On June 23, 2022 Almac Diagnostic Services, a member of the Almac Group, reported it has signed a Master Collaboration Agreement (MCA) with AstraZeneca to develop and commercialise multiple companion diagnostic (CDx) products (Press release, Almac, JUN 23, 2022, View Source [SID1234616199]). Almac will work to support AstraZeneca in its drive to bring new therapies to patients globally in disease areas of high unmet need.

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Under the terms of the agreement, Almac will develop and validate specific CDx assays for patient selection in various AstraZeneca clinical trials across a range of therapeutic areas including kidney disease, non-alcoholic steatohepatitis, and respiratory disease. Almac will seek regulatory approval for individual CDx assays in agreed jurisdictions in tandem with linked AstraZeneca therapeutics. To date, a number of programmes have already been initiated under this model.

Professor Paul Harkin, President & Managing Director, Almac Diagnostic Services, commented: "We are delighted to have signed this CDx master collaboration agreement, which represents a further strategic alignment with AstraZeneca, and enhancement of an already strong relationship. We are looking forward to working collaboratively together to develop and commercialise these companion diagnostic tests to help identify the right patient populations that will benefit from future AstraZeneca targeted therapies."

Maria Orr, Head of Precision Medicine, BioPharmaceuticals R&D, AstraZeneca said: "Precision medicine is at the heart of AstraZeneca’s ambition to dramatically improve patients’ lives globally; it is an interconnected cycle from early research, innovative pharmacology and drug modalities, to clinical trial design and diagnostic development. Through collaborating with our partners we can lead the way in a new era of precision medicines for complex chronic diseases. We are committed to matching life-changing medicines to patients most likely to benefit and we believe our collaboration with Almac will help us achieve this."

On June 23, 2022 Philogen S.p.A., a clinical-stage biotechnology company focused on antibody- and small molecule-based targeted therapeutics, reported an update regarding recent corporate developments (Press release, Philogen, JUN 23, 2022, View Source [SID1234616198]).

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Prof. Dr. Dario Neri, Chief Executive Officer of Philogen commented: "Philogen has made significant progress over the past few months as we continue investing our IPO proceeds to strengthen our GMP manufacturing capacity and speed up patient enrolment in clinical trials. We are particularly pleased with the progress of our Phase III European study investigating Nidlegy treatment of Stage IIIB/C melanoma, of which we have nearly completed patient recruitment.

Fibromun’s trials in soft-tissue sarcoma are also ongoing in the U.S., Germany, Poland, Spain, and Italy (France planned), with the participation of leading clinical centers. We expect to have more than 30 active clinical centers by the end of this year for the European and US pivotal studies.

My thanks go to our investors and to everyone at Philogen for their hard work and unwavering support."

MAIN EVENTS AND RECENT HIGHLIGHTS

Proprietary products

Nidlegy is a pharmaceutical product, proprietary to Philogen, consisting of two active ingredients, L19IL2 and L19TNF. The L19 antibody is specific to the B domain of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are inflammatory cytokines with anti-tumor activities
Phase III European study in Stage IIIB/C melanoma
211 out of 214 patients have been recruited. The trial will read when 95 events (tumor recurrence or patient death) have occurred, as per protocol
21 clinical centers opened in Germany, France, Italy, and Poland
Phase III U.S. study in Stage IIIB/C melanoma
13 clinical sites are currently open. We expect to have more than 25 centers active by the end of 2022 to speed up recruitment
Non-melanoma skin cancer
Progress in Phase II studies ongoing in France, Germany, Poland, and soon in Italy
Fibromun (L19TNF) is a pharmaceutical product, proprietary to Philogen, consisting of the L19 antibody fused to TNF
European Phase III study in metastatic/advanced soft-tissue sarcoma
32 patients have been recruited. The recruitment rate of patients is progressing according to planned timelines
10 clinical centers opened in Germany, Spain, Italy, and Poland. We expect to have more than 20 centers active by the end of 2022
Phase I/II study in glioblastoma at first progression
The Phase I dose escalation part of the study is exploring different doses of Fibromun and Lomustine (3-6 subjects per cohort)
Cohort 1 has been completed with 6 patients.
Recruitment for cohort 2 is ongoing, with 4 out of 6 patients recruited.
The historical objective response rate (ORR) for recurrent glioblastoma treated with Lomustine is 4.3-13.9%. The median progression free survival of these patients with lomustine monotherapy is 6 weeks. In unmethylated MGMT tumors, objective responses are virtually never observed (0% ORR) (Wick et al., J Clin Oncol 2010, 28,1168; Weller and Le Rhun et al., Cancer Treat Rev 2020, 87,102029). In cohort 1, we observed durable major responses in 2 out of 6 patients which are ongoing for more than 12 months. In addition, 3 patients had disease stabilization for over 4.5 months (follow up ongoing), while one patient had Covid-19 and had to exit the study without receiving the combination treatment.
OncoFAP is a small organic molecule ligand with ultra-high affinity for Fibroblast Activation Protein (FAP)
OncoFAP-radio conjugates
Imaging – excellent targeting properties of 68Ga-DOTAGA-OncoFAP confirmed in more than 50 patients with various types of malignancies.
Therapy – 177Lu-DOTAGA-BiOncoFAP, featuring a bivalent OncoFAP ligand, cures cancer in murine models and has been identified as the therapeutic candidate for clinical development.
Signed a contract with Senn Chemicals to manufacture DOTAGA-BiOncoFAP
OncoFAP-drug conjugates – these drugs consist of (i) the OncoFAP ligand, (ii) a cleavable linker and (iii) a cytotoxic payload, which is released selectively at the tumor site. A novel OncoFAP-drug conjugate, featuring an optimized cleavable linker, is being studied in animal models of cancer and may represent a novel potential clinical candidate.
The R&D center in Zürich has recently generated promising novel prototypes, including a highly active small molecule drug conjugate targeting PSMA. The company is well poised for the definition of the clinical candidates to be moved into the clinic in 2023.

On June 23, 2022 Minomic International Ltd reported that it has taken a step forward to bring the MiCheck Prostate test to Australians (Press release, Minomic, JUN 23, 2022, View Source [SID1234616197]).

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MiCheck Prostate detects aggressive prostate cancer overcoming the low accuracy of conventional screening tests, reducing unnecessary intervention such as painful biopsies and improving overall management of the patient.

The performance of MiCheck Prostate is supported by numerous clinical studies, including a recent one at Macquarie University Hospital, that found that MiCheck Prostate has a sensitivity of 93% and a specificity of 45%.

With testing available now at selected Sonic Healthcare Australia Pathology laboratories, Minomic can offer MiCheck Prostate to many more Australian men.

Minomic CEO Dr Brad Walsh says the availability of the test will help Australia’s urologists to provide better patient care; "The use of MRI for the detection of prostate cancer, in Australia, has been a revolutionary step forward in the early and accurate detection of this cancer. MRI, when combined with results from MiCheck Prostate provide urologists with an additional aid in clinical decision-making before proceeding to more invasive investigations such as biopsy."

"The test is now market ready in both Australia and the US, while China and other markets such as Europe are also in our sights."

An estimated 25,000 Australian men and two million American men undergo biopsies each year to diagnose prostate cancer after an elevated Prostate-Specific Antigen (PSA) test result. Approximately 50% of these biopsies are unnecessary as the patient does not have cancer or has a low-grade cancer that requires monitoring rather than intervention. In addition, 1-3% of these biopsies can lead to sepsis and death. These unnecessary biopsies lead to patient anxiety and pain that should be avoided.

Prostate cancer remains an ongoing global challenge. Each year around 250,000 men in the US and 20,000 men in Australia are diagnosed with prostate cancer. It is estimated that 1 in 8 males will be diagnosed with a prostate cancer in their lifetime.

Minomic opened a capital raise earlier this year to take the test to market in both Australia and the US ahead of a planned stock market listing in 2023. Last year it received a $400,000 co-investment from the Advanced Manufacturing Growth Centre’s (AMGC) Commercialisation Fund and the Federal Government’s Modern Manufacturing Initiative.

Minomic has established a US based marketing team and obtained a CLIA license enabling availability of MiCheck Prostate in the world’s largest healthcare market.

On June 22, 2022 Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary proteomics-based technologies driving a new era of precision medicine, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its lead asset ACR-368 in a Phase 2 master protocol trial to treat patients with ovarian, endometrial and urothelial cancer based on predicted ACR-368 sensitivity (Press release, Acrivon Therapeutics, JUN 22, 2022, View Source [SID1234621404]). ACR-368 is a potent, selective inhibitor of checkpoint kinase 1 and 2 (CHK1/2) which has previously shown durable monotherapy efficacy in a proportion of patients across several high unmet need solid tumor types. Acrivon will stratify patients for its trial into two treatment groups using its pioneering OncoSignature proteomic companion diagnostic. OncoSignature-positive patients will receive ACR-368 monotherapy in a Phase 2 Simon two-stage study design at the recommended Phase 2 dose, while OncoSignature-negative patients will receive ACR-368 in combination with low-dose gemcitabine in a Phase 1b/2 study design.

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Acrivon’s Predictive Precision Proteomics (AP3) technology platform enables the development of drug-tailored OncoSignature companion diagnostics, which apply quantitative protein multiplex imaging tests to pretreatment tumor biopsies and are designed to enable the identification of the patients whose tumors are regulated by and sensitive to the drug. Acrivon’s AP3 platform was also used to identify key mechanisms associated with ACR-368 resistance, and that the addition of low-dose gemcitabine substantially re-sensitizes resistant tumors to ACR-368, which was subsequently confirmed in multiple preclinical studies.

"Our clinical development approach is quite different than the industry norm, and this clinical trial design is equally unprecedented," said Peter Blume-Jensen, M.D., Ph.D., president and chief executive officer of Acrivon. "Acrivon’s next generation proteomics-based precision medicine platform is engineered to uncover the disease-driving mechanisms that are uniquely sensitive to our drugs or rational drug combinations in individual patient tumors, independent of genetic alterations. Our strategy is to apply the ACR-368-tailored OncoSignature test to a tumor biopsy from the patient before the start of treatment and use that result to direct ACR-368 to only those patients predicted to be most likely to benefit from either monotherapy treatment or the combination therapy."

"Acrivon’s OncoSignature tests are designed to predict drug sensitivity regardless of tumor type," said Erick Gamelin, M.D., Ph.D., chief medical officer of Acrivon. "By using OncoSignature to screen across human cancer tissue samples, we found that a proportion of endometrial and urothelial cancers is also sensitive to the drug, and following further confirmation in preclinical patient-derived xenograft models, we have included these together with platinum-resistant ovarian cancer in our upcoming trial. With Acrivon’s rigorous science-based and selective methodologies, we aim to forge a paradigm change in personalized medicine for optimal patient care."

The Phase 2, multicenter, open-label study will enroll patients with histologically confirmed, locally advanced or metastatic, recurrent platinum-resistant high-grade ovarian cancer, or endometrial adenocarcinoma, or platinum-resistant urothelial carcinoma. Based on the results of the company’s proprietary OncoSignature predictive test, patients will be allocated to one of two treatment arms. Patients who test positive for predicted sensitivity to ACR-368 monotherapy will be enrolled into a single-arm Phase 2 study to assess primarily the anti-tumor activity (confirmed overall response rate) of the recommended Phase 2 dose of ACR-368 (105 mg/m2) for each of the three cancers. Patients who test negative on the OncoSignature test will be enrolled in a single-arm Phase 1b/2 study. The Phase 1b portion of the study will evaluate the safety and tolerability of the combination of the recommended Phase 2 dose of ACR-368 with escalating doses of low-dose gemcitabine for each of the three cancers. Once the recommended Phase 2 dose of low-dose gemcitabine has been determined, the study will expand into a Phase 2 study to assess the anti-tumor activity (confirmed overall response rate) of ACR-368 and low-dose gemcitabine for each of the three cancers.

About ACR-368
ACR-368 is a potent, selective inhibitor of CHK1 and CHK2 which has shown deep durable single agent activity, including complete responses, in a proportion of patients across several Phase 2 studies of platinum-resistant ovarian cancer and in squamous cell cancers, including anal cancer for which FDA has granted orphan drug designation. ACR-368 has been tested in >1,000 patients as monotherapy and in combination, showing excellent pharmacokinetic and pharmacological properties and a favorable safety profile at the recommended Phase 2 dose across monotherapy studies. Acrivon has obtained exclusive, world-wide rights to develop and commercialize ACR-368 (also known as prexasertib) under a license agreement with Eli Lilly and Company.

On June 22, 2022 OCTALFA reported that its subsidiary ORPHELIA Pharma, the French biopharmaceutical company dedicated to the development and commercialization of orphan medicines for the treatment of rare and pediatric diseases, has included the first patient in the KIMOZO French Early Access Program for the treatment of relapsed or refractory neuroblastoma (Press release, ORPHELIA Pharma, JUN 22, 2022, View Source;utm_medium=rss&utm_campaign=octalfa-announces-the-inclusion-of-the-first-patient-in-the-french-early-access-program-granted-to-its-subsidiary-orphelia-pharma-for-the-use-of-kimozo-40-mg-ml-temozolomide-oral-suspension-in [SID1234619551]).

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KIMOZO 40 mg/ml (oral suspension of temozolomide) was granted an early access pre-marketing authorization (Autorisation d’Accès Précoce, AAP) in France on March 31st, 2022 by the Haute Autorité de Santé (HAS) for the treatment of relapsed or refractory neuroblastoma in patients aged 1 to 6 years as well as patients unable to swallow temozolomide capsules.

The goal of Early Access Programs in France is to accelerate access to innovative drugs before or after Market Authorization is granted once all conditions specified in Article L.5121-12 of the French Public Health Code (Code de la Santé Publique) are met:

No appropriate treatment exists;
The treatment’s implementation cannot be postponed;
The efficacy and safety of these drugs are strongly presumed based on therapeutic trials;
These drugs are considered to be innovative, particularly when compared to a possible clinically-relevant comparator.
Full details of the early access program can be found at the Haute Autorité de Santé and the ANSM websites.

About KIMOZO 40 mg/ml

KIMOZO 40 mg/ml is a liquid, taste-masked and ready-to-use oral formulation of temozolomide developed to treat rare pediatric cancers.

In France, KIMOZO has been granted an Early Access Program, to be used as monotherapy or in combination with irinotecan or topotecan in the treatment of pediatric patients aged 1 to 6 years and in patients with incapacity to swallow capsules of temozolomide and who suffer from:

refractory high-risk neuroblastoma or presenting an insufficient response to induction chemotherapy;
relapsed high-risk neuroblastoma after at least a partial response to induction chemotherapy followed by myeloablative therapy and stem cell transplantation.
KIMOZO was developed by ORPHELIA Pharma in collaboration with Gustave Roussy.