On May 10, 2024 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that the Company executed a collaboration agreement with The Swiss Group for Clinical Cancer Research SAKK ("SAKK") to conduct a Phase 2 randomized, (one to one), controlled trial evaluating clinical and biological effects of intratumoral INT230-6 followed by the standard of care ("SOC") immuno/chemotherapy vs. SOC immune/chemotherapy alone in early-stage triple-negative breast cancer ("TNBC") in 54 patients in Switzerland and selected countries in Europe (the "INVINCIBLE-4 Study") (Press release, Intensity Therapeutics, MAY 10, 2024, View Source [SID1234643093]). The INVINCIBLE-4 Study is an open-label randomized two-cohort phase 2 clinical trial.

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SAKK shall undertake the trial as the "Legal Sponsor" of the study, with the regulatory agencies in Switzerland and the European Union as described in the study protocol. SAKK will also ensure that all investigators and personnel who participate in the study are informed and trained. Intensity shall fund the study, provide the investigational drug product, and other necessary information to conduct the trial. The primary efficacy endpoint of the INVINCIBLE-4 Study is pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0). Additional key research questions include the immune landscape of the tumor microenvironment and peripheral blood, magnetic resonance imaging (MRI) changes predictive for pCR, and adverse events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

"We are excited to be working with SAKK on our INVINCIBLE-4 Study in early-stage triple-negative breast cancer," said Lewis H. Bender, Founder, President and CEO of Intensity Therapeutics, Inc. "TNBC poses significant challenges due to its aggressiveness, high relapse rates, and increased mortality especially in patients with large tumors. Achieving pathological complete response (pCR) and clearing positive lymph nodes are crucial prognostic factors for event-free survival. Results from our first INVINCBLE-2 study showed that INT230-6 could cause greater than 95% necrosis in large breast cancer tumors following a single dose with the induction of an immune response. By adding up to 2 doses of our unique drug before the standard of care, we hope to increase the rate of patients’ pCR, which is an FDA-approved endpoint for accelerated approval. The pCR data from this study, which we expect in the second half of 2025, should provide the information needed to size our Phase 3 trial in presurgical TNBC."

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression that so often occurs with systemic chemotherapy.

About Triple Negative Breast Cancer

Approximately 11-17% of breast cancers test negative for estrogen receptors (ER), progesterone receptors (PR), and excess human epidermal growth factor receptor 2 (HER2) protein, qualifying them as triple negative. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, mainly because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery.

On May 9, 2024 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines, reported that the first patient has been dosed in the Phase 2 portion of the AlphaBreak trial evaluating FPI-2265 (225Ac-PSMA I&T) in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Fusion Pharmaceuticals, MAY 10, 2024, View Source [SID1234643092]).

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"Actinium-based PSMA targeting RCs have demonstrated compelling safety and clinical activity, which is supported by Fusion’s encouraging data from the Phase 2 TATCIST trial reported recently at the AACR (Free AACR Whitepaper) Annual Meeting. We believe FPI-2265 represents an important potential new treatment option for patients with mCRPC, and with the initiation of the AlphaBreak trial we are pleased to move forward," said Chief Medical Officer Dmitri Bobilev, M.D.

"Despite recent advances in the field, we see many patients with mCRPC still in need of additional treatment options, especially after progressing on lutetium-based radiotherapy. It is encouraging to see the promising clinical activity and good safety profile demonstrated by FPI-2265. The initiation of the AlphaBreak trial brings us a step closer to addressing the gap for patients and providing this needed treatment option," said investigator Luke Nordquist, M.D., FACP, XCancer Chief Executive Officer.

The AlphaBreak trial is a Phase 2/3, randomized, open-label, multicenter study to evaluate the safety and efficacy of FPI-2265 in patients with mCRPC previously treated with 177Lu-PSMA radiotherapy. The Phase 2 dose optimization portion is designed to evaluate whether there are added safety and/or efficacy benefits of two alternative dosing regimens in comparison to the previously studied regimen of 100 kBq/kg every eight weeks. The Phase 2 portion of the AlphaBreak trial is expected to complete enrollment of approximately 60 patients by the end of 2024. Following analysis of the Phase 2 data and an end of Phase 2 meeting to determine the recommended Phase 3 dosing regimen with the U.S. Food and Drug Administration (FDA), the Phase 3 global registration portion of the AlphaBreak trial will enroll approximately 550 patients and is expected to begin in 2025.

About FPI-2265

FPI-2265 is an actinium-225 based PSMA targeting RC, for mCRPC, currently in a Phase 2 trial. Actinium-225 emits alpha particles and holds the promise of being a next-generation radioisotope in cancer treatment. By delivering a greater radiation dose over a shorter distance, alpha particles such as actinium-225 have the potential for more potent cancer cell killing, and targeted delivery, thereby minimizing damage to surrounding healthy tissue.

On May 10, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (the "Company") reported that it has closed the second tranche (the "Second Tranche") of its previously announced non-brokered private placement (the "Private Placement") with the issuance of 4,301,923 units (the "Units") of the Company at a price of $0.065 per Unit for aggregate gross proceeds of $279,625.00 (Press release, Biohaven Pharmaceutical, MAY 10, 2024, View Source [SID1234643090]).

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Each Unit consists of one common share in the capital of the Company (each, a "Share") and one whole common share purchase warrant (each, a "Warrant"), whereby each Warrant is convertible into one additional Share at an exercise price of $0.15 until May 10, 2026, being the date that is 24 months from the date of issue.

The Company intends to use the net proceeds of the Private Placement for general working capital purposes, including, enabling the Company to fund and advance its business plans in regard to its successful recent acquisition on February 16, 2024, of the entire portfolio of discovery, preclinical and clinical development stage assets in oncology, infectious disease, antigen desensitization, and other immunological fields based on the DPX immune educating platform technology, developed by the former Canadian biotechnology company, IMV Inc., Immunovaccine Technologies Inc., and IMV USA.

All securities issued pursuant to the Second Tranche are subject to a statutory hold period under applicable Canadian securities laws expiring September 11, 2024, being the date that is four months and one day from the date of closing of the Second Tranche.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities offered have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons unless registered under the U.S. Securities Act and applicable state securities laws, unless an exemption from such registration is available.

On May 10, 2024 iTeos Therapeutics, Inc. (Nasdaq: ITOS) ("iTeos"), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported that it has entered into a securities purchase agreement to sell 1,142,857 shares of the Company’s common stock (the "Common Stock") at a price of $17.50 per share, representing a premium of approximately 44% to iTeos’ closing price on May 9, 2024 and pre-funded warrants to purchase up to 5,714,285 shares of the Common Stock (the "Pre-Funded Warrants") at a price of $17.499 per pre-funded warrant, in a registered direct offering (Press release, iTeos Therapeutics, MAY 10, 2024, View Source [SID1234643089]). Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately, and will be exercisable until exercised in full. The aggregate gross proceeds from the offering are expected to be approximately $120 million, before deducting offering expenses payable by iTeos. The financing is expected to close on or about May 14, 2024, subject to the satisfaction of customary closing conditions.

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The financing is being led by existing investors, RA Capital Management and Boxer Capital.

iTeos expects to use net proceeds from the financing to advance its clinical programs and preclinical pipeline, and for working capital and other general corporate purposes.

The shares of Common Stock, Pre-Funded Warrants and the shares of Common Stock issuable upon the exercise of the Pre-Funded Warrants were offered pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") on May 10, 2023 (File No. 333-271793) and was declared effective on May 19, 2023. A final prospectus supplement containing additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On May 10, 2024 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported financial results for the first quarter ended March 31, 2024 and provided a business update (Press release, iTeos Therapeutics, MAY 10, 2024, View Source [SID1234643088]).

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"After reviewing headline data for an interim assessment of GALAXIES Lung-201, we are thrilled to announce that belrestotug + dostarlimab exceeded our pre-defined efficacy criteria for clinically relevant activity with clinically meaningful tumor reduction at each dose. The data also indicate an acceptable safety profile in line with the TIGIT:PD-1 class," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "We believe this early interim assessment supports our view that quality of components matters and that our TIGIT:PD-1 doublet has the potential to deliver differentiated clinical data. Our GALAXIES clinical development plans remain on track, and we look forward to GSK’s update on the GALAXIES program in June. We are also excited to present data from GALAXIES Lung-201 at a medical congress later in 2024."

"Additionally, we completed enrollment with no new safety signals observed and passed the futility analysis for efficacy in both combined positive score (CPS) cohorts in the first portion of the TIG-006 trial in first-line recurrent/metastatic PD-L1 positive head and neck cancer. iTeos and GSK have agreed to not continue beyond stage 1 recruitment in the open-label TIG-006 cohorts 2C & 2D and instead focus on generating randomized, controlled data in the ongoing Phase 2 GALAXIES H&N-202 platform study to further support a path to late-stage development in this indication. We are excited to provide an update on the TIG-006 trial at a medical congress later this year," concluded Dr. Detheux.

Program Highlights

Belrestotug (EOS-448/GSK4428859A): IgG1 anti-TIGIT monoclonal antibody targeting first-line non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) in collaboration with GSK

Preparation underway to advance GALAXIES clinical program that will evaluate the belrestotug + dostarlimab doublet
GALAXIES Lung-201: Interim assessment exceeded pre-defined efficacy criteria for clinically relevant activity with clinically meaningful tumor reduction and showed an acceptable safety profile in line with the TIGIT:PD-1 class. Interim data from Phase 2 platform trial assessing belrestotug + dostarlimab doublet in first-line advanced / metastatic PD-L1 high NSCLC anticipated in second half of 2024.
GALAXIES H&N-202: Enrollment ongoing in randomized Phase 2 platform study assessing belrestotug + dostarlimab doublet and a triplet with GSK’s investigational anti-CD96 antibody, nelistotug, in first-line patients with PD-L1 positive recurrent / metastatic HNSCC.
TIG-006 HNSCC: Completed enrollment and passed futility analysis for efficacy of both CPS arms of the first portion of TIG-006 in 1L HNSCC (Cohorts 2C & 2D). iTeos and GSK have agreed to not continue beyond stage 1 recruitment in these open-label cohorts in order to focus on the randomized, controlled GALAXIES H&N-202 trial. Topline data from the first portion of TIG-006 Cohorts 2C & 2D assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced / metastatic HNSCC anticipated in second half 2024.
TIG-006 mNSCLC: Enrollment completed in Phase 1b expansion trial assessing belrestotug, dostarlimab, and chemotherapy triplet in first-line advanced or metastatic NSCLC.
Continued advancement of Phase 1b trials exploring two novel triplets in advanced solid tumors: belrestotug + dostarlimab and GSK’s nelistotug (anti-CD96 antibody), and belrestotug + dostarlimab and GSK’s investigational anti-PVRIG antibody (GSK’562)
Adenosine Pathway

Inupadenant (EOS-850): insurmountable small molecule antagonist targeting adenosine A2A receptor in second-line NSCLC

A2A-005: Completed enrollment of Phase 2 A2A-005 dose escalation. Data from the dose escalation portion of the Phase 2 trial with inupadenant and platinum-doublet chemotherapy in post-IO metastatic non-squamous NSCLC anticipated in late 2024.
EOS-984: potential first-in-class small molecule inhibiting ENT1, a dominant transporter of adenosine on lymphocytes involved in T cell metabolism, expansion, effector function, and survival

Topline data from the Phase 1 trial anticipated in the second half of 2024
First Quarter 2024 Financial Results

Cash and Investment Position: The Company’s cash, cash equivalents, and investments position, which included $13.0 million of receivables from matured investments recorded in prepaid expense and other current assets on the balance sheet, was $595.0 million as of March 31, 2024, as compared to $706.6 million as of March 31, 2023. Pro forma cash, cash equivalents, and investments position were $715.0 million as of May 10, 2024, inclusive of approximately $120 million in proceeds from the May 2024 registered direct offering. The Company expects its cash balance to provide runway through 2027, which includes the potential initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet.

Research and Development (R&D) Expenses: R&D expenses were $34.5 million for the quarter ended March 31, 2024, as compared to $25.6 million for the same quarter of 2023. The increase compared to the comparative period was primarily due to increases in activities related to the belrestotug, inupadenant, and EOS-984 programs, and included the addition of new R&D employees hired to help advance these programs.

General and Administrative (G&A) Expenses: G&A expenses were $12.7 million for the quarter ended March 31, 2024, as compared to $11.9 million for the same quarter of 2023. The increase was primarily due to increases in headcount and related costs and an increase in stock-based compensation compared to the prior year. The increases were partially offset by a decrease in recruiting costs.

Net Income/Loss: Net loss attributable to common shareholders was $38.2 million, or net loss of $1.07 per basic and diluted share for the quarter ended March 31, 2024, as compared to a net loss of $15.6 million, or a net loss of $0.44 per basic and diluted share for the quarter ended March 31, 2023.