On April 11, 2022 Recursion (NASDAQ: RXRX), the clinical-stage biotechnology company industrializing drug discovery by decoding biology, reported that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for REC-4881 for the potential treatment of familial adenomatous polyposis (FAP) in patients who have previously undergone a colectomy/proctocolectomy (Press release, Recursion Pharmaceuticals, APR 11, 2022, View Source [SID1234617988]). REC-4881 is an orally bioavailable, non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in FAP patients.

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"The Fast Track designation for REC-4881 is an important addition to our work to rapidly develop this potential medicine to treat patients with FAP, for which there is significant unmet need," said Recursion Chief Medical Officer Ramona Doyle, M.D. "I am pleased that the team continues to advance this drug candidate towards a Phase 2 study to evaluate safety, pharmacokinetics and efficacy in FAP patients, for which we expect to begin enrolling patients in the third quarter of this year."

The FDA’s Fast Track designation was established to expedite the review of investigational drugs to treat serious conditions and address unmet medical needs by enabling important drugs to get to patients earlier if approved. Fast Track designation can lead to more frequent interactions with the FDA, as well as Accelerated Approval and/or Priority Review eligibility if certain criteria are met.

Learn more about Recursion and view its pipeline at Recursion.com/pipeline.

About REC-4881
REC-4881 is an orally bioavailable, non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in FAP patients. REC-4881 has been well tolerated in prior clinical studies, consistent with the intended use, and has a gut-localized PK-profile that may be advantageous for FAP, and potentially other APC-driven gastrointestinal tumors. REC-4881 has been granted Orphan Drug designation for FAP by the FDA. We expect to enroll the first patient in a Phase 2, double-blind, randomized, placebo-controlled basket trial in the third quarter of 2022.

About Familial Adenomatous Polyposis
FAP is a rare tumor syndrome with no approved therapies. In the US, France, Germany, Italy, Spain and the UK alone the disease affects approximately 50,000 patients. FAP is caused by autosomal dominant inactivating mutations in the tumor suppressor gene APC. FAP patients develop polyps in the gastrointestinal tract throughout their lives. These growths have a high risk of malignant transformation and can give rise to invasive cancers of the colon, stomach, duodenum, rectum, and other tissues. Standard of care for patients with FAP is colectomy, and without surgical intervention, affected patients will progress to colorectal cancer in adulthood. Even after colectomy, patients receive endoscopic surveillance every 6-12 months to monitor disease progression. While surgical management and surveillance have improved the prognosis for FAP patients, duodenal and desmoid tumors remain major causes of death following colectomy in patients with FAP.

On April 11, 2022 Circle Pharma, a pre-clinical stage company focused on developing macrocycle therapeutics against targets previously considered to be undruggable, reported that it will present a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 8-13, in New Orleans, Louisiana (Press release, Circle Pharma, APR 11, 2022, View Source [SID1234613861]).

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The Company’s presentation will provide details of its progress towards structure-guided macrocycles that inhibit the protein-protein interaction between the cyclin A:CDK2 complex and key substrates that are phosphorylated by this complex. Inhibition of Cyclin A substrate binding has been postulated to be synthetic lethal in Rb mutated cancers. The data presented include evidence that macrocycle inhibitors of cyclin A induce G2/M arrest and apoptosis in small cell lung cancer (SCLC) cell lines and have anti-tumor efficacy in SCLC xenograft animal models. Circle plans to advance its cyclin A inhibitor program to the clinic for testing in a range of cancer types, including SCLC where Rb mutations are highly prevalent.

The presentation will be made as part of the Mechanisms of Drug Action / Experimental and Molecular Therapeutics session at the AACR (Free AACR Whitepaper) meeting, Abstract No. 5379.

On April 11, 2022 Adcendo ApS ("Adcendo"), a biotech company focused on the development of breakthrough antibody-drug conjugates (ADCs) for the treatment of underserved cancers, reported that a poster presentation will be provided on data of uPARAP targeting Antibody-Drug Conjugates in osteosarcoma preclinical xenograft models at the ongoing American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held in New Orleans from April 8-13, 2022 (Press release, ADCendo, APR 11, 2022, View Source [SID1234613272]).

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American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022
Presentation title: 2016 / 20 – Preclinical Evaluation of uPARAP (MRC2) Antibody-drug Conjugates (ADCE-003,010,011) in Osteosarcoma PDX Models
Session: Clinical Research Excluding Trials
Session Title: Paediatric Oncology: Clinical Investigation
Presenter: Yifei Wang
Authors: Yifei Wang, Wendong Zhang, Zhongting Zhang, Xiangjun Tian, Rossana N Lazcano Segura, Pooja Hingorani, Michael Roth, Jonathan Gill, Douglas Harrison, Zhaohui Xu, Jing Wang, Niels Behrendt, Christoffer F. Nielsen, Lars H. Engelholm, and Richard Gorlick
Date & Time: April 11th at 1:30 – 5.00 pm CDT

uPARAP is a cell-surface receptor, which is involved in collagen degradation and displays a differentiated expression profile between healthy tissue and cancer tissue, with several cancer types significantly overexpressing the receptor, including soft-tissue sarcoma, osteosarcoma, mesothelioma and glioblastoma multiforme (GBM). The preclinical study in Osteosarcoma PDX models presented at the 2022 AACR (Free AACR Whitepaper) meeting was carried out by researchers at the University of Texas MD Anderson Cancer Center.

Principal Investigator Richard Gorlick, M.D., Department Chair of the Department of Pediatrics Patient Care and Director of the Department of Pediatric Sarcoma Research Laboratory of The University of Texas MD Anderson Cancer Center, Houston, TX, said: "ADCs have shown robust clinical activity in several solid tumor cancers but, due to the lack of suitable targets, none are yet available for osteosarcoma. Osteosarcoma are the most common primary malignant bone tumors in children and young adults, where treatment has shown limited progress in the last few decades. We are encouraged by this data and look forward to further support the ongoing development of a uPARAP-targeting ADC in order to improve the outcome of our patients."

Niels Behrendt, Professor of the Finsen Laboratory, University of Copenhagen and Copenhagen University Hospital, and Scientific Co-founder of Adcendo, said: "After 25 years of research on the biology of uPARAP we are very encouraged by the promising activity data, suggesting that targeting uPARAP via ADCs could represent a novel therapeutic option for osteosarcoma patients and other underserved cancer indications."

On April 11, 2022 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, reported the appointment of Cristina Oliva, MD as Chief Medical Officer (CMO), effective 25 April 2022 (Press release, BerGenBio, APR 11, 2022, View Source [SID1234612476]). Cristina joins the senior leadership team heading up clinical development of BerGenBio’s selective AXL inhibitor programs.

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Cristina is a Board-certified oncologist and brings over 20 years of senior clinical development experience across large pharmaceutical, biotechnology and Clinical Research Organizations (CROs). Most recently Cristina was Vice President, Oncology and Head of Oncology Centre of Excellence at IQVIA Ltd, where she led the development of decentralized trials and established and led the IQVIA Oncology Global Scientific Advisory Board. Prior to her role at IQVIA, Cristina held senior positions leading oncology development programs for Nordic Nanovector, Takeda Pharmaceuticals, GlaxoSmithKline and Eli Lilly.

Martin Olin, Chief Executive Officer of BerGenBio, commented: "I’m delighted to welcome Cristina as our new Chief Medical Officer. Cristina’s leadership experience within oncology drug development across big pharma, biotech and CRO environments will be instrumental in executing BerGenBio’s development strategy for our AXL inhibitor programs, including our most advanced program bemcentinib, currently in phase II trials."

On her appointment as Chief Medical Officer at BerGenBio, Cristina Oliva, MD, commented:"BerGenBio is on the frontier of developing novel, highly selective AXL inhibitors for the treatment of severe diseases such as oncology and respiratory infections. I’m very excited to join BerGenBio at this critical phase and look forward to working with the senior leadership team to help further advance its AXL inhibitor programs."

On April 11, 2022 Bio-Platform NewStem Ltd reported the filing of a pre-submission to the FDA for a De Novo Request and an in vitro diagnostic device (IVDD) for EMA for their NewStem Software Diagnostic Device (Press release, NewStem, APR 11, 2022, View Source [SID1234612062]). The announcement followed the company’s graduation from Illumina’s Accelerator 3rd funding cycle in March 2022.

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The NewStem Software Diagnostic Device (NSDD), a bioinformatics-based software medical device platform, provides oncologists with information regarding the presence of mutations in tumors, which may confer patient resistance to certain anti-cancer drugs. The information provided by NSDD, will aid oncologists when deciding which treatment regime to apply.

Cancer is the second leading cause of death globally. Despite efforts and achievements made in treating cancer over the past several decades, resistance to anti-cancer drugs continues to be a major problem in cancer therapies. Resistance is the leading cause of relapses in cancer and one of the significant causes of death due to the disease. Drug resistance (whether pre-existing or generated after therapy) is responsible for over 90% of deaths in cancer patients receiving traditional chemotherapeutics or novel targeted drugs treatments.

NewStem is a biotechnology company established as a bio-platform for genome wide screenings based on proprietary Haploid human Embryonic Stem Cells (HhESCs) technology. These cells can potentially change how we develop genetic based therapeutics and diagnostics, as they are superior to other cells used for whole genome screenings. NewStem is currently the only company worldwide to develop innovative practice-changing products based on this innovative and exclusive technology. The company is now raising funds to deepen its internal personnel capabilities and for further research and development.

"The technology, based on our proprietary haploid cells, has changes the dogma and enables what was formerly impossible", says Prof. Nissim Benvenisty. "NSDD will give oncologists a better understanding of the many variances that present challenges in the treatment of cancer and in the identification of drug-type resistance. That is unprecedented."