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.

On August 22, 2022 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported the appointment of Thomas Willemsen as its President and Chief Executive Officer effective October 1, 2022 (Press release, Tessa Therapeutics, AUG 22, 2022, View Source [SID1234623200]). Mr. Willemsen has also been named as a member of Tessa’s Board of Directors.

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Mr. Willemsen brings more than 25 years of experience to Tessa with extensive international management and leadership experience in the pharmaceutical industry. He joins Tessa from Takeda Pharmaceuticals, where he served as Senior Vice President, Asia Pacific, leading the transformation of Takeda across 10 markets and enhancing its focus on rare and genetic diseases, oncology, and vaccines.

As President and CEO, Mr. Willemsen will lead Tessa’s corporate, business and development strategy focused on maximizing the value potential of the company’s proprietary autologous and allogeneic CAR-T platforms, including ongoing clinical programs involving its autologous CD30-CAR-T therapy (TT11) and allogeneic CD30.CAR EBVST therapy (TT11X). Mr. Willemsen will lead Tessa from its global headquarters in Singapore. John Ng, who had served as Tessa’s acting CEO since November 2021, will continue as the company’s Chief Technical Officer.

"Tessa is extremely pleased to add an executive of Thomas’ caliber as our new President and CEO, coming at a time of significant optimism at the company as we pursue a multi-tier development strategy built around our proprietary CAR-T technologies and fueled by the recently completed US$126 million financing," stated Göran Ando, M.D., Chairman of the Board of Tessa Therapeutics. "Thomas’ career is highlighted by senior leadership positions at several global pharmaceutical companies, including Takeda, GlaxoSmithKline and Merck KGaA. His combination of executive experience at global pharma companies and deep understanding of commercialization and oncology makes Thomas an ideal executive to lead Tessa’s next stage of growth."

Prior to Takeda, Mr. Willemsen held the position of Vice President, Oncology, at GlaxoSmithKline (GSK) for its Intercontinental & Emerging Markets business, where he was assigned to develop the business’ strategy for Asia & Emerging Markets, including Access Strategy and Commercial Structure design. Prior to that, Mr. Willemsen served as Chairman and General Manager for GSK in China, and as General Manager of GSK Taiwan. He also spent 12 years with Merck KGaA in various commercial and regional roles in the Asia Pacific region, and as the Head of its German Oncology business unit.

Mr. Willemsen graduated with an MBA from Trier University, Germany, and attained a Chinese Language Degree from Sun Yat-Sen University, Guangzhou, China. He speaks German, English, and Mandarin.

"Tessa is at the forefront of developing the next generation of CAR-T therapies, including our allogeneic ‘off-the-shelf’ EBVST technology, which has demonstrated very encouraging safety and efficacy data in the ongoing Phase 1/2 clinical trial in CD30 positive lymphomas," said Mr. Willemsen. "I look forward to working with the entire Tessa team and continuing the positive progress with our CAR-T programs as we strive to ultimately bring these important therapies to patients with high unmet medical needs."

Dr. Ando concluded, "On behalf of Tessa, I would like to commend John Ng for serving as our acting CEO during the past several months. Under John’s leadership, Tessa achieved numerous clinical and business successes, including the close of the Series A financing and the recent initiation of a clinical trial of TT11 in combination with nivolumab, which has the potential to introduce TT11 as a second-line therapy for relapsed and refractory CD30+ classical Hodgkin lymphoma patients."

On August 22, 2022 The Canada Foundation for Innovation (CFI) reported its continued support of Canadian glycomics research with an investment of $10.68 million to GlycoNet Integrated Services (GIS) through its Major Science Initiatives Fund (Press release, GlycoNet, AUG 22, 2022, View Source;utm_medium=rss&utm_campaign=glyconet-integrated-services-awarded-10-million-investment-from-the-canadian-foundation-for-innovation [SID1234623186]).

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GIS is the world’s largest and most advanced comprehensive suite of specialized glycomics tools and services. This glycomics "toolbox" uniquely equips academic and industrial researchers with the synthetic and analytical screening technologies needed to undertake world-class glycomics research and technology development.

"This is an exciting time to be in the field of glycomics," says Dr. Warren Wakarchuk, Scientific Director of GlycoNet. "Technological advances have allowed glycomics to take a huge leap forward, and the next decade will undoubtedly see explosive growth in the biotechnology and pharma sectors. We are grateful to CFI for giving GlycoNet Integrated Services the ability to provide these tools and support Canadian glycomics research that seeks to develop solutions to health and environmental concerns."

Glycomics is an interdisciplinary science focusing on the role of glycans (sugars or carbohydrates) in biological ecosystems. In all living organisms, glycans are vital to biological processes. For example, the COVID-19 virus uses its spike protein to attack human cells through proteins and lipids that carry glycans while evading our immune systems. How we fight infection, how our bodies heal, how our immune systems protect us, and how our agricultural crops resist drought and pests are all precisely controlled by glycans.

"Over the last few years, the study of glycans has become a quickly growing and increasingly crucial field as it holds important potential for human health and biotechnology. By supporting GlycoNet Integrated Services, the Canada Foundation for Innovation is proud to invest in a critical network of infrastructure that facilitates world-class glycomics work and has made Canada an international leader in glycoscience," says Dr. Roseann O’Reilly Runte, President and CEO, Canada Foundation for Innovation.

GIS supports both fundamental research and translational research that advances discoveries into applied and commercial outcomes. For example, GIS has supported the development of a glycomics-based technology for advanced disease-modifying therapies and tools to monitor the progression of Parkinson’s disease directly in living cells derived from patients.

"The ability to monitor the progression of Parkinson’s disease could lead to a major breakthrough in the treatment and management of the disease. GlycoNet’s advances in this area have attracted the interest of several pharmaceutical and biotechnology companies," says Dr. Elizabeth Nanak, Chief Executive Officer of GlycoNet.

"This is an example of a research and development program with significant socioeconomic impact that GlycoNet was able to support because of the cutting-edge glycomics tools provided by GlycoNet Integrated Services," continues Dr. Nanak. "With CFI’s investment in GIS, GlycoNet now has the critical ‘toolbox’ it needs to further support glycomics research in many of Canada’s strategic industrial sectors, including human and animal health, agriculture, and resource management."

At a glance: GlycoNet Integrated Services

World’s largest and most advanced suite of specialized glycomics tools and services enabling groundbreaking research
One-stop access to glycomics tools, specialized expertise and unique infrastructure for Canadian researchers and companies
Distributed across seven Canadian institutions and leverages $35 million in federal and provincial infrastructure investment
Coordinates five specialized types of glycomics services: Glycan–Ligand Screening and Discovery, Glycan Analyses, Carbohydrate Synthesis, Drug Discovery & High-Throughput Screening (HTS) and Molecular Glycobiology & Glycoengineering

On August 22, 2022 RS Research, a clinical-stage biotechnology start-up developing smart nanomedicines for targeted chemotherapy, reported the acceptance of a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2022 Congress to be held in person on 9-13 September 2022 in Paris – France (Press release, RS Research, AUG 22, 2022, View Source [SID1234618595]).

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Poster Title: Phase Ia/Ib study of RS-0139, a novel tumor-targeted delivery of docetaxel, in patients with recurrent, locally advanced, or metastatic non-small cell lung cancer (NSCLC)

Presenter: Prof. Dr. Hakan S. Orer, Medical Pharmacology, Koc University Hospital; Dr. Gülşah Nomak, Medical Director, RS Research

The poster will be published online via the ESMO (Free ESMO Whitepaper) website on 5 September 2022.