On June 8, 2022 BioVaxys Technology Corp. (CSE: BIOV; FRA: 5LB; OTCQB: BVAXF) ("BioVaxys" or "Company"), reported that its Lyon, France-based bioproduction partner, BioElpida ("BioElpida"), has completed the creation of multiple OVCAR-3 cell banks as the next step in the GMP manufacturing process development for BVX-0918, BioVaxys’ vaccine for treatment of platinum-resistant ovarian cancer (Press release, BioVaxys Technology, JUN 8, 2022, View Source [SID1234615747]).

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The OVCAR-3 cell line is mandatory for creating the identity assays that will have to be performed on every batch of ovarian cancer vaccine. This assay is required by regulatory bodies in the EU and United States. The cell line is derived from a human ovarian adenocarcinoma, established from a patient refractory to cisplatin, a chemotherapeutic agent used in late-stage ovarian cancer. Patients whose tumors are innately cisplatin-resistant at the time of initial treatment generally have poor prognosis, which is the patient population target for BVX-0918.

BioVaxys President and Chief Operating Officer Kenneth Kovan stated that "Completion of OVCAR-3 cell banks is another step towards our ability to produce GMP yields of BVX-0918, and brings us closer to our Phase I study in the EU planned for later this year."

BioVaxys recently entered collaborations with Hospices Civils de Lyon in France and Deaconess Research Institute in the United States to provide the Company with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients. Tumor samples from both hospitals are being used to validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction for prospective patients in the US and EU. Tumor samples from HCL will also be used for process testing and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production.

BioVaxys’ vaccine platform is based on the established immunological concept that modifying surface proteins—whether they are viral or tumor—with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient’s immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys’ cancer vaccines are created by extracting a patient’s own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors.

A first generation single-hapten vaccine invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study. These studies were conducted under an FDA-reviewed IND. A first generation autologous, haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy. The results were encouraging: In 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; 8 patients survived for more than 2 years. BioVaxys has enhanced the first-generation approach by utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results.

On June 8, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported the appointment of Darrel P. Cohen, MD, PhD as Chief Medical Officer of Cell Therapy to lead its clinical development, clinical operations, and regulatory affairs functions (Press release, Athenex, JUN 8, 2022, View Source [SID1234615746]). He will be replacing Kurt Gunter, MD, who has decided to pursue other opportunities outside of cell therapy.

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"We are delighted to welcome Dr. Cohen to Athenex during this transformative period, as we strategically pivot to focus on advancing first-in-class therapies from our differentiated NKT cell platform," said Dr. Johnson Lau, Chief Executive Officer of Athenex. "Darrel’s proven leadership plus extensive experience in the clinical development and multinational regulatory approvals of several new cancer drugs over the past decade will position us well for success as we continue to rapidly advance our investigational cell therapy pipeline in the clinic."

"We are enthusiastic about the promising benefits NKT cells may offer cancer patients and to the scientific community, and we look forward to working with Darrel to bring these much-needed products closer to regulatory approval," said Daniel Lang, MD, President of Athenex Cell Therapy. "Additionally, we would like to thank Kurt for his dedication and meaningful contributions to the company, and we wish him the very best in his future endeavors."

Dr. Cohen is a hematologist/oncologist with over 25 years of oncology clinical research and drug development experience in both solid tumors and hematological malignancies. He has held leadership positions of increasing responsibility at Pharmacia, Sanofi-Aventis, and Pfizer, including Vice President of Late-Phase Clinical Development at Pfizer Oncology where he was involved in multiple successful regulatory submissions of new molecularly targeted cancer drugs such as SUTENT (sunitinib), XALKORI (crizotinib), and IBRANCE (palbociclib). More recently, Dr. Cohen was Head of Clinical Development at EUSA Pharma then Chief Medical Officer at Biosight Pharmaceuticals, having been a principal investigator on several clinical trials in the past and co-authored numerous peer-reviewed publications. Darrel received his MD and PhD degrees in Medicine and Microbiology from Boston University School of Medicine, trained as a resident in Internal Medicine at Georgetown University Medical Center, and completed a fellowship in Hematology/Oncology at Duke University Medical Center.

"Athenex is pioneering the development of NKT cell immunotherapy, offering an outpatient treatment with potential for improved safety, efficacy, and accessibility over existing approved cell therapy options," said Dr. Cohen. "The early clinical trial data from patients with solid tumors or hematological malignancies are very encouraging, and I am truly excited to join the company to further advance its cell therapy pipeline and unlock its full therapeutic potential."

On June 8, 2022 Race Oncology Limited ("Race") reported it is expanding the FTO-targeted BISECT (RAC-006) clinical trial in extramedullary Acute Myeloid Leukaemia (EMD AML) and Myelodysplastic Syndromes (MDS) to include five additional trial sites in Spain and Italy and has signed a new clinical support agreement with global Clinical Research Organisation, Parexel International to support the additional trial monitoring activities (Press release, Race Oncology, JUN 8, 2022, View Source [SID1234615743]).

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BISECT (RAC-006) is an open label Phase 1b/2a clinical trial in patients with EMD AML and MDS which recently received Ethics and Governance approval to commence patient recruitment at the Calvary Mater Hospital Newcastle (ASX announcements: 6 April 2022 and 12 May 2022). The intention to expand the BISECT trial to Europe was announced at the 2021 Race Annual General Meeting (ASX Announcement: 23 November 2021).

"We are pleased that we have received strong interest in our BISECT (RAC-006) EMD AML and MDS study from experienced European haematologists. These clinicians identify a significant unmet need for the treatment of EMD AML and MDS and want to be actively involved in EMD clinical research. We look forward to activating these sites once we have cleared the necessary European Regulatory and Ethics approval process."

Race CMO Dr David Fuller
The total study costs are expected to be in the range of A$7.7 million to a maximum of A$15.4 million. The final cost is dependent on the location and number of patients screened and enrolled in the trial. Due to the adaptive (Bayesian) design of this study, the total study costs cannot be precisely determined, but are expected to be lower than the maximum cited here.

Payments will be made to Parexel throughout the study upon reaching key milestones as patients are recruited and other operational variables are achieved.

On June 7, 2022 Karyopharm Therapeutics Inc. (the "Company") reported that received written notice from Biogen MA Inc. ("Biogen") that Biogen has elected to terminate the Asset Purchase Agreement entered into between the Company and Biogen dated January 24, 2018, as amended (the "Agreement") (Filing, 8-K, Karyopharm, JUN 7, 2022, View Source [SID1234616002]).

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Pursuant to the Agreement, the Company sold to Biogen rights to the Company’s oral Selective Inhibitor of Nuclear Export compound KPT-350 and certain related assets. Biogen was developing KPT-350 for use in amyotrophic lateral sclerosis, or ALS. Under the terms of the Agreement, the Company received an upfront payment of $10.0 million in 2018, and was eligible to receive additional payments of up to $207.0 million based on the achievement by Biogen of future specified development and commercial milestones. The Company was also eligible to receive tiered royalty payments that reach low double-digits based on future net sales until the later of the tenth anniversary of the first commercial sale of the applicable product and the expiration of specified patent protection for the applicable product, determined on a country-by-country basis.

As a result of the termination, the Company is not entitled to receive any milestone payments or royalties under the Agreement, although the Company has specified rights relating to the purchased assets upon the termination of the Agreement, which the Company is evaluating.

The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, as amended, which was filed collectively with the Securities and Exchange Commission as (i) Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q on May 10, 2018 and (ii) Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q on November 3, 2021, and is incorporated herein by reference.

On June 7, 2022 Elevar Therapeutics has reported the Phase II clinical trial results of its small-molecule tyrosine kinase inhibitor (TKI) rivoceranib in progressive recurrent or metastatic adenoid cystic carcinoma (R/M ACC) patients (Press release, Elevar Therapeutics, JUN 7, 2022, View Source [SID1234615922]).

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The open-label Study RM-202 of the orally administered TKI was carried out at 11 sites in the US and South Korea.

It has been designed to investigate the therapy’s safety and efficacy in patients with progressive R/M ACC.

Study RM-202 evaluated rivoceranib in 80 patients, including 53 (66.3%) based in the US.

Within six months before the trial, all the participants demonstrated tumor progression.

An overall response rate (ORR) of 15.1% was observed in the trial, and the remaining 85% of patients had a tumour size reduction, though not an endpoint of the trial.

Elevar Therapeutics CEO Saeho Chong said: "With every participant exhibiting a recent growing lesion upon entering this Phase II trial of rivoceranib, these results demonstrate significant clinical effectiveness and rivoceranib’s promise as a potential new treatment for patients with R/M ACC.

"Our entire Elevar team is greatly encouraged by these results, and we are fully focused on advancing rivoceranib through the regulatory process."

In this trial, 52% of subjects reported a response according to CHOI (size or density), which is believed to be more correlated with median overall survival (mOS) than RECIST v1.1 (size only).

Irrespective of previous vascular endothelial growth factor (VEGFR) therapy, median progression-free survival (mPFS) of nine months was observed versus published data of a baseline of 2.8 months for R/M ACC.