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 Pepscan, the all-in-one peptide service provider, reported that it will supply personalized peptide pools for six patients in a phase I trial led by Mayo Clinic principal investigator Yanyan Lou, M.D., Ph.D., in collaboration with Keith L. Knutson, Ph.D (Press release, Pepscan Therapeutics, JUN 28, 2022, View Source [SID1234616347]). The trial tests the safety and tolerability of an experimental personalized peptide vaccine when given in combination with pembrolizumab in treating patients with a wide range of advanced solid tumors and tumors that have spread to other places in the body (metastases). The vaccine is designed to target certain proteins (neoantigens) on individuals’ tumor cells. Combination immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer and thereby interfere with the ability of the tumor cells to grow and spread.

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"Mayo Clinic is recognized as one of the best hospital groups in the US and we are excited to provide the peptide pools for their investigational phase I study. Supplying top researchers and clinicians worldwide to turn their ideas into better treatment outcomes for patients is what we aim for at Pepscan." says Hans de Backer, CEO of Pepscan.

The primary objective of the study "Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors" is to evaluate the safety, side effects, optimal dosages and risks/benefits of a personalized neoantigen peptide vaccine in combination with pembrolizumab in advanced solid cancers. Pepscan will manufacture up to 20 unique peptides and combine them into peptide pools, making up the active pharmaceutical ingredient (API) of the vaccine. All within only 5 weeks to shipment (under quarantine). Besides the manufacturing, Pepscan also supported Mayo Clinic with the CMC (chemistry, manufacturing and control) report, which was submitted as part of Mayo’s Investigational New Drug (IND) Application and has been approved by the FDA. Manufacturing personalized peptides for neoantigen vaccines requires a very specific set of process development and manufacturing skills, facilities and analytical methods. With 25 years of experience in mastering peptides and flexible manufacturing capabilities, Pepscan reliably delivers individual or pooled peptide sets that fit its customers’ timelines.

On June 28, 2022 Hokkaido University (Location: Sapporo, Hokkaido, Japan) and NEC Corporation (NEC; TSE: 6701) reported that they have concluded a collaborative agreement to promote the realization of a "safe and secure society through spatial sensing" (*1) that helps to prevent the spread of illness (Press release, NEC, JUN 28, 2022, View Source [SID1234616292]).

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In recent years, COVID-19 has had a devastating impact on people’s lives and economic activities throughout the world. Moreover, in the future, it is possible that additional pandemics may occur due to known viruses or currently unknown viruses. In response, Hokkaido University and NEC aim to offer virus visualization services based on spatial sensing technologies developed through collaborative research, and to link these with measures for business continuity planning (BCP) in the event of a pandemic.

Background on the agreement
Hokkaido University is a multi-disciplinary education and research organization that includes undergraduate, graduate, research laboratories and university hospitals. The university supports interdisciplinary research, such as collaborative research that spans multiple departments and facilities across one of the largest university campuses in Japan.

NEC proposes digital transformation (DX) that can contribute to solving social issues with cutting-edge digital technologies, such as world-class biometric identification technologies and proprietary AI technologies, in addition to the industry and operational know-how that it has cultivated over many years.

To date, Hokkaido University and NEC have been conducting collaborative research (*2) on the detection of viruses with biosensors (*3) using aptamers (*4) and collaborative research on virus aerosol collection methods (*5). Based on these initiatives, Hokkaido University and NEC aim to further contribute to society by expanding this collaborative research.

Collaboration details

(1)Establishment of technologies for detection of viruses in the air through collaborative research currently underway
(2)Verification of spatial sensing services through implementation of virus detection technology on campus and networking of spatial information
(3)New co-creation of spatial sensing that makes use of technologies possessed by both parties
(4)Expansion beyond campus as part of contributing to society
Future initiatives
Through ongoing collaborative research, Hokkaido University and NEC will establish technologies for the detection of known viruses and efficient aerosol collection, aiming to conduct demonstration tests and implement these technologies on campus by fiscal 2023. Going forward, Hokkaido University and NEC seek to ensure safe, secure, and comfortable conditions by providing spatial sensing services that combine virus detection information with other spatial information to students and other campus visitors.

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 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that selection of a potential first-in-class Pol Theta Helicase development candidate (DC) (Press release, Ideaya Biosciences, JUN 28, 2022, View Source [SID1234616348]).

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The Pol Theta Helicase DC is a potential first-in-class small molecule inhibitor of the helicase domain of DNA Polymerase Theta. IDEAYA is collaborating with GSK on IND-enabling studies to support the evaluation of the Pol Theta Helicase DC in combination with niraparib, GSK’s PARP inhibitor, for patients having tumors with BRCA or other homologous recombination (HR) mutations or homologous recombination deficiency (HRD).

"We are excited about potential clinical development opportunities for this potential first-in-class Pol Theta Helicase inhibitor. Pol Theta promotes DNA repair by Microhomology-Mediated End-Joining (MMEJ), an error-prone mutagenic DNA repair pathway, which is active in BRCA mutant and other HRD cancer cells. PARP1 is also involved in MMEJ DNA repair, supporting a hypothesis for synergistic combination of our Pol Theta Helicase DC with niraparib," said Michael White, Senior Vice President and Chief Scientific Officer of IDEAYA Biosciences.

"The development candidate has demonstrated robust in vivo efficacy in combination with niraparib, with significant tumor regressions and durable responses in multiple cancer models. We believe the Pol Theta helicase and niraparib combination has the opportunity to deliver meaningful patient benefit," said Benjamin Schwartz, Ph.D., Vice President, Head of Oncology Synthetic Lethality Research Unit at GSK.

IDEAYA and GSK are targeting an IND submission for the Pol Theta Helicase DC, subject to satisfactory completion of ongoing preclinical and IND-enabling studies, to enable first-in-human studies in the first half of 2023.

IDEAYA and GSK are collaborating on the ongoing IND-enabling studies, and GSK will lead clinical development for the Pol Theta program. GSK holds a global, exclusive license to develop and commercialize the Pol Theta Helicase DC and is responsible for all research and development costs for the program, including those incurred by IDEAYA. IDEAYA is eligible to receive future development and regulatory milestones of up to $485 million aggregate, inclusive of preclinical and clinical milestones of up to $10 million aggregate for advancing this asset through IND effectiveness.

Upon potential commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones and tiered royalties on global net sales by GSK, its affiliates and their sublicensees ranging from high single digit to sub-teen double digit percentages, subject to certain customary reductions.