On August 27, 2024 Portage Biotech Inc. ("Portage" or the "Company") (NASDAQ: PRTG), a clinical-stage immuno-oncology company with a portfolio of novel multi-targeted therapies for use as monotherapy and in combination, reported its financial results for the fiscal quarter ended June 30, 2024 (Press release, Portage Biotech, AUG 27, 2024, View Source [SID1234646121]).

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"We continue to explore strategic alternatives. These may include finding a partner for one or more of our assets, a sale of our company, a merger, restructurings (both in and out of court), a company wind down, further financing efforts, or other strategic actions," said Dr. Ian Walters, Chief Executive Officer and Chairman of Portage. "We are encouraged by the two advanced patients that continue on PORT-6 beyond 6 months who we continue to follow, and we plan to replace one patient in the ADPORT-601 trial who withdrew prior to dose limiting toxicity assessment for an unrelated adverse event. We also continue our collaborations with numerous experts to further understand the biology and utility of our product candidates," continued Dr. Walters.

Financial Results for the Quarter Ended June 30, 2024

The Company incurred a net loss of approximately $1.7 million during the three months ended June 30, 2024 (the "Fiscal 2025 Quarter"), compared to a net loss of approximately $4.2 million during the three months ended June 30, 2023 (the "Fiscal 2024 Quarter"), representing a $2.5 million decrease in net loss.

Operating expenses, including research and development ("R&D") costs and general and administrative ("G&A") expenses, were $2.8 million in the Fiscal 2025 Quarter, down from $5.0 million in the Fiscal 2024 Quarter, a decrease of $2.2 million, as detailed below.

R&D costs decreased by approximately $2.3 million, or 64%, from $3.6 million in the Fiscal 2024 Quarter, to $1.3 million in the Fiscal 2025 Quarter. This reduction was primarily due to the winding down of clinical trial costs (principally CRO-related), which decreased by $0.3 million, from $1.0 million in the Fiscal 2024 Quarter to $0.7 million in the Fiscal 2025 Quarter, as the Company paused enrollment in its sponsored clinical trials in the third and fourth quarters of the fiscal year ended March 31, 2024. Manufacturing-related costs decreased by $0.7 million, from $0.8 million in the Fiscal 2024 Quarter to $0.1 million in the Fiscal 2025 Quarter. These decreases reflect reduced clinical activity and manufacturing costs following the Company’s decision to discontinue the iNKT program and pause further patient accrual in the adenosine program. Additionally, R&D non-cash share-based compensation expense decreased from $0.4 million in the Fiscal 2024 Quarter to nil in the Fiscal 2025 Quarter. Payroll-related expenses also decreased by $0.2 million, from $0.5 million in the Fiscal 2024 Quarter to $0.3 million in the Fiscal 2025 Quarter, due to the resignation of two employees in January 2024. Further, in the Fiscal 2024 Quarter, the Company incurred a $0.5 million milestone payment for dosing its first adenosine patients. Consulting fees decreased by $0.1 million, from $0.2 million in the Fiscal 2024 Quarter to $0.1 million in the Fiscal 2025 Quarter, reflecting the decline in consulting-related activity. Lastly, there was a $0.1 million decrease in fees paid related to the transition of the iNKT study before its discontinuation.

G&A expenses increased by $0.1 million, or 7%, from $1.4 million in the Fiscal 2024 Quarter to $1.5 million in the Fiscal 2025 Quarter. Professional fees increased by $0.1 million, from $0.5 million in the Fiscal 2024 Quarter to $0.6 million in the Fiscal 2025 Quarter, primarily due to legal fees associated with regulatory filings, corporate matters, and related audit fees. Payroll-related expenses increased by $0.4 million from $0.2 million in the Fiscal 2024 Quarter to $0.6 million in the Fiscal 2025 Quarter due to the amounts associated with retention agreements executed with an employee and a consultant. Additionally, G&A non-cash share-based compensation expense decreased by $0.2 million due to the continued vesting of stock options with higher fair values, partially offset by recording all Fiscal 2025 Quarter share-based compensation expense as G&A expenses as the result of the discontinuation of the iNKT study and the pause of further patient accrual in the adenosine program. Directors’ fees also decreased by $0.1 million in the Fiscal 2025 Quarter, as all directors, except for two who resigned in April 2024, waived their fees.

The primary reasons for the quarter-over-quarter differences in the Company’s pre-tax items of income and expense were the $1.1 million non-cash gain from the change in the fair value of certain warrants accounted for as liabilities, issued in connection with an equity offering in October 2023, in the Fiscal 2025 Quarter, and the non-cash loss from the increase in the fair value of the deferred purchase price payable to the former Tarus shareholders and the deferred obligation for the iOx milestone, totaling $1.1 million, in the Fiscal 2024 Quarter.

As of June 30, 2024, the Company had cash and cash equivalents of approximately $3.3 million and total current liabilities of approximately $3.0 million.

On August 27, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that Chen Schor, President and Chief Executive Officer, will present at the H.C. Wainwright 26th Annual Global Investment Conference being held from September 9-11, 2024 in New York (Press release, Adicet Bio, AUG 27, 2024, View Source [SID1234646138]).

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Details of the event are as follows:
Date: Tuesday, September 10, 2024
Time: 2:30 p.m. ET

The live audio webcast can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

On August 27, 2024 Privo Technologies reported the receipt of $4.5 million in funding from the National Cancer Institute to support our pivotal Phase 3 clinical trial for a groundbreaking nanotechnology-based treatment targeting carcinoma in situ of the oral cavity (Stage 0 oral cancer) (Press release, Privo Technologies, AUG 27, 2024, View Source;utm_medium=rss&utm_campaign=privo-technologies-receives-4-5m-funding-from-national-cancer-institute-for-phase-3-clinical-trial-of-innovative-oral-cancer-treatment [SID1234646122]). This funding is a critical milestone in our journey toward seeking regulatory approval for PRV111, our innovative treatment designed to revolutionize the standard of care for patients with rare, orphan diseases.

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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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The continued support from the National Cancer Institute not only affirms the potential of our technology but also accelerates our ability to move forward in the regulatory process. With these resources, Privo can conduct the necessary research and clinical studies to demonstrate the safety and efficacy of our treatment, bringing us closer to delivering new therapies to patients who have limited options. This funding is instrumental in advancing our mission to make a meaningful impact on the lives of those battling rare forms of cancer, as we strive to bring this promising treatment to market.

On August 27, 2024 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that data from a Phase 1 study of ZL-1218, the company’s anti-CCR8 antibody, will be presented in a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 taking place September 13-17, 2024, in Barcelona, Spain (Press release, Zai Laboratory, AUG 27, 2024, View Source [SID1234646139]). The preliminary results from the ongoing dose-escalation clinical trial (NCT05859464) will highlight the potential of ZL-1218 to reduce regulatory T cells and modulate T-cell function in the tumor microenvironment (TME) of advanced solid tumors.

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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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"The reduction of suppressive tumor-associated regulatory T cells by ZL-1218 offers promise to re-stimulate the immune attack on advanced solid tumors. We look forward to sharing preliminary results from our Phase 1 study at ESMO (Free ESMO Whitepaper) 2024."

Post this
ZL-1218 is a humanized monoclonal antibody with an enhanced Fc region that targets CCR8, a chemokine receptor selectively expressed on tumor-associated regulatory T cells (Treg) and may enhance antitumor immune response by depletion of CCR8+ Treg cells via antibody-dependent cellular cytotoxicity activity. ZL-1218 offers potential as a novel therapeutic to treat solid tumors. Enrollment is ongoing in the global Phase 1 study of ZL-1218 as a single agent and in combination with pembrolizumab in patients with advanced solid tumor malignancies.

"The ability to overcome the complexities of the tumor microenvironment are critical to improving patient outcomes in cancer immunotherapy," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "The reduction of suppressive tumor-associated regulatory T cells by ZL-1218 offers promise to re-stimulate the immune attack on advanced solid tumors. We look forward to sharing preliminary results from our Phase 1 study at ESMO (Free ESMO Whitepaper) 2024."

Details regarding the Zai Lab poster presentation at ESMO (Free ESMO Whitepaper) 2024 are as follows:

Title: Preliminary Clinical PK and PD analysis of a Phase 1 Study of ZL-1218, a humanized anti-CCR8 IgG1 antibody, in patients with advanced solid tumors

Presentation Number: 1008P

Presenter: Oriol Mirallas, Medical Oncology Specialist, Vall d’Hebron Institute of Oncology, Barcelona, Spain

Date: Saturday, September 14, 2024

Location: Fira Barcelona Gran Via

On August 27, 2024 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), and Quantum Leap Healthcare Collaborative reported Sermonix completed enrollment of its Phase 2 clinical trial evaluating lasofoxifene, its lead investigational drug, as a neoadjuvant endocrine therapy (NET) in molecularly selected HR+/HER2-, locally advanced breast cancer (Press release, Sermonix Pharmaceuticals, AUG 27, 2024, View Source [SID1234646210]).

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The open-label, randomized, multicenter trial is an arm of the Endocrine Optimization Pilot Protocol (EOP), a sub-study of Quantum Leap’s ongoing I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2). Twenty patients (10 pre- and nine postmenopausal women, and one male) were enrolled in the lasofoxifene arm of the study.

"Sermonix is delighted to have quickly completed enrollment of this I-SPY 2 EOP study of lasofoxifene as a neoadjuvant endocrine therapy, complementing our ongoing ELAINE-3 Phase 3 combination study of lasofoxifene with abemaciclib in the ESR1-mutated metastatic breast cancer setting," said Dr. David Portman, Sermonix founder and chief executive officer. "With a recent preclinical study also suggesting lasofoxifene could be an effective therapy for all hormone treatment-resistant breast tumors, and other data suggesting beneficial effects of lasofoxifene on genitourinary syndrome of menopause and bone health, we are focused on exploring the drug’s broad potential as a therapy for people confronted with breast cancer – and one that does so while potentially offering unique quality of life benefits across the treatment continuum."

NET can downstage breast tumors and may facilitate breast conservation as does neoadjuvant chemotherapy in women with locally advanced HR+/HER2- breast cancer, but with lower toxicity. Aromatase inhibition is the standard NET for HR+/HER2- breast cancer. However, the toxicity profile of AIs causes poor tolerance. Lasofoxifene is a next-generation selective estrogen receptor modulator (SERM) that has shown efficacy and a favorable toxicity profile in women with HR+/HER2- mBC.

"We are pleased to complete enrollment of this I-SPY 2 EOP arm," said Dr. Jo Chien, principal investigator of the sub-study. "Aromatase inhibitors can be difficult for our patients to tolerate. Based on prior data, lasofoxifene has a more favorable tolerability profile, particularly as it relates to vaginal and sexual health. Tolerance is a vital concern and quality-of-life preservation is an important element of successful cancer treatment. We look forward to gaining greater understanding of lasofoxifene’s potential in the neoadjuvant setting."

The EOP study has a primary objective of determining the feasibility of enrolling and treating molecularly selected patients with early-stage HR+ breast cancer in a randomized neoadjuvant trial using novel endocrine therapy. Feasibility is defined as ≥75% of enrolled patients completing at least 75% of protocol-defined study therapy. Secondary objectives include safety and tolerability of 5 mg daily lasofoxifene; assessment of efficacy: Ki-67, PEPI score, residual cancer burden at time of surgery, change in tumor volume by dynamic contrast enhanced MRI, rates of breast conservation; 3/5/10-year relapse-free survival and overall survival. Patient-reported outcomes will be assessed as well.

Quantum Leap partners with a consortium that includes the U.S. Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 41 major U.S. cancer research centers.

A poster reviewing the study’s background, objectives and design is available: EOP Trial in Progress.Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), and Quantum Leap Healthcare Collaborative reported Sermonix completed enrollment of its Phase 2 clinical trial evaluating lasofoxifene, its lead investigational drug, as a neoadjuvant endocrine therapy (NET) in molecularly selected HR+/HER2-, locally advanced breast cancer.
The open-label, randomized, multicenter trial is an arm of the Endocrine Optimization Pilot Protocol (EOP), a sub-study of Quantum Leap’s ongoing I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2). Twenty patients (10 pre- and nine postmenopausal women, and one male) were enrolled in the lasofoxifene arm of the study.

"Sermonix is delighted to have quickly completed enrollment of this I-SPY 2 EOP study of lasofoxifene as a neoadjuvant endocrine therapy, complementing our ongoing ELAINE-3 Phase 3 combination study of lasofoxifene with abemaciclib in the ESR1-mutated metastatic breast cancer setting," said Dr. David Portman, Sermonix founder and chief executive officer. "With a recent preclinical study also suggesting lasofoxifene could be an effective therapy for all hormone treatment-resistant breast tumors, and other data suggesting beneficial effects of lasofoxifene on genitourinary syndrome of menopause and bone health, we are focused on exploring the drug’s broad potential as a therapy for people confronted with breast cancer – and one that does so while potentially offering unique quality of life benefits across the treatment continuum."

NET can downstage breast tumors and may facilitate breast conservation as does neoadjuvant chemotherapy in women with locally advanced HR+/HER2- breast cancer, but with lower toxicity. Aromatase inhibition is the standard NET for HR+/HER2- breast cancer. However, the toxicity profile of AIs causes poor tolerance. Lasofoxifene is a next-generation selective estrogen receptor modulator (SERM) that has shown efficacy and a favorable toxicity profile in women with HR+/HER2- mBC.

"We are pleased to complete enrollment of this I-SPY 2 EOP arm," said Dr. Jo Chien, principal investigator of the sub-study. "Aromatase inhibitors can be difficult for our patients to tolerate. Based on prior data, lasofoxifene has a more favorable tolerability profile, particularly as it relates to vaginal and sexual health. Tolerance is a vital concern and quality-of-life preservation is an important element of successful cancer treatment. We look forward to gaining greater understanding of lasofoxifene’s potential in the neoadjuvant setting."

The EOP study has a primary objective of determining the feasibility of enrolling and treating molecularly selected patients with early-stage HR+ breast cancer in a randomized neoadjuvant trial using novel endocrine therapy. Feasibility is defined as ≥75% of enrolled patients completing at least 75% of protocol-defined study therapy. Secondary objectives include safety and tolerability of 5 mg daily lasofoxifene; assessment of efficacy: Ki-67, PEPI score, residual cancer burden at time of surgery, change in tumor volume by dynamic contrast enhanced MRI, rates of breast conservation; 3/5/10-year relapse-free survival and overall survival. Patient-reported outcomes will be assessed as well.

Quantum Leap partners with a consortium that includes the U.S. Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 41 major U.S. cancer research centers.

A poster reviewing the study’s background, objectives and design is available: EOP Trial in Progress.