NANOBIOTIX Announces Publication of New Preclinical Immunotherapy Data Showcasing the Combination Potential of NBTXR3 With anti-PD-1 and anti-CTLA-4

On January 26, 2022 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’) (Paris:NANO) (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the publication of new preclinical immunotherapy data for novel, potentially solid tumor- and therapeutic combination-agnostic radioenhancer NBTXR3 in the Journal of Nanobiotechnology (Press release, Nanobiotix, JAN 26, 2022, View Source [SID1234607403]).

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The Nanobiotix preclinical program aims both to provide a deeper understanding of the NBTXR3 mechanism of action and to discover new pathways for the radioenhancer to potentially improve treatment outcomes for patients. Given preclinical and early clinical data suggesting a potential immune priming effect triggered by radiotherapy (RT)-activated NBTXR3 and the medical unmet need for patients with primary or secondary resistance to immune checkpoint inhibitors, Nanobiotix and The University of Texas MD Anderson Cancer Center are exploring several therapeutic combinations involving checkpoint inhibitors, radiotherapy, and NBTXR3.

"We believe that we have only scratched the surface of opportunity for NBTXR3 as a potentially-ideal combination agent with immune checkpoint inhibitors," said Laurent Levy, co-founder and chairman of the executive board at Nanobiotix. "As the industry continues to advance development of these powerful immunotherapy agents, we feel there is an urgent need for novel combinations that can help improve efficacy for naïve patients and overcome resistance for non-responders. Our view is that the results presented in this new publication add to the growing body of data suggesting therapeutic potential for NBTXR3 in combination with immune checkpoint inhibitors, and we look forward to further investigation in the lab and in the clinic."

Following previously reported positive preclinical data on the addition of NBTXR3 to a combination of radiotherapy and anti-PD-1 in anti-PD-1 sensitive and resistant lung cancer models, this evaluation investigated the addition of NBTXR3 to a combination of radiotherapy, anti-PD-1, and anti-CTLA-4 in an anti-PD-1 resistant model. Mice were inoculated with metastatic lung cancer cells in their right (primary tumor) and left (secondary tumor) legs. They were then treated with various combinations of anti-PD-1, anti-CTLA-4, NBTXR3, and radiotherapy in an effort to isolate the effect of adding NBTXR3, modifying the RT protocol, or both. Mice surviving after 178 days were rechallenged with tumor cells and monitored for tumor growth.

The evaluation showed that both modifications to RT protocol and the addition of NBTXR3 improved outcomes of combination therapy, and that the cohorts in which NBTXR3 was included in the regimen outperformed all others. Of note, the cohort treated with NBTXR3 and modified RT together showed that the therapy had significant antitumor effects against both primary and secondary tumors, improving the mouse survival rate from 0% to 50%. None of the re-challenged survivor mice developed tumors, and they had higher percentages of memory T cells versus control, suggesting the induction of long-term antitumor immune memory. The authors concluded that NBTXR3 in combination with radioimmunotherapy significantly improved anti-PD-1 resistant lung tumor control in mice by promoting antitumor immune response.

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy either naïve or resistant to prior PD-1 (either primary or secondary as per SITC (Free SITC Whitepaper) criteria).

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in strategic collaborations to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations. In 2021, the Company entered into an additional strategic collaboration agreement with LianBio to support its global phase III study in Asia along with four future registrational studies.

SELLAS Life Sciences Announces IND Acceptance for First Clinical Trial of GPS in China

On January 26, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS” or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported that an IND application to initiate the first clinical trial in China for 3D189, also known as SELLAS’ galinpepimut-S (GPS), has been accepted by China’s National Medical Products Administration ("NMPA") (Press release, Sellas Life Sciences, JAN 26, 2022, View Source [SID1234607422]). The IND, for a small Phase I clinical trial investigating safety, was submitted by SELLAS’ partner in China, 3D Medicines Inc. ("3D Medicines"). 3D Medicines expects to initiate the trial by mid-2022 and will be responsible for all expenses related to executing the trial in China. The approval of the IND by the NMPA will trigger a milestone payment to SELLAS. The current clinical development plan provides for initiation of a Phase II clinical trial following receipt of satisfactory safety data from the Phase I study; the initiation of the Phase II study will also trigger a milestone payment to SELLAS. Total remaining potential milestone payments to SELLAS under the license agreement between the two companies could total $192.5 million, not including future royalties.

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"Acceptance from China’s NMPA of 3D Medicines’ IND application to initiate a Phase I clinical trial of GPS in patients with hematological malignancies in China marks an important regulatory milestone for SELLAS," said Angelos Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS. "The results of our own Phase I and II clinical trials in acute myeloid leukemia (AML), malignant pleural mesothelioma (MPM), multiple myeloma (MM), and relapsed ovarian cancer have been extremely encouraging. We look forward to expanding the reach of GPS outside the U.S. and Europe and we view 3D Medicines’ initiation of the clinical development program of GPS in China to be a key step in our plans to improve clinical outcomes for cancer patients, not only in China, but worldwide."

"In addition, we are exploring the possibility of 3D Medicines participating in SELLAS’ ongoing randomized, multi-center Phase III REGAL clinical trial currently underway in the U.S. and Europe in patients with AML who have achieved their second complete remission. Such participation would trigger a milestone payment to SELLAS. Furthermore, GPS has the potential to create synergies in combination with envafolimab, 3D Medicines’ PD-L1 product formulated for subcutaneous injection, which received marketing approval from the NMPA in China at the end of 2021. We, together with 3D Medicines, plan to explore the combination for advanced treatment for different types of cancers," concluded Dr. Stergiou.

About 3D189
3D189, also known as SELLAS’ lead product candidate, GPS, is an immunotherapeutic that targets the Wilms Tumor 1 (WT1) protein which is present and over-expressed in an array of hematological malignancies and solid tumors. When administered to a patient as a monotherapy or in combination with standard treatments, GPS’ induced immune response has the potential to recognize and destroy cancer cells and provide ongoing support to the immune system so that it can continue to target and destroy recurring tumors and residual cancer cells. The immunotherapy has the potential to be a highly effective approach to prolonging survival by delaying or preventing recurrence in patients in complete remission or with minimal residual disease.

3D Medicines holds the exclusive license from SELLAS to develop, manufacture and commercialize 3D189 in China, Hong Kong, Macau and Taiwan region for all therapeutic and other diagnostic uses.

Prokarium Expands R&D Capabilities with London Biofoundry to Deepen Microbial Immunotherapy Pipeline

On January 26, 2022 Prokarium, a biopharmaceutical company pioneering the oncology field of microbial immunotherapy, reported that has entered into an agreement, through Imperial Projects, to work with independent researchers from Imperial College London to develop Prokarium’s next-generation therapeutic candidates, engineered to deliver payloads within the tumor microenvironment (Press release, Prokarium, JAN 26, 2022, View Source [SID1234606801]).

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"Prokarium is designing the perfect bacteria to be the next cancer immunotherapy, and we believe leveraging Salmonella’s unique biology will allow us to combine a powerful innate approach with a tailored adaptive response," said Kristen Albright, PharmD, Chief Executive Officer of Prokarium. "This agreement will significantly expand our R&D capabilities and will further deepen our immunotherapy pipeline."

This new multi-year agreement builds on work between Prokarium and London Biofoundry that was initiated in 2020 and will further expand Prokarium’s operations. The team from Imperial’s and SynbiCITE’s London Biofoundry specializes in the design, engineering and functional characterisation of synthetic DNA and organisms.

"Prokarium has uniquely positioned their Salmonella platform as an innovative immunotherapy approach for the treatment of solid tumors, and we are excited to support their efforts in pioneering the cancer treatment paradigm shift from synthetic chemistry to synthetic biology," said Marko Storch, PhD, Head of Synthetic Biology and Automation. "At the London Biofoundry, we developed a cutting-edge SynBio stack and the expertise to collaborate with researchers and biotechs to advance their R&D. We are thrilled to leverage our leading research capabilities to support the development of Prokarium’s new class of medicines in oncology."

Aeterna Zentaris Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Rule

On January 26, 2022 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported that the Listing Qualifications Staff of The Nasdaq Stock Market LLC ("Nasdaq") has notified the Company that it has been granted an additional 180 calendar day period, through July 23, 2022, to evidence compliance with the US$1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market (Press release, AEterna Zentaris, JAN 26, 2022, View Source [SID1234607404]).

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If at any time before July 23, 2022, the bid price for the Company’s common shares closes at or above US$1.00 per share for a minimum of 10 consecutive business days (and generally not more than 20 consecutive business days, in Nasdaq’s discretion), it is expected that Nasdaq would provide formal notice that the Company has regained compliance with the bid price requirement.

In the event the Company does not evidence compliance with the minimum bid price requirement during the 180-day grace period, it is expected that Nasdaq would notify the Company that its shares are subject to delisting. At such time, the Company may appeal such determination to a Nasdaq Hearings Panel (the "Panel’) and it is expected that the Company’s securities would continue to be listed and available to trade on Nasdaq at least pending the completion of the appeal process. There can be no assurance that any such appeal would be successful or that the Company would be able to evidence compliance with the terms of any extension that may be granted by the Panel.

The Nasdaq notification letter does not impact the Company’s compliance or listing status on the Toronto Stock Exchange.

Adlai Nortye Announces Global License-out Agreement with Biotime for Several Products Including PD-L1 Inhibitor (AN4005) and Anti-hTNFR2 Antibody (AN3025)

On January 26, 2022 Adlai Nortye Ltd. ("Adlai Nortye"), a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, reported that it has entered into a Global License Agreement with Xiamen Biotime Biotechnology Co., Ltd. ("Biotime") for several compounds (Press release, Adlai Nortye Biopharma, JAN 26, 2022, View Source [SID1234607423]). This includes the rights and interests of Adlai Nortye in the development, manufacturing and commercialization of AN4005 and AN3025 in Greater China, and AN1005, AN6015 and AN9015 worldwide. According to the terms of the agreement, the total amount of this cooperation will reach hundreds of millions of yuan, including the upfront payments, progress-dependent milestone payments and tiered royalties on sales.

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According to Jianping Yu, the chairman secretary of Biotime, "Based on independent innovation, Biotime has started involving in innovative drug business, increased R&D investment, actively integrated into the global innovation network and focused on creating an innovation engine for high-quality development. The cooperation with Adlai Nortye, a leading brand of innovative drugs, will be a win-win attempt."

Dr. Nanhai He, the head of drug discovery of Adlai Nortye, said, "We are very happy to reach this agreement with Biotime, who has strong technical capabilities and scientific and technological strength, and puts a high value on product R&D and technological innovation. This cooperation will pave the way for the development and commercialization of several products, including AN4005 and AN3025, on a global scale, and benefit patients all over the world. We firmly believe that the partnership with Biotime will greatly accelerate the R&D and commercialization of these drugs."

About AN4005

AN4005 is an orally available, small-molecule PD-L1 inhibitor that demonstrates anti-tumor activity by the blockade of PD-1/PD-L1 interaction. In preclinical studies, AN4005 has demonstrated significant pharmacological activity, target affinity and acceptable safety profiles, which support the clinical development as a potential therapy for advanced malignancies. In pharmacology studies, AN4005 was shown to overcome the inhibition derived from PD-1/L1 interaction in hPBMC-based functional assays. Small molecule PD-L1 inhibitors are expected to provide several benefits over mAbs, such as, allowing for oral administration, lower production costs, improved tumor penetration, and lack of immunogenicity.

About AN3025

AN3025 is a novel humanized IgG1 (variant) anti-hTNFR2 antibody that is currently under preclinical study. This antibody binds to the extracellular domain of human TNFR2 with sub-nanomolar affinity and occludes its ligand TNFa from accessing TNFR2. Since TNFR2 is highly expressed on a subset of immunosuppressive cells, including regulatory T cells (Tregs) and MDSCs, within the tumor microenvironment, AN3025 is expected to amplify the antitumor immune response to aid in immunotherapy.