On July 2, 2024 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported it has completed the resubmission of its Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation (Press release, Checkpoint Therapeutics, JUL 2, 2024, View Source [SID1234644647]).

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The BLA resubmission follows Checkpoint recently reaching alignment with the FDA on its BLA resubmission strategy to potentially address all approvability deficiencies outlined in the complete response letter ("CRL") received last December, in which FDA only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization ("CMO") as approvability issues to address in a BLA resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.

The BLA resubmission is supported by the results of Checkpoint’s studies in selected recurrent or metastatic cancers, including pivotal cohorts in metastatic and locally advanced cSCC. Safety and efficacy results from the metastatic cSCC cohort were published in October 2023 in the Journal for ImmunoTherapy of Cancer (JITC) (doi:10.1136/jitc-2023-007637).

Additionally, in July 2023, Checkpoint announced longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC demonstrating a deepening of response over time, resulting in higher complete response rates than previously reported (55% objective response rate; 26% complete response rate in locally advanced cSCC and 50% objective response rate; 13% complete response rate in metastatic cSCC).

Cosibelimab is a potential differentiated, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to PD-L1 and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T-cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained high tumor target occupancy of PD-L1 to reactivate an antitumor immune response and the additional potential benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potential enhanced efficacy.

On July 2, 2024 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported it has entered into a definitive agreement with a single healthcare-dedicated institutional investor for the issuance and sale of an aggregate of 5,853,659 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $2.05 per share of common stock (or per common stock equivalent in lieu thereof), in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Checkpoint Therapeutics, JUL 2, 2024, View Source [SID1234644646]). In addition, in a concurrent private placement, Checkpoint will issue and sell unregistered warrants to purchase up to 5,853,659 shares of common stock. The warrants will have an exercise price of $2.05 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the warrant and will expire five years following the issuance date.

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

The closing of the offering is expected to occur on or about July 3, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $12 million. Checkpoint intends to use the net proceeds of this offering for working capital and general corporate purposes.

The shares of common stock (or common stock equivalents) described above (but not the unregistered warrants issued in the concurrent private placement or the shares of common stock underlying such unregistered warrants) are being offered by Checkpoint pursuant to a shelf registration statement on Form S-3 (File No. 333-270843) that was previously filed with the Securities and Exchange Commission ("SEC") on March 24, 2023, and subsequently declared effective on May 5, 2023. The shares of common stock (or common stock equivalents) offered in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and 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 at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the offering, when available, may also be obtained by contacting 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 described above are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement with the SEC or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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

On 2 July 2024 Ipsen reported confirmation of an expanded collaboration and license agreement with Exelixis, Inc. for the development of Cabometyx (cabozantinib) in advanced pancreatic neuroendocrine tumors (pNETs) and advanced extra-pancreatic neuroendocrine tumors (epNETs) (Press release, Ipsen, JUL 2, 2024, View Source [SID1234644631]). The agreement is based on positive outcomes from the CABINET Phase III trial, led by the Alliance for Clinical Trials in Oncology and sponsored by the National Cancer Institute (NCI), which investigated Cabometyx versus placebo in people living with advanced pNETs or advanced epNETs whose disease had progressed after prior systemic therapy. An independent Data and Safety Monitoring Board recommended to stop accrual to the study, unblind patients and allow crossover from placebo to Cabometyx. This was due to early efficacy demonstrated at an interim analysis in both of the trial’s cohorts, with clinically meaningful improvements in progression-free survival (PFS).1

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"With many people diagnosed with neuroendocrine tumors at an advanced stage of disease and treatment options limited upon progression, the need for efficacious new therapies is extensive," said Christelle Huguet, EVP and Head of Research and Development, Ipsen. "The positive results demonstrated for Cabometyx within the CABINET Phase III trial represent clinically meaningful improvements in progression-free survival at a challenging stage of disease where there are few or no available treatment options. We look forward to discussing these clinical findings with regulatory authorities."

Neuroendocrine tumors (NETs) are a group of uncommon tumors that develop in the cells of the neuroendocrine system throughout the body.2,3 The symptoms of NETs are often not distinct and difficult to identify, leading to delays in diagnosis, with 58% of people presenting with metastatic disease at diagnosis.3 The number of people newly diagnosed with NETs is believed to be rising due to increasing awareness and better methods of diagnosis, with approximately 35 in every 100,000 people currently living with NETs globally.3,4 The survival rate varies greatly depending on the primary site and stage of disease, however for people living with advanced pNETs which has spread to distant parts of the body, the prognosis is poor, with a five-year survival rate of 23%.5

CABINET Phase III trial

Data from the study, which demonstrated PFS benefits at interim analyses, were presented at the European Society for Medical Oncology Congress 2023 by Professor Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute, Boston:1

In the pNET cohort, at a median follow-up of 16.7 months, median PFS based on local radiology review was 11.4 months for Cabometyx versus 3.0 months for placebo (hazard ratio (HR) 0.27 [95% confidence interval (CI) 0.14-0.49] p<0.0001)1
In the epNET cohort, at a median follow-up of 13.9 months, median PFS based on local radiology review was 8.3 months for Cabometyx versus 3.2 months for placebo (HR 0.45 [95% CI 0.30-0.66] p<0.0001)1
The safety profile of Cabometyx observed in each cohort was consistent with its known safety profile; no new safety signals were

On July 1, 2024 Monta Biosciences reported the successful completion of the current dose level study involving our immunotherapeutic drug, MBS8, at clinical sites in Denmark, Belgium, and Spain (Press release, MonTa Biosciences, JUL 1, 2024, View Source [SID1234644686]). Our findings demonstrate good safety and strength of MBS8, as evidenced by an increased Therapeutic Index compared to benchmark compounds. The unique formulation of our small molecule drug within lipid nanoparticles allows targeting immune cells involved in anti-tumor activity. Importantly, this formulation minimizes effects on non-target cell types, reducing toxicity of MBS8 in patients. In preclinical models, MBS8 has exhibited superior antitumor activity compared to benchmark compounds, resulting in an impressive twentyfold expansion of the therapeutic window. Monta Biosciences’ CEO, Simon Jensen, emphasizes the significance of this dramatic increase in therapeutic index and expresses optimism about its potential impact in patients at the next dose level.

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On July 1, 2024 Kanvas Biosciences, a full-stack spatial biology company, reported it has raised $12.5 million in additional funding co-led by existing investors DCVC and Lions Capital LLC, and participation from FemHealth Ventures, Germin8, Ki Tua Fund, and Pangaea Ventures as well as existing investors. Paul Theunissen, Managing Partner at Lions Capital Partners LLC, will join the company’s Board, and Ashlie L Burkart, MD, Chief Scientific Officer of Germin8 Ventures, will join as a board observer (Press release, Kanvas Bioscience, JUL 1, 2024, View Source [SID1234644644]). The fresh capital closely follows a June 2023 round and brings Kanvas’s total funding to $29.5 million. The funding will be used to further develop the company’s spatial biology platform and advance two novel therapeutics in its Immuno-oncology Program, KAN-001 and KAN-003 — KAN-001 to an Investigational New Drug (IND) filing in 2025.

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The Kanvas platform is unique in its ability to spatially map gene expression and cellular function across all kingdoms of life. Its unprecedented capability to illuminate host-microbiome interactions marks a significant advancement in understanding diseases related to the microbiomes, finally unlocking the promise of microbiome-based therapies. The platform provides not only a path to breakthroughs in drug development, but also clinical diagnostics, agriculture and food safety.

Kanvas Bioscience’s spatial biology platform provides the unique ability to map host-microbiome interactions and leverage the resulting data to design live biotherapeutic products (LBPs), which can be used to create novel microbiome-based therapies that optimize the microbiome – a critical factor in human health. KAN-001, the company’s lead drug candidate, is an LBP demonstrating significant potential to improve outcomes for cancer patients who have been resistant to immune checkpoint inhibitors (ICIs). Designed with the goal of increasing the percentage of patients who respond to ICIs across all ICI-approved cancer types, KAN-003 will be a defined consortium for cancer patients, administered just before starting ICI treatment. Kanvas is collaborating with The University of Texas MD Anderson Cancer Center and its Platform for Innovative Microbiome and Translational Research (PRIME-TR) to conduct additional preclinical studies for KAN-001 to optimize the drug’s formulation and prepare it for an IND filing in 2025, preparatory to recruiting the first patients for a clinical trial the same year.

"We have a remarkable opportunity to help patients by offering them an effective, novel therapeutic approach to some of the most common and debilitating conditions, starting with improving the efficacy of immunotherapy in the treatment of solid organ cancer. I’m so proud of the extraordinary progress the Kanvas team has already achieved," said Matthew Cheng, co-founder and CEO of Kanvas Biosciences. "Because of this progress and with additional capital, Kanvas is positioned to accelerate its growth and build on its early success in illuminating host-microbiome interactions by launching a clinical pipeline of precision microbiome therapeutics."

With a market expected to grow at a 21% CAGR to over $3 billion by 2031, LBPs are living microbes and can improve treatment outcomes for microbiome-addressable conditions, including solid organ cancer, inflammatory bowel disease and metabolic disorders. By acting in a synergistic and complementary manner to existing therapies, LBPs provide a safe method for targeting underlying disease processes, but through different pathways and with greater efficacy. Historical approaches to LBP development have generally focused on single strains of bacteria – which don’t have an appropriate ecosystem to add therapeutic value – or fecal microbiota transplants (FMTs), which are complex and consist of many bacterial strains, but are difficult to scale commercially, highly variable and cannot be optimized. Kanvas has demonstrated the ability to develop and manufacture complex microbial consortia of 148 bacterial strains, providing the benefits of a complex community with multiple mechanisms of action, which make LBPs more effective.

"Not only does Kanvas’s spatial biology platform offer much-needed discovery capabilities, it also now enables the manufacturing of complex LBPs as a therapeutic modality. KAN-001 and KAN-003 have the potential to be breakthrough, complementary therapeutics for ICI-refractory and ICI-naive cancers," said Jason Pontin, General Partner at DCVC and chair of Kanvas’s board. "By providing the missing link between microbiome drug design rationale and therapeutic outcomes, Kanvas has the unique and exciting ability to provide a better mechanistic understanding of microbiome-addressable conditions, and ultimately improve clinical success for the next generation of LBPs."

"I’m thrilled to support Kanvas’s mission as a board observer," remarked Dr. Burkart, Germin8’s Chief Scientific Officer and a board-certified pathologist specializing in gastrointestinal pathology. "Their exceptional team and groundbreaking technology will revolutionize our understanding of host-microbiome interactions, driving transformative discoveries in human health and beyond. This tool isn’t just relevant for human health; it holds promise for sectors like animal health and agriculture. Understanding microbes in these areas is vital for global health and sustainability."

The past 12 months have been a period of momentous growth for Kanvas. This fall, the company opened a new research laboratory and drug manufacturing facility in South San Francisco. Kanvas also recently expanded its leadership team: Lee Swem, formerly Federation Bio’s Chief Science Officer, joined Kanvas as Chief Development Officer, Steve Kujawa, who previously led business development at 10x Genomics, joined as Vice President of Business Development, and Kevin Cutler joined the company as Lead Scientist with expertise in AI. Swem is driving the execution of Kanvas’s LBP portfolio, with a focus on KAN-001, and Kujawa is leading partnerships for the company’s spatial biology platform and licensing of non-core LBP assets. Cutler is spearheading the curation of a state-of-the-art training database for machine learning segmentation of microbes, development of deep learning models for spectral identification of microbes, and integration of advanced AI into the company’s analytical platform.

For more information on Kanvas Biosciences or to inquire about pharmaceutical discovery partnership opportunities, visit View Source