HPV E7

Vancouver, British Columbia--(News - February 29, 2024) - Defence Therapeutics Inc. (CSE: DTC) (OTCQB: DTCFF) (FSE: DTC) ("Defence" or the "Company"), one of the leading Canadian biotechnology companies working in the field of immune-oncology, is pleased to announce the publication of a peer-reviewed study on the anticancer properties of its dual Accum®-E7 vaccine, one of Defence's experimental product designed to treat established cervical cancer. The study, which was published in the prestigious journal of Cancer Science, is entitled, "An engineered Accum®-E7 protein-based vaccine with dual anti-cervical cancer activity", and can be directly accessed at the following address . The human papillomavirus (HPV) can cause genital warts subsequently leading to cervical, anal, or head and neck cancers. Prophylactic HPV vaccines were therefore developed to prevent these infections and their associated complications. The most widely used of all four commercially available HPV vaccines is Gardasil-9®. However, this vaccine has challenges: it requires three doses and the vaccine manufacturing remains costly, which may be prohibitive to low-income countries. In addition, the vaccine cannot provide complete protection against all 14 high-risk HPV subtypes as it only targets 9 of them. Furthermore, the vaccine should be administered before HPV exposure implying that it cannot treat existing infections or established cervical cancer. The peer-reviewed study on Defence's Accum®-E7 anti-cancer vaccine presents an engineered Accum®-E7 protein-based vaccine capable of providing a durable memory response when used prophylactically. In addition, the selection of E7 as a target "non-self" antigen widened the vaccine scope of application as it can also control the growth of pre-established cervical tumors through the generation of potent cytotoxic T lymphocytes (CTLs). "Overall, this engineered Accum®-E7 vaccine is safe, simple to engineer and manufacture making it an elixir candidate capable of providing both prophylactic and therapeutic activity against cervical cancer," says Dr. Rafei, the Chief Scientific Officer of Defence Therapeutics. The key highlights of the Accum®-E7 study are: Prophylactic vaccination using the Accum®-E7 vaccine confers complete protection despite multiple challenges. Accum®-E7 elicits antibodies capable of interfering with cancer cell proliferation in vitro. Therapeutic vaccination using Accum®-E7 synergises with multiple immune-checkpoint inhibitors. The therapeutic effect of Accum®-E7 relies on cross-presenting dendritic cells (DCs) and CD8 T cells. Vaccination using Accum®-E7 is safe and immunogenic as shown in the conducted GLP study. "This prestigious peer-reviewed publication provides an additional example of how the Accum® technology can be exploited in the development of vaccines. It also opens up a new line of investigations where Defence's more potent Accum® variants could be tested as bioconjugates to protein antigens," said Mr. Plouffe, Chief Executive Officer of Defence Therapeutics. In summary, our study shows that Accum®-E7: i) provides potent protection (prophylactic vaccination) and durable memory responses, ii) triggers antibodies exhibiting a non-negligible role in fighting cervical tumors, iii), controls established tumors when delivered in combination with several immune-checkpoint inhibitors (therapeutic vaccination), and iv) is relatively safe, well tolerated and immunogenic by animals even when used at higher doses (GLP study). Financing Update The Company also provides an update to its previously announced non-brokered private placement of up to 1,500,000 units of the Company (each a "Unit") at a price of $1.50 per Unit for gross proceeds of up to $2,250,000 (the "Offering"). Following the first tranche closing of 567,000 Units for aggregate proceeds of $850,500 on January 30th, 2024, the Company has received a 45-day extension from the Canadian Securities Exchange to complete the Offering. About Defence: Defence Therapeutics is a publicly-traded biotechnology company working on engineering the next generation vaccines and ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUM® technology, which enables precision delivery of vaccine antigens or ADCs in their intact form to target cells. As a result, increased efficacy and potency can be reached against catastrophic illness such as cancer and infectious diseases. For further information: Sebastien Plouffe, President, CEO and Director P: (514) 947-2272 Splouffe@defencetherapeutics.com Cautionary Statement Regarding "Forward-Looking" Information This release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change. Neither the CSE nor its market regulator, as that term is defined in the policies of the CSE, accepts responsibility for the adequacy or accuracy of this release. 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BOSTON, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, announced today that the company’s lead clinical asset, CUE-101, will be featured in a presentation at the 2024 Multi-disciplinary Head and Neck Cancers Symposium given by Alexander Dimitrios Colevas, M.D., a principal investigator at Stanford University participating in the CUE-101 clinical trial. The symposium is being held in Phoenix, Arizona and virtually from February 29 – March 2, 2024. Dr. Colevas will discuss previously presented data from the company’s ongoing Phase 1 trial evaluating CUE-101, as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) for patients with recurrent/metastatic HPV+ head and neck squamous cell carcinoma (HNSCC). Data highlights include an overall response rate (ORR) of 47% in first line (1L) patients treated with CUE-101 and pembrolizumab, compared to the historical ORR of 19% reported in the KEYNOTE-48 trial. In second line (2L) and beyond patients treated with CUE-101 monotherapy, the reported median overall survival (mOS) was 20.8 months, compared to a mOS of approximately eight months reported in the KEYNOTE-40 trial. “Preliminary data of CUE-101 in combination with immunotherapy has been really promising with a much higher response rate than we would expect from immunotherapy alone, and a very tolerable side effect pro stated Dr. Colevas. Presentation Details Poster Title: A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy in 3L and in combination with pembrolizumab in 1L recurrent/metastatic (R/M) HPV16+ head and neck cancer patients. Poster Number: 7 Poster Session: III Presenter: Alexander Dimitrios Colevas, M.D., professor of medicine and medical oncologist, Stanford Cancer Center, Stanford University School of Medicine Date and Time: Friday, March 1, 2024 at 2:35 p.m. MST About CUE-101 and the Phase 1 Trial CUE-101 is Cue Biopharma’s lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting two signals or “cues” to T cells. Signal #1 incorporates the HPV E7 protein, harbored by HPV-induced cancer cells, to provide selectivity through interaction with the HPV-specific T cell receptor. Signal #2 consists of an engineered IL-2 variant to stimulate the activity of T cells. CUE-101 is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study, for the treatment of HPV16+ driven recurrent/metastatic head and neck squamous cell carcinoma in second line (2L) and beyond patients as a monotherapy, and as a first line (1L) therapy in combination with pembrolizumab (KEYTRUDA®). About Cue Biopharma Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation. Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics. For more information please visit and follow us on Twitter and LinkedIn. Investor Contact Marie Campinell Senior Director, Corporate Communications Cue Biopharma, Inc. mcampinell@cuebio.com Media Contact Jonathan Pappas LifeSci Communications jpappas@lifescicomms.com

Published data shows lymph node-targeted Amphiphile (“AMP”)-peptide and CpG combination with TCR-T cell therapy led to complete eradication and durable responses against established murine solid tumors refractory to TCR-T cell monotherapy Long-term protection against tumor recurrence in AMP-treated mice was associated with antigen spreading to additional tumor-associated antigens not targeted by the treatment Preclinical efficacy in solid tumors, including those with KRAS mutations, provides a strong rationale for the clinical advancement of a combination AMP immunotherapy strategy with TCR-T cell therapies to augment anti-tumor activity Jan. 25, 2024 -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the publication of promising preclinical data in Cancer Immunology Research, a journal of the American Association for Cancer Research (“AACR”). These preclinical data demonstrate that Elicio’s proprietary “AMP” lymph node-targeting immunotherapy platform, carrying cognate peptide and adjuvant cargos, boosted T cell receptor-modified T cell therapies (“TCR-T cells”) enhancing anti-tumor function and eradicating solid tumors. “Optimization of TCR-T cell therapy could potentially have wide-ranging therapeutic benefits in many previously intractable solid tumors,” said Peter DeMuth, Ph.D., Chief Scientific Officer at Elicio Therapeutics. “In this study, we’ve demonstrated that boosting TCR-T cell therapy directly in the lymph nodes with AMP immunotherapy resulted in durable anti-tumor T cell responses and tumor eradication. The AMP treatment uniquely promoted potent mechanisms for immune activation in lymph nodes to invigorate both adoptive and endogenous anti-tumor T cell immunity. Simple application to a variety of cancer targets including mKRAS, HPV E7 and NY-ESO-1 could elevate existing TCR-T cell therapies to generate powerful new combinations for hard-to-treat solid tumors.” Previous Elicio studies have demonstrated that AMP immunotherapy promoted specific trafficking and retention of payloads into lymph nodes, yielding enhanced T cell numbers, persistence and functional quality. Preliminary Phase 1 data from the ongoing study of Elicio’s lead asset, ELI-002, an mKRAS-specific AMP vaccine, demonstrated significant T cell responses including both CD4+ and CD8+ when administered as an adjuvant monotherapy in patients with pancreatic and colorectal cancers. The strength of the T cell response induced by ELI-002 was further correlated to significant improvements in tumor biomarker response, and reduced risk of progression and death indicating an association between the ELI-002 mechanism of action and clinical outcome. Robert Connelly, Chief Executive Officer at Elicio Therapeutics, added, “This study adds to our growing body of preclinical and clinical evidence demonstrating the importance of the lymph nodes and the robust efficacy that our AMP immunotherapy strategy can potentially achieve for patients with solid tumors, both as a monotherapy and in combination with other strategies. The AMP platform provides attractive potential for broad and rapid application to clinical and developmental TCR-T cell programs. We look forward to finding the right partner to advance this promising combination into the clinic for patients with solid tumors.” Key Study Findings: AMP immunotherapy in combination with TCR-T cell therapy led to complete eradication and durable responses against established murine solid tumors refractory to TCR-T cell monotherapy. AMP immunotherapy led to enhanced lymph node delivery and correlated with pro-inflammatory lymph node transcriptional reprogramming and increased antigen-presenting cell maturation, resulting in TCR-T cell expansion and functional enhancement. Enhanced anti-tumor efficacy was correlated with simultaneous in vivo invigoration of adoptively transferred TCR-T cells and in situ expansion of the endogenous anti-tumor T cell repertoire. AMP immunotherapy enhanced the infiltration and function of TCR-T cells in the tumor microenvironment and led to epitope spreading against diverse tumor targets. Long-term protection against tumor recurrence in AMP-treated mice was associated with antigen spreading to additional tumor-associated antigens not targeted by the treatment. In vitro evaluation of AMP peptides with matched human TCR-T cells targeting NY-ESO-1, mutant KRAS and HPV16 E7 illustrated the clinical potential of AMP to enhance human TCR-T cell proliferation, activation and anti-tumor activity. Our proprietary Amphiphile (“AMP”) platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based upon preclinical studies. Our AMP platform, originally developed at the Massachusetts Institute of Technology has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships. The Amphiphile platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving immune responses of increased magnitude, function, and durability. ELI-002 is a structurally novel investigational AMP therapeutic immunotherapy targeting mutant KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. The seven KRAS driver mutations targeted by the ELI-002 7P formulation are present in 25% of all solid tumors. In particular, 93% of pancreatic ductal adenocarcinoma and 52% of colorectal cancers, those most prevalent in the AMPLIFY-201 study, are positive for KRAS mutations. In addition, 27% of non-small cell lung cancers are positive for KRAS mutations. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide CpG adjuvant available as an off-the-shelf subcutaneous administration. The AMP mKRAS peptides and AMP CpG are targeted to the lymph node where they can potentially enhance the action of key immune cells. ELI-002 2P is currently being studied in a Phase 1 trial (AMPLIFY-201) in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P, is currently being studied in AMPLIFY-7P, a Phase 2 trial in patients with high relapse risk mKRAS-driven solid tumors (NCT05726864). The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, thereby increasing the potential patient population for ELI-002 and potentially reducing the chance of bypass resistance mechanisms. Elicio Therapeutics is a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer. By combining expertise in immunology and immunotherapy, Elicio is engineering investigational AMP immunotherapies intended to precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated. Elicio is engineering lymph node-targeted AMPlifiers, immunomodulators, adjuvants and vaccines for an array of aggressive cancers. 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