On January 15, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported that Germany’s medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study (Press release, Oncolytics Biotech, JAN 15, 2025, View Source [SID1234649740]). This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq) in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients.

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Following a positive safety review by the independent Data Safety Monitoring Board (DSMB), which recommended continuation, the PEI’s approval allows Cohort 5 to progress to full enrollment. Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year.

"Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep’s promise in this disease. GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy. Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed."

About GOBLET Cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic PDAC patients;

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients;

4.Pelareorep in combination with atezolizumab in 2nd line or later advanced and unresectable anal cancer patients; and

5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

On January 15, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported significant progress in its ongoing discussions with the U.S. Food and Drug Administration (FDA) regarding three areas of its clinical development pipeline in non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC) (Press release, ImmunityBio, JAN 15, 2025, View Source [SID1234649739]).

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NMIBC BCG Unresponsive Papillary Disease: ImmunityBio is preparing to submit a supplemental Biologics License Application (sBLA) in 2025 for its innovative treatment targeting Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) in the papillary indication. As published in the Chamie 2022 NEJM1 publication, the primary endpoint was met with a disease-free rate of 55% at 12 months, 51% at 18 months, and 48% at 24 months. In addition, patients receiving ANKTIVA + BCG achieved a 93% avoidance of cystectomy with a median follow up of 20.7 months. This immunotherapy of rescuing BCG with ANKTIVA (nogapendekin alfa inbakicept-pmln), now approved in the CIS indication, represents a step towards providing therapeutic options in patients with BCG unresponsive NMIBC in papillary disease who currently have limited treatment choices and face radical total cystectomy (removal of bladder). The addition of the papillary indication could expand the potential patient population benefiting from this therapy and may allow patients to avoid the high morbidity and mortality associated with radical total cystectomy.

Alternative Source of BCG: In collaboration with the Serum Institute of India, ImmunityBio plans a regulatory submission for an alternative source of BCG in the first quarter of 2025. Serum Institute’s GMP capacity to manufacture large-scale volumes of BCG, already tested for safety and efficacy in clinical trials in Europe in subjects with NMIBC, aims to address the shortage of BCG, ensuring a reliable supply for patients in need. This initiative underscores ImmunityBio’s commitment to addressing critical supply issues and expanding the opportunity for patients and physicians to have access to high quality and quantities of BCG to initialize and maintain treatments for bladder cancer, subject to regulatory approvals.

Second-Line and Third-Line NSCLC Patients Who Have Progressed on Checkpoint Inhibitors: A Phase 2b study (QUILT-3.055) included (N=86) NSCLC patients and demonstrated prolonged overall survival when ANKTIVA was combined with the same checkpoint inhibitors on which patients were progressing, validating the rescue potential of ANKTIVA for T cells and checkpoint inhibitors. Compared to the most frequently used chemotherapy docetaxel in this setting with overall survival ranging from 7 to 10 months and associated with high toxicities of this chemotherapeutic agent, ANKTIVA plus a checkpoint inhibitor represents an immunotherapeutic advance for this disease.

ImmunityBio plans to submit a Biologics License Application (BLA) in 2025 for second- and third-line treatment of patients with NSCLC, who are progressing on checkpoint inhibitors. As presented at the IASLC 2024 World Conference on Lung Cancer by Dr. Wrangle2, the QUILT-3.055 study (Phase 2b, N=86) has shown promising results demonstrating a median overall survival for all patients at 14.1 months. In PD-L1 negative subjects, the median overall survival extended to 15.8 months.

"The potential to improve outcomes for NSCLC patients who have already relapsed on checkpoints is an unmet need. The combination of administering ANKTIVA plus a checkpoint even after checkpoint relapse/refractory represents a large potential for ANKTIVA to rescue checkpoint failure and prolong overall survival without the toxicities of chemotherapy," said Dr. Patrick Soon-Shiong, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. "This submission underscores ImmunityBio’s dedication to advancing cancer treatment and providing new hope for patients battling this aggressive disease. This BLA submission together with our randomized ResQ201A-NSCLC (NCT06745908) Phase 3 trial in NSCLC is a potential stepping stone towards advancing novel immunotherapies in this indication for patients who have failed checkpoint inhibitor therapy."

About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

On January 15, 2025 ImmunityBio, Inc. (NASDAQ: IBRX) reported the completion of the submissions of its marketing authorization applications (MAA) for ANKTIVA (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, to both the European Union (EU) European Medicines Agency (EMA) and the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) (Press release, ImmunityBio, JAN 15, 2025, View Source [SID1234649738]).

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The EMA covers 27 countries in the EU, as well as Iceland, Norway, and Liechtenstein. The assessment is expected to be complete by the fourth quarter of 2025. Similarly, the UK assessment of the MAA is anticipated to be completed by the fourth quarter of 2025. ImmunityBio is in continued dialog for requests for information from the two agencies, with the potential of approval by 2026.

"The submission of our applications to EMA and MHRA represents a significant milestone in our efforts to address this critical need and improve patient outcomes globally," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio.

ImmunityBio continues to make strides in its mission to provide innovative therapies for patients with limited treatment options. The U.S. launch of ANKTIVA for NMIBC CIS has gained momentum, with the product now widely accessible through commercial and government insurance programs. The company recently announced the unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9028) assigned by the Centers for Medicare & Medicaid Services (CMS) in the United States for ANKTIVA (nogapendekin alfa inbakicept-pmln) under J9028 (Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram). To date, commercial and governmental insurance cover over 240 million lives for ANKTIVA.

About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

On January 15, 2025 Be Biopharma, Inc. ("Be Bio" or "the Company"), a leader in B Cell Medicines (BCMs), reported the closing of its $92M Series C financing (Press release, Be Biopharma, JAN 15, 2025, View Source [SID1234649737]). The round includes participation from new investor Nextech with existing investors including ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb, and Takeda Ventures, among others. In conjunction with the financing, Melissa McCracken, Ph.D. of Nextech will join Be Bio’s Board of Directors.

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The proceeds from the Series C financing will be used to generate clinical proof-of-concept for BE-101 in the ongoing BeCoMe-9 Phase 1/2 clinical trial for people with hemophilia B and to advance BE-102 for the treatment of hypophosphatasia to the clinic. Both programs are built on Be Bio’s BCM product platform, creating durable, titratable, and redosable therapeutics that require no preconditioning and produce sustained and constant levels of therapeutic proteins.

"With this funding in hand, we are well-equipped to advance our two lead programs and solidify our position as a multi-program, clinical-stage company," said Joanne Smith-Farrell, Ph.D., Chief Executive Officer of Be Bio. "We are on track to demonstrate clinical proof-of-concept for BE-101 in Hemophilia B this year. Additionally, BE-102 is poised to enter the clinic next year, potentially demonstrating BCMs’ potential to become a new gold standard in enzyme replacement by providing hypophosphatasia patients with a transformative new option. I am grateful to our existing and new investors, who share our vision that BCMs can transform the treatment landscape for a wide range of diseases with potentially best-in-class medicines."

"We are excited to partner with Be Biopharma at this pivotal stage," stated Melissa McCracken, Ph.D., Partner at Nextech. "Be Bio has established itself as a leader in this field with their lead programs having best-in-class potential. We believe BCMs, as a class, could revolutionize treatment paradigms across indications . We look forward to supporting their groundbreaking work and witnessing the transformative impact on patient care."

On January 15, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported the pricing of its previously announced public offering of 4,857,780 shares of common stock at a public offering price of $0.30 per share (Press release, Azitra, JAN 15, 2025, View Source [SID1234649736]). The gross proceeds for the offering are expected to be approximately $1.5 million before deducting placement agent fees and other offering expenses. This offering is expected to close on January 16, 2025, subject to customary closing conditions. Azitra intends to use the net proceeds of this offering for working capital and general corporate purposes.

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Maxim Group LLC is acting as sole placement agent in connection with the offering.

The public offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-280648), previously filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2024, as amended, and declared effective on July 8, 2024. The shares may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the public offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus, and when filed, the final prospectus supplement and accompanying prospectus, relating to the public offering may also be obtained by contacting Maxim Group LLC, at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at [email protected].

This press release does 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 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.