On October 26, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported the presentation of one-year tumor and renal function outcomes data from its Phase 3 ROMAN trial of avasopasem manganese 90 mg for radiotherapy-induced severe oral mucositis (SOM), as well as topline results from a recently completed meta-analysis of the ROMAN and GT-201 SOM trial results, at the 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting (Press release, Galera Therapeutics, OCT 26, 2022, View Source [SID1234622391]). Final data from its Phase 2 AESOP trial of avasopasem for radiotherapy-induced esophagitis were also presented today in a separate session. In addition, poster presentations during ASTRO highlighted the completed Phase 2 EUSOM trial of avasopasem for SOM in Europe and the ongoing GRECO-1 trial of rucosopasem for non-small cell lung cancer. The presentations and posters are currently available in the ASTRO digital program.

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Highlights from the Phase 3 ROMAN data presented at ASTRO:

After one-year follow-up, patients with locally advanced head and neck cancer treated with avasopasem in combination with the standard-of-care regimen (intensity-modulated radiation therapy (IMRT) + cisplatin) demonstrated comparable tumor outcomes and overall survival to patients in the placebo arm.
Patients treated with avasopasem in combination with IMRT + cisplatin had a 10 percent incidence of chronic kidney disease (CKD) after one year of post treatment follow-up, compared to 20 percent of patients in the placebo arm (p=0.0043). CKD (eGFR <60) is a known toxicity risk with cisplatin for these patients and the results highlight success on a predefined exploratory endpoint of renal function. The prospective exploration of this potential benefit of avasopasem was driven by published preclinical data and a post hoc assessment of patients from the GT-201 trial presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
"The ROMAN one-year follow-up data show that avasopasem can protect head and neck cancer patients from severe oral mucositis without affecting the treatment benefit of standard-of-care chemoradiotherapy," said Dr. Carryn Anderson, Clinical Associate Professor of Radiation Oncology at the University of Iowa. "Treatment with avasopasem also significantly reduced the likelihood of patients developing cisplatin-related chronic kidney disease compared to placebo at one-year follow-up, suggesting avasopasem can reduce cisplatin renal toxicities and greatly improve patient quality of life."

In addition to the ROMAN long-term endpoints, a meta-analysis of Galera’s two randomized placebo-controlled trials (ROMAN and GT-201; n=551) was included in Dr. Anderson’s ASTRO presentation; these results reinforced that avasopasem therapy resulted in clinically meaningful reductions in radiotherapy-induced SOM, including a significant reduction in the incidence, duration, onset and severity of SOM compared to placebo.

"The data presented today affirm our belief that avasopasem is providing real benefit for patients with head and neck cancer undergoing the current standard of care," said Mel Sorensen, M.D., Galera’s President and CEO. "We look forward to submitting the NDA to the FDA by the end of 2022 with the intention of bringing avasopasem to patients as the first FDA-approved drug for radiotherapy-induced SOM."

About Severe Oral Mucositis (SOM)

Approximately 42,000 patients with head and neck cancer undergo standard-of-care radiotherapy every year in the U.S. and are at risk of experiencing SOM. In patients with head and neck cancer, radiotherapy is a mainstay of treatment. Approximately 70 percent of patients receiving radiotherapy for head and neck cancer develop SOM, defined by the inability to eat solid food or drink liquids. The impact on patients who develop SOM is substantial, particularly when hospitalization and/or surgical placement of PEG tubes to maintain nutrition and hydration are required. SOM can adversely affect cancer treatment outcomes by causing interruptions in radiotherapy, which may compromise the otherwise good prognosis for tumor control in many of these patients. There is currently no drug approved to prevent or treat SOM for these patients.

About Avasopasem

Avasopasem manganese (avasopasem, or GC4419) is a selective small molecule dismutase mimetic in development for the reduction of radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) and for the reduction of radiotherapy-induced esophagitis in patients with lung cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy.

On October 26, 2022 Targovax ASA (OSE: TRVX) reported that it will announce its third quarter 2022 results on Thursday 3 November 2022 (Press release, Targovax, OCT 26, 2022, View Source [SID1234622390]). Targovax’s management will present the results at a live streamed webcast at 10:00 am CET to investors, analysts and the press.

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The results report and the presentation will be available at www.targovax.com in the Investors section from 07:00 am CET, on 3 November 2022.

Presentation
There will be a virtual presentation of the results with a live webcast 3 November at 10.00 am CET. You can join the webcast here. It will be possible to ask questions during the presentation

On October 26, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that it is supporting a Phase 2 investigator initiated study (ISS) of trilaciclib and lurbinectedin in patients with extensive stage small cell lung cancer (ES-SCLC) (Press release, G1 Therapeutics, OCT 26, 2022, View Source [SID1234622389]). An ISS is a study that is proposed, developed, and conducted by a qualified sponsor external to G1 Therapeutics who assumes full responsibility for the conduct of the study.

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Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes.

"Pretreatment with trilaciclib may improve the therapeutic potential of lurbinectedin, another important medication for SCLC, in multiple ways," said Jared Weiss, M.D., Professor of Medicine, Division of Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina Chapel Hill, NC and principal investigator in this study. "Trilaciclib is a proven myeloprotective agent, but studies to date have only assessed it in the context of topotecan-containing and platinum/etoposide-containing chemotherapeutic regimens. Lurbinectedin is effective, but also highly myelosuppressive, which is particularly problematic given recent data that clarify the importance of maintaining adequate exposure for efficacy. The opportunity for immunological synergy with lurbinectedin – which potently suppresses myeloid derived suppressor cells (MDSCs) – is also evident given data that suggest trilaciclib’s ability to induce novel T cell clonality, improve the CD8+ T cell/Treg ratio, and increase antigen expression and presentation."

This is a prospective, non-randomized, single-arm Phase 2 study, to evaluate trilaciclib administered intravenously prior to lurbinectedin in approximately 30 subjects with platinum refractory ES-SCLC. Patients will receive trilaciclib and lurbinectedin on day one of each 21-day cycle until discontinuation or disease progression.

The primary endpoint is the rate of grade 4 neutropenia in any cycle when trilaciclib is administered prior to lurbinectedin in subjects with extensive stage small cell lung cancer (ES-SCLC). Secondary endpoints include mean duration (days) of grade 4 neutropenia in cycle 1, overall survival (OS), progression-free survival (PFS), overall rate of response (ORR), quality of life assessments, and the use of secondary/reactive supportive measures including G-CSF administration.

About Small Cell Lung Cancer
In the United States, about 29,000 cases of small cell lung cancer (SCLC) are diagnosed each year. SCLC, one of the two main types of lung cancer, accounts for about 10% to 15% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general 5-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%, and for extensive stage (cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for SCLC.

On October 26, 2022 Orionis Biosciences, a life sciences company pioneering innovation of highly selective and tunable therapeutics for cancer and beyond, reported that it will present preclinical data supporting its Allo-GlueTM protein degradation platform for discovery and rational design of small molecule molecular glues at the 5th Annual Targeted Protein Degradation Summit, taking place October 25 – 28 in Boston (Press release, Orionis Biosciences, OCT 26, 2022, View Source [SID1234622388]). The data include platform achievements for ligase-centric and target-centric discovery of molecular glue compounds with potential to modulate previously intractable disease targets.

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"Molecular glues have the potential to greatly extend the treatment of challenging diseases like cancer, and there is vast untapped power in this modality. A lack of systematic, scalable discovery and design approaches to molecular glues has, however, limited the field," said Riccardo Sabatini, Ph.D., Chief Data Scientist at Orionis. "Today we are presenting new data that demonstrate the ability of Orionis’ proprietary Allo-GlueTM platform to transform glue discovery into a genome-scale, high throughput and rational discovery paradigm. Our large-scale interrogation of small molecule-triggered protein-protein interactions makes it abundantly clear that molecular glue mechanisms are more common than previously appreciated. Clearly, this presents a large and exciting space for chemistry innovation."

The Allo-Glue platform can interrogate more than 18,000 target proteins simultaneously — virtually the entire human proteome — as well as diverse and privileged chemical libraries, at scale and in an unprecedented, unbiased manner across large number of targets and target classes, including traditionally intractable disease targets. To date, Orionis has mapped more than 150 million molecular glue interactions. This growing data set will provide the company with unique opportunities to further evolve and apply its novel numerical modelling approaches to the rational design of molecular glues.

To date, Orionis’ Allo-Glue platform has:

Identified multiple monovalent glues and targets for new ligases beyond the E3 ligase cereblon: A series of molecules have demonstrated strong and highly selective target recruitment and degradation in preclinical studies, further validating the concept that drug-induced, selective degradation of proteins is achievable with multiple types of E3 ligases and targets
Established the feasibility of target-centric approaches to glue discovery, as exemplified by discovery of drug-like molecules for traditionally intractable oncology targets
Evolved and applied computational methods and machine learning models to rational expansion and design of new molecular glues
Details of today’s presentation are as follows:

5th Annual Targeted Protein Degradation, October 25-28, 2022, Boston, Massachusetts

Title: Monovalent Molecular Glues: Cereblon and Beyond
Date and Time: Wednesday, October 26, 5:00 p.m. ET
Presenter: Riccardo Sabatini, Chief Data Scientist, Orionis Bio
Last week Orionis announced a $55 million financing to support entry of its lead cancer immunotherapy programs into the clinic. In addition to its Allo-Glue molecules, Orionis is rapidly advancing a deep pipeline of biologics for the treatment of cancer based on its A-KineTM platform, which engineers target-selective, conditionally active cytokines designed to trigger anti-tumor immune responses even in cold tumors that lack prevalent immune involvement and are refractory to checkpoint inhibitor therapies. A-Kines aim to avoid the systemic toxicities observed with traditional cytokine therapies. The company anticipates IND submission and start of a Phase 1 study of a conditionally active cytokine, driven by its proprietary A-Kine platform, in 2023.

"We are all very excited about the continued progress the company is making with its multipronged technology and therapeutic approaches to currently hard to treat cancers. Our R&D engine has the potential to address some of the biggest challenges in drug discovery, including diseases beyond cancer," said Nikolai Kley, co-founder, President and Chief Executive Officer of Orionis Biosciences.

On October 26, 2022 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that Mr. James Nathanielsz, Propanc’s Chief Executive Officer and Co-Founder, will conduct investor meetings and present at the upcoming Sidoti & Company’s upcoming Micro-Cap Virtual Investor Conference, which will be held on Wednesday and Thursday, November 9 – 10, 2022 (Press release, Propanc, OCT 26, 2022, View Source [SID1234622387]).

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Mr. Nathanielsz will deliver his corporate presentation on Wednesday, November 9, at 4:00pm, Eastern Standard Time.

The Sidoti & Company Micro-Cap Investor Conference is a virtual event featuring dynamic, micro-cap companies interacting with a number of institutional investors from across the United States. Sidoti & Company is a provider of independent securities research focused on small and micro-cap companies and the institutions that invest in their securities. Their investor conferences have emerged as a leading forum for interaction between issuers and investors in the small and micro-cap investment community.

"The demand for innovative healthcare companies by institutional investors to present at the upcoming Sidoti & Company Micro-Cap Conference led to an exciting opportunity for Propanc to present the latest developments of our lead product candidate, PRP, as we advance towards a First-In-Human study in advanced cancer patients suffering from solid tumors," said Mr. Nathanielsz. "I look forward to demonstrating how PRP treats and prevents metastatic cancer by targeting and eradicating cancer stem cells, free from side effects associated with standard treatment approaches. Furthermore, we recently announced potential future clinical applications in conjunction with our joint research partners, where PRP alters the tumor microenvironment. This means pre-treating tumors which are chemo-resistant so that they are susceptible to standard therapies once again."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.