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.

On June 7, 2022, Olema Pharmaceuticals, Inc. ("Olema") and Aurigene Discovery Technologies Limited ("Aurigene"),reported that entered into an exclusive global license agreement (the "License Agreement") to research, develop and commercialize novel small molecule inhibitors of an undisclosed oncology target (Filing, 8-K, Olema Oncology, JUN 7, 2022, View Source [SID1234615809]).

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Under the terms of the License Agreement, Olema will make an upfront licensing payment of $8 million for rights to a pre-existing Aurigene program. Aurigene will also be eligible to receive up to $60 million in potential clinical development and regulatory milestones, up to $370 million in potential commercial milestones, and royalties ranging from the mid-single digits to the low teens based on annual net sales. During the initial research term, Olema will contribute funding to Aurigene to facilitate ongoing discovery efforts and the companies will jointly direct further preclinical work. Upon successful completion of the research term, Olema will lead clinical development as well as regulatory and commercial activities.

The foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement, which will be filed as an exhibit to Olema’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2022. Olema intends to redact certain portions of the License Agreement for confidentiality purposes.

On June 7, 2022 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-US) specialty pharmaceutical company, announced today that Amal Khouri, Chief Business Officer, reported that present at the 2022 BIO International Convention on Tuesday, June 14, 2022 at 2:45 pm Pacific Time (Press release, Knight Therapeutics, JUN 7, 2022, View Source [SID1234615769]).

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Knight’s Business Development team will also be participating in BIO’s One-on-One Partnering which facilitates meetings with senior biotech executives, business development leaders, and investors from premier firms around the globe.

The annual BIO International Convention, hosted by Biotechnology Innovation Organization (BIO), is the world’s largest industry gathering and brings together thousands of global biotechnology and biopharmaceutical leaders. The four-day, in-person event includes networking, programming, and partnering opportunities.