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Plus Strengthens Commercial RNL Supply Chain with Ten Year Exclusivity Agreement

On July 27, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported it entered into an exclusivity agreement with ABX Advanced Biochemical Compounds GmbH (ABX) for the supply of a key component required to manufacture the drug substance in Rhenium-186 NanoLiposome (186RNL), the Company’s lead radiotherapeutic (Press release, Cytori Therapeutics, JUL 27, 2021, View Source [SID1234585439]).

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"In parallel to our clinical progress, we are simultaneously strengthening our commercial RNL supply chain for long-term success", said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "ABX has extensive experience manufacturing and supplying chemical components for the radiopharmaceutical industry and exclusivity provides us an additional layer of market protection around our RNL portfolio."

As part of the agreement, ABX will produce a high purity precursor that meets current Good Manufacturing Practices (cGMP) and all relevant requirements of the U.S. Food and Drug Administration and other similar global regulatory entities. Plus Therapeutics will have up to 10 years of exclusive access to the cGMP precursor. This strategic partnership secures the commercial supply chain for 186RNL and extends to future products under the RNL platform.

186RNL is being developed to potentially treat recurrent glioblastoma and other rare and difficult-to-treat cancers. Plus Therapeutics is currently enrolling patients with recurrent glioblastoma in the U.S. multi-center ReSPECT-GBM Phase 1 dose-finding clinical trial which is designed to safely, effectively and conveniently deliver high doses of radiation directly to brain tumors.

Redx Pharma Announces Phase 2 Dose Selection of its Porcupine Inhibitor, RXC004

On July 27, 2021 Redx Pharma (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, reported it has selected 2 mg once daily as the dose of RXC004 for the planned Phase 2 monotherapy, proof of concept clinical trials based on the safety profile observed in Phase 1 (Press release, Redx Pharma, JUL 27, 2021, View Source [SID1234585437]). The studies are expected to start during the second half of 2021. RXC004 is the Company’s lead drug candidate and is a highly potent, orally active porcupine inhibitor being developed as a targeted therapy for Wnt-ligand driven cancer. Porcupine is a key enzyme in the Wnt pathway, well established as a key driver of both tumour growth and immune evasion.

The selection of a dose and decision to move RXC004 into Phase 2, follows the successful recruitment of all patients to the monotherapy arm of the Company’s ongoing open label dose escalation Phase 1 study (NCT03447470). The primary objective of the Phase 1 study was to establish the safety and tolerability of RXC004 in patients. Preliminary data from the study in patients with unselected advanced solid tumours, showed that RXC004 2mg once daily was safe, tolerated and provided target coverage at levels required to assess monotherapy efficacy in Phase 2 clinical trials in selected patients with Wnt-ligand driven cancers. Whilst the Phase 1 study was in genetically unselected cancers, the data suggested a differential level of activity between Wnt-ligand driven cancers and non Wnt-ligand driven cancers, in line with observations of other molecules in this class. Redx plans to present the monotherapy results from the Phase 1 study at the ESMO (Free ESMO Whitepaper) Congress in September 2021.

Lisa Anson, Chief Executive Officer of Redx Pharma commented "Our Phase 1 monotherapy study supports our belief that RXC004 has the potential to be a significant, novel targeted medicine for the treatment of Wnt-ligand driven cancer. Our distinctive approach to drug discovery has enabled our highly talented scientific team to design our Porcupine Inhibitor to unlock the therapeutic potential of Wnt pathway blockade, a long sought-after oncology target. The decision to progress to Phase 2 and the selection of our monotherapy dose represent major milestones in the clinical development of our lead asset."

Jane Robertson, Chief Medical Officer of Redx Pharma added "The Redx team and our investigators are excited to move forward into Phase 2 clinical studies to evaluate the efficacy of RXC004 as monotherapy in selected patients with mCRC, pancreatic and biliary tract cancers, whose tumours have high Wnt-ligand dependency. We look forward to initiating these studies in the coming months."

About the Phase 2 programme

Redx plans to commence a global Phase 2 monotherapy programme in three tumour types to assess RXC004 efficacy in patients with Wnt ligand-driven cancers. In two tumour types, microsatellite stable metastatic colorectal cancer (MSS mCRC) and pancreatic cancer, the studies will enrol only patients whose tumours have high Wnt-ligand dependency resulting from specific genetic aberrations (RNF43 mutations and/or RSPO fusions). A third proof of concept study will enrol patients diagnosed with biliary tract cancer, a tumour known to have high Wnt-ligand dependency. All three of these cancer types have high unmet need with limited treatment options and poor 5-year survival rates of less than 3% for biliary and pancreatic cancer and 14% for mCRC. All three studies are planned to commence in H2 2021 and initial results could be available from 2022. RXC004 is also currently being investigated in a Phase 1 study in combination with nivolumab (OPDIVO – Bristol Myers Squibb, an anti-PD-1 antibody). The primary objective of this arm of the study is to evaluate the safety and tolerability of this combination in patients with unselected advanced malignancies. The results from this combination study are expected in H2 2021 and will be used to define a dose of RXC004 to be used in combination with standard dose nivolumab in a Phase 2 study in patients with genetically selected microsatellite stable (MSS) metastatic colorectal cancer (MSS mCRC).

SynOx Therapeutics Strengthens Team with Appointment of Ton Logtenberg as Chairman and Ray Barlow as Chief Executive Officer

On July 27, 2021 SynOx Therapeutics Limited ("SynOx" or the "Company"), the late-stage clinical biopharmaceutical company developing emactuzumab for the treatment of Tenosynovial Giant Cell Tumours (TGCT), reported the appointment of a new Chairman and Chief Executive Officer and plans for a registrational trial of emactuzumab in the USA and EU (Press release, SynOx Therapeutics, JUL 27, 2021, View Source [SID1234585435]).

Professor Ton Logtenberg has been appointed non-executive Chairman. Ton has over 25 years’ experience in the biopharmaceutical industry, including as Co-Founder and Chief Scientific Officer of Crucell N.V. (acquired by Johnson & Johnson for $2.4 billion) and Founder, President and CEO of Merus N.V (NASDAQ: MRUS).

Ton Logtenberg, Chairman of SynOx, said: "I am delighted to be joining SynOx as non-executive Chairman. SynOx’s mission is to focus on the unmet clinical needs of patients with TGCT, a group of rare tumours that form in the joints and is often a progressive disease that negatively impacts young adults in the prime of their life. SynOx is well funded and backed by world leading investors to enable the development of emactuzumab, a late-stage clinical asset with the potential to provide a safe and efficacious treatment for this debilitating disease."

Ray Barlow joins SynOx as CEO from Kiadis Pharma N.V. where he was Chief Business Officer up to the successful conclusion of its sale to Sanofi in April 2021. Ray has over 20 years’ experience in the biopharmaceutical industry gained through leadership positions in scientific, clinical, commercial, and executive roles in global pharmaceutical companies (AstraZeneca, J&J and Amgen), publicly listed biotech companies (Emergent BioSolutions Inc, Crucell N.V., e-Therapeutics PLC and Kiadis Pharma N.V.) and a number of private biotech companies.

Ray Barlow, Chief Executive Officer of SynOx, commented: "I am excited to be joining SynOx as CEO at this critical point in the Company’s journey to establish emactuzumab as a potentially best-in-class treatment for patients with TGCT on a global basis. Emactuzumab, an IgG1 CSF-1R targeted antibody, has already generated highly promising results as a monotherapy in over 60 patients with TGCT and we look forward to continuing to work with the regulatory agencies to enable the initiation of our upcoming registrational clinical trial (TANGENT) in the USA and EU."

Jacob Gunterberg, Partner at HealthCap, noted: "We are delighted to welcome Ton and Ray to the SynOx Therapeutics Board and leadership team. We are confident that they will bring significant energy and experience to our mission to establish emactuzumab as the therapeutic treatment of choice for patients with TGCT. We would like to thank Nick La Thangue for his contributions as CEO in the period before the transition to the new leadership."

Francesco De Rubertis, Partner at Medicxi, added: "We remain excited by the potential of emactuzumab as a best-in-class treatment for TGCT and are pleased to have Ton and Ray join the Company as we continue the development of the asset through confirmatory clinical trials."

NexImmune to Announce Second Quarter 2021 Financial Results and Provide Corporate Update on August 9, 2021

On July 27, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported it plans to report second quarter financial results and provide a corporate update on Monday, August 9, 2021, via press release, after market close (Press release, NexImmune, JUL 27, 2021, View Source [SID1234585303]).

The press release will be accessible under the investor section of the NexImmune’s website at www.neximmune.com.

More good safety results as Prescient Therapeutics continues cancer treatment tests

On July 27, 2021 Prescient Therapeutics reported that it has successfully finished a round of safety testing on its PTX-100 drug in a basket trial of patients with solid and blood cancers, revealing an "excellent" safety profile (Press release, Prescient Therapeutics, JUL 27, 2021, View Source;utm_medium=rss&utm_campaign=more-good-safety-results-as-prescient-therapeutics-continues-cancer-treatment-tests [SID1234585286]).

On Tuesday, Prescient Therapeutics announced it had completed Phase 1b trials of its novel PTX-100 cancer treatment, with none of the ten patients in the study suffering serious adverse effects linked to the medication.

Additionally the study found PTX-100 was well tolerated by patients even at the highest administered dosage of 2,000 mg/m2.

Steven Yatomi-Clarke, Prescient Therapeutics’ Chief Executive, said he was "pleased" with the results, and noted there were other reasons for the company to celebrate.

Phase 1b testing was primarily designed to test for PTX-100’s safety profile, however clinical benefits were also observed in two of the study’s patients who have previously failed other treatments.

One of these patients had endured five failed treatments before joining the study, and each time was only able to control the disease for a few months before it advanced again.

Following the administration of PTX-100, the patient saw a reduction in their cancer burden and the disease has not progressed for 17 months.

The patient has undergone 24 treatment cycles with PTX-100 and is still taking the drug.

Another patient with cutaneous T cell lymphoma (CTCL) with K-Ras mutation also had aggressive disease and had failed three prior treatments. This patient had a partial response on the study, with reduced cancerous lesions and symptomatic relief. The patient was on therapy for 12 months, receiving 19 cycles of therapy.

"We are encouraged by the biological activity demonstrated by PTX-100 in certain patients on the basket trial with T cell lymphomas," Mr Yatomi-Clarke said.

"Whilst numbers are small, the observation is encouraging in that it indicates activity of PTX-100 as a monotherapy in patients where other therapies have failed."

"We look forward to exploring this in the expansion cohort study as we pursue the quickest route to market for PTX-100 in areas of unmet clinical need."

Positive results in OmniCAR testing
Earlier in July, separate immunogenicity testing on Prescient Therapeutics’ OmniCAR universal CAR-T platform provided similarly positive safety results.

The in-silico tests (meaning they were conducted by complex computer algorithms) found two binding components used in OmniCAR treatments, SpyTag and SpyCatcher, are unlikely to trigger adverse immune responses in patients.

However, Prescient Therapeutics did acknowledge that due to limitations with modern algorithms, in silico testing can often be over-predictive.

Even so, the results substantially de-risk the platform’s development and Mr Yatomi-Clarke said the results leave him confident patients’ immune systems won’t react dangerously to treatments.

OmniCAR is a next-generation CAR-T platform, designed to give medical practitioners greater control over traditional CAR-T treatments – which genetically re-engineer a patients’ own immune system to identify and attack cancerous cells.

The platform is also designed to make treatment safer for patients.