On July 29, 2024 Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, reported a research collaboration with Dr. Simon Turcotte, hepatopancreatobiliary surgeon and scientist at Université de Montréal’s affiliated hospital research centre, the CRCHUM, to utilize Haystack Oncology’s personalized MRD technology (Haystack MRD) to evaluate treatment effectiveness in patients with metastatic colorectal cancer (mCRC) with metastases confined to the liver (Press release, Quest Diagnostics, JUL 29, 2024, View Source,-the-CRCHUM,-to-Deploy-Haystack-MRD-TM-Technology-in-Research-Study-for-Metastatic-Colorectal-Cancer [SID1234645136]).

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This prospective, observational study, Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients (eDetect), will use Haystack MRD to assess circulating tumor DNA (ctDNA) as an early biological marker of treatment response and disease recurrence in patients with mCRC undergoing systemic treatment and liver surgery with curative intent. Haystack MRD is a blood-based liquid biopsy test that measures ctDNA shed into circulation by solid tumors in order to identify residual, recurrent, or resistant cancer, at the earliest possible stage.

"Our collaboration with the CRCHUM presents a valuable opportunity to leverage the performance of our Haystack MRD technology in a population of mCRC patients for whom cure is possible," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "Designed for detecting ctDNA with exceptional sensitivity, Haystack MRD is well-suited to measure treatment response in oligometastatic CRC patients to better understand how ctDNA can guide the sequence and intensity of therapy in the future."

Université de Montréal’s affiliated hospital research centre, the CRCHUM, is one of North America’s leading hospital research centres. Located in the heart of Montreal, the CRCHUM is a major centre for creation, knowledge generation and training.

"mCRC is a challenging disease in need of improved biomarkers to guide optimal patient care," said Dr. Simon Turcotte, hepatopancreatobiliary surgeon and scientist at the CRCHUM, also principal investigator of the eDetect study. "By teaming up with Haystack, we will be able to understand the best use of the MRD technology to inform treatment decisions. This will guide the design of future interventional trials to assess impact on patient survival."

Colorectal cancer is the second leading cause of cancer death in Canada and the United States, representing approximately 62,310 related deaths in 2023.1,2 While early-stage CRC can frequently be cured by surgery (with or without adjuvant chemotherapy), mCRC is often treatment-resistant and can be more difficult to address.3

Metastases are the primary cause of colorectal cancer-related mortality, with the liver being the most frequent site for metastasis, followed by the lung. Patients presenting with metastases confined to the liver represent a unique clinical opportunity to pursue surgery with intent to cure. However, even after surgery with no evidence of residual tumor by medical imaging, 80% of patients relapse. A more sensitive diagnostic tool, such as ctDNA, is needed to detect whether residual microscopic cancer cells remain after surgery, to detect relapse earlier than medical imaging so as to treat before the disease burden is too high, and to know as early as possible whether chemotherapy is effective to limit unnecessary use and side effects.

On July 29, 2024 Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for revumenib for the treatment of adults and pediatric patients with relapsed or refractory (R/R) KMT2Ar acute leukemia (Press release, Syndax, JUL 29, 2024, View Source [SID1234645137]).

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The FDA notified Syndax on July 26, 2024 that they required additional time to conduct a full review of supplemental information provided to the FDA in response to their requests. The submission of additional information to the FDA was determined to constitute a Major Amendment to the NDA and resulted in a standard three-month extension to the original PDUFA action date of September 26, 2024. No additional trials or manufacturing information have been requested by the FDA.

"Revumenib, upon approval, will be the first drug indicated to treat patients with KMT2A-rearranged acute leukemia, a population with significant unmet need," said Michael A. Metzger, Chief Executive Officer. "We are confident that the data from the AUGMENT-101 trial, as well as the additional information provided to the FDA, support approval and continue to demonstrate the meaningful benefit revumenib brings to patients with this devastating disease. We look forward to continuing our engagement with the FDA as they complete their review of the NDA by December 26, 2024."

The NDA for revumenib was granted Priority Review and is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program. The FDA previously granted Breakthrough Therapy, Fast Track and Orphan Drug designations for revumenib.

About Revumenib
Revumenib is a potent, selective, small molecule inhibitor of the menin-KMT2A binding interaction that is being developed for the treatment of KMT2A-rearranged (KMT2Ar), also known as mixed lineage leukemia rearranged or MLLr, acute leukemias including ALL and AML, and mutant nucleophosmin (mNPM1) AML. Positive topline results from the Phase 2 AUGMENT-101 trial in R/R KMT2Ar acute leukemia showing the trial met its primary endpoint were presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, and data from the Phase 1 portion of AUGMENT-101 in acute leukemia was published in Nature. Revumenib was granted Orphan Drug Designation for the treatment of AML and ALL by the FDA and for the treatment of AML by the European Commission, and Fast Track designation by the FDA for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation. Revumenib was granted Breakthrough Therapy Designation by the FDA for the treatment of adult and pediatric patients with R/R acute leukemia harboring a KMT2A rearrangement.

About the Real-Time Oncology Review Program (RTOR)

RTOR provides a more efficient review process for oncology drugs to ensure that safe and effective treatments are available to patients as early as possible, while improving review quality and engaging in early iterative communication with the applicant. Specifically, it allows for close engagement between the sponsor and the FDA throughout the submission process and it enables the FDA to review individual sections of modules of a drug application rather than requiring the submission of complete modules or a complete application prior to initiating review. Additional information about RTOR can be found at: View Source

On July 26, 2024 Rakovina Therapeutics Inc. (TSX-V: RKV) (the "Company"), a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies, reported that, further to the press releases dated May 23, 2024, June 20, 2024, July 19, 2024, and July 22, 2024, the Company has closed its previously announced over-subscribed non-brokered private placement (the "Private Placement") for gross proceeds to the Company of $2 million (Press release, Rakovina Therapeutics, JUL 27, 2024, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-closes-previously-announced-over-subscribed-private-placement [SID1234645110]).

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In connection with the Private Placement, the Company issued 19,950,000 units (each, a "Unit") at a purchase price of $0.10 per Unit. Each Unit is comprised of one common share of the Company (each, a "Common Share") and one Common Share purchase warrant (each, a "Warrant"). Each Warrant entitles the holder thereof to subscribe for and purchase one Common Share at a purchase price of $0.20 for a period of three years from the date of issuance. If the closing price for the Common Shares on the TSX Venture Exchange (the "TSXV") is $0.25 or greater for five consecutive trading days, the Company will have the right to accelerate the expiry date of the Warrants, upon written notice to the holder, to the date that is 30 days following such notice.

According to Executive Chairman Jeffrey Bacha, the funds will be used to further the company’s Artificial Intelligence (AI) fueled drug candidate research. Bacha said, "We are continuing activities under our AI collaboration to screen billions of drug candidates against DNA-damage response targets. We anticipate having initial output from this effort in the form of recommended molecular structures for validation in our laboratories at the University of British Columbia in early fall, which puts us on track to have initial data from validating in vivo models later this year."

Defects on our natural DNA-damage response mechanism are involved in the formation and growth of approximately three out of every four cancers. First generation DDR-inhibitors, called PARP-inhibitors, currently generate approximately $3 billion in annual sales and have provided significant benefit to patients diagnosed with certain types of breast, ovarian, and prostate cancer. Rakovina Therapeutics’ goal is to advance one or more next-generation DDR drug candidates into human clinical trials in collaboration with pharmaceutical partners.

In connection with the Private Placement, the Company paid a cash finder’s fee to Hampton Securities Limited totaling $1,200 and issued 12,000 finder’s warrants (each, a "Finder’s Warrant"). Each Finder’s Warrant entitles the holder thereof to subscribe for and purchase one Common Share at a purchase price of $0.20 for a period of three years from the date of issuance, subject to acceleration on the same terms as the Warrants issued in connection with the Private Placement.

The Private Placement is subject to the final acceptance of the TSX-V and all securities issuable in connection with the Private Placement are subject to resale restrictions for a period of four months plus one day from the date of issuance.

On July 26, 2024, Aileron Therapeutics, Inc., a Delaware corporation (the "Company"), reported to have entered into an Equity Distribution Agreement (the "Agreement") with Citizens JMP Securities, LLC, as agent and/or principal (the "Agent"), pursuant to which the Company may offer and sell shares of its common stock, $0.001 par value per share, from time to time up to amounts to be determined through or to the Agent (the "Offering") (Filing, 8-K, Aileron Therapeutics, JUL 26, 2024, View Source [SID1234645102]). The Company filed a prospectus supplement with the Securities and Exchange Commission (the "SEC") to register shares of common stock having an aggregate offering price of up to $50,000,000 (the "Shares") in connection with the Offering (the "Prospectus Supplement") under the Company’s existing shelf Registration Statement on Form S-3 (File No. 333-265470) filed with the SEC on June 8, 2022, which became effective on June 16, 2022 (as it may be amended or supplemented, the "Registration Statement").

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Upon delivery of a placement notice to the Agent and subject to the terms and conditions of the Agreement, the Agent may sell the Shares in sales deemed to be "at the market offerings" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including sales made directly on or through the Nasdaq Capital Market.

The Company or the Agent may suspend or terminate the offering of Shares upon notice to the other party, subject to certain conditions. The Agent is not required to sell any specific amount of Shares, but will act as sales agent using commercially reasonable efforts consistent with its normal sales and trading practices and applicable state and federal law, rules and regulations and the rules of The Nasdaq Stock Market LLC.

The Company has agreed to pay the Agent commissions for its services of acting as agent of 3.0% of the gross proceeds from the sale of the Shares pursuant to the Agreement. The Company has also agreed to provide the Agent with customary indemnification and contribution rights with respect to certain liabilities.

A copy of the Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the Agreement is qualified in its entirety by reference to such exhibit.

Wilmer Cutler Pickering Hale and Dorr LLP, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

The Shares will be sold pursuant to the Registration Statement, and offerings of the Shares will be made only by means of the Prospectus Supplement. This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

On July 26, 2024 Aptose biosciences presented its corporate presentation (Presentation, Aptose Biosciences, JUL 26, 2024, View Source [SID1234645103]).

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