On June 28, 2022 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immuno-modulatory antibodies for cancer immunotherapy, reported a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ., USA, to evaluate the oncolytic virus BT-001 in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a Phase I/IIa clinical trial for the treatment of patients with solid tumors (Press release, Transgene, JUN 28, 2022, View Source [SID1234616332]).

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Under the terms of the supply agreement, MSD will provide pembrolizumab to be used in combination with BT-001 in the ongoing Phase I/IIa clinical trial.

"By combining BT-001 with the anti-PD-1 drug KEYTRUDA we expect to optimize the patient’s immune response to induce a strong and effective anti-tumor response. This agreement will allow us to move further on the clinical development of our promising co-developed oncolytic candidate BT-001" said Hedi Ben Brahim, CEO of Transgene.

"We are very pleased to be signing another collaboration with MSD, supporting the expansion of the clinical trial program of BT-001, the oncolytic virus expressing our proprietary anti-CTLA-4 antibody, jointly developed by Transgene and BioInvent. It marks a further validation of our expanding and promising clinical pipeline of anti-cancer treatments, which currently encompasses three compounds in four ongoing clinical trials" added Martin Welschof, CEO of BioInvent.

Recruitment in the clinical study (NCT04725331) is ongoing. The trial is a Phase I/IIa of BT-001, which is being co-developed as part of a 50/50 collaboration between Transgene and BioInvent, as a single agent and in combination with KEYTRUDA for the treatment of solid tumors.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About the trial

The ongoing Phase I/IIa (NCT04725331) study is a multicenter, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment). Patient inclusions are ongoing in Europe (France, Belgium) and the trial has been authorized in the US.

This Phase I is divided into two parts. In part A, patients with metastatic/advanced tumors receive single agent, intra-tumoral administrations of BT-001. Part B will explore the combination of intra-tumoral injections of BT-001 with pembrolizumab. The Phase IIa will evaluate the combination regimen in several patient cohorts with different tumor types. These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.

About BT-001

BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. As a consequence, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA-4 antibody will be greatly improved.

BT-001 is being co-developed as part of a 50/50 collaboration on oncolytic viruses between Transgene and BioInvent. To know more on BT-001, watch our video here.

On June 28, 2022 The Swiss National Science Foundation reported that it is supporting two University of Zurich projects with CHF 2.5 million each (Press release, University of Zurich, JUN 28, 2022, View Source [SID1234616331]). Sebastian Jessberger is investigating the aging process in the brain, while Nicola Serra is on the trail of a sensational development in particle physics . The SNSF grants plug the hole left by the loss of funding from the EU Horizon program, until Swiss universities can participate again.

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Two researchers from the University of Zurich are awarded an Advanced Grant from the Swiss National Science Foundation. (Image: Manfred Richter)

Switzerland is still not associated with the EU’s Horizon Europe funding program. The Swiss National Science Foundation (SNSF) has introduced the SNSF Advanced Grants as a transitional solution. The SNSF grants were awarded according to similarly strict criteria and distinguish excellent scientists who have been conducting successful research for several years. The chance of receiving an SNSF Advanced Grant at all is about the same as for ERC grants. Two researchers from the University of Zurich have now received funding of around CHF 2.5 million each over five years.

Increasing age is a significant risk factor for a variety of brain diseases, such as Alzheimer’s. The team led by Sebastian Jessberger, a professor at the Brain Research Institute, is using imaging and newly developed genetic and molecular biological methods to study aging processes in the brain. The focus is on the stem cells as well as the surrounding cells in the hippocampus, a brain region that plays an important role in certain learning and memory processes, among other things. "What changes in brain cells as they biologically age? Why do some cells age faster than others? We want to find answers to these questions," says Jessberger.

The brain researchers are developing novel sensors to directly visualize the aging state of individual cells. "Our goal is to lay the groundwork so that in the future the aging process in the brain can be slowed down."

Nicola Serra wants to get to the bottom of a potentially sensational development in physics: recent measurements from the Large Hadron Collider beauty (LHCb) experiment at CERN have shown a series of discrepancies with respect to the predictions of the standard model of particle physics, known as flavor anomalies. "If any of these anomalies are confirmed, this would imply the existence of a new fundamental force – in addition to gravity, electromagnetic, weak and strong force. This would amount to a revolution in the field of particle physics," enthuses the professor of physics.

Serra and his research group therefore want to play devil’s advocate by examining whether flavor anomalies in the LHCb could be caused by a combination of statistical fluctuation, underestimated theory uncertainties and detector effects. The research project proposes a paradigm shift in terms of rethinking experimental measurements as constraints in a large system of equations whose variables are physics and detector parameters. "This will hopefully allow us to determine if these anomalies are really due to a new force or not, and pave the way for future discoveries," adds Serra.

On June 28, 2022 Panbela Therapeutics, Inc.- (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported the publication of preclinical data from studies of SBP-101 that demonstrated a 42% increase in median survival in a mouse model of VDID8+ ovarian cancer (Press release, Panbela Therapeutics, JUN 28, 2022, View Source [SID1234616330]). Data published in the International Journal of Molecular Sciences also showed SBP-101 delayed tumor progression and decreased the overall tumor burden. SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The company expects to initiate an ovarian cancer clinical program for SBP-101 during 2022.

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"This data highlights the importance of polyamines as a cancer therapeutic. These preclinical studies are foundational to the expansion of our clinical development program. We look to expand SBP-101 into ovarian cancer, and later the potential for other cancers. This compliments our current clinical development program with SBP-101’s ongoing global randomized trial (ASPIRE) in first-line metastatic pancreatic cancer, and eflornithine in combination with an anti PD-1 into non-small cell lung cancer (NSCLC) to begin later this year," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "We look forward to advancing our development program for SBP-101 and eflornithine into the clinic for ovarian cancer and NSCLC indications to help as many patients as possible."

About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.

SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months which is final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal (GI) tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose powder sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment is well tolerated and has potential activity.

On June 28, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that the pancreatic cancer cohort of the multi-indication phase 1/2 GOBLET study has met the efficacy expansion criteria for Stage 1 of the trial. The data from the phase 1b portion of this cohort, which are featured in an abstract accepted for a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer 2022, show a strong efficacy signal as evidenced by all patients achieving a partial response (n = 3) (Press release, Oncolytics Biotech, JUN 28, 2022, View Source [SID1234616329]). An independent safety review noted no toxicity concerns in these patients. The trial’s metastatic colorectal and advanced anal cancer cohorts are proceeding as planned.

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The GOBLET study’s pancreatic cancer cohort is evaluating the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel. Per the study’s Simon two-stage design, any cohort meeting a pre-specified efficacy threshold in Stage 1 (defined as achieving a minimum number of objective radiologic responses by week 16) may be expanded to enroll additional patients in an optional Stage 2 study expansion. In addition to evaluating the safety and efficacy of pelareorep-atezolizumab combinations, the study seeks to assess the potential of CEACAM6 and T cell clonality to serve as predictive biomarkers that may increase the probability of success in subsequent trials by informing patient selection. The study is being conducted at 14 clinical sites in Germany and is being managed by AIO, a leading academic cooperative medical oncology group.

"With Stage 1’s pre-specified efficacy threshold met after just the first three patients, the GOBLET trial’s pancreatic cancer cohort is clearly exceeding expectations," said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "Novel therapeutic approaches are urgently needed in pancreatic cancer, as standard-of-care chemotherapy has a limited response rate, and less than 2% of patients are eligible for treatment with checkpoint inhibitors. Prior data in pancreatic cancer patients demonstrated pelareorep’s ability to remodel the tumor microenvironment to be less immunosuppressive. These latest results indicate that pelareorep’s immunotherapeutic effects may enhance the efficacy of checkpoint inhibitors in pancreatic cancer and increase tumor response rates. This promising finding suggests that pelareorep has the potential to dramatically improve the current therapeutic approach in an indication that is amongst the most difficult to treat."

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "Though early, these data provide a strong and exciting signal of efficacy for the studied combination. Looking forward, we will continue to follow this cohort closely to see if its initial positive results are substantiated as additional patients are evaluated and the data mature. If this impressive signal persists, it may enable us to pursue regulatory paths in pancreatic cancer that include subsequent trials designed to facilitate an expedited approval. We intend to engage regulators to gain insights on pelareorep’s optimal path forward in pancreatic cancer later this year and believe this program has the potential to provide a significant source of value that will complement our core efforts in breast cancer."

Additional details related to the upcoming poster and corresponding abstract, entitled, GOBLET: A phase 1/2 multiple indication signal finding and biomarker study in advanced gastrointestinal cancers treated with pelareorep and atezolizumab – safety and preliminary response results, are shown below.

Congress Location: Centre de Convencions Internacional de Barcelona (Barcelona, Spain)

The poster’s corresponding abstract is currently available for viewing on the congress website (LINK). A copy of the poster will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the congress.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients (n=12);

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Gastrointestinal Cancer
Excluding skin cancers, colorectal cancer is the third most common cancer, with estimates indicating that 106,180 new cases of colon cancer and 44,850 new cases of rectal cancer will be diagnosed in the U.S. in 20221. Also, for the 2022 year, the American Cancer Society estimates there will be 62,210 new cases of pancreatic cancer2 and 9,440 new cases of anal cancer3 in the U.S.

On June 28, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported that it is enhancing its central laboratory presence and drug development capabilities in Japan through an expansion of CB Trial Laboratory, the central laboratory co-managed by Labcorp Drug Development and BML, a leading Japanese provider of clinical laboratory testing services (Press release, LabCorp, JUN 28, 2022, View Source [SID1234616327]).

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Extending their strategic relationship that dates back more than a decade, Labcorp Drug Development and BML will begin work on a new laboratory facility in the city of Kawagoe, Saitama, expanding capacity and services for pharmaceutical and biotechnology clients. This will bolster Labcorp Drug Development’s central laboratory services offerings in Japan and sets the stage for a continued acceleration of companion diagnostic capabilities.

"Labcorp Drug Development remains committed to growing its Japanese operations and services through continued expansion and partnerships," said Honggang Bi, senior vice president and head of Asia-Pacific for Labcorp Drug Development. "Broadening our work with BML and increasing our laboratory footprint means we will be able to offer shorter turnaround times, superior in-country sample management and full lab testing services for global clinical trials in Japan. This will benefit patients, clients and health care providers by providing them with the information needed to make key decisions."

The new facility will be located near BML’s General Laboratory in Kawagoe where the current CB Trial Laboratory is located, providing over 4,000 square meters of dedicated space for global clinical trials managed by Labcorp Drug Development. The new space will be greater than five times the size of the current facility, with additional capabilities such as genomics, microbiology and companion diagnostics in addition to expanded offerings in current lab capabilities including flow cytometry, immunology, and anatomical pathology and histology. Completion of the expanded laboratory is expected by early 2025.

Through the planned laboratory expansion, Labcorp will advance biomarker and esoteric testing services, expand its companion diagnostics portfolio and deepen the integration with its clinical development services. In addition, the company will be able to intensify its focus on cell and gene therapy research and development, part of a broader commitment to precision medicine and fortifying the company’s position as an oncology leader.

"In collaborating with Labcorp, we are able to offer our pharmaceutical and biotechnology clients access to both comprehensive clinical laboratory testing and drug development opportunities," said Dr. Kensuke Kondo, president of BML. "The laboratory expansion provides additional capabilities and capacity and opens the door to enriched services, more resources and better outcomes for our clients and patients."

Labcorp and BML have successfully provided central laboratory services for global clinical trials in Japan since 2010 through kit production, sample logistics and laboratory operations at CB Trial Laboratory. Their partnership agreement was renewed in 2020.