Collaboration Aims to Accelerate Development of BupiZenge™, a Novel Pain Treatment for Oral Mucositis Associated with Cancer Treatment

合作旨在加速BupiZenge的发展™, 与癌症治疗相关的口腔粘膜炎的新型疼痛治疗

SAN DIEGO, CA and STOCKHOLM, SWEDEN / ACCESSWIRE / November 28, 2023 / Ensysce Biosciences, Inc. ('Ensysce' or the 'Company') (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, and OncoZenge AB ('OncoZenge') (STO:ONCOZ), a clinical-stage company developing a transformative treatment for oral pain, are pleased to announce today that they have signed a letter of intent (LOI) to explore a strategic collaboration to accelerate the commercialization of BupiZenge™ in the United States..

加利福尼亚州圣地亚哥和瑞典斯德哥尔摩/ACCESSWIRE/2023年11月28日/Ensysce Biosciences，Inc。（'Ensysce'或'公司'）（纳斯达克股票代码：ENSC），一家应用转化化学来改善处方药安全性的临床阶段公司，和OncoZenge AB（'OncoZenge'）（STO:ONCOZ），一家开发口腔疼痛转化治疗的临床阶段公司，今天很高兴地宣布，他们签署了一份意向书（LOI），以探索加速BupiZenge商业化的战略合作™ 在美国。。

BupiZenge™ is OncoZenge's novel approach to treating pain caused by oral mucositis, an often severely debilitating condition of painful swelling and ulcerations of the mouth that commonly results from head and neck radiation and/or chemotherapy used to treat cancer. Left untreated, oral intake of food or fluids may be severely impeded and may adversely impact a patient's prognosis and quality of life..

布比岑™ 是OncoZenge治疗由口腔粘膜炎引起的疼痛的新方法，口腔粘膜炎通常是由用于治疗癌症的头颈部放射和/或化学疗法引起的口腔疼痛肿胀和溃疡的严重衰弱状况。如果不及时治疗，口服食物或液体可能会严重阻碍，并可能对患者的预后和生活质量产生不利影响。。

BupiZenge™ is a non-opioid oral formulation of the well-established local anesthetic bupivacaine. OncoZenge has successfully progressed BupiZenge™ through Phase 2 in the European Union (EU) and is currently in planning for the registrational Phase 3 program. Results from the Phase 2 study conducted in head and neck cancer patients with oral mucositis demonstrated strong efficacy in relieving pain with good safety and tolerability..

布比岑™ 是一种非阿片类药物口服制剂，由成熟的局部麻醉剂布比卡因组成。OncoZenge成功推进了BupiZenge™ 到欧盟（EU）的第二阶段，目前正在计划注册第三阶段计划。对头颈部肿瘤口腔粘膜炎患者进行的2期研究结果显示，在缓解疼痛方面具有很强的安全性和耐受性。。

The proposed collaboration aims to leverage the expertise and resources of both companies to accelerate the path to market in the United States for this innovative therapy that addresses critical unmet needs in the fields of analgesia and oncology.

拟议的合作旨在利用两家公司的专业知识和资源，加速美国市场的路径，以解决镇痛和肿瘤学领域未满足的关键需求。

Stian Kildal, CEO of OncoZenge, commented, 'This collaboration aligns with our mission to enhance patient quality of life and provides a firm foundation for access to the important US market. In Ensysce we have found an experienced team that shares our passion and commitment to progress BupiZenge towards market approval.

OncoZenge首席执行官Stian Kildal评论说：“这项合作符合我们提高患者生活质量的使命，并为进入重要的美国市场提供了坚实的基础。在Ensysce中，我们找到了一支经验丰富的团队，他们分享我们的激情和承诺，致力于推进市场认可。

Together we have the potential to accelerate the introduction of our pain medication to those millions of patients who lack safe and effective treatment options under today's Standard of Care.'.

我们有可能加速将止痛药引入数百万在当今护理标准下缺乏安全有效治疗方案的患者。

'We are thrilled to embark on this co-development with OncoZenge to further diversify our current portfolio of highly novel opioid pain products with BupiZenge,' said Dr. Lynn Kirkpatrick, CEO of Ensysce. 'Joining forces strengthens the opportunity to accelerate the development and delivery of this transformative therapy while working to gain regulatory approval and launch in the United States.

Ensysce首席执行官Lynn Kirkpatrick博士说：“我们很高兴与OncoZenge合作开展这项合作，以进一步多样化我们目前使用BupiZenge的高度新型阿片类疼痛产品组合。”联合力量加强了加速发展和提供这种变革性疗法的机会，同时努力获得监管部门的批准并在美国启动。

Together, we aim to make a meaningful impact in the field of pain management and oncology to improve patients' quality of life.'.

我们的目标是在疼痛管理和肿瘤学领域产生有意义的影响，以改善患者的生活质量。

About Ensysce Biosciences

关于恩赛斯生物科学

Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAPTM) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose.

Ensysce Biosciences是一家临床阶段公司，使用其专有技术平台开发更安全的处方药。该公司利用其胰蛋白酶激活的滥用保护（TAAPTM）和多药滥用抵抗（MPAR®）平台，为疼痛开发独特的防篡改治疗方案，最大限度地降低药物滥用和过量服用的风险。

Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions.

预计Ensysce的产品将为治疗患有严重疼痛的患者提供更安全的选择，并有助于预防药物滥用导致的死亡。这些平台涵盖了广泛的全球知识产权组合，适用于各种处方药组合物。

For more information, please visit www.ensysce.com..

欲了解更多信息，请访问www.ensysce.com。。

About OncoZenge AB

关于OncoZenge AB

OncoZenge develops a novel, effective, safe and well-tolerated treatment for oral pain in conditions where currently available treatment options either do not achieve sufficient pain relief or are associated with significant side effects. BupiZenge™ is a new oral lozenge formulation of bupivacaine, an anaesthetic with decades of clinical experience.

OncoZenge开发了一种新颖，有效，安全且耐受性良好的口腔疼痛治疗方法，目前可用的治疗方案要么不能达到足够的疼痛缓解，要么伴有明显的副作用。布比岑™ 是一种新的布比卡因口服锭剂配方，具有数十年临床经验的麻醉剂。

OncoZenge's lead indication is oral pain due to an inflammatory condition called oral mucositis that affects millions of patients receiving cancer treatment. Oral mucositis causes profound physical and psychological suffering and is a large unmet medical need for an effective, opioid-sparing treatment option.

OncoZenge的主要适应症是由于称为口腔粘膜炎的炎症引起的口腔疼痛，其影响数百万接受癌症治疗的患者。口腔粘膜炎引起严重的身体和心理痛苦，并且是对有效的阿片类药物节省治疗选择的大量未满足的医疗需求。

BupiZenge™ has shown significantly better pain relief compared to standard of care in this indication in a Phase 2 trial. OncoZenge has its headquarters in Stockholm, Sweden, and its share is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ..

布比岑™ 在第2阶段试验中，与该适应症的护理标准相比，已显示出明显更好的疼痛缓解。OncoZenge总部设在瑞典斯德哥尔摩，其股份在ONCOZ票务公司的纳斯达克第一北增长市场上公开交易。。

Forward-Looking Statements

前瞻性声明

Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as 'may,' 'intends,' 'can,' 'might,' 'will,' 'expect,' 'plan,' 'possible,' 'believe' and other similar expressions are intended to identify forward-looking statements.

根据1995年“私人证券诉讼改革法”和其他联邦证券法，本新闻稿中包含的不纯粹具有历史意义的陈述可被视为安全港条款的前瞻性陈述。在不限制上述内容的情况下，使用诸如“可能”，“意图”，“可以”，“可能”，“将会”，“期望”，“计划”，“可能”，“相信”等词语以及其他类似的表达方式旨在确定前瞻性陈述。

The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized.

所讨论的候选产品在临床上未经批准，无法保证临床计划将成功证明安全性和/或有效性，Ensysce不会遇到临床开发中的问题或延误，或者任何候选产品都将获得监管部门批准或成功商业化。

All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected.

所有前瞻性陈述都是基于恩赛斯管理层的估计和假设，尽管恩赛斯认为是合理的，但本质上是不确定的。所有前瞻性陈述都存在风险和不确定性，可能导致实际结果与预期结果大不相同。

In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce'.

此外，Ensysce的业务还面临其他风险和不确定性，其中包括启动和开展临床前研究和临床试验；来自临床前研究和临床试验的数据的时间和可用性；对监管提交和批准的期望；与恩赛斯产品候选人有关或有效的潜在安全问题；候选产品的可用性或商业潜力；Ensysce资助其持续运营的能力，包括计划的临床试验；我们筹集资金的股票发行的稀释效应；和恩赛斯'。

Ensysce Biosciences Company Contact:

恩赛斯生物科学公司联系人：

Lynn Kirkpatrick, Ph.D.

Lynn Kirkpatrick博士。

Chief Executive Officer

首席执行官

(858) 263-4196

(858) 263-4196

Ensysce Biosciences Investor Relations Contact:

Ensysce Biosciences投资者关系联系人：

Shannon Devine

Shannon Devine

MZ North America

MZ北美

Main: 203-741-8811

主要：203-741-8811

ENSC@mzgroup.us

ENSC@mzgroup.us

OncoZenge AB Contact:

OncoZenge AB联系人：

Stian Kildal

Stian Kildal

Chief Executive Officer

首席执行官

+46 76 115 3797}

+46 76 115 3797}

stian.kildal@oncozenge.se

stian.kildal@oncozenge.se

SOURCE: Ensysce Biosciences Inc. and OncoZenge AB

资料来源：Ensysce Biosciences Inc.和OncoZenge AB

View source version on accesswire.com:

在AccessWire.com上查看源版本：

https://www.accesswire.com/810266/ensysce-biosciences-and-oncozenge-announce--letter-of-intent-for-the-co-development-of-bupizengetm-in-the-united-states

https://www.accesswire.com/810266/ensysce-biosciences-and-oncozenge-announce--letter-of-intent-for-the-co-development-of-bupizengetm-in-the-united-states