On January 27, 2022 Case Western Reserve University reported that About 1.2 million people with HIV in the United States live relatively normal lives with uncompromised immune systems and the virus medically controlled (Press release, Case Western Reserve University, JAN 27, 2022, View Source [SID1234607435]).

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But there are two rising concerns, said Ge Jin, a professor in the Department of Biological Sciences at the Case Western Reserve University School of Dental Medicine.

"One, they are aging and will develop all the diseases or illnesses of the general population, like you or me," he said. "The other problem—those morbidities, like cancer or co-infection with other viruses, happen at an earlier stage, occur at a higher rate and are more severe (for people with HIV)."

With two new research grants totaling $3.7 million from the National Institutes of Health (NIH), Jin and his co-investigators hope to learn why.

The new grants will focus on identifying the reasons for higher rates of cancers in the head and neck within this population, as well as co-infection with the herpes virus (Kaposi sarcoma herpesvirus or KSHV).

Jin, also a member of the Case Comprehensive Cancer Center’s Molecular Oncology Program, received:

A five-year, $3.3 million grant from the National Cancer Institute at NIH to investigate the mechanisms underlying transmission of KSHV in the oral cavity in people living with HIV.
KSHV causes Kaposi sarcoma (KS), one of the most common malignancies in people living with HIV. While the oral cavity contains the highest levels of infectious KSHV—and saliva is the most common way to transmit the infection—how that happens isn’t understood.

Jonathan Karn, professor and chair of the Department of Molecular Biology and Microbiology at the School of Medicine and director of the Case Center for AIDS Research, is co-investigator on this project.

A related $401,000 grant from the National Institute of Dental and Craniofacial Research at NIH to study why cases of oral diseases, like lesions that could develop into oral cancers, are increasing as people with HIV age—and then identify new therapies. Michael Lederman, professor emeritus at the School of Medicine, is co-investigator.
This new round of funding builds on a $3.7 million grant Jin and his research team received from NCI in July 2020 to study HIV and lung cancer—specifically why lung cancer rates are higher for people living with HIV, and the mechanism and markers to predict and treat the disease.

HIV infects immune cells; cancers in the lung and oral cavity affect epithelial cells. If researchers can figure out the link between HIV and higher cancer rates—and how to break that connection—then the next step would be to focus on therapies to treat the diseases.

"The first thing is," Jin said, "identifying how and why they can talk with each other."

On January 27, 2022 Redx (AIM:REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that audited financial results for the year ended 30 September 2021, as well as an operational update (Press release, Redx Pharma, JAN 27, 2022, View Source [SID1234607428]).

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Lisa Anson, Chief Executive Officer of Redx, commented:
"During the period, we have made strong progress in advancing our pipeline. Our lead oncology asset, RXC004, entered a Phase 2 clinical trial and our lead fibrosis asset, RXC007, entered a Phase 1 clinical trial. Our discovery pipeline of differentiated programmes continues to progress driven by the strength of our science and validated by milestone revenue increasing during the year. We are in a position to deliver meaningful results in the clinic which could drive benefits for patients and value for shareholders."

Operational Highlights
· Significant clinical progress on lead oncology asset, RXC004, an oral, potent, selective, small molecule Porcupine inhibitor product candidate:
o Completed monotherapy module of Phase 1 trial showing differentiated level of activity in Wnt-ligand dependent tumours; o Presented Phase 1 data at theEuropean Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress; o Selected 2 mg as recommended dose for monotherapy Phase 2 studies;
o Post period, initiated Phase 2 trial in monotherapy treatment in genetically selected MSS metastatic colorectal cancer, with US IND now open (PORCUPINE trial); and o Post period, initiated second Phase 2 trial in monotherapy treatment in genetically selected pancreatic cancer and unselected biliary cancer (PORCUPINE2 trial). · Initiated Phase 1 clinical trial in healthy volunteers for RXC007, an orally bioavailable selective Rho Associated Protein Kinase 2 (ROCK2) inhibitor with potential for development in multiple fibrotic conditions:
o Post period, reported interim Phase 1 safety, tolerability and pharmacokinetic (PK) data on11 October 2021 showing no adverse events and an attractive PK profile. · Progressed discovery portfolio, including our Discoidin Domain Receptor (DDR) inhibitor fibrosis programme:
o Developed potent proprietary DDR inhibitors with drug-like characteristics that are now in lead optimisation. · Increased milestone revenue from progress of partnered programmes: o Milestones totalling $7 million received from AstraZeneca ($4 million related to RXC006) and Jazz Pharmaceuticals ($3 million related to Pan-RAF) during the period; o Revenue from the Jazz Pharmaceuticals collaborations received during the year for the progress on research programmes;
o Post period, on9 December 2021 Redx announced a $10 million milestone was earned from Jazz Pharmaceuticals for the progress in ongoing research collaboration and on 23 December 2021 Redx announced a $9 million milestone was earned from AstraZeneca as RXC006 entered clinical trials.

· Further strengthened the Redx management team and Board of Directors reflecting the transformation of the company into a clinical stage organisation: o Appointment of experienced key senior management-DrJane Robertson as Chief Medical Officer andPeter Collum as US-based Chief Financial Officer; o Creation of new role of Chief Operating Officer to be held byJames Mead and General Counsel role held byClaire Solk, who joined Redx on 17 January 2022 from her previous role as Senior Legal Counsel at AstraZeneca; o Board appointments of Natalie Berner in May 2021 as Non-Executive Director and DrJane Griffiths in December 2021 as new Chair, following the departure of Iain Ross in June 2021.

Financial Highlights
· Placing and Open Offer inDecember 2020 of £25.7 million (gross), which received strong support from existing investors and added healthcare specialist investors including Polar Capital; · Cash balance at30 September 2021 of £29.6 million (30 September 2020: £27.5 million);
· Total revenue for the year of£10.0 million (2020: £5.7 million); o Including milestone payments of $4 million from AstraZeneca, and $3 million from Jazz Pharmaceuticals;
· Loss for the year of£21.5 million (2020: £9.2 million);
· Total R&D expenditure of £24.4 million (2020: £10.5 million); · Cash balance funds operations through calendar year 2022.

For the purposes of MAR, the person responsible for arranging for the release of this announcement on behalf of Redx iAsndrew Booth, Company Secretary

On January 27, 2022 OncoArendi Therapeutics S.A. ("OncoArendi"; WSE: OAT), a clinical stage biotechnology company that uses its world leading medicinal capabilities to discover and develop first in class small molecule drug candidates that directly modulate RNA and unexplored protein targets to treat multiple incurable diseases, reported the appointment of Samson Fung, M.D. as Chief Medical Officer (Press release, OncoArendi Therapeutics, JAN 27, 2022, View Source;utm_medium=rss&utm_campaign=oncoarendi-therapeutics-appoints-samson-fung-m-d-as-chief-medical-officer [SID1234607426]). Dr. Fung will be responsible for the company’s global clinical development, translational science and regulatory strategies and will lead the advancement of OATD-02, its novel dual arginase inhibitor into Phase 1.

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"Samson’s extensive experience in drug development and translational medicine together with his background in oncology and deep knowledge gained working at blue-chip biopharmaceutical companies, makes him a crucial addition to our team," said Marcin Szumowski, CEO and President of the Management Board. We are delighted to welcome Samson at this exciting time as we prepare to progress our pipeline of first in class cancer and fibrosis therapies, including our lead wholly owned candidate OATD-02, a highly potent dual arginase inhibitor, which is on track to start Phase 1 in the second half of 2022. "

Dr Fung added, "I am thrilled to be joining OncoArendi at such an important stage of its development. I am looking forward to working with the company’s talented team to build a robust pipeline of small molecule drugs that has the potential to transform the care of cancer and fibrosis patients around the world. "

Dr Fung brings more than two decades of global industry and senior leadership experience across the life science sector.

He has significant biotech experience with senior leadership roles (Head of Clinical Development, interim CMO) at several of Europe’s most successful biotech companies including argenx, Micromet, later acquired by AMGEN, and Morphosys.

Dr. Fung has also held senior roles in clinical development, medical affairs, business development and strategic marketing at leading global pharmaceutical companies including Roche, Novartis, Pharmacia/Pfizer, Novo Nordisk and AstraZeneca.

Dr. Fung graduated from the University of Freiburg, Germany and obtained his board certification in internal medicine with sub-specialization in oncology and hematology.

On January 27, 2022 EORTC reported The MINDACT (EORTC 10041/BIG3-04) study, a multicentre, randomised phase 3 clinical trial, aims to identify those women with early-stage breast cancer who can be spared chemotherapy after surgery through the use of a genomic and clinical risk assessment. Between 2007 and 2011, 6693 patients aged 18 to 70 whose cancer had either not spread to the lymph nodes under the arm, or to no more than three nodes, were enrolled to the trial, which was carried out in 112 institutions in nine European countries (Press release, EORTC, JAN 27, 2022, View Source [SID1234607424]).

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The latest sub-group analysis, published recently in the Journal of Clinical Oncology* looked at the 15% of patients who had an ultra-low genomic risk of recurrence based on the 70-gene signature MammaPrint. After a median follow-up of 8.7 years, 99% of these patients had not died from their disease, and their risk of cancer spreading to other parts of the body (distant metastasis) was significantly less than for patients with low-risk tumours. Patients with ultra-low risk tumours had an excellent prognosis regardless of the result of their clinical risk assessment.

Of the ultralow-risk patients, 67% were aged 50 years or more, and 99% were estrogen receptor (ER)-positive. Systemic therapy was received by 84% of patients (69% endocrine therapy (ET), 14% endocrine therapy plus chemotherapy, 1% other) and 16% received no adjuvant systemic treatment.

"Although trials have shown that gene signatures can be used to identify subgroups of patients who can safely be spared chemotherapy, current guidelines still include the use of ET in all hormone receptor positive patients, even those at very low risk" said Dr Josephine Lopes Cardozo, from the Netherlands Cancer Institute and EORTC. "ET side effects are often underestimated, and, as a result, adherence to the treatment is poor, with only half of all patients finishing a five-year course. Our analysis of ultra-low risk patients shows that these patients might be candidates for further reduction of treatments such as ET."

The investigators hope that the ultra-low risk gene signature will be used in future trials investigating the de-escalation of ET in order to achieve a better balance between benefit and harm. Findings from earlier studies have suggested that the introduction of population-based screening programmes has led to an increase of tumours with low-risk and ultra-low risk molecular profiles, and that these are over-represented within screen-detected cancers. "Being able to identify these patients who may have a limited benefit from ET could help to personalize treatment by reducing treatment durations or completely omitting ET and ultimately preventing overtreatment," says Dr Lopes Cardozo. "This would have benefits not only for patients, but also save money for healthcare systems."

On January 27, 2022 Chimeric Therapeutics Ltd (ASX:CHM) reported that it has been issued a patent from the Unites States Patent and Trademark Office covering certain applications of chimeric antigen receptor (CAR) technology using chlorotoxin (CLTX), including Chimeric’s clinical-stage CAR T asset CHM 1101 and preclinical-stage CAR NK asset CHM 1301 (Press release, Chimeric Therapeutics, JAN 27, 2022, https://chimerictherapeutics.com/wp-content/uploads/2022/01/CHM-Receives-US-Patent-covering-CLTX-CAT-Technology.pdf [SID1234607406]).

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The patent has been granted under patent number US 11,230,577 B2 and entitled ‘Chimeric antigen receptors containing a chlorotoxin domain’.

Chimeric Therapeutics holds the exclusive worldwide licence to develop and commercialise US 11,230,577 B2 and related patent applications filed in other global territories.

Continued IP portfolio momentum
Chimeric Therapeutics CEO and managing director Jennifer Chow said: "We are delighted to have patent protection granted for CLTX CAR therapies in the United States, the single largest global market for biopharmaceutical products.

"The granting of this key US patent continues the momentum for the intellectual property portfolio underpinning our CLTX CAR pipeline assets, following the recent patent grant in Europe in September."

CHM 1101 (CLTX CAR T) is a novel and promising CAR T therapy developed by scientists at the City of Hope Medical Centre in California for the treatment of patients with solid tumours.It is currently being studied in a phase 1 clinical trial in recurrent/ progressive glioblastoma.

A second CLTX CAR T phase 1 clinical trial is planned to begin in 2022 in additional solid tumours.

CHM 2101 (CDH17 CAR T) is a novel, third-generation CDH17 CAR T invented at the University of Pennsylvania. CHM 2101 is in preclinical development with a planned phase 1 clinical trial in 2022 in Neuroendocrine Tumours, Colorectal, Pancreatic and Gastric Cancer.