limited treatment options. Data from the registration study of HBI-8000 has demonstrated clinically meaningful responses despite the advanced stage of disease and acceptable safety profile to address an important unmet medical need in this patient population", said Dr. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of HBI-8000 Phase 2 study.

The application of the supplemental indication for R/R PTCL is based on data from a Phase 2b study of 55 patients with aggressive PTCL in Japan and Korea. These patients all had advanced disease, refractory or relapsed relative to prior therapies. HBI-8000 40mg orally administered twice weekly resulted in a 46% Objective Response Rate, median Progression-Free Survival of 5.6 months and a median Overall Survival of 22.8 months.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This second regulatory approval for our lead oncology drug, Hiyasta, in Japan expands our drugs’ indications for patients with severe hematologic malignancies. We are looking forward to additional future indications for Hiyasta that will benefit even more patients."

About Hiyasta

HBI-8000 is an epigenetic immunomodulator with several approved indications including monotherapy for two subtypes of Non-Hodgkin’s Lymphoma in Japan and in combination therapy for metastatic breast cancer in China. This oral agent targets class I histone deacetylases causing cell cycle arrest and tumor cell death as the mechanism underlying its single agent activity against lymphoma. The drug also has demonstrated immunomodulatory impact and is being tested in a global pivotal trial in melanoma combined with the checkpoint inhibitor nivolumab.

Celleron Therapeutics Deploys a Digital Pathology Biomarker Platform in Pivotal Colorectal Cancer Clinical Study

On November 30, 2021 Celleron Therapeutics, the UK-based company developing novel medicines for cancer patients, reported the adoption of a precision medicine biomarker platform in its registrational immune combination therapy study in colorectal cancer patients (Press release, Celleron, NOV 30, 2021, View Source [SID1234596260]).

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!

CAROSELL Clinical Study Programme

Celleron Therapeutics have completed a Phase II clinical study testing the effect of CXD101 in combination with the immune checkpoint inhibitor (ICI) nivolumab in microsatellite stable colorectal cancer (MSS CRC), which typically does not respond to ICI agents alone (the CAROSELL Study). The therapeutic strategy rests on compelling pre-clinical results which provide novel insights into how CXD101 and ICI drugs work together to re-engage recognition of tumours by the immune system, colloquially, to turn ‘cold’ tumours ‘hot’.

The study enrolled 55 previously treated patients from five UK academic centres and demonstrated significant disease control and objective response rates. In addition, the combination therapy was very well tolerated.

This promising data merits further investigation in a large-scale, group comparator, randomised study. As a next step, Celleron Therapeutics has designed a Phase III adaptive study. This will incorporate a composite tumour microenvironment biomarker, which integrates computerised digital analysis of the percentage of stromal cells and T-lymphocytes. As an exploratory endpoint, the clinical study will test whether the artificial intelligence-led digital pathology platform can be used as a basis for enriching patients that respond to CXD101 in combination with ICIs to MSS CRC patients.

Professor David Kerr, Co-founder and Chief Medical Officer of Celleron Therapeutics, commented: "The inclusion of this digital pathology biomarker platform in our CAROSELL 2 clinical study design is exciting and a superb example of how Celleron Therapeutics can deploy its precision medicine platforms to potentially improve and enhance the lives of patients suffering from colorectal cancer. It is our hope that that our biomarker platform can also be validated in other tumour types moving forward."

About Colorectal Cancer

Colorectal cancer is the second most common tumour type in women, and the third most common in men. The approximate 5-year survival rate for colorectal cancer patients with advanced (metastatic) disease is 10% in the United States.

Surgery is indicated for localised disease, whilst chemotherapy (eg 5-fluorouracil, capecitabine, oxaliplatin, irinotecan) has been the standard management for patients with metastatic colorectal cancer. Two agents have been approved for third-line management of advanced colorectal cancer, namely regorafenib (Stivarga) and Trifluridine-tipiracil hydrochloride (Lonsurf), but for both, the response rates are low, and toxicity high.

A subset (5%) of colorectal cancers is characterized with deficient DNA mismatch repair. These tumours tend to have a high expression of checkpoint proteins (PD-1 and PD-L1), which interfere with the body’s normal anti-tumour T-cell response. By disabling these proteins, checkpoint inhibitors such as nivolumab allow the immune system to function properly, and T-cells to kill tumour cells.

However, for the greater majority of patients with a normal Mismatch Repair proficient expression, the microsatellite phenotype is stable (MSS), antigen presentation is believed to be much decreased, and the tumour is thus resistant to checkpoint inhibition. Most MSS patients will ultimately relapse or become resistant to chemotherapy. Thus there remains a very significant unmet clinical need to find novel agents, singly and/or in combination, for the treatment of these late-stage patients.