On October 6, 2022 Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported that its onCARlytics (CF33-CD19) oncolytic virus technology will be featured in three abstracts at the renowned Annual Meeting for the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), to be held in Boston, USA on 8-12 November 2022 (Press release, Imugene, OCT 6, 2022, View Source [SID1234621790]).

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Known as one of the most prestigious immunotherapy events on the calendar, SITC (Free SITC Whitepaper) 2022 will feature cuttingedge research presentations by various experts, oral, and poster abstract presentations and various opportunities for networking and discussion with members of the oncology community.

The abstract titles were released at 8am EDT (US Eastern Daylight Time) 5 October 2022, with those featuring Imugene’s onCARlytics as follows:

Title: Combination immunotherapy using a novel chimeric oncolytic virus to redirect CD19 bispecific T cell engagers to target solid tumors Abstract #: 305 Title: CF33-CD19t oncolytic virus (onCARlytics) targets hepatocellular carcinoma (HCC) and in combination with Artemis CD19 T cells results in significant tumor killing Abstract #: 368

Title: CF33-CD19t oncolytic virus (onCARlytics) in combination with off-the-shelf allogeneic CyCART-19 T cells targeting de novo CD19+ solid tumors Abstract #: 847

Imugene will announce further detail from these abstracts at the time of the event.

onCARlytics is a CD19-expressing oncolytic virus that enters tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for CD19 targeting therapies. Imugene exclusively IMUGENE LIMITED ACN 009 179 551 2 licensed the technology from City of Hope, one of the largest cancer research and treatment organisations in the US.

On October 6, 2022 Sigyn Therapeutics, Inc. ("Sigyn" or the "Company") (OTCQB: SIGY), a development-stage company focused on creating therapeutic solutions to address unmet needs in global health, reported that a provisional patent application entitled: "SYSTEM AND METHODS TO ENHANCE CHEMOTHERAPY DELIVERY AND REDUCE TOXICITY" has been filed with the United States Patent and Trademark Office ("USPTO") (Press release, Sigyn Therapeutics, OCT 6, 2022, View Source [SID1234621788]).

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Cancer is the second leading cause of death in the United States1. Despite therapeutic advances, treatment toxicity, drug resistance and inadequate tumor site delivery restrict the benefit of chemotherapeutic agents administered to cancer patients. More specifically, less than 5% of systemically administered chemotherapeutic agents are reported to reach their target tumor site2,3. Off-target chemotherapeutic agents contribute to treatment toxicity2,3 and may promote the spread of cancer metastasis4,5,6,7,8.

To overcome these challenges, Sigyn’s patent submission describes a therapeutic device system whose primary objective is to enhance chemotherapy delivery and reduce its toxicity. A secondary objective of the therapeutic system is to reduce treatment dosing without sacrificing patient benefit, or conversely increase chemotherapy dosing without added toxicity. In concert with these objectives, the therapeutic system offers to reduce drug resistance and inhibit the potential spread of cancer metastasis induced by the administration of chemotherapeutic agents.

"This patent submission is dedicated to friends and family members whose lives were taken by cancer," stated Jim Joyce, CEO of Sigyn Therapeutics and the inventor underlying the patent submission. "Additionally, as we advance Sigyn TherapyTM to address life-threatening conditions that are beyond the reach of drugs, I want to clarify that the intent of this patent submission is to protect the development of a therapeutic system to improve the benefit of chemotherapeutic drugs already approved to treat cancer," concluded Joyce.

On September 14, 2022, the Company announced plans to initiate first-in-human studies of Sigyn Therapy in End-Stage Renal Disease (ESRD) patients suffering from excess inflammation and/or endotoxemia. Sigyn Therapy is a broad-spectrum blood purification technology designed to treat pathogen-associated inflammatory disorders that are not addressed with approved drug therapies. Candidate treatment indications for Sigyn Therapy also include sepsis, community acquired pneumonia and emerging pandemic threats.

On October 6, 2022 GT Biopharma, Inc. (the "Company" or "GTB") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE platform, reported two poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 37th Annual Meeting (SITC 2022), to be held in Boston, Massachusetts and virtually on November 8-12, 2022 (Press release, GT Biopharma, OCT 6, 2022, View Source [SID1234621787]). The two posters will highlight preclinical data on tri-specific NK cell engagers for the treatment of mesothelioma and prostate cancer.

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Poster Presentations

Title: Tri-specific killer engagers target natural killer cells towards mesothelioma
Abstract Number: 1202
Presenter: Pippa Kennedy and Martin Felices
Date: November 11, 2022
Location and time: Poster Hall from 9:00am – 8:30pm ET

Title: Enhancing NK cell function in the ‘cold’ tumor microenvironment of prostate cancer with a novel Tri-specific Killer Engager against prostate-specific membrane antigen (PSMA)
Abstract Number: 1204
Presenter: Shee Kwan Phung and Martin Felices
Date: November 11, 2022
Location and time: Poster Hall from 9:00am – 8:30pm ET

About SITC (Free SITC Whitepaper)

Established in 1984, the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is a nonprofit organization of medical professionals dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology. SITC (Free SITC Whitepaper) is comprised of influential basic and translational scientists, practitioners, health care professionals, government leaders and industry professionals around the globe. Through educational initiatives that foster scientific exchange and collaboration among leaders in the field, SITC (Free SITC Whitepaper) aims to one day make the word "cure" a reality for cancer patients everywhere. Learn more about SITC (Free SITC Whitepaper) at sitcancer.org.

On October 6, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully-integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, reported it received validating written feedback on October 4, 2022 from the FDA pursuant to its Type B Pre-IND meeting request regarding its Deltacel development strategy (Press release, Kiromic, OCT 6, 2022, View Source [SID1234621786]).

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The purpose of the Pre-IND meeting request was to seek alignment with and to obtain FDA guidance on Kiromic’s proposed development strategy about the chemistry, manufacturing, and controls (CMC), nonclinical studies, and clinical study plan for Deltacel/KB-GDT for treating subjects with Non-Small Cell Lung Cancer (NSCLC). Kiromic will leverage this FDA Pre-IND written confirmatory feedback and recommendations into a robust IND submission package for a projected clinical trial launch in Q1 2023.

"We are delighted to receive this very productive feedback about Deltacel/KB-GDT from the FDA, confirming our development strategy for this therapeutic candidate," stated Pietro Bersani, Chief Executive Officer of Kiromic. "It was a strategic decision to focus on metastatic stage 4 lung cancer as our first indication in addressing solid malignancies, and we are very heartened to be continuing to fulfill our mission to address solid malignancies, which represent more than 90% of all cancers."

Further reiterating Management’s focus on executing the Deltacel-aligned development strategy, the Company has streamlined its operations and aligned key resources to advance its Deltacel product candidate while maintaining its other product candidates Procel and Isocel. As part of that aligned strategy and following a thorough evaluation to maximize operational efficiencies, Kiromic’s management made the difficult yet necessary decision to eliminate 20 positions or approximately 29% of its workforce. The Company believes these key actions and overall strategy align with financing options it is actively pursuing.

"Deltacel is our most advanced therapeutic candidate, and its use of allogeneic, non-viral, non-engineered off-the-shelf Gamma Delta T-cells (GDT) is a next-generation solution for patients. As such, this prioritization also mitigates supply-chain challenges associated with a virus-based approach. We believe these advantages will allow us to efficiently establish the platform’s safety and tolerability and build upon Deltacel’s previously demonstrated preclinical efficacy across multiple indications. With the FDA guidance in hand, we believe we’ve further strengthened our case to align operations with Deltacel and deliver value sooner to our shareholders," commented Bersani.

On October 6, 2022 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") reported that it has executed a binding Term Sheet ("Term Sheet" or "Agreement") with Procare Health Iberia, S.L. ("Procare Health"), of Barcelona, Spain ("Procare Health"), for exclusive marketing and distribution in the United States of Procare Health’s leading patented product, Papilocare, the world’s first and only vaginal gel product with clinical evidences to prevent and treat HPV-dependent cervical lesions, and for Immunocaps, an oral over-the-counter nutritional supplement that supports immune function and vaginal microbiota to help re-epithelialization of cervical lesions (Press release, BioVaxys Technology, OCT 6, 2022, View Source [SID1234621784]). As Immunocaps is an OTC supplement, BioVaxys anticipates that regulatory approval is not required, allowing the rapid build out of sales channels and revenue generation from the product.

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In addition, the agreement gives BioVaxys right-of-refusal in the United States for Ovosicare and Libicare, Procare Health’s over-the-counter supplements to support fertility enhancement for late maternity or IVF processes and Menopausal symptoms improvements which includes low libido among women suffering menopausal changes.

Financial terms include milestone payments and royalties on sales. The companies have agreed to complete an initial ten-year duration exclusive supply and distribution agreement ("Distribution Agreement") by December for Papilocare Gel (packs of 7 and 21 5ml cannulas), 2x40ml and applicators, packs of 1x5ml samples, and 30 capsule packs of Immunocaps. Manufacturing will remain in Spain under Procare Health.

Founded in 2012, Procare Health is a leading privately-held pharmaceuticals company in the women’s health field based in Spain with several affiliates in Europe including France, Portugal and the UK, with marketed products including Papilocare, Libicare, Palomacare, Idracare, Pronolis HD and Ovosicare. Procare Health commercializes its products within more than 60 countries in the world via distribution agreements with well-known and established pharmaceuticals company within the Women’s Health field.

The Agreement follows the Letter of Intent ("LOI") signed last year outlining several collaborations between the two companies, including Papilocare and the clinical development of BioVaxys’ BVX-0918 for late-stage ovarian cancer. Whereas the LOI had originally granted BioVaxys right of first refusal for Papilocare, today’s agreement grants BioVaxys exclusive right to market and distribute the brand in the United States and establishes marketing support from Procare Health for Papilocare and Immunocaps.

Left untreated, HPV infection can lead up to cervical cancer (World Health Organization, HPV and Cervical Cancer, 11 November 2020). In Procare Health’s PALOMA PhaseIIb clinical trial for Papilocare, which results were recently published into the Journal of Lower Genital Tract Disease, which is affiliated with the American Society of Cervical Pathologies (ASCCP), showed consistent and significant efficacy in normalizing cervical cytology at 3 months and at 6 months in the total study population, with 50% to 70% of High-Risk HPV clearance at 6 months in six different international studies and more than 600 patients. HPV infection causes 528,000 cases of cervical cancer and 266,000 cervical cancer deaths each year.1 Papilocare has a CE mark valid for the entire EU and is currently marketed as a Class IIa medical device in Spain, France, Portugal, Italy, Belgium, Luxembourg, Lithuania, Latvia, Poland, Czech Republic, Hungary, Bulgaria, and Romania. A "CE mark" indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

Under the Term Sheet, BioVaxys will have responsibility for US regulatory approval for Papilocare and anticipates US registration as a Class II medical device.

James Passin, the CEO of BioVaxys, stated, "We are honored to expand the terms of our partnership with Procare Health, one of Europe’s leading innovators in women’s healthcare, further strengthening our women’s healthcare product pipeline."