On November 15, 2022 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized immunotherapies, reported the first patient has been dosed in a randomized Phase 2 clinical trial evaluating NOUS-209 in combination with anti-PD1 checkpoint inhibitor (CPI) pembrolizumab versus pembrolizumab alone (Press release, NousCom, NOV 15, 2022, View Source [SID1234624092]). NOUS-209 is an off-the-shelf immunotherapy targeting 209 specific neoantigens for the treatment of Mismatch Repair/Microsatellite Instable High (dMMR/MSI-H) unresectable or metastatic gastric, colorectal and gastro-esophageal junction tumors.

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!

Nouscom is assessing the efficacy and safety of NOUS-209 in combination with pembrolizumab at multiple sites across Europe and the US (NCT04041310). The Phase 2 study will include two cohorts in dMMR/MSI-H unresectable and metastatic colorectal cancer (CRC):

A randomized cohort enrolling patients who are eligible for first line treatment of NOUS-209 plus pembrolizumab versus pembrolizumab alone;
A single arm cohort enrolling patients who have stopped responding to previous anti-PD1 and other approved therapies
Dr Michael J. Overman, Principal Investigator of the trial and Professor in the Department of GastroIntestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, said: "The continued clinical development of NOUS-209 is critical as there remains a significant unmet need in the treatment of CRC, including overcoming tumor resistance to anti-PD1 immunotherapies. Data from the Phase 1 study presented at ASCO (Free ASCO Whitepaper) 20221 and published in Science Translational Medicine2 demonstrated how NOUS-209 induces neoantigen specific CD8+ T cells which infiltrate metastatic tumors and exert anti-tumor efficacy, providing hope for better treatment options for this patient population with difficult to treat cancers."

Dr Marina Udier, Chief Executive Officer of Nouscom, added: "The initiation of the Phase 2 study is another significant milestone this year for our company. Building on our published safety, immunogenicity and mechanism of action clinical data, the trial, together with the Phase 1 ‘cancer interception’ monotherapy study in Lynch Syndrome carriers, will allow us to demonstrate the efficacy of NOUS-209 and illustrate the power of our platform. We look forward to presenting interim results at key conferences during 2023."

References

ASCO Presentation: First clinical and immunogenicity results including all subjects enrolled in a phase I study of NOUS-209, an off-the-shelf immunotherapy, with pembrolizumab, for the treatment of tumors with a deficiency in mismatch repair/microsatellite instability (dMMR), Professor Marwan G. Fakih, M.D.
A.M. D’Alise et al. Adenoviral Based-Vaccine Promotes Neoantigen Specific CD8+ T Cell Stemness And Tumor Rejection, Science Translational Medicine; 14, 657, 2022
About NOUS-209

NOUS-209 is an off-the-shelf cancer immunotherapy for Microsatellite Instable High (MSI-H) tumors. MSI-H tumors are characterized by a defective DNA mismatch repair system, which generates highly immunogenic neoantigens called frame shift peptides (FSP) that are not present in healthy tissue.

NOUS-209 encodes for 209 shared FSP neoantigens, selected by Nouscom’s proprietary GENESIS (GE(netic)NE(oantigen)S(election)I(n)S(ilico)) algorithm. In published prospective validation studies, approximately 50 of the 209 neoantigens are expressed in any one patient’s tumor. These FSPs are cloned into Nouscom’s heterologous prime / boost viral vector platform of a Great Ape Adenoviral (GAd) and Modified Vaccinia Ankara (MVA) and potently generate FSP neoantigen specific CD8+ T cells, which have been shown to successfully infiltrate tumor microenvironments to exert anti-tumor activity.

NOUS-209 is being investigated in multi-center EU and US Phase 2 randomized clinical trials in patients with dMMR/MSI-H unresectable and metastatic colorectal cancer (CRC) (NCT04041310) in combination with checkpoint inhibitors (CPI) versus CPI alone and in patients who have stopped responding to previous anti-PD1 and other approved CPI therapies.

On November 15, 2022 AskGene reported that the pre-clinical results of ASKG315 (IL-15 prodrug) and ASKG915 (PD-1/IL-15 prodrug) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting in Boston on November 8 – 12, 2022. For ASKG315 phase I clinical study design was also presented (Press release, AskGene Pharmaceuticals, NOV 15, 2022, View Source [SID1234624091]). The two posters were:

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!

#1101, Chunxiao Yu et al., ASKG315 – An IL-15 Prodrug with Antibody-like PK, Enhanced Safety and Expanded Therapeutic Window
#1183, Kurt Shanebeck et al., ASKG915 – An Anti-PD-1 Antibody-IL-15 Prodrug Fusion Molecule with Enhanced Therapeutic Potential
About ASKG315

ASKG315 is the first prodrug molecule derived from the SmartKine platform, which is AskGene’s proprietary cytokine prodrug technology platform. It is projected to be the world’s first IL-15 prodrug to enter clinical development. Preclinical data of ASKG315 showed that this molecule can selectively activate NK cells and CD8+ cells. Compared to previous generations of cytokine drugs, the prodrug design effectively improved the safety window, significantly extended the half-life, and reduced toxicity. ASKG315 has been approved for clinical trials in Australia and China, and phase I trials will be initiated in both countries in the near future.

About ASKG915

ASKG915 is projected to be the world’s first PD-1 antibody-IL-15 prodrug fusion molecule to enter clinical development. The molecule can achieve tumor targeting through PD-1 and be locally activated at the tumor site. At the same time, the molecule can achieve high dosage, so the PD-1 antibody has full PD-1 blockage functionality. Preclinical data showed that ASKG915 has extended PK, significantly better efficacy than PD-1 antibody monotherapy, and expanded therapeutic window. ASKG915 is expected to benefit more patients than existing PD-1 antibody monotherapies. IND applications for ASKG915 will be submitted in US and China in the fourth quarter of 2022. Phase I clinical trials are expected in 2023.

On November 15, 2022 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported financial results for the third quarter ended September 30, 2022 and provided a business update (Press release, BerGenBio, NOV 15, 2022, View Source [SID1234624090]).

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 recent initiation of two clinical trials and bolstering of our cash position has been transformational for the Company as we continue to execute on our strategy," said Martin Olin, Chief Executive Officer of BerGenBio. "Mounting evidence substantiates that AXL plays a significant role in exacerbating many severe cancers and respiratory diseases. We believe that AXL inhibition by our lead compound, bemcentinib, can make a life-changing difference in patients suffering from STK11m NSCLC and hospitalized COVID-19.

Clinical Development

Bemcentinib

BerGenBio’s lead compound, bemcentinib, is a potentially first-in-class highly selective inhibitor of the receptor tyrosine kinase AXL, which is activated in response to oxidative stress, inflammation, hypoxia and drug treatment, resulting in a number of deleterious effects in cancer and severe respiratory diseases. Bemcentinib inhibits AXL activation to prevent the progression of serious disease through the modulation of resistance mechanisms and the adaptive immune system.

The Company is advancing bemcentinib development in two lung indications, STK11 mutated (STK11m) Non-Small Cell Lung Cancer (NSCLC) and Hospitalized COVID-19 patients, where bemcentinib’s novel mechanisms of action and primary accumulation in the lungs make it uniquely positioned to address severe lung diseases.

First-Line STK11m NSCLC

Subsequent to the quarter end, BerGenBio announced in October the initiation of a Phase 1b/2a trial evaluating bemcentinib in combination with the current standard of care, the checkpoint inhibitor pembrolizumab and platinum doublet chemotherapy, for the treatment of 1L NSCLC patients harboring STK11 mutations.

Approximately 20% of non-squamous NSCLC patients harbor STK11m, which are a recognized resistance mechanism for anti-PD-1/L1 therapy and currently result in a poor prognosis with standard of care treatment in 1st line NSCLC. The Company believes that STK11m patients almost universally express AXL, causing a severely immunosuppressed tumor microenvironment, the development of drug resistance, immune evasion, and metastasis. Preclinical and clinical data suggest that bemcentinib’s inhibition of AXL on immune and cancer cells sensitizes STK11m NSCLC patients to checkpoint inhibitors and improves the effects of chemotherapy.

The global, open-label Phase 1b/2a trial is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care in 1st line untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no other actionable co-mutations. The first patient is expected to begin treatment in the fourth quarter of 2022.

Hospitalized COVID-19 Patients

BerGenBio announced in September that the first patient was randomized in a Phase 2b trial evaluating bemcentinib in hospitalized COVID-19 patients. The trial is part of the EU-SolidAct platform, a pan-European research project designed to investigate treatment options for hospitalized patients with COVID-19 and emerging infectious diseases.

Higher levels of AXL expression and activation caused by COVID-19 infection have been linked to an increase in disease severity. The interaction of AXL and SARS-CoV-2 is believed to promote the entry and enhancement of infection in pulmonary and bronchial epithelial cells. Through the inhibition of AXL, bemcentinib blocks viral entry, stimulates the innate immune system and promotes lung tissue repair.

The Phase 2b, multi-center, randomized, placebo-controlled trial will enroll up to 500 patients, includes 68 clinical sites in 8 countries and is sponsored by Oslo University Hospital, Norway, in collaboration with the Institut National de la Santé Et de la Recherche Médicale (Inserm), France, and the not-for-profit intergovernmental organization European Clinical Research Infrastructure Network (ECRIN).

Update on Relapsed/Recurrent AML (BGBC003) and 2L NSCLC (BGBC008) studies

In study BGBC003 of Relapsed/Recurrent AML patients, the last patient completed their last visit in late Q2, with database lock completed in Q3. In study BGBC008 of 2L NSCLC patients, the last patient’s last visit occurred in Q4 2022. The Company expects to provide results of these studies following database lock and subsequent data analysis in H1 of 2023.

Corporate Activities

Following the end of the third quarter, BerGenBio announced in October that it secured a NOK 100 million shareholder loan facility from Meteva AS, a 27.23% shareholder in BerGenBio. In addition to the Company’s existing cash position, the facility will enable BerGenBio to continue advancing its lead compound, bemcentinib, in 1L STK11m NSCLC and hospitalized COVID-19 patients.

Third Quarter 2022 Financial Highlights

(Figures in brackets = same period 2021 unless otherwise stated)

Revenue amounted to NOK 0.0 million (NOK 0.0 million) for the third quarter 2022
Total operating expenses for the third quarter were NOK 62.4 million (NOK 71.4 million)
The operating loss for the third quarter came to NOK 62.4 million (NOK 71.4 million)
Cash and cash equivalents amounted to NOK 225.1 million (NOK 292.1 million at the end of the second quarter 2022).
Presentation and Webcast Details

The live webcast link is available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.

The third quarter report and presentation are available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.

On November 15, 2022 ImmunityBio Presented the corporate Presentation (Presentation, ImmunityBio, NOV 15, 2022, View Source [SID1234624089])

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!

On November 15, 2022 QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next-generation therapeutic radiopharmaceuticals, including Samarium-153-DOTMP (CycloSam), for the treatment of bone cancer and related diseases, reported financial results for the third quarter ended September 30, 2022, as filed with the SEC on November 14, 2022 in the Company’s Form 10-Q, and provides a corporate update (Press release, QSAM Biosciences, NOV 15, 2022, View Source [SID1234624088]).

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!

Recent Corporate Highlights:

●Second patient dosed in Phase 1 clinical trial; data continues to demonstrate preliminary positive results. Completion of the initial cohort grouping of patients is expected in the fourth calendar quarter.
●Rutgers Cancer Institute of New Jersey (RCINJ) has been added as a clinical trial site to begin enrolling patients; expected to help accelerate pace of study and add key expertise.
●Approximately $1 million was raised in a common stock / warrant private placement during third quarter.

"Initial, preliminary data from our second patient dosed with CycloSam continues to show positive signals in terms of safety and efficacy. While it is too early for formal conclusions to be made of these results, CycloSam generally performed how we expected it to perform, even given the lowest dosage in our dose-escalating study. This is all very encouraging," stated Douglas R. Baum, CEO and co-founder of the Company.

"We expect the pace of our clinical trials to accelerate in the fourth quarter of 2022 and into 2023. This is partly due to the onboarding as a trial site the highly-regarded Rutgers Cancer Institute of New Jersey, which is a National Cancer Institute (NCI) – designated Comprehensive Cancer Center that treats a significant population of patients who could potentially qualify for our study. We have also been able to raise equity funding on favorable terms from supportive investors who share our long-term vision for QSAM. Our team continues to work towards creating shareholder value in conjunction with our most important mission to help adult and pediatric patients suffering from bone cancer," added Baum.

Summary Financial Results for the Quarter Ended September 30, 2022:

(All numbers except shares are approximated)

For the three months ended September 30, 2022, we recorded a net loss of $1.23 million, an increase of $0.18 million from our net loss of $1.05 million for the same period in 2021. Our operating expenses were $1.21 million for the third quarter of 2022 as compared to $1.20 million in the 2021 period. The slight increase in operating expenses was largely due to an increase in compensation and related expenses of $0.23 million, an increase in research and development expenses of $0.08 million, and an increase in general and administrative expenses of $0.07 million, offset by a decrease in professional fees of $0.36 million in the three months ended September 30, 2022.

Net loss attributable to common stockholders for the third quarter of 2022 was $1.28 million as compared to $1.92 million for the 2021 period. The net loss attributed to common stockholders includes Series A and Series B preferred contractual dividends and deemed dividends. The net loss attributable to common stockholders, basic and diluted, for the three months ended September 30, 2022 was a loss of $0.75 per share as compared to a loss of $2.45 per share for the 2021 period.

As of September 30, 2022, we had cash on hand of $899,290, primarily from the closing of the first tranche of a common stock and warrant private placement.

As of November 10, 2022, the Company had 1,922,142 common shares outstanding, which includes the issuance of 205,556 shares in the quarter in connection with a private placement and 30,000 shares for a services contract. At the end of the second quarter of 2022 there were approximately 705,419 shares of common stock that could be issued upon the conversion of preferred stock, warrants and convertible debt, excluding employee stock options.

The following tables summarize our results of operations for the periods indicated, and are qualified in their entirety by the Company’s Form 10-Q for the period ended September 30, 2022, filed with the SEC on November 14, 2022, including the financial footnotes contained therein: