On May 24, 2023 OSE reported completion of patient enrollment in the Phase 2 clinical trial TEDOPaM sponsored and conducted by the GERCOR Group and evaluating Tedopi in advanced or metastatic pancreatic ductal adenocarcinoma (Press release, OSE Immunotherapeutics, MAY 24, 2023, View Source [SID1234632027]).

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This randomized, non-comparative Phase 2 trial is designed to evaluate Tedopi plus FOLFIRI* chemotherapy versus FOLFIRI as maintenance treatment in patients (HLA-A2 genotype) with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with no progression after 8 cycles of FOLFIRINOX induction chemotherapy**. The primary endpoint of the trial is the one-year overall survival (OS) rate (Fleming- futility analysis; null hypothesis ≤25%; alternative hypothesis ≥ 50%), and the key secondary endpoint is the progression-free survival [TEDOPaM GERCOR D17-01 PRODIGE 63 study: Maintenance With OSE2101 Plus FOLFIRI, or FOLFIRI After FOLFIRINOX-based Induction Therapy in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma NCT03806309].

Prof. Cindy Neuzillet, MD PhD (Curie cancer research Institute, Paris), Principal Investigator of the TEDOPaM study, comments: "Completing enrollment of this Phase 2 trial represents a major milestone in evaluating an innovative activating immunotherapy-based maintenance strategy for patients with pancreatic cancer. Tumor-associated antigens selected for Tedopi are found overexpressed in pancreatic tumor, thus giving a rationale for testing this cancer vaccine in a very hard to treat patient population. We now look forward to advancing on the patients’ follow-up period and to reporting the research main findings, including survival and predictive biomarkers. We are very grateful to the patients involved and their families, and to the clinical investigators and centers for their trust and participation in this important development program."

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, concludes: "We are very pleased with the progress of the TEDOPaM clinical study and are now expecting the final results in Q3 next year as additional source of clinical value of Tedopi beyond non-small lung cancer, further to the first encouraging interim results shared at the 2022 ASCO (Free ASCO Whitepaper) meeting. We warmly thank the GERCOR academic group, sponsor of the trial, and the PRODIGE Intergroup, for this important milestone in Tedopi’s development program in pancreatic cancer. This step brings us closer to delivering potential evidence to assess the use of Tedopi as a potentially maintenance treatment in an aggressive disease with a generally poor prognosis, demanding for novel therapeutic approaches and representing significant unmet medical need."

The interim results from the TEDOPaM Phase 2 trial presented at the 2022 ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) meeting referred to the first 29 randomized HLA-A2 positive patients with no progression after 8 cycles of FOLFIRINOX: 9 patients included in standard arm A (FOLFIRI) with a 1-year OS rate of 44% and one partial response (11%); 10 patients in experimental arm B (Tedopi monotherapy) with a similar 1-year OS rate of 40% and one partial response (10%); and 10 patients in experimental arm C (nivolumab + Tedopi) with a 1-year OS rate of 30% and no partial response.

Tedopi as maintenance monotherapy showed a favorable safety profile and encouraging time to strategy failure warranting further evaluation. Nivolumab + Tedopi was associated with poorer outcomes leading to the closing of this arm. Following an Independent Data Monitoring Committee (IDMC) recommendation, the study continued with an amended protocol comparing a maintenance treatment Tedopi in combination with FOLFIRI versus FOLFIRI chemotherapy after treatment with FOLFIRINOX. A total of 107 patients were enrolled in this second part.

* FOLFIRI: A combination chemotherapy with folinic acid, fluorouracil and irinotecan
**FOLFIRINOX: A combination chemotherapy with folinic acid, fluorouracil, irinotecan and oxaliplatin

PDAC is the most common type of pancreatic cancer with approximately 60,000 patients diagnosed in the U.S. each year and nearly 500,000 new cases per year globally1,2. Due to lack of initial symptoms at early stage and high invasive potential, PDAC diagnosis is made at an advanced stage in 80% of cases, when patients already have metastases (50%) or locoregional extension (30%) precluding surgical treatment3, 4, 5. Advanced PDAC remains a challenging, non-curable disease6,7. Currently, fewer than half of patients diagnosed with metastatic PDAC and treated with FOLFIRINOX8 survive longer than one year and overall, pancreatic cancer has the lowest 5-year OS rate of all cancer types globally and in the U.S, not exceeding 10%1,2. The global pancreatic cancer treatment market size was estimated at USD 2.527 billion in 2022 and is projected to reach USD 6.859 billion by 2030.

On May 24, 2023 A recently published paper in Translational Lung Cancer Research reported encouraging results from nonclinical studies conducted with Humanetics Corporation’s (Humanetics) novel radioprotective drug, BIO 300 (Press release, Humanetics, MAY 24, 2023, View Source [SID1234632026]). The studies evaluated the therapeutic utility of BIO 300 when lung cancer undergoes treatment by radiation therapy. The positive results showcased that BIO 300 can protect normal tissues from collateral damage associated with radiotherapy without protecting the lung tumor, while potentially sensitizing the tumors to radiotherapy.

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"We are delighted with the outcome of these nonclinical studies. Showing that BIO 300 can protect normal tissues during radiotherapy has the potential to revolutionize cancer treatment by reducing the risk of debilitating side effects."

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These studies, which were conducted by researchers at Henry Ford Health in Detroit, Michigan, assessed the impact of daily, oral administration of BIO 300 in a model of human lung cancer exposed to thoracic or abdominal radiotherapy. The studies compared the effect of radiotherapy, with and without BIO 300 dosing, on normal tissue and tumors.

The researchers concluded that BIO 300 was radioprotective of normal lung tissue without compromising the efficacy of radiotherapy on lung tumors. The drug appeared to sensitize lung tumors to radiotherapy, suggesting a role in enhancing the therapeutic efficacy of radiotherapy. Importantly, BIO 300 was well-tolerated with no toxic effects following continuous daily oral dosing for up to 20 weeks. Taken together, this work highlights the therapeutic utility of BIO 300 and supports clinical investigation in patients with lung cancer.

Radiation therapy is a vital component of cancer treatment, often delivering highly targeted doses of radiation to tumor sites to eliminate cancer cells. However, the challenge lies in minimizing the damage to surrounding healthy tissues, which can lead to adverse side effects and limit treatment options. Humanetics aims to address this critical issue with BIO 300 which can safeguard normal tissues during radiotherapy, thereby enhancing patient outcomes and their quality of life.

Ronald J. Zenk, CEO at Humanetics, expressed his enthusiasm regarding the study results, stating, "We are delighted with the outcome of these nonclinical studies. Showing that BIO 300 can protect normal tissues during radiotherapy has the potential to revolutionize cancer treatment by reducing the risk of debilitating side effects."

BIO 300 is in clinical development for oncology applications to protect cancer patients from unintentional side effects caused by radiation therapy. Humanetics has completed a phase 1b/2a clinical trial in lung cancer patients (NCT02567799). In addition, a phase 2b trial is currently in progress evaluating the clinical utility of BIO 300 to protect lung tissues against the long-term effects of COVID-19 (NCT04482595).

The views expressed herein are those of Humanetics Corporation and may not reflect the official policy or position of Henry Ford Health.

On May 24, 2023 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported that Elisabet de los Pinos, PhD, Chief Executive Officer, will participate in the following upcoming investor conferences (Press release, Aura Biosciences, MAY 24, 2023, View Source [SID1234632025]):

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TD Cowen 4th Annual Oncology Innovation Summit on Tuesday, May 30, 2023.
Fireside Chat at 10:00 a.m. ET.

Jefferies Healthcare Conference on Thursday, June 8, 2023.
Presentation at 9:00 a.m. ET.

The live webcasts of the fireside chat and presentation will be available on the "Investors & Media" page under the "Events & Presentations" section of the Company’s website at View Source, where a replay of the webcast will be archived for 90 days following the presentation date.

On May 24, 2023 Biocept, Inc. (NASDAQ: BIOC) ("Biocept" or the "Company"), a leading provider of molecular diagnostic assays, products and service, reported the pricing of an underwritten public offering of 1,176,470 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 2,352,940 shares of its common stock at a combined offering price of $4.25 per share (or pre-funded warrant in lieu thereof) and an accompanying warrant to purchase two shares of common stock (Press release, Biocept, MAY 24, 2023, View Source [SID1234632024]). The warrants will have a per share exercise price of $4.25, are exercisable immediately, will expire five years from the date of issuance and contain an alternative cashless exercise provision whereby, subject to certain conditions, a warrant may be exchanged cashlessly for shares of common stock at the rate of half a share of common stock per full share otherwise issuable upon a cash exercise. The gross proceeds to Biocept from this offering are expected to be approximately $5.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Biocept. The offering is expected to close on May 26, 2023, subject to customary closing conditions. Biocept expects to use the net proceeds from the offering for the advancement of its FORESEE trial for CNSide, working capital and general corporate purposes. Biocept has also granted the underwriters a 45-day option to purchase up to an additional 176,470 shares of common stock and accompanying warrants to purchase up to 352,940 shares of common stock, at the public offering price less discounts and commissions.

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EF Hutton, division of Benchmark Investments, LLC, is acting as the sole book-running manager and Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as lead manager in connection with the offering. Maxim Group LLC is acting as financial advisor to the Company.

The shares of common stock, pre-funded warrants and warrants are being offered pursuant to a registration statement on Form S-1 (File No. 333-271355), which was declared effective by the United States Securities and Exchange Commission ("SEC") on May 24, 2023. The securities may be offered only by means of a prospectus. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus and, when available, copies of the final prospectus relating to the offering may be obtained at the SEC’s website at www.sec.gov or from EF Hutton, division of Benchmark Investments, LLC, Attention: Syndicate Department, 590 Madison Avenue, 39th Floor, New York, NY 10022, by email at [email protected], or by telephone at (212) 404-7002.

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

On May 24, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate in a fireside chat during the TD Cowen 4th Annual Oncology Innovation Summit on Wednesday, May 31, 2023, at 10:30 a.m. ET (Press release, Nuvalent, MAY 24, 2023, View Source [SID1234632022]).

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A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.