On May 31, 2024 MBrace Therapeutics, Inc. ("MBrace"), a clinical-stage oncology company developing novel antibody-drug conjugates (ADCs) against solid tumor targets, reported that the Company will be presenting a Trial in Progress (TIP) poster at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held from May 31-June 4, 2024, in Chicago, Illinois (Press release, MBrace Therapeutics, MAY 31, 2024, View Source [SID1234643904]).

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The poster will highlight the trial design, dosing regimen and study protocol for the Company’s ongoing Phase 1/1b clinical trial of MBRC-101. This first-in-human, multicenter, open-label study (NCT06014658) is examining the safety and efficacy of MBRC-101 in patients with advanced metastatic solid tumors refractory to standard treatment. The Company expects to report initial clinical data from this trial in the first half of 2025.

MBRC-101 selectively targets the EphA5 receptor tyrosine kinase, a cell surface receptor highly expressed in many commonly occurring cancers. Through its precision targeting of EphA5, a novel mechanism for solid tumor-directed therapy, MBRC-101 offers a potential new treatment modality, particularly for patients with advanced tumors that are non-responsive to prior cancer therapy.

"ADCs are an incredibly promising class of therapeutics with the potential to offer improved efficacy and greater tolerability," said Shiraj Sen, M.D., Ph.D., medical oncologist and director of clinical research at NEXT Oncology – Dallas, and an investigator in the Phase 1/1b study of MBRC-101. "I look forward to seeing the clinical progress for MBRC-101 and the potential impact that this investigational therapy could have for patients with a cancer that isn’t responding to current treatments."

Details of the ASCO (Free ASCO Whitepaper) 2024 presentation are as follows:
Abstract Title: A multi-center, open-label phase 1/1b dose finding, safety, and pharmacokinetic study of MBRC-101, an Anth-EphA5 monomethyl auristatin (MMAE) antibody drug conjugate, in advanced refractory solid tumors
Presenter: Shiraj Sen, M.D., Ph.D., Medical Oncologist and Director of Clinical Research, NEXT Oncology – Dallas
Session Type and Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Saturday, June 1, 2024, 9:00 AM-12:00 PM CDT
Poster Bd #: 305b
Abstract Number: TPS3161

About MBRC-101
MBRC-101 is an investigational antibody-drug conjugate (ADC) that uniquely targets the EphA5 receptor tyrosine kinase, which is present in multiple cancers including, but not limited to, breast, non-small cell lung (NSCLC), colorectal, gastric, and pancreatic cancers. MBRC-101 is currently being evaluated in the MBRC-101-001 Phase 1/1b clinical trial, a first-in-human, open-label, multicenter, dose escalation and dose expansion study enrolling patients with advanced metastatic solid tumors refractory to standard-of-care treatment. For more information about the MBRC-101-001 clinical trial and to review patient eligibility criteria visit clinicaltrials.gov (NCT06014658).

On May 31, 2024 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported Phase 1 data with the first off-the-shelf ImmTAC targeting PRAME, brenetafusp (IMC-F106C), in patients with late-line, post-checkpoint cutaneous melanoma (Press release, Immunocore, MAY 31, 2024, View Source [SID1234643903]). Brenetafusp was shown to be well tolerated, in monotherapy and in combination with anti-PD1, and demonstrated durable clinical benefit.

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"Brenetafusp continues to demonstrate promising monotherapy clinical activity in late-line cutaneous melanoma patients who were previously treated with checkpoint therapies," said Dr. Omid Hamid, Chief, Translational Research and Immunotherapy, Co-Director, Melanoma Therapeutics at Cedars-Sinai Cancer at the Angeles Clinic and Research Institute. "The disease control and PFS benefit for these brenetafusp-treated melanoma patients compares favorably to data with other immunotherapies."

"The best measure of brenetafusp monotherapy activity is disease control, which is observed in 56% of checkpoint pre-treated melanoma patients," said David Berman, Head of Research and Development. "We expect brenetafusp PFS to be even higher in first-line based on our analysis of blood T cell fitness. These data points, in conjunction with the significant molecular response and the expected additive benefit of combining with an active anti-PD1, provide confidence for PFS as an endpoint in our ongoing Phase 3 first-line trial."

Phase 1 data in post-checkpoint cutaneous melanoma

As of 18 March 2024, 47 patients have received brenetafusp (IMC-F106C) monotherapy at clinically active target dose levels. All monotherapy treated patients had received prior immune checkpoint inhibitors (100% anti-PD1, 81% anti-CTLA4). PRAME expression was high amongst evaluable patients (median H score of 215). Only 11% of patients had PRAME negative tumors, as measured by immunohistochemistry.

Brenetafusp was well-tolerated, with treatment-related adverse events (TRAEs) that were manageable and consistent with the mechanism of action. The most frequent TRAE reported was Grade 1 or 2 cytokine release syndrome (CRS) and rash; these events occurred predominantly following the initial three doses. There were no Grade 3 or higher CRS TRAEs.

Of the 47 monotherapy patients, 36 had a RECIST evaluable tumor assessment. The disease control rate (DCR), consisting of partial response (PR) and stable disease (SD), was 56% including 4 PR (ORR 11%) and 16 SD (44%). Durable tumor reduction, confirmed by at least one subsequent scan, was observed in 28% of patients and is an attribute of the ImmTAC platform1. Clinical benefit was enriched in the 31 evaluable PRAME positive patients. The DCR in this group was 58% and included all 10 patients (32%) with confirmed tumor reduction.

Both median progression free survival (mPFS) and 6-month overall survival (OS) rates were greater in PRAME positive than in PRAME negative monotherapy patients: 4.2 vs 2.1 months and 95% vs 40%, respectively.

42% of ctDNA-evaluable, PRAME positive monotherapy patients had a molecular response (10/24) and there was a trend for longer PFS and OS in molecular responders. No ctDNA-evaluable PRAME negative patients had ctDNA reduction.

In addition to the monotherapy patients treated with brenetafusp, there were 9 cutaneous melanoma patients who received brenetafusp in combination with an anti-PD1 (pembrolizumab), all of whom had received prior checkpoint inhibitors (100% prior anti-PD1, 89% prior CTLA4). Overall, patients were more heavily pre-treated in the combination cohort compared to monotherapy (median prior lines: 4 vs 2; PD-1 refractory: 67% vs 30%). Brenetafusp in combination with pembrolizumab was well tolerated, with TRAEs that were manageable and consistent with the mechanism of action of both agents. There was one dose-limiting toxicity (transaminitis) reported in one patient with prior history of checkpoint inhibitor induced autoimmune hepatitis.

Of the 7 patients evaluable for efficacy in combination, 4 achieved disease control including 1 ongoing PR (confirmed after the data cut off for the presentation), and 3 of the 4 ctDNA evaluable patients having molecular response.

In 41 gene-expression evaluable monotherapy patients, a gene signature was identified from baseline peripheral blood that was a measure of systemic T cell fitness. Patients with gene signature expression levels greater than or equal to the median had higher clinical benefit including a median PFS of 6 months and DCR of 69%, compared to those with less than the median gene expression levels (2 months and 42%, respectively). Patients with only 1-2 prior lines of therapy had higher T cell fitness gene signature, on average, than those with 3 or more prior lines of therapy.

The advanced cutaneous melanoma data from the ongoing Phase 1/2 trial of brenetafusp will be presented today at 2:45 PM CT / 3:45 PM ET, in the Melanoma/Skin Cancers oral abstract session at the 2024 American Society of Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The presentation will be accessible in the ‘Events & Presentations’ section of the Investor Relations section of the Company’s website.

PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma

The Company is enrolling patients in a registrational Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma (CM) with a primary endpoint of progression-free survival (PFS) (NCT06112314). The trial will randomize HLA-A*02:01-positive, first-line advanced CM patients to brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab, depending on the country where the patient is enrolled.

Under the terms of a clinical trial collaboration and supply agreement, Immunocore will sponsor and fund this registrational Phase 3 clinical trial, and Bristol Myers Squibb will provide nivolumab.

Audio Webcast

Immunocore will host a conference call today, May 31, 2024 at 7:15 PM ET / 6:15 PM CT, to discuss the Phase 1 PRAME expansion data and Phase 3 registrational trial in cutaneous melanoma. The call will also be available via webcast by visiting the Events & Presentations section on Immunocore’s website. A replay of this webcast will be available for 30 days.

Conference Call Details:
U.S. (toll-free): 877-405-1239
International (toll): +1 201-389-0851

On May 31, 2024 Bio-Techne Corporation (NASDAQ: TECH) reported that Kim Kelderman, President and Chief Executive Officer will present at the following investor conferences (Press release, Bio-Techne, MAY 31, 2024, View Source [SID1234643902]):

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William Blair 44th Annual Growth Conference
June 4, 2024
9:20 AM CDT

Jefferies Global Healthcare Conference
June 6, 2024
9:30 AM EDT

Goldman Sachs 45th Annual Global Healthcare Conference
June 11, 2024
9:20 AM EDT

A live webcast of the presentations can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

On May 31, 2024 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), reported that the Company will present at the 2024 Biotechnology Innovation Organization (BIO) International Convention taking place June 3-6, 2024, in San Diego, California (Press release, Bexion, MAY 31, 2024, View Source [SID1234643901]).

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Presentation Details:

Location: Theater 1, Hall A, Exhibition Hall

Session Date and Time: Wednesday, June 5 at 11:15am PT

"We are delighted to participate in the BIO International Convention in San Diego," said Scott Shively, Bexion’s Chief Executive Officer. "Bexion is approaching critical milestones for our mCRC and CIPN clinical programs, and we look forward to sharing the tremendous progress our team has made."

To schedule a meeting at the BIO International Convention with Bexion Pharmaceuticals, please submit a meeting request through the BIO One-on-One Partnering platform. More details are available on the BIO International Convention 2024 website.

About BIO International Convention

The BIO International Convention is the largest and most comprehensive event for biotechnology, representing the full ecosystem of biotech with over 20,000 industry leaders from across the globe. The convention includes innovative programming around the current and future state of biotech including areas like therapeutic frontiers, the business of biotech, regulatory and policy outlooks, and human capital.

About BXQ-350

Bexion’s lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional, sphingolipid activator protein, Saposin C, and a phospholipid. BXQ-350 has pre-clinical antitumor effects in vitro and in vivo, particularly in colorectal, brain and other solid tumors. Two Phase 1 clinical trials, one in adults and one in pediatric DIPG patients, demonstrated a strong safety profile for BXQ-350 with evidence of single agent activity across multiple solid tumors. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy.

On May 31, 2024 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, reported that it has entered into a definitive agreement for the issuance and sale of 3,855,000 of its common shares (or common share equivalents in lieu thereof) at a purchase price of $1.15 per share (or per common share equivalent in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Aptose Biosciences, MAY 31, 2024, View Source [SID1234643900]). Additionally, in a concurrent private placement, Aptose has agreed to issue unregistered series A warrants to purchase up to 3,855,000 common shares and series B warrants to purchase up to 3,855,000 common shares, each at an exercise price of $1.15 per share. The unregistered warrants will be exercisable beginning on the effective date of shareholder approval of the issuance of the shares issuable upon exercise of the warrants. The series A warrants will expire five years from the date of shareholder approval and the series B warrants will expire eighteen months from the date of shareholder approval. The offering is expected to close on or about June 3, 2024, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be approximately $4.43 million, before deducting the placement agent’s fees and other offering expenses. The Company currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

The common shares (or common share equivalents in lieu thereof) offered in the registered direct offering (but excluding the unregistered warrants or the common shares underlying such unregistered warrants) described above are being offered pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-267801), including a base prospectus, initially filed with the Securities and Exchange Commission ("SEC") on October 11, 2022, and declared effective by the SEC on October 21, 2022. The offering of the common shares (or common share equivalents in lieu thereof) are being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and an accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and accompanying base prospectus relating to the registered direct offering, when available, may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

The unregistered warrants have not been registered under the Securities Act of 1933 and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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.