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]):

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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.

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.

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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.

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.

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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.

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]).

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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.

On June 3, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that results from FRUTIGA, HUTCHMED’s Phase III trial of fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric cancer in China, were published in Nature Medicine (Press release, Hutchison China MediTech, JUN 3, 2024, View Source [SID1234643928]). Updated efficacy data in key subgroups and data on quality of life (QoL) within this publication were also presented on June 1 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") 2024 Annual Meeting.

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Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors ("VEGFRs") 1, 2 and 3. It works as an anti-cancer therapy by blocking tumor angiogenesis, a proliferation of blood vessels that is critical for cancer growth. The VEGFR pathway plays a key role in the pathogenesis of gastric cancer, which is the fifth most common malignant cancer worldwide, with 1.1 million new cases per year[1]. The FRUTIGA trial results published by Nature Medicine suggest that fruquintinib could be another effective treatment option for gastric cancer patients.

FRUTIGA was a 1:1 randomized, double-blind, Phase III study conducted across 35 sites in China (NCT03223376). It evaluated fruquintinib in combination with paclitaxel chemotherapy, compared with paclitaxel monotherapy, for second-line treatment in 703 patients with advanced gastric or gastroesophageal junction adenocarcinoma. The study was declared positive due to a statistically significant improvement in progression-free survival ("PFS"), one of two dual primary endpoints. Median PFS for patients who received fruquintinib plus paclitaxel was 5.6 months, compared to 2.7 months for those who received paclitaxel monotherapy (stratified hazard ratio ["HR"] = 0.569; p < 0.0001). An improvement was also observed in the dual primary endpoint of median overall survival ("OS"), (9.6 months vs. 8.4 months) but this was not statistically significant. Fruquintinib plus paclitaxel demonstrated statistically significant improvements in multiple other endpoints including objective response rate ("ORR"), disease control rate (DCR) and duration of response (DoR). It was well tolerated, with a safety profile consistent with expectations and previously reported studies.[2]

In further analysis of key subgroups presented at ASCO (Free ASCO Whitepaper), PFS and OS results were consistent with the primary analysis compared to the intention-to-treat (ITT) population. There was a clear PFS benefit observed for fruquintinib plus paclitaxel in the majority of subgroups, with particular benefit in both PFS and OS in the intestinal-type and lymph node metastasis subgroups. An exploratory post-hoc analysis for patients with lymph node metastasis revealed superior benefits of fruquintinib versus placebo in PFS, OS, ORR, disease control rate and duration of response. A possible mechanism for this effect is fruquintinib’s potent inhibition of VEGFR­‑3, which is closely linked to lymph node metastasis and tumor invasion. Further analysis of patient-reported quality of life ("QoL") revealed no adverse impact on QoL at end of treatment compared to current standard of care. Together, these additional findings, alongside previously reported results, support fruquintinib plus paclitaxel as another treatment option in this indication.

Key results from FRUTIGA were previously disclosed at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series Session on February 6, 2024, with the full presentation available here.[3]

Fruquintinib is approved in China and the United States for the treatment of certain patients with metastatic colorectal cancer ("CRC"). A New Drug Application ("NDA") for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma in China was accepted for review by the China National Medical Products Administration (NMPA) in April 2023.

About Gastric Cancer
Gastric cancer is a cancer that starts in the stomach. It is the fifth most common cancer worldwide in 2020. It was estimated to have caused approximately 770,000 deaths worldwide.[4] In China, it was estimated that over 478,000 people were diagnosed with gastric cancer, and approximately 374,000 people died from gastric cancer.[5]

About Fruquintinib
Fruquintinib is a selective oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for its potential use as part of combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combinations with other anti-cancer therapies.

About Fruquintinib Approval in China
In China, fruquintinib is co-developed and co-marketed by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. The approval was based on data from the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, which were published in the Journal of the American Medical Association, JAMA. Since its launch in China and as of mid‑2023, more than 80,000 colorectal cancer patients have been treated with fruquintinib.

About Fruquintinib Approval in the U.S.
Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. Fruquintinib received approval in the U.S. in November 2023, where it is marketed by Takeda under the brand name FRUZAQLA. The approval was based on data from two large, randomized, controlled Phase III trials: the multi-regional FRESCO-2 trial, data from which were published in The Lancet, along with the FRESCO trial conducted in China, showing consistent benefit among a total of 734 patients treated with fruquintinib. Safety profiles were consistent across trials. Please see FRUZAQLA full Prescribing Information here.