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Bio-Path Holdings Presents Data from Ongoing Phase 2 Combination Study of Prexigebersen for Treatment of Acute Myeloid Leukemia at American Society of Clinical Oncology (ASCO) Annual Meeting

On June 3, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML) in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, on June 1, 2024 in Chicago, IL (Press release, Bio-Path Holdings, JUN 3, 2024, View Source [SID1234643996]).

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Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center, presented data showing prexigebersen continues to be well-tolerated and has demonstrated compelling efficacy results in two reporting cohorts including newly diagnosed AML patients and refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy. "We were honored to have our data selected for oral presentation at ASCO (Free ASCO Whitepaper) as it underscores not only the quality of our data, but also highlights the continued unmet need for these most vulnerable cancer patients," said Peter Nielsen, Chief Executive Officer of Bio-Path.

"We continue to advance this important study confident that prexigebersen can make a difference in the lives of these patients for whom there are limited treatment options."

Data Highlights

In Cohort 1, 31 newly diagnosed patients were enrolled; 20 evaluable patients (9 male: 45%) with a median age of 75 years (range, 69-84), treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk (n=12, 2017 ELN guidelines) or secondary AML (sAML; n=7) evolved from myelodysplastic syndromes (n=4), chronic myelomonocytic leukemia (n=1) or treatment-related AML (n=2). Fifteen patients (75% of evaluable; 54% of enrolled) achieved complete remission (CR), CRh (CR with partial recovery of peripheral blood counts), or CRi (CR with incomplete hematologic recovery); two patients achieved partial remission (PR) and two patients achieved stable disease (SD).

In Cohort 2, 38 relapsed/refractory patients were enrolled; 23 evaluable patients (13 male: 57%) with a median age of 63 years (range, 24-89), treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk (n=13) or sAML (n=5). Twelve patients (55% of evaluable; 32% of enrolled) achieved CR/CRi/CRh; one patient achieved PR, eight patients achieved SD and one patient had treatment failure.

Among the evaluable patients of both cohorts, adverse events were consistent with those expected with decitabine and venetoclax and/or AML, including fatigue (72%), anemia (60%) and neutropenia (49%), while the most frequent severe adverse events were febrile neutropenia (26%) and sepsis (5%). Given these promising interim results, Bio-Path expects to continue enrollment of up to 98 and 54 evaluable patients for Cohorts 1 and 2, respectively.

Bicycle Therapeutics to Participate in Upcoming Investor Conferences

On June 3, 2024 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in the following investor conferences in June (Press release, Bicycle Therapeutics, JUN 3, 2024, View Source [SID1234643995]):

Jefferies Global Healthcare Conference on Wednesday, June 5, 2024; fireside chat at 8:30 a.m. ET
Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10, 2024; fireside chat at 1:20 p.m. ET
TD Cowen 2nd Annual Radiopharmaceutical Innovation Summit on Monday, June 17, 2024; fireside chat at 3:00 p.m. ET
Live webcasts of the fireside chats will be accessible in the Investor section of the Company’s website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available following the fireside chat dates.

Aptose Announces Closing of $4.43 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On June 3, 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 the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules 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) (Press release, Aptose Biosciences, JUN 3, 2024, View Source [SID1234643994]). Additionally, in a concurrent private placement, Aptose has issued 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.

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

The gross proceeds to the Company from the offering were 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 were 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) was 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 was filed with the SEC and is 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 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.

Alligator Bioscience’s Phase 2 mitazalimab Pancreatic Cancer Data Published in The Lancet Oncology

On June 3, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the publication of positive Phase 2 data on its lead drug candidate mitazalimab in first line metastatic pancreatic cancer in The Lancet Oncology. The journal is an internationally trusted source of clinical, and global health knowledge (Press release, Alligator Bioscience, JUN 3, 2024, View Source [SID1234643992]). With an Impact Factor of 51.1, it is the world-leading clinical oncology research journal.

With a 5-year overall survival rate of less than 5%, current systemic therapies for metastatic pancreatic ductal adenocarcinoma (mPDAC) are associated with poor outcomes. Data presented in The Lancet Oncology, from the OPTIMIZE-1 trial of mitazalimab in combination with mFOLFIRINOX, showed a confirmed ORR of 40.4% in 57 evaluable patients (unconfirmed ORR was 50.9%). Median DoR was 12.5 months and the median OS was 14.3 months. Median Progression Free Survival (PFS) was 7.7 months. These data compare favorably to the historically reported outcomes with FOLFIRINOX (ORR 31.6%, mDoR 5.9 months, mOS 11.1 months and mPFS 6.4 months)[1]. The recently approved new treatment regimen of NALIRIFOX was associated with an ORR of 42%, mDoR of 7.3 months, mPFS 7.4 months and a mOS of 11.1 months.[2]

"The long-lasting responses and related biomarker associations reported in OPTIMIZE-1 are highly encouraging, demonstrating a critical immunomodulatory contribution of mitazalimab. The increase in ORR and PFS, compared to FOLFIRINOX alone, are superior outcomes and we believe that the reported depth and duration of response are strong indicators that the observed increases in survival will remain evident," said Prof. Jean-Luc van Laethem, Head of the Digestive Oncology Department of Erasme Hospital (ULB) Brussels, Principal Investigator of the OPTIMIZE-1 trial and lead author of the article in The Lancet Oncology. "Furthermore, mitazalimab showed a favorable safety profile and it could offer better quality of life for pancreatic patients who currently have few treatment options. The data from OPTIMIZE-1 are very promising and are strongly supportive of the continued development of mitazalimab and mFOLFIRINOX in mPDAC, in a confirmatory trial."
OPTIMIZE-1, an open-label, single-arm, multicenter, Phase 1b/2 study, assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX.

The DoR and OS are expected to improve further, as a majority of the patients were still alive at the time of the analysis (cut-off date November 2023). The OPTIMIZE-1 results compare favorably to the previously reported outcomes with FOLFIRINOX[1] as well as more recently reported data of the NALIRIFOX regimen in the NAPOLI 3 Phase 3 trial[2]. The OS at 12 months in OPTIMIZE-1 was 59.3%, compared to 48.1% for FOLFIRINOX[1] and 45.6% for NALIRIFOX[2].

"This publication in The Lancet Oncology is an important validation of the highly promising results of our OPTIMIZE-1 mitazalimab study. A substantial number of patients were either in the treatment or in the follow-up at the time of the primary analysis. Consequently, the 18-month survival follow-up data, which we expect at the end of June 2024, should provide further important insights into the potential of mitazalimab," said Søren Bregenholt, CEO of Alligator Bioscience.
Click here for the full article in The Lancet Oncology.

Title:
Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study.
Provisional Publication Date: June 1st, 2024
Article Number: 24TLO0432

Two posters (abstracts 2569 and 4133) detailing the positive OPTIMIZE-1 data were presented on June 1 at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

[1] Conroy et al., N Engl J Med 2011; 364:1817-1825; DOI: 10.1056/NEJMoa1011923
[2] Wainberg et al., Lancet 2023; 402(10409):1272-1281; DOI: 10.1016/S0140-6736(23)01366-1

About pancreatic cancer

Pancreatic cancer is the 12th largest cancer by number of patients. It is expected to become the second leading cause of cancer death in the western world by 2030. There are about 200,000 annual cases in the U.S. and the EU, with very poor prognosis: five-year survival is about 10% and median survival about 6 months. For 80% of patients, the only option is chemotherapy that offers only marginal benefit. FOLFIRINOX is expected to be the preferred first line regimen in the U.S. and the EU for patients with good performance status.

Alector to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference

On June 3, 2024 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that management will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10, 2024, at 1:20 p.m. ET (Press release, Alector, JUN 3, 2024, View Source [SID1234643991]).

A live webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event.