On November 28, 2023 TOLREMO therapeutics AG (TOLREMO) reported that the first patient has been dosed in its first-in-human clinical trial evaluating the safety and tolerability, pharmacokinetics, and pharmacodynamics of its lead candidate, TT125-802, in patients across a range of solid tumor indications (Press release, TOLREMO, NOV 28, 2023, View Source [SID1234638014]). TT125-802 is an orally available small molecule CBP/p300 bromodomain inhibitor designed to prevent non-genetic cancer drug resistance and thereby improve the response rates and durability of targeted cancer treatments. In preclinical testing, the compound has demonstrated the ability to block critical transcriptional resistance pathways responsible for cancer’s earliest escape mechanisms to targeted therapies.

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"Initiating our Phase 1 clinical trial is an important corporate milestone for TOLREMO. With TT125-802, we are leveraging our scientific insights to develop an effective CBP/p300 inhibitor with the potential to prevent resistance mechanisms across a broad spectrum of current and future targeted cancer treatments," said Stefanie Flückiger-Mangual, PhD, Co-founder and Chief Executive Officer of TOLREMO. "We are deeply committed to overcoming transcriptionally mediated cancer drug resistance for patient benefit, and this trial marks the start of an exciting new phase for the company."

The Phase I dose-escalation study will enroll patients across a range of solid tumor indications. The primary objective will be a safety assessment of TT125-802 as a monotherapy. Secondary objectives include the analysis of the drug’s biological activity, pharmacokinetics, pharmacodynamics, and target engagement, as well as the identification of the recommended dosing regimen and potential biomarkers for future patient stratification. The trial will be conducted initially at clinical centers in Europe, with the potential to include sites in the U.S. through an open Investigational New Drug (IND) application with the Food and Drug Administration (FDA). Stepwise, TOLREMO will advance TT125-802 into clinical testing in combination with targeted therapies, such as KRAS, EGFR or AR inhibitors, in specific advanced solid tumor indications.

"TOLREMO’s in-depth preclinical analyses have showcased potency, selectivity, and safety data that demonstrate that TT125-802 has a highly differentiated profile, providing the foundation for translating these findings into the clinical setting. By specifically inhibiting transcriptional resistance pathways to targeted treatments, TT125-802 has the potential to profoundly improve the response rate and durability of other therapeutic interventions," said Alessandra Cesano, MD, PhD, consulting Chief Medical Officer at TOLREMO therapeutics.

On November 28, 2023 Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company advancing novel multi-targeted therapies for use as monotherapy and in combination, reported financial results for the fiscal quarter ended September 30, 2023 (Press release, Portage Biotech, NOV 28, 2023, View Source [SID1234638012]).

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"The Company is focused on developing its two lead clinical programs and maximizing its resources given market conditions. We continue to build on the favorable interim data and early evidence of single agent activity from the Phase 1/2 trial of our lead program, PORT-2, presented at SITC (Free SITC Whitepaper) earlier this month and the near-term focus is defining the recommended Phase 2 dose," said Dr. Ian Walters, Chief Executive Officer, and Chairman of Portage Biotech. "We are also excited with the progress and investigator interest in our ADPORT-601 adaptive Phase 1a/1b trial for PORT-6 (A2A inhibitor) and PORT-7 (A2B inhibitor) in multiple solid tumors, which was presented at SITC (Free SITC Whitepaper) by Sumit K. Subudhi of the University of Texas MD Anderson Cancer Center. Clinical enrollment for PORT-6 is progressing well, we have completed dosing in the low dose cohort and are enrolling patients in the next dose cohort." continued Dr. Walters. "Accrual in the Phase 1 portion of the PORT-2 trial is expected to be completed in the first calendar quarter of 2024, and we expect to make clinical updates at ASCO (Free ASCO Whitepaper) and SITC (Free SITC Whitepaper) during 2024 on both programs".

Company Highlights

Presented updated data support the proof of concept of using an iNKT engager monotherapy (PORT-2) to induce immune response for patients with non-small cell lung cancer (NSCLC) and melanoma at SITC (Free SITC Whitepaper).
Presented trial in progress of ADPORT-601: the Adenosine 2A(A2A) and Adenosine 2B(A2B) trial for patients with solid tumors with high adenosine receptor expression which has attracted strong academic interest in the clinical design.
Portage completed a $6 million financing in October 2023 for continued clinical development, general corporate and working capital purposes.
Financial Results from Quarter Ended September 30, 2023

The Company incurred a net loss of approximately $5.2 million and total comprehensive loss of approximately $6.5 million during the three months ended September 30, 2023 (the "Fiscal 2024 Quarter"), compared to a net loss and total comprehensive loss of approximately $1.1 million during the three months ended June 30, 2022 (the "Fiscal 2023 Quarter"), an increase in net loss of $4.1 million and an increase in total comprehensive loss of $5.4 million from the Fiscal 2023 Quarter.

Operating expenses for the Fiscal 2024 Quarter, which include research and development ("R&D") costs and general and administrative ("G&A") expenses, were $5.9 million compared to $3.6 million in the Fiscal 2023 Quarter, an increase of $2.3 million, which is discussed more fully below.

R&D costs increased by approximately $2.7 million to approximately $4.2 million, or approximately 180%, for the Fiscal 2024 Quarter from approximately $1.5 million in the Fiscal 2023 Quarter. The increase was primarily attributable to an overall increase in clinical trial and manufacturing-related costs associated with the clinical trials for PORT-2 (iNKT) and the PORT-6 and PORT-7 (adenosine assets). These increases in R&D costs reflect the clinical activity and manufacturing-related costs related to developing the Company’s adenosine and iNKT development programs.

G&A expenses decreased by approximately $0.4 million to approximately $1.7 million, or approximately 19%, from approximately $2.1 million in the Fiscal 2023 Quarter, due to the decreases in D&O insurance premiums, non-cash share-based compensation, and decreases in consulting fees relating to the Tarus acquisition incurred in the Fiscal 2023 Quarter.

As of September 30, 2023, the Company had cash and cash equivalents of approximately $3.4 million, and total current liabilities of approximately $3.1 million. Giving effect to the completion of the recent $6 million equity financing in October 2023, which generated proceeds, net of offering expenses, of $5.3 million, the Company’s cash and cash equivalents as of September 30, 2023, was approximately $8.7 million.

On November 28, 2023 Peptomyc, a Spanish clinical stage biotech company spin-off of the Vall d’Hebron Institute of Oncology (VHIO) and the Catalan Institute of Research and Advanced Studies (ICREA) in Barcelona, reported that in November the first patient of its Phase Ib clinical trial was successfully treated with OMO-103 – the first direct pan-Myc inhibitor to have completed Phase I clinical trial last year – in combination with the standard of care (SoC) drugs gemcitabine and nab-paclitaxel (Press release, Peptomyc, NOV 28, 2023, View Source [SID1234638010]).

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This Phase Ib trial includes patients with treatment-naïve metastatic pancreatic ductal adenocarcinoma (PDAC). 4 sites in Spain are currently recruiting: the Hospital Universitari Vall d’Hebrón in Barcelona, the Instituto Catalán de Oncología in Barcelona, the Hospital General Universitario Gregorio Marañón in Madrid and the Hospital Universitario Miguel Servet in Zaragoza. The objective of this study is to evaluate the safety and efficacy of OMO-103 in combination with SoC in first-line metastatic PDAC.

Peptomyc CMO Manuela Niewel said: "We are thrilled to see the first patient successfully treated in this trial and this represents a major milestone for the company and patients we hope to serve" and Peptomyc CEO Laura Soucek added: "I am proud of the work of our team and thankful for the support from clinicians and hospitals who have enabled this important milestone."

On November 28, 2023 Oxford Vacmedix (OVM), the UK-based biopharma company developing vaccines to treat cancer reported ongoing licensing discussions with its largest shareholder DxVx for lead cancer vaccine OVM-200 (Press release, Oxford Vacmedix, NOV 28, 2023, View Source;utm_medium=rss&utm_campaign=licensing-deal-for-ovm-200 [SID1234638009]). If concluded the licensing deal will grant DxVx rights to develop and to commercialise OVM-200 in South Korea and China, in return for an upfront payment, development milestone payments and royalties on sales. Under the proposed agreement DxVx would run trials in South Korea and China and manage regulatory and commercial aspects of development. All clinical trial data will be shared with OVM.

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OVM-200 targets survivin, a protein overexpressed by cancer cells that allow unregulated growth and stimulates an immune response. The vaccine is in a Phase 1 trial in the UK which is both the first time OVM-200 has been used in people and also the first time any ROP based vaccine has been tested in the clinic. The Phase I trial of OVM-200 is focused on safety and on establishing an immune response in advanced cancer patients in three cancer indications – non small cell lung cancer (NSCLC), prostate cancer and ovarian cancer. Patients are being treated at five leading hospitals in the UK. Twelve patients were treated in Phase 1a, the dose escalation part of the trial, with initial results showing very good safety and a strong immune response. A further 24 patients are now being treated in Phase 1b.

The announcement by DxVx stresses the benefits of the ROP technology and in particular the wide applicability of ROPs to treat cancer by being suitable for all HLAs (human leucocyte antigen).

William Finch, CEO of OVM said:

"We are very pleased that are largest shareholder will be licensing OVM-200 for South Korea and China. DxVx undoubtedly have the expertise and capabilities to run clinical trials and to commercialise in these countries and we look forward to working closely together on his programme. The OVM-200 vaccine will be used both alone and in combination to help patients with advanced cancer."

A DxVx official added:

"We plan to complete the license-in process soon and proceed with Phase 1b and Phase 2 clinical trials in major Asian countries (Korea, China and considering India in the future). We will try to launch it through an accelerated approval that will allow patients to benefit early from effective drugs before all clinical trials are completed around 2027."

On November 28, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at the JMP Securities Hematology and Oncology Summit at 2:00 p.m. ET / 11:00 a.m. PT on Tuesday, December 5, 2023 (Press release, Kura Oncology, NOV 28, 2023, View Source [SID1234638008]).

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A live audio webcast of the presentation will be available in the Investors section of Kura’s website at www.kuraoncology.com, with a replay available shortly after the live event.