On August 23, 2022 Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), reported that the company’s interim report for January–June 2022 is now available on the company’s website, www.isofolmedical.com (Press release, Isofol Medical, AUG 23, 2022, View Source [SID1234618562]).

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The information in the press release is intended for investors.

Second quarter, April–June 2022
Net revenue amounted to TSEK 4,027 (7,333) and other revenue to TSEK 0 (0)
The result for the period amounted to TSEK -54,033 (-45,394)
Earnings per share amounted to SEK -0.33 (-0.48)
Cash and cash equivalents at June 30 amounted to TSEK 277,727 (530,682)
First half of the year, January-June 2022
Net revenue amounted to TSEK 8,033 (12,548) and other revenue to TSEK 1 (0)
The result for the period amounted to TSEK -101,907 (-88,055)
Earnings per share amounted to SEK -0.63 (-0.99)
Significant events during the second quarter 2022
On April 22, it was announced that the analysis process of study data from the AGENT study had begun.
Jan Törnell was elected as new Chairman of the Board of the company in conjunction with the Annual General Meeting on May 19.
Significant events after the event of the period
On August 3, Isofol presented the topline results of the global pivotal AGENT study in advanced colorectal cancer. The data revealed that the study did not achieve the primary endpoint of objective response rate (ORR) or the key secondary endpoint of progression-free survival (PFS).
In July, Isofol received approval of a biomarker analysis patent.
CEO´s comment:
" It is incredibly disappointing that the results from the top-line analysis did not demonstrate the advantages we had hoped for. Final data and sub-group analyses will be decisive for the final assessment of our application options. I would like to point out that Isofol has a strong financial position, which will enable us to complete the AGENT study and analyze the final data in an efficient and reliable manner. This is very important in the situation we now find ourselves in.", says CEO Ulf Jungnelius.

Audiocast, August 23, at 12:30 p.m. CEST
In conjunction with the publication of the interim report for the second quarter of 2022, Isofol invites investors, analysts, and media to an audiocast on August 23, 2022 at 12:30 p.m. CEST. The presentation will be held by Isofol´s CEO Ulf Jungnelius and CFO Gustaf Albèrt, who will present and comment the report, followed by a Q&A-session. The presentation will be held in English.

This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CEST, on August 23, 2022.

On August 23, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that members of its senior management team are scheduled to participate in the following upcoming investor conferences (Press release, Innate Pharma, AUG 23, 2022, View Source [SID1234618561]):

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Citi’s 17th Annual BioPharma Conference
Event Date: September 7-8, 2022 (in-person event)
H.C. Wainwright 24th Annual Global Investment Conference
Event Date: September 12-14, 2022

On August 23, 2022 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported its new publication in Cancer Research Communications that compares the immunogenomic response profiles to anti-PD-(L)1 or IL-2 therapy and the development of a novel response classifier to IL-2 treatment1 (Press release, GeneCentric Therapeutics, AUG 23, 2022, View Source [SID1234618560]). Cancer Research Communications is an open access peer-reviewed journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The study was conducted as a collaboration between Atrium Health Levine Cancer Institute, Sanofi, and GeneCentric and evaluated real-world data from patients diagnosed with renal cell carcinoma (RCC) who were treated with immune-oncology agents. Results suggest that common and distinct immune-related response markers for IL-2 and anti-PD-(L)1 therapy may help guide their use, either alone or in combination.

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"It is exciting to share the initial findings from this important collaboration where we attempted to identify the immunogenomic differences between IL-2 and anti-PD-1 responders in renal cell carcinoma," said Dr. Asim Amin, medical oncologist, Atrium Health Levine Cancer Institute, and study co-principal investigator. "Using RNA expression analysis, we were able to identify key characteristics that are unique to each treatment modality, as well as those that are shared between the two. With this work we were able to develop a novel IL-2 response signature that may have prognostic potential."

A primary focus of the study was to obtain a deeper understanding of the tumor microenvironment similarities and/or differences that may lead to IL-2 or anti-PD-(L)1 therapy response. Retrospective tumor samples and corresponding clinical response data were collected from patients with a primary diagnosis of RCC who were treated with high-dose IL-2 (HD-IL-2; aldesleukin) and compared to existing data from a similar cohort of RCC patients treated with the anti-PD-1 nivolumab2. Tumor samples from HD-IL-2 treated patients underwent RNA sequencing (RNAseq) prior to immunogenomic analysis. As a result, a novel RNA-based IL-2 treatment response signature was discovered that could ultimately assist in further developing diagnostics for next-generation IL-2 agents, several of which are in clinical development.

About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney and renal pelvis cancer in adults. In the United States, it is estimated that there will be approximately 79,000 new cases of kidney and renal pelvis cancer in 2022 and almost 14,000 deaths. Kidney and renal pelvis cancer, which includes RCC, is considered the 8th most common type of cancer. Standard treatment options for RCC are surgery, radiation, chemotherapy, targeted therapy or immunotherapy.

On August 23, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported it has completed cohort 2 and advanced to cohort 3 in the theranostic 64Cu/67Cu SARTATE neuroblastoma trial (CL04 trial) (Press release, Clarity Pharmaceuticals, AUG 23, 2022, View Source [SID1234618559]).

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The independent Safety Review Committee (SRC) assessed the safety data from cohort 2 in all three participants, confirming no Dose Limiting Toxicities (DLTs) occurred following the administration of a single therapy cycle of 67Cu-SARTATE. The SRC has recommended the trial progress to cohort 3, without modification, increasing the 67Cu SARTATE dose from 175MBq/kg body weight in cohort 2 to 275MBq/kg body weight in cohort 3. Additional therapy cycles of 67Cu SARTATE have been requested by clinical sites and are being administered to participants in cohorts 1 and 2. Subsequent therapy cycles are contingent on the Investigators assessment that the participant is demonstrating therapeutic benefit.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "Our team of colleagues and collaborators are very excited to advance the SARTATE product in neuroblastoma, an aggressive childhood cancer. With cohort 2 of this theranostic trial now completed, we look forward to exploring the therapeutic benefits of using an increased dose of 67Cu SARTATE in these children, where no other options are available. The further increase in dose between cohorts 2 and 3 is significant, and we look forward to analysing the safety and efficacy data in these higher-level cohorts in neuroblastoma, a radiation sensitive disease.

"We are also pleased with the speed of recruitment in cohort 2 and have been able to close this cohort in 6 months. The increased pace of recruitment is due to the subsided effects of the global pandemic. We continue to progress the trial at some of the leading cancer centres in the US and will aim to open additional clinical sites in the US over the coming months to further accelerate the speed of recruitment in this trial.

"Improving treatment outcomes of children with cancer is at the heart of our mission and something we are very passionate about. As such, we hope that Clarity will be able to continue building upon the mounting diagnostic and therapeutic benefits of the SARTATE products and improve the treatment paradigm for children with this insidious disease," said Dr Taylor.

About CL04
The CL04 trial is a Phase I/IIa theranostic (diagnosis and therapy) trial in paediatric patients with high-risk neuroblastoma using 64Cu/67Cu SARTATE in the US (NCT04023331)1. It is a multi-centre, dose-escalation, open label, non-randomised clinical trial with up to 34 patients currently conducted at five clinical sites in the US, with additional US clinical sites opening for recruitment in the coming months.

About SARTATE
SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2), including neuroblastoma and neuroendocrine tumours (NETs). Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu SARTATE) or copper-67 (67Cu) for therapy (67Cu SARTATE).

About Neuroblastoma
Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.2 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.3

In 2020, the US Food and Drug Administration (FDA) awarded Clarity two Orphan Drug Designations (ODDs), one for 64Cu SARTATE as a diagnostic agent for the clinical management of neuroblastoma and one for 67Cu SARTATE as a therapy of neuroblastoma, as well as two Rare Paediatric Disease Designations (RPDDs) for these products. Should Clarity be successful in achieving marketing approval from US FDA for these two products, RPDDs may allow the Company to access a total of two tradeable Priority Review Vouchers (PRVs) which most recently traded at USD110M per voucher.4

On August 23, 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 second quarter and half year ended June 30, 2022 and provided a business update (Press release, BerGenBio, AUG 23, 2022, View Source [SID1234618557]).

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"The prioritization of bemcentinib development in two key areas in the second quarter has created momentum entering the second half of the year," said Martin Olin, Chief Executive Officer of BerGenBio. "By following strong scientific rationale, clinical and preclinical data, and areas of significant unmet medical need, we are confidently enthusiastic about bemcentinib’s potential in aiding patients in two indications of focus: STK11 mutated Non-Small Cell Lung Cancer and patients hospitalized by COVID-19. The initiation of the next phase of clinical development for both indications in 2H22 moves us a meaningful step closer to addressing two large patient populations that are in need of better treatments."

Clinical Development

Bemcentinib

BerGenBio’s lead compound, bemcentinib, is a potent, first-in-class, oral, small molecule, highly selective inhibitor of the receptor tyrosine kinase AXL, which is overexpressed in response to cellular stress, inflammation, hypoxia and chemotherapy. Bemcentinib inhibits the host cells’ ability to propagate 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

BerGenBio is preparing a Phase 1b/2a trial of bemcentinib in 1L STK11m NSCLC, a group that represents approximately 20% of NSCLC patients. Mutations in the STK11 gene are highly correlated with poor treatment response and survival with today’s standard of care treatments, including immune checkpoint inhibitors in NSCLC. Through inhibition of AXL, bemcentinib seeks to prevent AXL activation, consequently removing the innate immunosuppression that it causes and driving the proliferation of immune cells to restore sensitivity to immune checkpoint therapy. UT Southwestern Medical Center in Texas has shown that bemcentinib in models of NSCLC has the ability to restore the sensitivity of checkpoint inhibitors. Further bemcentinib is also believed to delay the development of chemoresistance.

The detrimental effect of mutations in the STK11 gene on clinical outcomes was further highlighted by several academic groups at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June 2022. In a retrospective study funded by Roche, Spain (Abstract #9047), of real-world outcomes in 1L NSCLC patients, STK11m was identified as having the poorest prognosis in all effectiveness outcomes, including lower response, progression free survival and overall survival, of 185 detected mutations.
The Company is preparing and has post period filed an IND with the purpose to initiate a Phase 1b/2a trial evaluating bemcentinib in combination with a checkpoint inhibitor and doublet chemotherapy in 1L STK11m NSCLC patients in the second half of 2022.
In parallel with the preparation of the Phase 1b/2a trial, the Company is evaluating the role of STK11 mutations in combination with other relevant co-mutations such as TP53, KRAS and KEAP1 to further characterize the potential of bemcentinib is this area of high unmet medical need.
Hospitalized COVID-19 Patients

Bemcentinib is currently being studied in a Phase 2b clinical trial in hospitalized COVID-19 patients. AXL, when induced by an infection, such as COVID-19, is known to play a variety of key roles in transporting the virus into cells, aiding replication, and dampening immune responses. Bemcentinib selectively inhibits AXL to block viral entry, stimulate the innate immune system and facilitate tissue repair regardless of known variants or mutations.

In the ACCORD2 UK platform study of hospitalized COVID-19 patients, bemcentinib treatment resulted in a clear reduction in clinical deterioration, causing: a significant reduction in deaths, patients requiring less supplementary oxygen, a significant reduction in the need for intubation or ventilation and a shortening of hospital stays compared to the control group.
Bemcentinib has been selected by an expert group to be studied in a Phase 2b trial under the EU-SolidAct platform through a sub-protocol enrolling 500 hospitalized COVID-19 patients across Europe.
Mipasetamab Uzoptirine

Post period, ADC Therapeutics announced that the first patient was dosed in a Phase 1 clinical trial evaluating mipasetamab uzoptirine as a single agent and in combination with gemcitabine in patients with selected advanced solid tumors. Mipasetamab uzoptirine contains an AXL-targeting humanized monoclonal antibody licensed from BerGenBio.

Corporate Activities

BerGenBio strengthened its leadership team in April 2022 with the addition of Cristina Oliva, M.D., as Chief Medical Officer. Dr. Oliva is a Board-certified oncologist with over 20 years of senior clinical development experience across large pharmaceutical, biotechnology and CROs, including her most recent position as Vice President, Oncology and Head of Oncology Centre of Excellence at IQVIA, Ltd.

Second 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 second quarter 2022
Total operating expenses for the second quarter were NOK 88.2 million (NOK 92.3 million)
The operating loss for the second quarter came to NOK 88.2 million (NOK 92.3 million)
Cash and cash equivalents amounted to NOK 292.1 million (NOK 367.8 million at the end of the first 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.

Webcast link: https://channel.royalcast.com/landingpage/hegnarmedia/20220823_9/

The first 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.