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.

On November 28, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that it will host a virtual KOL event to discuss new data from the VISTA-101 clinical trial of KVA12123 in patients with advanced solid tumors (Press release, Kineta, NOV 28, 2023, View Source;utm_medium=rss&utm_campaign=kineta-to-host-kol-event-to-review-new-data-from-vista-101-clinical-trial-of-kva12123-in-patients-with-advanced-solid-tumors-on-december-5-2023 [SID1234638007]). Details are as follows:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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KOL Event to Review New Data from VISTA-101 Clinical Trial of KVA12123 in Patients with Advanced Solid Tumors
Tuesday, December 5, 2023 at 2:00 P.M. Eastern Time
To register, click here.

The event will feature presentations from two key opinion leaders in immuno-oncology:

Michael A. Curran, Ph.D., Associate Professor at MD Anderson Cancer Center Department of Immunology, who will discuss key challenges with current cancer therapies and the potential for VISTA blocking immunotherapy to reverse immunosuppression in the tumor microenvironment (TME) and drive anti-tumor activity.
Evan Y. Yu, M.D., Professor and Medical Oncology Section Head at Fred Hutchinson Cancer Center, who will join Kineta leadership to discuss immuno-oncology clinical trials and review the new positive monotherapy data from the ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123, the company’s VISTA blocking immunotherapy, in patients with advanced solid tumors.
A live question and answer session will follow the formal presentations.