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3rd Dose Level Initiated in CLTX CAR T Phase I Trial

On February 25, 2022 Chimeric Therapeutics (ASX:CHM, "Chimeric"), a clinical-stage cell therapy company and an Australian leader in cell therapy, reported that the first patient in dose level 3 of the phase 1 CHM 1101 (CLTX CAR T) clinical trial in recurrent/ progressive glioblastoma has now initiated therapy at City of Hope, one of the largest cancer research and treatment organizations in the United States (Press release, Chimeric Therapeutics, FEB 25, 2022, View Source [SID1234609034]).

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Patients in this dose level will receive a total dose of 240 X 106 CHM 1101 (CLTX CAR T) cells through dual routes of intratumoral and intraventricular administration. Advancement to this dose level has come about rapidly following on the completion of the 2nd dose cohort without any dose limiting toxicities in December 2021.

"We are very pleased with the continued progress of the trial," said Jennifer Chow, Chimeric Therapeutics Chief Executive Officer. "With the encouraging safety and activity signs shown in the lower two dose levels we are excited to be advancing to the higher dose levels that may provide more therapeutic benefit to patients with progressive or recurrent glioblastoma."

Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper.

ABOUT CHLOROTOXIN CAR T
Chlorotoxin CAR T (CLTX CAR T) cell therapy is a first and best in class CAR T cell therapy that has the potential to address the high unmet medical need of patients with recurrent/ progressive glioblastoma. Research to develop the intellectual property covering this CAR T cell therapy took place at City of Hope.

CLTX CAR T cell therapy uniquely utilizes chlorotoxin (CLTX), a peptide derived from scorpion toxin, as the tumour-targeting component of the chimeric antigen receptor (CAR). CLTX and CLTX CAR T cells have been shown in preclinical models to bind more broadly and specifically to GBM cells than other targeting domains like EGFR, HER-2 or IL-13.

In preclinical models, CLTX CAR T cells also demonstrated potent antitumor activity against glioblastoma while not exhibiting any off-tumor recognition of normal human cells and tissues, indicating a potentially optimal safety and efficacy profile.

First patient treated in cohort 2 SARTATE™ neuroblastoma therapy trial

On February 25, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that it has successfully treated its first participant in cohort 2 of the 64Cu/67Cu SARTATE neuroblastoma therapy trial (CL04) at the increased dose level of 175MBq/kg body weight (Press release, Clarity Pharmaceuticals, FEB 25, 2022, https://www.claritypharmaceuticals.com/news/1patient_cohort2/ [SID1234608956]).

Clarity has recently progressed to cohort 2 of the CL04 trial following the completion of cohort 1 where three participants received therapy with 67Cu SARTATE at a dose of 75MBq/kg body weight. The Safety Review Committee assessed the data from cohort 1 where no dose limiting toxicities have occurred and recommended to progress the trial to cohort 2, without modification, increasing the dose to 175MBq/kg body weight.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very excited to dose the first patient in cohort 2 in our neuroblastoma therapy trial in the US, having successfully completed cohort 1 in January 2022. The increase in administered activity between cohorts 1 and 2 is significant in radiation-sensitive disease, such as neuroblastoma, and cohort 2 will see administered activities more than double in comparison to cohort 1. We look forward to continuing recruitment in cohort 2 at all five clinical sites in the US, building upon the encouraging initial data from cohort 1 and further gathering evidence of diagnostic and therapeutic benefits of the SARTATE product for the treatment of children with neuroblastoma."

The CL04 trial is a theranostic (diagnosis and therapy) trial in paediatric patients with high-risk neuroblastoma (NCT04023331)1. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a clinical trial with up to 34 participants conducted at five clinical sites in the US.

Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.2 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.3

In 2020, the US Food and Drug Administration (FDA) awarded Clarity two Orphan Drug Designations (ODDs), one for 64Cu SARTATE as a diagnostic agent for the clinical management of neuroblastoma and one for 67Cu SARTATE as a therapy of neuroblastoma, as well as two Rare Paediatric Disease Designations (RPDDs) for these products. Should Clarity be successful in achieving US FDA New Drug Applications for these two products, RPDDs may potentially allow the Company to access a total of two tradeable Priority Review Vouchers (PRVs) which most recently traded at USD110M per voucher.4

Dr Taylor said, "Our team, clinicians and collaborators have all shown strong dedication to progressing the neuroblastoma trial at some of the best cancer centres in the US, driven by our mutual goal of improving the treatment paradigm for children with this insidious disease. In the times when the pandemic was having a significant impact on clinical site operations and recruitment, this support is indicative of the importance and urgency of improving the prognosis of children with high-risk neuroblastoma, where current treatment strategies are limited. We continue working closely with the clinical sites and the US FDA to progress this trial swiftly, building upon the mounting evidence of the advantages of the SARTATE treatment paradigm over current treatment regiments, in pursuit of Clarity’s ultimate goal of improving treatment outcomes for children and adults with cancer."

This announcement has been authorised for release by the Executive Chairman.

Update on recent developments regarding Dasynoc

On February 24, 2022 Xspray Pharma AB (publ), (Nasdaq Stockholm: XSPRAY) reported an update on recent developments regarding Xspray Pharma’s first product, Dasynoc, currently under review by the United States Food & Drug Administration ("FDA") (Press release, Xspray, FEB 24, 2022, View Source [SID1234650013]).

Bristol Myers Squibb ("BMS") has filed a lawsuit in the United States District Court for the District of New Jersey against Xspray Pharma claiming patent infringement in relation to the filing of Xspray Pharma’s Dasynoc New Drug Application ("NDA") with the FDA.

"Xspray Pharma has a process for making stable amorphous products that are not covered by BMS’s patents. While we cannot predict the outcome of any litigation, BMS’s lawsuit is entirely expected, and I am confident the court will ultimately rule in our favor and allow us to provide an improved product", said Per Andersson, CEO Xspray Pharma.

The ongoing work with Dasynoc remains on track and these developments will not mean any change of strategic or operational direction for Xspray Pharma. It is also worth noting that the ongoing FDA approval process will proceed in parallel.

Xspray Pharma will not be providing any additional information or comments on this matter for the time being.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Clovis Oncology has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

MacroGenics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .