On September 29, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies (Press release, Regeneron, SEP 29, 2023, View Source [SID1234635547]). The target action date for the FDA decision is March 31, 2024. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

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The BLA was supported by data from a Phase 1 and pivotal Phase 2 trial (ELM-1 and ELM-2). Results from these studies investigating odronextamab in both FL and DLBCL were last presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

The FDA previously granted odronextamab Orphan Drug Designation and Fast Track Designation for FL and DLBCL. In August, the European Medicines Agency accepted for review a Marketing Authorization Application for odronextamab for the treatment of adult patients with R/R FL or R/R DLBCL who have progressed after at least two prior systemic therapies.

FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). FL is a slow-growing subtype, and although many patients are responsive to initial treatment, approximately 20% are expected to relapse within two years and have shorter remissions with each successive line of therapy. DLBCL is an aggressive subtype, with up to 50% of high-risk patients experiencing progression after first-line treatment (e.g., relapsing or refractory to treatment). As these blood cancers progress, they become increasingly hard to treat, especially in the third-line setting and beyond, leaving patients with few treatment options.

Odronextamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

About the Odronextamab Clinical Program
ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to investigate the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies previously treated with CD20-directed antibody therapy, including an expansion cohort evaluating DLBCL patients who had progressed on CAR-T therapy (post-CAR-T). ELM-2 is an ongoing, open-label, multicenter pivotal Phase 2 trial investigating odronextamab in 375 patients across five independent disease-specific cohorts, including DLBCL, FL, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-NHL. The primary endpoint of ELM-2 is objective response rate according to the Lugano Classification, and secondary endpoints include complete response, progression-free survival, overall survival, duration of response, disease control rate, safety and quality of life.

Regeneron is also initiating a broad Phase 3 development program to investigate odronextamab in earlier lines of therapy and other B-NHLs, representing one of the largest clinical programs in lymphoma.

On September 29, 2023 Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company advancing novel multi-targeted therapies for use as single agents and in combination, reported that it has entered into a definitive agreement for the purchase and sale in a registered direct offering of an aggregate of 3,157,895 shares of its common stock (or common stock equivalents in lieu thereof), at a purchase price of $1.90 per share (or common stock equivalent in lieu thereof) (Press release, Portage Biotech, SEP 29, 2023, View Source [SID1234635546]). The Company has also agreed to issue in a concurrent private placement unregistered series A warrants to purchase up to an aggregate of 3,157,895 shares of common stock, series B warrants to purchase up to an aggregate of 3,157,895 shares of common stock and series C warrants to purchase up to an aggregate of 3,157,895 shares of common stock. The closing of the offering is expected to occur on or about October 3, 2023, subject to the satisfaction of customary closing conditions.

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

The series A warrants will have an exercise price of $1.90 per share, will become exercisable immediately upon issuance and have a term of eighteen months from the date of issuance, the series B warrants will have an exercise price of $2.26 per share, will become exercisable immediately upon issuance and have a term of three years from the date of issuance and the series C warrants will have an exercise price of $2.26 per share, will become exercisable immediately upon issuance and have a term of five years from the date of issuance.

The gross proceeds to the Company from the offering are expected to be approximately $6.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for clinical development, general corporate and working capital purposes.

The securities described above (excluding the unregistered warrants and the shares of common stock underlying such unregistered warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form F-3 (File No. 333-253468) that was originally filed with the Securities and Exchange Commission (the "SEC") on February 24, 2021 and became effective on March 8, 2021. The offering of such securities in the registered direct offering is being made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to 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 may also be obtained, when available, from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the unregistered warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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 September 29, 2023 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the initiation of the Phase 1/2a clinical trial (Press release, Nykode Therapeutics, SEP 29, 2023, View Source [SID1234635545]). The trial evaluates VB10.16, the Company’s wholly owned off-the-shelf therapeutic cancer vaccine candidate for HPV16-positive cancers, in combination with MSD’s (Merck & Co., Rahway, NJ, USA) PD-1 inhibitor KEYTRUDA1 (pembrolizumab) in first line (1L) setting in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

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"Initiating the VB10.16 trial for HPV16-positive head and neck cancer, is a significant step in our clinical strategy," said Michael Engsig, CEO of Nykode Therapeutics. "The strong results in advanced cervical cancer patients in VB-C-02 boost our confidence in VB10.16’s potential for HPV16-positive HNSCC. The VB-C-03 trial launch shows our commitment to expanding VB10.16 as an innovative immunotherapy for HPV16 cancers across more indications and treatment stages."

VB-C-03 is a Phase 1/2a open-label, dose-finding trial investigating safety, tolerability, and efficacy. It consists of two consecutive phases, a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a), testing VB10.16 in doses up to 9 mg, in combination with pembrolizumab in a 1L setting in patients with HPV16-positive, PD-L1-positive HNSCC. The trial will take place in Europe.

"The C-03 trial is our first trial in a first line setting. We are encouraged by the C-02 trial which showed that moving up in the treatment line may further improve the clinical outcome. In addition, we are exclusively focusing on the subset of patients with PD-L1+ tumors as these were found to demonstrate the best efficacy in the C-02 trial. We will also be testing doses up to 9 mg, three times higher than previously used. All in all, we are eager to see the potential clinical benefit for the important head and neck cancer patient population," said Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics.

Merck will supply KEYTRUDA, while Nykode retains all commercial rights to VB10.16 worldwide.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About the Phase 1/2a Trial

The open-label, dose-finding Phase 1/2a trial will evaluate the safety, immunogenicity, and anti-tumor activity of VB10.16 in combination with MSD’s PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who are eligible for pembrolizumab monotherapy. The trial consists of two consecutive phases, a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a). The trial will determine the biological optimal dose of VB10.16 in combination with a fixed dose of pembrolizumab and elicited by doses of 3 mg, 6 mg, and 9 mg VB10.16. The trial will take place in Europe. More information is available at ClinicalTrials.gov Identifier: NCT06016920.

About VB10.16

VB10.16 is a potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate in development for the treatment of human papillomavirus type 16 (HPV16)-positive cancers. The cancer vaccine is designed based on Nykode’s Vaccibody technology platform of targeting antigens to antigen presenting cells. VB10.16 has reported positive data from a Phase 2 trial in advanced cervical cancer patients (NCT04405349) in combination with atezolizumab with mOS not reached but estimated to be greater than 25 months at the time of analysis in PD-L1+ patients. The vaccineinduced significant HPV16-specific T cell responses were correlated with clinical responses. The candidate has also demonstrated favorable clinical data in a Phase 1/2a trial in pre-cancerous HPV16-induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses.

About Head and Neck Cancer

Every year, around 660,000 patients globally are diagnosed with HNSCC. HPV16 accounts for nearly 90% of such cases. HNSCC can be managed effectively in early stages, however, most patients are diagnosed at advanced stages where treatment outcomes are less favorable.

On September 29, 2023 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the oral presentation of the final readout on primary objectives from Study 102 Dose Expansion—the expansion part of a Phase 1 dose escalation and dose expansion study evaluating potential first-in-class radioenhancer NBTXR3 for elderly patients with locally advanced head and neck cancer—at the 65th Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Press release, Nanobiotix, SEP 29, 2023, View Source [SID1234635544]). These data have also been selected for inclusion in two scientific highlight sessions for review and discussion during the congress.

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Oral Presentation Highlights

ABSTRACT #55260: Novel Radioenhancer NBTXR3 Activated by Radiotherapy in Cisplatin-ineligible Locally Advanced HNSCC Patients: Final Results of a Phase 1 Trial

· Date/Time: Wednesday, October 4, 2023, 3:00 PM EDT / 9:00 PM CEST
· Session: Head and Neck – Augmenting the Potential of Radiation Therapy with Novel Therapeutics and Imaging
· Presenter: Dr. Christophe Le Tourneau, Institut Curie, Paris, France
· Location: Room 1, San Diego Convention Center, San Diego, California

This oral presentation at ASTRO will be followed by a conference call on Thursday, October 5, 2023, at 8:00 AM EDT / 2:00 PM CEST. During the call, Laurent Levy, chief executive officer, will review the Study 102 final data before taking questions from participants.

Details for the call are as follows:
Live (US): 1-877-423-9813
Live France: 0 800 912 848
Live (international): 1-201-689-8573
Call me: click here

Participants can use guest dial-in numbers above and be answered by an operator or they can click the Call me link for instant telephone access to the event (dial-out). The Call me link will be made active 15 minutes prior to scheduled start time. A live webcast of the call may be accessed by visiting the investors section of the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior the event start. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website.

Participants are invited to email their questions in advance to [email protected].

On September 29, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported that data from an ongoing Phase II study (PNOC022, NCT05009992) of paxalisib, an investigational drug for the treatment of diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs), sponsored by the Pacific Pediatric Neuro-Oncology Consortium (PNOC), has been awarded a late breaking oral presentation at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting (Filing, 6-K, Kazia Therapeutics, SEP 29, 2023, View Source [SID1234635541]).

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SNO exists to advance multi-disciplinary brain tumour research, education, and collaboration to drive discovery and improve patient care. The 28th Annual Meeting of the Society for Neuro-Oncology will take place from November 15 – 19, 2023 in Vancouver, Canada.

In line with conference publication guidelines, Late-Breaking Abstracts, for which no more than six will be selected, will be made public at 7:00 AM (EST) on the first day of the scientific meeting, Friday, November 17, 2023 and at View Source

Kazia Chief Executive Officer, Dr John Friend commented, "The Society for Neuro-Oncology conference is a high-profile meeting where many of the best ideas are discussed in brain tumour research. We are very excited that the abstract from the PNOC022 study has been selected for oral presentation in this forum and look forward to sharing data with our shareholders and the market in due course."

About the PNOC phase II study

The PNOC022 Phase II study is sponsored by PNOC, an international consortium focused on the development of novel combination therapies. It is an adaptive platform study that is examining paxalisib in combination with ONC201, an experimental dopamine receptor D2 (DRD2) antagonist developed by Chimerix, Inc. (Durham, NC). PNOC022 is enrolling children and young adults with diffuse midline gliomas, a category of brain tumours that includes DIPG. The study includes separate cohorts comprising newly diagnosed patients, patients who have completed initial radiotherapy, and patients who have experienced disease progression after treatment. The primary endpoint will be the proportion of patients who are progression-free at six months (PFS6) for newly diagnosed patients, and overall survival (OS) for recurrent patients.