Antibe Announces Appointment of Receiver




Antibe Announces Appointment of Receiver

TORONTO–(BUSINESS WIRE)–$ATBPF–Antibe Therapeutics Inc. (“Antibe” or the “Company”) (TSX: ATE) announced that the Company’s request for an extension of its previously announced stay of proceedings under the Companies’ Creditors Arrangement Act (the “CCAA”) was heard before the Ontario Superior Court of Justice (Commercial List) (the “Court”) on April 18, 2024 and the decision was reserved.

On April 22, 2024, the Court issued its decision terminating CCAA proceedings and appointing FTI Consulting Canada Inc. as receiver of Antibe.

The Company also announced that Roderick Flower, Robert Hoffman, Dan Legault, Walt Macnee and Yung Wu have resigned from Antibe’s Board of Directors. In addition, the Company today received notification from the TSX that it will be delisting Antibe’s common shares from the TSX effective as of May 24, 2024.

Contacts

Antibe Therapeutics Inc.

Christina Cameron

VP Investor Relations

+1 416-577-1443

christina@antibethera.com

New Pandemic Agreement: Pharma Wins, Developing World Loses, says AHF Global Public Health Institute




New Pandemic Agreement: Pharma Wins, Developing World Loses, says AHF Global Public Health Institute

MIAMI–(BUSINESS WIRE)–As the final Intergovernmental Negotiating Body (INB) meeting of the World Health Organization (WHO) Pandemic Agreement approaches, the AIDS Healthcare Foundation and the AHF Global Public Health Institute are voicing significant concerns about the April 16, 2024, Proposal for the WHO Pandemic Agreement.

This latest iteration of the text, which has been significantly watered down through the negotiation process, is filled with platitudes, anemic in obligations, and devoid of any accountability. Falling victim to least-common-denominator policymaking in Geneva, this text now lacks the requisite power to operationalize equity and achieve its intended objectives.

We express profound concern that developed nations have vehemently defended the private interest of pharmaceutical companies over the collective common interest of achieving global health security in a sustainable and equitable manner. Such disregard has been observed in the proposed compromise for the WHO Pathogen Access and Benefit-Sharing System (PABS), which the Lancet has described as not only “shameful, unjust, and inequitable” but also “ignorant.”

Under the present terms of PABS, a mere 20% of pandemic-related health products are guaranteed to the WHO in the event of a pandemic. As the Lancet points out, such an arrangement will effectively leave 80% of crucial vaccines, treatments, and diagnostics “prey to the international scramble seen in COVID-19.” Furthermore, such pandemic-related health products are now made available only in the event of a pandemic rather than upon the declaration of public health emergencies of international concern, as previously proposed. In addition, we consider that monetary financial contributions to PABS should not be “administered by WHO” but rather directed to existing global health financing mechanisms according to formulations agreed-upon in advance of the conclusion of negotiations.

Have we learned nothing from the COVID-19 Pandemic?

While the INB co-chairs, vice-chairs and some delegates have undoubtedly been working diligently to reach an agreement, a simple fact remains: equity will not be operationalized without effective mechanisms for accountability and enforcement.

Despite warnings by technical experts, the INB has persistently failed to incorporate tangible provisions for accountability and enforcement. In the current proposal, Article 8 language regarding Preparedness Monitoring and Functional Reviews has been withered to nothing; Article 19, Implementation and Support, contains no reporting or verification requirements; previously proposed mechanisms for an accountability committee have been deleted instead of strengthened, and the text now moves forward without any effective means for timely and accurate verification of party compliance.

Calls for strong mechanisms of accountability in the pandemic agreement are widespread but have not been heeded. They have been made by the United Nations General Assembly and prominent international bodies, including the Global Preparedness Monitoring Board (GPMB) and the Independent Panel for Pandemic Preparedness and Response (IPPPR). In addition to the GPMB and the IPPPR, the Panel for a Global Public Health Convention and Spark Street Advisors have also emphasized the critical need for independent monitoring.

The absence of any form of independent oversight is concerning because proven and practical experience confirms that relying solely on state self-reporting mechanisms does not work. Yes, instead of learning from the widespread delays and incomplete self-reporting experience of the International Health Regulations (IHR), the pandemic agreement promotes more of the same practices that have compromised global health security in the past. To ensure its objectivity and effectiveness, the agreement should, at minimum, consider establishing an independent oversight body that is “politically, financially, technically and operationally independent of the WHO and donors.”

In addition to oversight, accountability also requires a clear enforcement framework with incentives and disincentives for compliance. The two major treaties under the authority of the WHO – the Framework Convention on Tobacco Control and the IHR – are described in the literature as “plagued by incomplete compliance.” Incomplete compliance with the IHR, for example, “contributed to COVID-19 becoming a protracted global health pandemic.”

Compliance, however, has largely been ignored by all parties and brushed under the rug throughout the negotiations. This is reflected in the current text, which does not mention the word compliance even once. To this end, we echo the concerns of the Panel for a Global Public Health Convention that the idea of a Compliance and Implementation Committee should not have been dropped from the text.

We also support the Panel’s assessment that an independent and autonomous Conference of the Parties (CoP) is critical because pandemics are not just a health issue but a “societal and governmental priority” that requires a whole-of-government and whole-of-society approach. We are, thus, concerned that modifications to the proposed text, which now call for the WHO to function as the Secretariat for the entire agreement, undermine the independence of the CoP. We are also not clear how this agreement will secure the necessary financial resources to achieve its objectives.

To this end, we emphasize that member states should commit the necessary funding to establish a fit-for-purpose pandemic prevention, preparedness, and response architecture, taking into account the existing global health financing mechanisms. “One of the central failings of the IHR has been that its requirements for states to collaborate, including with respect to mobilizing financing, lacks specificity,” and that “without benchmarks, formulas, or other such details” such “requirements have little real force.” Here, the same mistakes are being repeated – most notably through the lack of binding financial commitments in the letter of the agreement. Furthermore, the removal of language from Article 20, calling for the development of a five-year financial implementation strategy is a step backwards.

We also highlight that the current text misses the opportunity to effectively engage civil society and other non-government actors. The sole mention of civil society, in Article 17, is immediately followed by a caution regarding potential conflicts of interest, as if conflicts only arise when civil society is involved. Despite their critical contributions during the COVID-19 pandemic and numerous previous health crises, the voices of civil society remain marginalized in the decision-making processes of the WHO, the pandemic agreement negotiations and its implementation. Moving forward, this could be solved by weaving civil society in the fabric of the CoP to ensure its meaningful participation.

In the final stretch of negotiations, countries will be wise to remember how we got here, what needs to be accomplished through this pandemic agreement, and most importantly – what the consequences will be if it fails. Hoarding of essential public health goods, and policies that tolerate corporate greed to take precedent over human lives should not be allowed anymore. We, therefore, urge that delegates heed the warnings of experts and take action to correct critical flaws in the proposed text. Empty handshakes in Geneva will not prevent another global health disaster, nor will it keep countries from trampling over each other when the next pandemic comes.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.9 million clients in 47 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare

The AHF Global Public Health Institute is as a joint initiative of the AIDS Healthcare Foundation and the University of Miami created to engage in global public health policy analysis and research to generate objective evidence that can inform improvements in public health policy at the global, regional, national and local levels, particularly for infectious diseases. To learn more about the AHF Global Public Health Institute, visit https://ahfinstitute.org/.

Contacts

Guilherme Faviero
Director

AHF Global Public Health Institute at the University of Miami

+1 561.929.9339 mobile

guilherme.faviero@ahf.org

Denys Nazarov,
Director of Global Policy &

Communications, AHF

+1.323.308.1829

denys.nazarov@ahf.org

Results of Novocure’s METIS Phase 3 Clinical Trial for Patients with Brain Metastasis from Non-Small Cell Lung Cancer to be Presented as Late-Breaking Abstract at ASCO 2024




Results of Novocure’s METIS Phase 3 Clinical Trial for Patients with Brain Metastasis from Non-Small Cell Lung Cancer to be Presented as Late-Breaking Abstract at ASCO 2024

ROOT, Switzerland–(BUSINESS WIRE)–$NVCR–Novocure (NASDAQ: NVCR) today announced the results of the METIS phase 3 clinical trial in brain metastases from non-small cell lung cancer (NSCLC) will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, to be held from May 31 to June 4.

METIS was a randomized phase 3 clinical trial of stereotactic radiosurgery with or without Tumor Treating Fields (TTFields) therapy for patients with 1-10 brain metastases from NSCLC. In March, Novocure announced METIS met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients with Tumor Treating Fields (TTFields) therapy and supportive care compared to supportive care alone.

“We are honored to present the results of the METIS clinical trial as a late-breaking abstract this year at ASCO, the largest global oncology conference,” said Asaf Danziger, Novocure’s Chief Executive Officer. “Patients with brain metastases from non-small cell lung cancer need more treatment options. The METIS trial demonstrated that TTFields Therapy delayed intracranial progression while preserving neurological function, which is critical for these underserved patients. We look forward to robust discussion around the positive results of the METIS clinical trial, as well as other TTFields therapy program updates at ASCO 2024.”

The METIS data will be presented on June 3 as a late-breaking abstract during ASCO’s Central Nervous System Tumors session from 8 a.m. to 10 a.m. CDT. Lead author Minesh Mehta, MD, Chief of Radiation Oncology and Deputy Director at Miami Cancer Institute, part of Baptist Health South Florida, will give the presentation.

The oral presentation of the METIS clinical trial data is one of four abstracts on TTFields therapy to be included at the 2024 ASCO Annual Meeting.

Abstract titles from Novocure-sponsored and partner programs include:

• Results from METIS (EF-25), an International, Multicenter Phase III Randomized Study Evaluating the Efficacy and Safety of Tumor Treating Fields (TTFields) Therapy in NSCLC Patients with Brain Metastases. Abstract 2008. 10:24 a.m. CDT on June 3.

• Tumor Treating Fields (TTFields) therapy in patients with glioblastoma: Long-term survival results from TTFields in Germany in routine clinical care (TIGER) study. Abstract 2036. 9 a.m. CDT on June 1.

• LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant with Pembrolizumab and Platinum Based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer. Abstract TPS8665. 1:30 p.m. CDT on June 3.

• Deep Learning Convolutional Neural Networks Reliably Monitor and Accurately Identifies Predictors of Response to Novo-TTFields. Publication Only.

ABOUT METIS

METIS [NCT02831959] was a phase 3 trial of stereotactic radiosurgery with or without TTFields therapy for patients with 1-10 brain metastases from NSCLC. 298 adult patients were enrolled in the trial and randomized to receive either TTFields therapy with supportive care or supportive care alone following SRS. Supportive care consisted of, but was not limited to, treatment with steroids, anti-epileptic drugs, anticoagulants, pain control or nausea control medications. Patients in both arms of the study were eligible to receive systemic therapy for their NSCLC at the discretion of their treating physician. Patients with known tumor mutations for which targeted agents are available were excluded from the trial.

The primary endpoint of the METIS trial is time to first intracranial progression, as measured from the date of first SRS treatment to intracranial progression or neurological death (per RANO-BM criteria), whichever occurs first. Time to intracranial progression was calculated according to the cumulative incident function. Patient scans were evaluated by a blinded, independent radiologic review committee. Secondary endpoints include, but are not limited to, time to distant progression, time to neurocognitive failure, overall survival, time to second intracranial progression, quality of life and adverse events. Key secondary endpoints (time to neurocognitive failure, overall survival, and radiological response rate) were planned to be used in labeling claims, if successful. Patients were stratified by the number of brain metastases (1-4 or 5-10 metastases), prior systemic therapy, and tumor histology. Patients were allowed to crossover to the experimental TTFields therapy arm following confirmation of second intracranial progression.

The METIS clinical trial data are expected to serve as the basis for future regulatory discussions.

ABOUT TUMOR TREATING FIELDS THERAPY

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

ABOUT NOVOCURE

Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma. Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.

Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.

FORWARD-LOOKING STATEMENTS

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2024, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

Contacts

INVESTORS AND MEDIA:
Ingrid Goldberg

investorinfo@novocure.com
media@novocure.com

Aulos Bioscience to Present Updated Phase 1/2 Clinical Trial Results for Novel IL-2 Therapeutic AU-007 in Advanced Solid Tumor Cancers at 2024 ASCO Annual Meeting




Aulos Bioscience to Present Updated Phase 1/2 Clinical Trial Results for Novel IL-2 Therapeutic AU-007 in Advanced Solid Tumor Cancers at 2024 ASCO Annual Meeting

LARKSPUR, Calif.–(BUSINESS WIRE)–Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today announced that updated Phase 1/2 data for AU-007 will be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting. AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors in patients with unresectable locally advanced or metastatic cancers. It is the first AI-designed human monoclonal antibody to be tested in a clinical trial. The ASCO meeting is being held online and at McCormick Place in Chicago, Illinois, from May 31–June 4, 2024.

Details of the poster presentation are as follows:

Poster Title: Updated results of a phase 1/2 study of AU-007, a monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, in patients with advanced solid tumors.

Abstract: 2527

Session Type/Title: Poster Session/Developmental Therapeutics—Immunotherapy

Session Date and Time: Saturday, June 1, 2024, 9:00 a.m.-12:00 p.m. CDT

The poster will be presented in the Exhibit Hall at McCormick Place. An electronic version will also be available on the ASCO 2024 online meeting platform.

About AU-007

AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

About Aulos

Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through best-in-class IL-2 therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AU-007, is a computationally designed human antibody that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and Apple Tree Partners (ATP) and is led by pioneers in the field of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulosbio.com, X (@AulosBioscience) and LinkedIn.

Contacts

Contact: info@aulosbio.com
Media inquiries: Mike Beyer, Sam Brown Inc. / 312-961-2502 / mikebeyer@sambrown.com

Sheppard Mullin Welcomes IP Partner Alex Chung in Washington D.C.




Sheppard Mullin Welcomes IP Partner Alex Chung in Washington D.C.

Firm Continues Expanding Life Sciences Footprint in the U.S. and Korea

WASHINGTON–(BUSINESS WIRE)–Sheppard, Mullin, Richter & Hampton LLP is pleased to announce that Kwan-Ho “Alex” Chung, Ph.D. has joined the firm’s Intellectual Property practice group and Life Sciences industry team in Washington, D.C. Chung was most recently a partner at Perkins Coie LLP. Chung’s move to Sheppard Mullin follows the recent hire of life sciences IP partner, Jaime Choi, Ph.D., in February.

Chung’s practice focuses on representing U.S., European, Korean and Japanese companies in the biotechnology, pharmaceuticals, chemicals and medical device industries. His extensive experience includes procuring, managing, evaluating, enforcing and defending patents and providing clients strategic IP counsel. He works with biotechnology and biopharma clients who are developing leading-edge technologies such as cell and gene therapy (including CAR-T cells, stem cells, viral vectors), immuno-oncology, CRISPR genome editing, RNA interference (RNAi), circular RNAs, targeted protein degradation (TPD), bispecific antibodies and antibody drug conjugate (ADC), pharmaceuticals and medical devices.

“Alex is another pillar in our strategic effort to continue to grow our Life Sciences team,” said Luca Salvi, chair of Sheppard Mullin. “His established foothold in the Korean market combined with our Seoul office will be valuable to our clients who do business in the Asia-Pacific region. His technical expertise is a highly valued addition to our Washington, D.C. office and firmwide.”

“We are pleased that Alex is joining our growing team,” said Scott Liebman, co-leader of Sheppard Mullin’s Life Sciences team. “His deep background in sophisticated biotechnology and biopharma patents further demonstrates our ability to work with some of the most innovative companies in the world.”

Daniel Yannuzzi, co-leader of Sheppard Mullin’s Intellectual Property practice group, remarked, “We’ve built a premier team of pharmaceutical, chemical, biotechnology and medical device patent attorneys that work with clients around the globe. Alex enhances our full-service intellectual property capabilities across a broad range of technical specialty areas on the East Coast and globally.”

Prior to his career in law, Chung worked as a postdoctoral fellow at the National Institutes of Health (NIH), where he researched photoreceptor differentiation and designed engineered adeno-associated virus (AAV) gene therapy vectors for clinical trials. He also co-invented a U.S. patent on microRNA-based RNAi expression vector, licensed to and currently marketed by one of the largest life sciences research and solution providers. Chung received his B.S. in Microbiology and M.S. in Immunology & Genetic Engineering from Seoul National University, his Ph.D. in Neuroscience from the University of Michigan Medical School, and his J.D. from The George Washington University Law School. He is admitted to practice before the U.S. Patent & Trademark Office.

About Sheppard Mullin’s Intellectual Property Practice Group

Sheppard Mullin is a leader in the protection of intellectual property rights, as well as in assisting our clients to exploit their commercial potential. The group has significant expertise in all laws governing patents, trademarks, copyrights, trade secrets, false advertising, unfair competition, counterfeiting and grey marketing. We also possess significant experience litigating in common forums for patent litigation, including in California, Delaware and the Eastern District of Texas, as well as before the Patent Trial and Appeal Board in inter partes review proceedings. Our prosecution and counseling team develops global IP portfolios, prepares opinions and performs product clearance. We perform IP due diligence for investors and acquirers of target IP. Our diverse client base ranges from Fortune 50 and multinational corporations to innovative start-ups and individuals across a wide spectrum of industries. Sheppard Mullin’s IP practice and partners are often recognized by Chambers, IAM Patent 1000, Managing IP, World Trademark Review, U.S. News and Best Lawyers, Law360 and The Daily Journal, among others.

About Sheppard Mullin’s Life Sciences Industry Team

Sheppard Mullin’s Life Sciences industry team represents a diverse client base in the biotechnology, pharmaceutical, medical device, diagnostic, digital health and medtech sectors, ranging from large publicly traded organizations to early and mid-stage start-up companies. Attorneys in the U.S., and internationally through our offices in London, Brussels, Seoul and Shanghai, assist companies with strategic issues in every phase of their growth cycle. Our team is comprised of a number of attorneys, patent agents and scientific advisors who possess hands-on research experience and advanced degrees, including in the areas of biochemistry, cell biology, chemistry, molecular biology, pharmacology and biomedical engineering, to fully support the legal needs of our clients.

About Sheppard, Mullin, Richter & Hampton LLP

Sheppard Mullin is a full-service AmLaw 50 firm with more than 1,000 attorneys in 16 offices located in the United States, Europe and Asia. Since 1927, industry-leading companies have turned to Sheppard Mullin to handle corporate and technology matters, high-stakes litigation and complex financial transactions. In the U.S., the firm’s clients include nearly half of the Fortune 100. For more information, please visit www.sheppardmullin.com.

Contacts

JILL SCHACHNER
(312) 499-0558
jschachner@sheppardmullin.com

LORENA LOPEZ
(619) 338-6650
ilopez@sheppardmullin.com

Nature Publication Highlights the Benefits of Tropis® Intradermal When Used to Administer a First-in-Class Self-Amplifying mRNA Vaccine




Nature Publication Highlights the Benefits of Tropis® Intradermal When Used to Administer a First-in-Class Self-Amplifying mRNA Vaccine

• Delivery of a novel self-amplifying mRNA (samRNA)-based vaccine with Tropis ID System directly into the dermis significantly boosts immune responses.
• This study shows that intradermal (ID) delivery of a samRNA vaccine with liquid nano-emulsion is safe and well-tolerated.
• GEMCOVAC^®-OM samRNA vaccine is a low dose, room temperature stable mRNA vaccine that was licensed under emergency use authorization in 2023.

GOLDEN, Colo.–(BUSINESS WIRE)–PharmaJet^®, a company that strives to improve the performance and outcomes of medicines with its innovative delivery systems, today announced the Nature publication¹ of Gennova Biopharmaceutical’s Phase 2/3 clinical trial conducted to evaluate the safety and immunogenicity of its novel samRNA-based Covid-19 vaccine booster. The results demonstrated that GEMCOVAC-OM, administered exclusively with Tropis, is well-tolerated with no related serious adverse events and significantly boosts immune responses against the Omicron variant. Furthermore, the publication cited that the self-amplifying, thermostable mRNA platform delivered intradermally with Tropis provides a framework for next-generation vaccines that can improve accessibility and global equity.

ID delivery is known to have the potential to improve the performance of vaccines, but this study is the first time a samRNA vaccine has been developed with a lipid nano-emulsion, and the data show that ID administration of this vaccine is safe and well-tolerated. Tropis unlocks the rich potential of the human dermis, paving the way for enhanced immune responses. Vaccine delivery directly into the dermis enables access to the immune system, with benefits on durability and breadth of immune response, and mucosal immunity. Tropis also enables access to immune cell populations more directly thus creating the potential for dose sparing.

PharmaJet has partnered with Gennova to improve the performance and outcomes of their samRNA platform with PharmaJet’s breakthrough ID delivery technology. The outcome of this collaboration is a needle-free self-amplifying vaccine with advantages over the other mRNA vaccines approved for COVID-19:

• GEMCOVAC-OM is a lyophilized vaccine, stable at 2-8°C, which means it can be distributed through the existing refrigeration supply chain. The booster vaccine is exclusively administered intradermally with Tropis.
• Tropis leverages the rich network of dendritic cells, macrophages, and T cells in the dermal layer providing a more potent and broader immunogenic response than vaccinating into the muscle. Tropis is prequalified by the WHO and approved by numerous regulatory bodies globally. As a needle-free delivery System, Tropis eliminates the need for sharps disposal and needle-stick injuries, as well as increases coverage due to its high acceptability among caregivers and healthcare workers.

“We congratulate our partner Gennova for their compelling data published in this prestigious journal,” said Chris Cappello, President, and Chief Executive Officer, PharmaJet. “This new data adds to the evidence base indicating Tropis needle-free ID administration is an enabler for vaccine platforms.”

Tropis ID (for intradermal administration) and Stratis^® SC/IM (for intramuscular and subcutaneous administration) are the only commercially scaled needle-free technologies that enhance the performance of several vaccines and therapeutics. PharmaJet has over 80 global development partners and Tropis has been used to perform over 10 million vaccinations in several countries.

For more information about PharmaJet visit https://pharmajet.com.

Refer to Instructions for Use to ensure safe injections and to review risks.

¹ An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial | Nature Medicine

About PharmaJet

The PharmaJet mission is to improve the performance and outcomes of medicines with our innovative delivery systems that better activate the immune system. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Precision Delivery Systems™ can improve increased vaccine effectiveness, allow for a preferred patient and caregiver experience, and offer a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis^® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis^® System has CE Mark and WHO PQS certification for intradermal injections. They are both commercially available for global immunization programs. For more information or if you are interested in partnering with PharmaJet to improve the impact of your novel development program, visit https://pharmajet.com or contact PharmaJet here. Follow us on LinkedIn.

Contacts

Nancy Lillie

Nancy.Lillie@pharmajet.com
1-888-900-4321 Option 3

n-Lorem Foundation Partners with Hongene Biotech Corporation to Support the Discovery of Personalized ASO Medicines for Nano-rare Patients




n-Lorem Foundation Partners with Hongene Biotech Corporation to Support the Discovery of Personalized ASO Medicines for Nano-rare Patients

SAN DIEGO–(BUSINESS WIRE)–#ASO—n-Lorem, a nonprofit foundation, announced a new partnership with Hongene Biotech Corporation that supports n-Lorem’s efforts to discover and provide personalized experimental antisense oligonucleotide (ASO) medicines to nano-rare disease patients (1 to 30 patients worldwide) for free, for life. As part of its commitment to n-Lorem and nano-rare patients, Hongene will provide amidites, compounds essential to developing ASO medicines, to n-Lorem to offset the costs of developing ASO medicines for up to 20 nano-rare patients.

“In many cases, nano-rare patients will succumb to their disease without ever having hope of a treatment that will halt their progressive diseases. At n-Lorem, we can and are changing this for nano-rare patients today. Our approach enables us to discover and develop an individualized ASO medicine that targets a nano-rare patient’s unique mutation, and we do this for free, for life,” said Stanley T. Crooke, M.D., Ph.D., Chairman, Founder, and CEO, n-Lorem Foundation. “The need from the nano-rare community is substantial and we cannot do this alone. Thanks to the generosity of Hongene, we will be able to discover and evaluate ASO medicines for nano-rare patients without having to worry about sourcing crucial amidites. At n-Lorem we are grateful for the support from our partners as together we work toward making a difference for our nano-rare patients today.”

Hongene is a global specialist in nucleic acid raw material supply and CDMO services, committed to providing high-quality, high-value products with best-in-class lead times. The company reached out to n-Lorem when it learned of the foundation’s work to provide experimental ASO medicines for free to nano-rare patients who need them.

“We are proud to be able to contribute to n-Lorem’s work to help people living with nano-rare illnesses. At Hongene, we are dedicated to making nucleic acid medicines universally accessible for all who need them, including patients in the non-rare disease community. We are confident that our expertise in the production and supply of these key raw materials will be a tremendous asset that will help further the foundation’s mission to bring ASO medicines to those who need them most,” said Wei Jiang, Founder and Chief Executive Officer at Hongene.

About Hongene

Hongene is an end-to-end partner for specialist nucleic acid manufacturing, offering a wide range of products to meet the needs of the life sciences industry. From standard raw material building blocks to complex oligonucleotides and mRNA, Hongene consistently delivers with exceptional quality and value. Through collaborations Hongene can help unlock the full potential of nucleic acids to develop life-changing treatments for patients worldwide.

For more information about Hongene and its range of nucleic acid products, visit the website at www.hongene.com and follow us on Linkedin.

About n-Lorem

n-Lorem Foundation is a non-profit organization established to apply the efficiency, versatility, and specificity of antisense technology to charitably provide experimental antisense oligonucleotide (ASO) medicines to treat nano-rare patients diagnosed with diseases that are the result of a single genetic defect unique to only one or very few individuals. Nano-rare patients describe a very small group of patients (1-30 worldwide) who, because of their small numbers, have few if any treatment options. n-Lorem Foundation was created to provide hope to these nano-rare patients by developing individualized ASO medicines, which are short strands of modified DNA that can specifically target the transcripts of a defective gene to correct the abnormality. The advantage of experimental ASO medicines is that they can be developed rapidly, inexpensively and are highly specific. To date, n-Lorem received over 260 applications for treatment with more than 120 nano-rare patients approved. n-Lorem was founded by Stanley T. Crooke, M.D., Ph.D., former chairman and CEO of Ionis Pharmaceuticals, who founded Ionis Pharmaceuticals in 1989 and, through his vision and leadership, established the company as the leader in RNA-targeted therapeutics. Follow us on Twitter, Facebook, LinkedIn and YouTube.

To learn more about n-Lorem’s mission at www.nlorem.org, and please consider giving to n-Lorem to bring hope, possibility and treatment options to these patients and families in need.

Contacts

n-Lorem Contact:
Amy Williford, Ph.D.

Sr. Director of Communications

amy.williford@nlorem.org

United Therapeutics Announces World’s First Successful Xenothymokidney Transplant




United Therapeutics Announces World’s First Successful Xenothymokidney Transplant

The first living recipient of a UThymoKidney, in conjunction with a heart pump implant, is recovering after a successful transplant

This transplant builds on two successful UHeart transplants completed in 2022 and 2023

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced the world’s first successful transplant of a UThymoKidney™, which the company produced, into a living person on April 12, 2024. This transplant represents several historic firsts for transplantation:

– The first-ever transplant of a xenothymokidney into a living human recipient;

– The first-ever combined mechanical heart pump and organ transplant; and

– The first-ever xenotransplant into a living human using only FDA-approved immunosuppressive medicines

The transplant is the third xenotransplant using United Therapeutics’ xeno organs, following two successful UHeart™ transplants at the University of Maryland Medicine in 2022 and 2023.

The transplant was authorized by U.S. Food and Drug Administration (FDA) under the expanded access pathway and performed by surgeons at NYU Langone Health led by Robert Montgomery, M.D., DPhil. The patient, a 54-year-old woman from New Jersey, suffers from heart and kidney failure. The combination of several chronic medical conditions, coupled with a lack of available human organs for transplant, prevented her from qualifying for human heart and kidney transplants.

United Therapeutics’ xenothymokidney, known by the proposed trade name UThymoKidney, is an investigational-stage xenokidney from a pig with a single genetic edit, together with tissue from the same pig’s thymus. The use of the pig’s thymus tissue is intended to condition the recipient human’s immune system to recognize the UThymoKidney as “self” and reduce the likelihood of rejection.

The single genetic modification in the pig is the inactivation, or “knock-out”, of the gene responsible for the synthesis of alpha-gal, a sugar on the surface of cells that can cause the immediate rejection of an organ when transplanted into the human body. Because tissues from pigs containing this modification do not contain detectable levels of alpha-gal, United Therapeutics refers to materials derived from this pig as GalSafe®.

The GalSafe pig was developed by Revivicor, Inc., a subsidiary of United Therapeutics. In December 2020, this pig line was approved by the FDA for use as human food or as a potential source for biomedical purposes, with this being the first investigational biomedical use in a living human.

“This historic transplant builds on the base of knowledge that the teams at United Therapeutics and our academic collaborators have established over the past two decades and demonstrates the potential utility for xeno organs to revolutionize the way patients with end-stage organ disease are managed in the future,” said Leigh Peterson, Ph.D., Executive Vice President, Product Development & Xenotransplantation at United Therapeutics. “We look forward to continuing our dialogue with the FDA with the goal of starting human clinical studies for xenotransplantation in 2025.”

According to the U.S. Health Resources and Services Administration, around 110,000 Americans are currently waiting for an organ transplant, and more than 6,000 patients – 17 every day – die each year before receiving one. More than 89,000 patients are waiting for kidneys, close to 10,000 for livers, over 3,400 for hearts, and almost 1,000 for lungs, with many more patients suffering from end-stage organ failure who are ineligible for the strict organ transplant waiting list who could benefit from a readily available supply of organs on demand.

“I am pleased and impressed that decades of research into expanding the supply of kidneys have resulted in this historic, successful xenokidney transplant using United Therapeutics’ gene editing and thymokidney technology,” said Dr. Louis Sullivan, Secretary of the United States Department of Health and Human Services in President George H.W. Bush’s administration, member of the United Therapeutics Board of Directors, and Chair of its Scientific Advisory Board.

“I am so proud of the many scientists and surgeons working with United Therapeutics on its xenotransplantation programs,” said Gov. Tommy Thompson, Secretary of the United States Department of Health and Human Services in President George W. Bush’s administration and member of United Therapeutics’ Board of Directors. “This major breakthrough is a revolutionary step forward in our quest to create an unlimited supply of transplantable organs.”

United Therapeutics’ organ manufacturing efforts consist of four platforms – xenotransplantation, regenerative medicine, 3D organ bioprinting, and bio-artificial organs – encompassing four different organs – hearts, kidneys, livers, and lungs. These groundbreaking programs are intended to address the ongoing shortage of transplantable organs for patients with end stage organ disease.

United Therapeutics initiated its xenotransplantation research work in 2011 and currently employs close to 50 scientists and support staff advancing xenotransplant science with three different organ programs: the UHeart xenoheart, the UThymoKidney, a one-gene modified kidney and thymus, and the UKidney™, a 10-gene modified kidney. In 2024, the company inaugurated the world’s first clinical-scale designated pathogen-free facility in Christiansburg, Virginia to support future clinical xenotransplantation studies with a capacity of approximately 125 organs per year.

To date, 11 xenotransplantation procedures using United Therapeutics’ UHearts, UThymoKidneys, and UKidneys have been performed in living and brain-dead human recipients: two living human recipients of UHearts, one living recipient of a UThymoKidney, six brain-dead UKidney and UThymoKidney recipients, and two brain-dead UHeart recipients. United Therapeutics has built on its history of innovation in xenotransplantation with strong research collaborations with top academic medical centers including NYU Langone Health, the University of Maryland Medicine, Johns Hopkins Medicine, and the University of Alabama at Birmingham.

United Therapeutics is preparing for clinical trials of its xenokidney, xenothymokidney, and xenoheart products, following completion of ongoing preclinical studies required by the FDA.

United Therapeutics: Enabling Inspiration

At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun; we do good. We are the first publicly traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

You can learn more about what it means to be a PBC here: unither.com/PBC.

Forward-looking Statements

Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding progress toward developing our organ manufacturing programs, including our plans to commence clinical trials of one or more xenotransplantation products in 2025, and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders and furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. In particular, our plans to commence clinical studies of one or more xenotransplantation products in 2025 are subject to regulatory clearance, including the completion of preclinical studies to the satisfaction of the FDA, and many other factors that we cannot control. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of April 24, 2024, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason.

GALSAFE is a registered trademark of United Therapeutics Corporation and its subsidiaries.

UHEART, UKIDNEY, and UTHYMOKIDNEY are trademarks of United Therapeutics Corporation and its subsidiaries.

Contacts

Dewey Steadman at (202) 919-4097

https://ir.unither.com/contact-uthr/

Naveris Announces Launch of Phase II Clinical Study in MRD+ Head and Neck Cancer




Naveris Announces Launch of Phase II Clinical Study in MRD+ Head and Neck Cancer

NavDx to be used to identify eligible patients with molecular relapse after definitive treatment for HPV16+ head and neck squamous cell cancer and to monitor throughout study

WALTHAM, Mass.–(BUSINESS WIRE)–Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, today announced the launch of a Phase II clinical study in minimal residual disease positive (MRD+) HPV-driven head and neck cancer. The study will be led by Memorial Sloan Kettering Cancer Center (MSKCC), a top cancer treatment and research institution.

The primary objective of this multicenter randomized study is to evaluate the efficacy of HB-200, a novel intervention, for patients with HPV16+ head and neck squamous cell cancer (HNSCC) with molecular relapse, defined as the presence of circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA without clinical or radiographic evidence of recurrence following definitive treatment. This will be the first MRD-treatment trial for this patient population.

NavDx®, Naveris’ proprietary flagship blood test that detects TTMV-HPV DNA to diagnose disease recurrence or relapse in HPV-driven head and neck cancer, will be utilized to enroll patients to the trial, with requirements including detectable TTMV-HPV DNA by the NavDx assay three or more months after a patient received treatment for HPV16+ HNSCC. The NavDx test will be performed prior to, during, and following treatment.

“This study will propose a novel intervention for patients with MRD+ HPV-driven head and neck cancer and will assess the ability of NavDx to identify MRD in these patients,” said Alan L. Ho, MD, PhD, Head and Neck Oncologist and Cellular Therapist, Memorial Sloan Kettering, and the primary principal investigator for the study. “The findings from this study will provide critical insights into the utility of treating patients identified at the early stage of molecular relapse.”

NavDx is the first and only clinically validated circulating tumor HPV DNA blood test that provides a non-invasive and precise method for detecting disease recurrence or relapse in HPV-driven head and neck cancer before there is clinical or radiographic evidence of cancer recurrence.

“We are excited to announce the beginning of Phase II of our landmark trial, which marks the next step in our mission to bring innovative resources to viral-driven cancer surveillance,” said Barry M. Berger, Chief Medical Officer of Naveris. “This trial is the first of its kind for this patient population and provides a promising look into the future of treatment paths, with NavDx being used to identify TTMV-HPV DNA and allowing for action earlier than ever before. We are grateful to the research team at Memorial Sloan Kettering Cancer Center for their collaboration and we look forward to presenting the results of this study when they are complete.”

About Naveris

Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Naveris is dedicated to improving outcomes for the millions of people at risk of developing viral-induced cancers by developing novel molecular diagnostics that enable earlier cancer detection. The company operates high-complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and are certified under CLIA. For more information on Naveris and the clinical impact of NavDx, please visit www.naveris.com and www.NavDx.com. NavDx has not been cleared or approved by the US Food and Drug Administration (FDA).

Contacts

Terri Clevenger

ICR Westwicke Healthcare PR

Tel: 203-682-8297

Terri.clevenger@westwicke.com

Quantum Health Launches Comprehensive Oncology Navigation Solution for Enhanced Employer and Family Support




Quantum Health Launches Comprehensive Oncology Navigation Solution for Enhanced Employer and Family Support

DUBLIN, Ohio–(BUSINESS WIRE)–Quantum Health, the leading consumer healthcare navigation and care coordination company, announced today the launch of its new end-to-end care management solution, Premier Oncology, tailored for employers and their members diagnosed with cancer. This innovative solution enhances support for members, caregivers and their families by integrating value-based Centers of Excellence (COE) that connect members with a rigorously vetted network of surgical and cancer care providers, prospective episodic bundles, reducing the strain and financial burdens inherent in treating cancer, ensuring and providing access to top-tier oncology care and expert medical guidance.

Quantum Health’s Premier Oncology solution is uniquely able to engage members and emphasize early detection, leveraging cancer-specific predictive modeling and Quantum Health’s enhanced Real-Time Intercept^® capability to proactively connect with members, potentially even before a cancer diagnosis is confirmed. It also provides a single point of contact for employees and their families to help streamline the cancer care journey, provide vital support from the outset, and ensure members and their families have the resources and guidance they need every step of the way. This solution also works to reduce the administrative load on HR teams and offers a more personalized and comprehensive support system for members confronted with multiple challenges when faced with a cancer diagnosis.

A 2024 Business Group on Health employer survey found that 86% of surveyed companies reported cancer as one of their top three cost drivers. The cancer journey is long, complex and expensive – posing challenges for employers and their employees. Employers are in urgent need of solutions that both control costs and provide comprehensive support for members from diagnosis to treatment and return to work, making the journey simpler, less burdensome and more effective overall.

In 2023, Quantum Health formed its Clinical Advisory Board in response to the unrelenting clinical, emotional and financial challenges faced by both employers and their employee populations. Expanding on the company’s already strong cancer care support for employers and their employees, Quantum Health analyzed current gaps in cancer care journeys and identified the need to further expand its ability to provide even broader support to members throughout their entire cancer care experience, including finding high-quality cancer care at leading cancer centers, accessing top-rated oncology providers and researchers, identifying clinical trial options in their geographic locations, managing financial impact, finding behavioral health support, and coordinating leave management.

After an extensive evaluation process, Quantum Health exclusively selected Carrum Health, which has the largest value-based network of COEs. It offers employers transparent and predictable pricing through the first and only cancer treatment bundles in the commercial market that are all-inclusive, covering everything from facility charges to physician fees to the cost of drugs, which are often excessively marked up in the traditional fee-for-service model. Carrum Health’s offering will now be integrated as part of Quantum Health’s larger Premier Oncology solution and navigation platform.

This proactive approach, enhanced by cancer-specific predictive modeling, enables Quantum Health to connect with members potentially before a cancer diagnosis is made, based on early indicators like biopsies or MRIs. Quantum Health’s certified and dedicated oncology nurse then serves as the single point of contact for members and their families, providing immediate support, evaluating the member’s mental health and any SDOH factors, and providing benefits education to connect them with their EAP or necessary disability assistance at the right point in their cancer journey and on an ongoing basis. After a member is diagnosed with cancer, Quantum Health also proactively manages the process of obtaining an expert medical opinion that is seamlessly integrated into Quantum Health’s comprehensive care coordination platform, supporting the full spectrum of care for all employees covered by their employer’s plan.

“Quantum Health supports over 3 million members today for every facet of their healthcare journey, and we have a front-row seat into where the hurdles exist for both members and their families when dealing with a cancer diagnosis and treatment,” said Chief Product Officer Dan Shur. “We understand the unique demands of navigating cancer care, which is why we’ve crafted our comprehensive oncology navigation service to be a centralized source of support and guidance. This service offers a personalized and tailored experience, combining cutting-edge technology with our highly skilled oncology clinicians, strong partnerships with healthcare providers and carefully selected partners.”

Learn more about Quantum Health’s approach to cancer and its new comprehensive oncology navigation solution: www.quantum-health.com/cancer/

About Quantum Health

Quantum Health celebrates its 25th year as industry-leading consumer healthcare navigation and care coordination company that delivers an unparalleled consumer experience to its members, as well as validated claims savings and high satisfaction rates for its self-insured employer clients. Quantum Health’s proprietary Real-Time Intercept^® capability identifies opportunities for early intervention in a member’s healthcare journey, resulting in better engagement, outcomes and cost efficiencies.

Founded in 1999 and based in Dublin, Ohio, Quantum Health has earned numerous awards and honors, including being named among the Fastest-Growing Private Companies by Inc. 5000, a Great Place to Work by FORTUNE Magazine and Entrepreneur Magazine, and one of FORTUNE’S Best Workplaces in Healthcare. The Women Presidents’ Organization has also ranked Quantum Health as one of the 50 Fastest-Growing Women-Owned/Led Companies for over 15 years.

To learn more about the company, visit Quantum-Health.com, and connect with us on LinkedIn and Twitter.

Contacts

John Hallock

Quantum Health, Corporate Communications

John.Hallock@quantum-health.com
800-257-2038 x16731

617-615-7712