On May 14, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, reported the issuance of several new patents, as well as new allowances of patent applications belonging to different Patent Families in Defence’s vast and diverse portfolio (Press release, Defence Therapeutics, MAY 14, 2024, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-strengthens-and-expands-global-patent-protection-on-key-technologies [SID1234643216]).

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Defence’s vaccine enhancer platform technology based on simple admixture of Accum and variants thereof with specific antigens, is further expanded by the recent allowance of Defence’s US application no. 18/169,440 by the USPTO. The newly allowed subject-matter, which includes valuable composition-of-matter claims directed to Accum or variants thereof as standalone agents for enhancing antigen presentation, or in admixture with of any vaccine antigen, elegantly compliments Defence’s previously granted US patent no. 11,612,651 covering methods of improving polypeptide antigen immunogenicity. Importantly, this Patent Family is the first family broadly covering Defence’s anticancer ARM vaccine platform. Recent pre-clinical studies using Defence’s ARM-002 vaccine suggest potent antitumor responses in in vivo melanoma, lymphoma, and pancreatic cancer models when combined with the anti-PD-1 immune-checkpoint inhibitor, paving the way for upcoming Phase I clinical trials.

Defence is also pleased to announce the securing of a new patent in Australia protecting its ADC platform technology based on the ability of the original Accum to form potent antibody-drug conjugates leading to targeted cellular accumulation of a payload. Granted on February 1, 2024, Australian patent no. 2017233725 broadly protects not only Defence’s original Accum but also important variants thereof, which further strengthens the company’s patent protection in this valuable and growing therapeutic space. This represents a significant milestone in the future development and commercialization of novel ADCs for treating and detecting many cancers, and adds to Defence’s previous granted patents in the United States (US 11,352,437), Japan (JP 7,126,956), and Israel (IL 261765).

In addition, Defence’s vaccine platform technology based on covalent conjugation of Accum and variants thereof to specific antigens, which already included US patent no. 11,291,717, now includes Canadian patent no. 3,201,103 granted on December 12, 2023, as well as Australian patent no. 2021402007 granted on March 14, 2024. Furthermore, counterpart Japanese application no. 2023-535891 was recently allowed by the Japanese Patent Office and the Japanese patent is expected to be granted imminently. These patents include claims broadly covering a method of improving polypeptide antigen immunogenicity by covalently conjugating any antigen to Accum or any variant thereof, and also include independent composition-of-matter claims covering potential vaccine compositions.

"We are thrilled to announce the issuance of these patents and allowances with broad claims covering our ADC and vaccine platforms, which underscore our relentless pursuit of innovation and our unwavering commitment to improving human health" says Mr. Plouffe, CEO and president of Defence.

Acceleration of examination of the remaining applications in both of Defence’s vaccine platform Patent Families via the Patent Prosecution Highway (PPH) program is currently being pursued based on these broad issued and allowed claims. The issuance of new patents in these families is therefore expected shortly.

On May 14, 2024 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that it has expanded its collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) to include a clinical trial collaboration and supply agreement for a phase 2 trial evaluating Nykode’s wholly-owned lead candidate, VB10.16, in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) (Press release, Nykode Therapeutics, MAY 14, 2024, View Source [SID1234643233]). This study will enroll HPV16-positive high-risk patients with locally advanced cervical cancer undergoing chemoradiotherapy.

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VB10.16 is a potentially first-in-class off-the-shelf therapeutic cancer vaccine specifically designed to treat HPV16-induced malignancies. The cancer vaccine is built on Nykode’s technology platform of targeting antigens to antigen presenting cells. Nykode has reported promising data from the phase 2 VB C-02 trial (NCT04405349) in heavily pre-treated cervical cancer patients receiving VB10.16 in combination with atezolizumab with a median overall survival not yet reached (estimated to 25 months at the time of analysis). These data support Nykode’s ongoing efforts with the phase 2 VB-C-04 trial (NCT06099418) in second-line recurrent/metastatic cervical cancer. Furthermore, the VB10.16 clinical development program is expanding into new indications, including head and neck cancer, for which Nykode has an existing clinical trial collaboration and supply agreement with MSD for the ongoing VBC-03 trial (NCT06016920) evaluating VB10.16 in combination with KEYTRUDA in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma.

Agnete Fredriksen, EVP, Chief Scientific Officer and Business Development, commented, "We are excited to expand our clinical development to include earlier stages of cervical cancer where there is a significant unmet medical need, and we see a huge potential for cancer vaccines. We are thrilled to continue building on our already established, highly valued collaboration with the experienced and talented team at MSD, a global leader in immuno-oncology."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On May 14, 2024 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported a presentation at The Essential Protein & Antibody Engineering Summit (PEGS) conference in Boston MA (Press release, Aptevo Therapeutics, MAY 14, 2024, View Source [SID1234643260]). The session, being offered today, Tuesday May 14, 2023 at 8:30 AM Eastern time and entitled "Development of Target Activated ADAPTIRs for Tumor Immunotherapy," will be led by Dr. Peter Pavlik, PhD, Senior Director of Protein Engineering at Aptevo and will focus on the strategic deployment of early functional screening of a diverse group of binding domains against a given target, combined with screening in multiple possible final formats to elicit varied functional activity, exemplified by preclinical and clinical data supporting predictive outcomes.

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"As a Company, Aptevo is focused on innovations in bispecific cancer therapeutics. We are excited to present at PEGS and share key learnings and expertise with a like-minded community," said Peter Pavlik, PhD, Senior Director, Protein Engineering at Aptevo. He continued, "As we have developed our portfolio of two clinical (APVO436 and ALG.APV-527) and three preclinical candidates (APVO603, APVO711 and APVO442), we have purposefully deployed engineering strategies intended to produce safe and efficacious drug candidates and our outcomes in both the clinic and the lab to date suggest that this approach is successful."

Aptevo continues to add to a growing body of clinical evidence that supports the preclinical predications of safety, conditional activation, and clinical activity of its portfolio of assets. Recent news from the Company’s two clinical programs includes:

A heavily pretreated breast cancer patient, enrolled in the ALG.APV-527 Phase 1 open-label, multi-center, multi-cohort trial for the treatment of multiple solid tumor types, entered the trial and improved from progressive disease to long-lasting stable disease (SD) while on therapy. The patient has remained on study for more than eleven months and been successfully transitioned to a higher dose level, with no new adverse events since the transition, which may allow for increased clinical benefit. The trial is more than 50% enrolled and we are dosing cohort 5
The Company is on track to initiate part 1 of its upcoming dose optimization trial in 2Q 2024. The study will further evaluate APVO436 for the treatment of acute myeloid leukemia (AML). Aptevo has partnered with premier CRO, Prometrika, for the upcoming study. The first part is a dose optimization trial evaluating standard of care venetoclax + azacitidine along with APVO436 as a frontline treatment for AML patients. It is planned as an open-label, multi-center, multi-cohort study. The trial will evaluate safety/tolerability and efficacy of the triplet combination at multiple dose levels

About Dr. Pavlik
Peter Pavlik is Senior Director of Protein Engineering at Aptevo Therapeutics. He has been working on bispecific antibody development at Aptevo for the last 8 years, focusing on discovery of new binding domains, their engineering into bispecific molecules, optimization of developability, and engineering of manufacturing cell lines. Before joining Aptevo, Peter worked for 8 years at MedImmune/AstraZeneca on antibody discovery and protein engineering and for 10 years at Los Alamos National Labs developing antibody discovery technologies at a genome scale. Peter obtained M.Sc. in Biochemistry from Comenius University in Slovakia and Ph.D. in Biochemistry from the University of Vienna in Austria.

On May 14, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the first quarter ended March 31, 2024 (Press release, Adicet Bio, MAY 14, 2024, View Source [SID1234643276]).

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"We are poised for a transformational year in 2024 as we advance our gamma delta T cell platform in autoimmune diseases and prepare to initiate a Phase 1 study evaluating our lead candidate ADI-001 in lupus nephritis in the second quarter of this year," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We recently shared encouraging preclinical data on ADI-270 at the ASGCT (Free ASGCT Whitepaper) annual meeting highlighting its highly differentiated profile and illustrating ADI-270’s robust anti-tumor activity in multiple CD70+ solid and hematological cancer indications and supporting ADI-270’s clinical development. In parallel, we are continuing to enroll mantle cell lymphoma patients in our ongoing Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma and expect to share a clinical update in the second half of this year."

First Quarter 2024 and Recent Operational Highlights:

Autoimmune diseases

On track to initiate Phase 1 study of ADI-001 in lupus nephritis in 2Q 2024. In December 2023, the FDA granted clearance for Adicet’s IND application to evaluate ADI-001 in lupus nephritis. The Company plans to commence a Phase 1 clinical trial to assess the safety and efficacy of ADI-001 in lupus nephritis in the second quarter of 2024. Preliminary data from the study are anticipated during the fourth quarter of 2024 or first quarter of 2025, depending on patient enrollment and study site activation.
Continuing to expand ADI-001 into additional autoimmune diseases. Adicet plans to continue broadening the clinical applications of ADI-001 to include additional autoimmune indications. The Company expects to share preliminary clinical data in the fourth quarter of 2024 or first half of 2025, subject to regulatory clearances and contingent upon successful site initiation and patient enrollment in the relevant clinical protocols.
Hematologic malignancies and solid tumor indications

Presentation of preclinical data from ADI-270 at the ASGCT (Free ASGCT Whitepaper) Annual Meeting. In May 2024, Adicet presented promising preclinical data in an oral presentation at the ASGCT (Free ASGCT Whitepaper) annual meeting demonstrating robust anti-tumor activity of ADI-270, an armored allogeneic "off-the-shelf" gamma delta CAR T cell therapy candidate targeting CD70+ cancers, in multiple CD70+ solid and hematological tumor indications. Based on ADI-270’s promising profile in preclinical studies to date, Adicet expects to submit an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024. Following regulatory clearance and contingent upon study initiation progress, the Company intends to present clinical data from a Phase 1 study in the first half of 2025.
Enrollment of mantle cell lymphoma (MCL) patients in ongoing ADI-001 Phase 1 GLEAN study. Adicet is continuing to enroll MCL patients in the Phase 1 trial evaluating ADI-001 in relapsed or refractory non-Hodgkin’s Lymphoma (NHL). The Company remains on track to provide a clinical update on safety, efficacy and 6-month complete response data in MCL patients in the second half of 2024.
Financial Results for First Quarter 2024:

Research and Development (R&D) Expenses: R&D expenses were $23.9 million for the three months ended March 31, 2024, compared to $26.8 million during the same period in 2023. The decrease in R&D expenses was primarily due to a net $3.1 million decrease in expenses related to contract development manufacturing organizations (CDMOs) and other externally conducted research and development.
General and Administrative (G&A) Expenses: G&A expenses were $7.0 million for the three months ended March 31, 2024, compared to $6.6 million during the same period in 2023. The $0.4 million increase was primarily driven by an increase in personnel expenses. The increase was partially offset by a $0.2 million decrease in contractor fees as well as a $0.1 million decrease in professional fees.
Net Loss: Net loss for the three months ended March 31, 2024 was $28.0 million, or a net loss of $0.35 per basic and diluted share, including non-cash stock-based compensation expense of $5.7 million, as compared to a net loss of $30.9 million, or a net loss of $0.72 per basic and diluted share, including non-cash stock-based compensation expense of $4.8 million during the same period in 2023.
Cash Position: Cash and cash equivalents were $247.6 million as of March 31, 2024, compared to $231.6 million during the same period in 2023. The Company expects that current cash and cash equivalents as of March 31, 2024, will be sufficient to fund its operating expenses into the second half of 2026.

On May 16, 2024 HEPHAISTOS-Pharma, a biotechnology company developing next generation immunotherapies against cancer targeting innate immunity to increase the cure rate of patients, reported its €4.5 million seed round to finance industrialization and advance its lead candidate ONCO-Boost towards the clinic (Press release, HEPHAISTOS-Pharma, MAY 14, 2024, View Source [SID1234643393]). Elaia leads a consortium previously initiated by xista science ventures, the Fondation Fournier-Majoie and Noshaq.

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Florian DENIS, Investment Director at Elaia, stated: "Elaia is very proud to join and strengthen the syndication. HEPHAISTOS’ core technology based on immunostimulants has the potential to turn cold tumors into hot tumors in hard-to-treat cancers. Frédéric CAROFF and his team have generated impressive preclinical data that will be scaled up towards additional value-creating milestones."

"ELAIA has a proven track record in supporting biotech companies through to the clinic and success, and we are delighted to have them on board " said Frederic CAROFF, CEO and co-founder of HEPHAISTOS-Pharma. "With xista science ventures, Fondation Fournier-Majoie and Noshaq, our consortium of seed investors brings not only the necessary funds, but also complementary expertise and a network that will structure the company. They will play a crucial role in the success of HEPHAISTOS. "

HEPHAISTOS’ innovative approach to innate modulation has received significant validation and support from prestigious programs, with a total of €5.8 million awarded to accelerate the development of ONCO-Boost for the treatment of hard-to-treat solid tumors, where there is a high unmet medical need, BPIFRANCE iNov national competition, EIC Accelerator European competition and RHU clinical grant from France 2030, that will include a clinical phase 1/2 in collaboration with prestigious clinical centers.

This seed round will mainly finance the industrialization of drug production and regulatory toxicity studies to file for the CTA in Europe. HEPHAISTOS already has a lot of preclinical data in many cancer indications, but they plan to generate new additional data in monotherapy against unmet medical needs and in combination with promising drugs from other pharmaceutical companies. Finally, it will also help to recruit new talents and complete the structuring of the board.