On October 4, 2023 Sigyn Therapeutics, Inc. ("Sigyn" or the "Company") (OTCQB: SIGY), a development-stage medical technology company, reported the submission of a Patent Cooperation Treaty (PCT) application entitled: "SYSTEM AND METHODS TO ENHANCE CHEMOTHERAPY DELIVERY AND REDUCE TOXICITY (Press release, Sigyn Therapeutics, OCT 4, 2023, View Source [SID1234635649])."

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The PCT submission is associated with medical technologies being advanced by Sigyn Therapeutics to enhance the clinical benefit of chemotherapeutic drugs administered to cancer patients. Among therapeutic technologies being developed by the Company are ChemoPrepTM and ChemoPureTM. Chemotherapy is the most commonly administered drug to treat cancer, the second leading cause of death in the United States. Despite utility across a broad-spectrum of cancers, there remains a critical need to optimize chemotherapy delivery as less than 5% of administered doses reach their tumor-site target.

ChemoPrepTM is being advanced to extract circulating molecules that restrict the tumor-site delivery of chemotherapy and induce an unresponsiveness to therapy (chemoresistance) associated with 90% of metastatic cancer deaths. The clinical intent of ChemoPrepTM is to safely increase the tumor-site saturation of chemotherapeutic agents with reduced doses. Achievement of this objective will likely improve treatment outcomes yet reduce treatment toxicity and long-term health consequences associated with chemotherapy administration. Beyond the potential to increase survival and enhance patient quality of life, reduced dosing of chemotherapeutic agents may alleviate ongoing supply chain issues associated with nationwide shortages of chemotherapy.

Post infusion of chemotherapy, Sigyn Therapeutics designed ChemoPureTM to extract off-target drug agents from the bloodstream as a means to further reduce patient toxicity.

The Patent Cooperation Treaty (PCT) is an international treaty with more than 150 Contracting States. A PCT submission makes it possible to seek patent protection for an invention simultaneously in a large number of countries by filing a single "international" patent application instead of filing multiple national or regional patent applications. However, the granting of patents remains under the control of the national or regional patent offices. Sigyn Therapeutics previously disclosed that a related provisional patent application was filed with the United States Patent and Trademark Office ("USPTO").

On October 4, 2023 Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, reported that it has raised $35 million in Series B funding, led by Kurma Partners’ Growth Opportunities Fund, with participation from existing investors Seroba Life Sciences and Irish, U.S. and Canadian based family offices and Enterprise Ireland (Press release, Shorla Oncology, OCT 4, 2023, View Source;utm_medium=rss&utm_campaign=press-release-shorla-oncology-secures-35m-series-b-funding-round-to-advance-its-oncology-product-portfolio [SID1234635648]). The funding will enable Shorla to accelerate the growth of its oncology portfolio by advancing its pipeline, bringing therapies to market that will address drug shortages, and improving the preparation and application of oncology medication(1).

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"We are thrilled to announce the successful conclusion of our Series B funding round," stated Sharon Cunningham, chief executive officer of Shorla Oncology. "The investment will underpin the advancement and commercialization of our oncology drugs ensuring we continue to deliver on our mission of bringing promising treatments to patients around the globe."

Shorla specializes in the development of oncology treatments, with a focus on orphan and pediatric cancers. Backed by a dedicated team of scientists and clinicians, the company is advancing a differentiated portfolio of oncology treatments aimed at addressing significant gaps in patient care. Shorla recently announced the FDA approval and market launch of Nelarabine Injection, marking its first approval in the US. Shorla aims to continuously bring further products to market with a significant and growing portfolio of late-stage assets. These products are improving efficiencies by providing more convenient formulations to clinicians and enabling easier application for patients(2).

"Shorla’s recent FDA approval is a testament to its capabilities for bringing differentiated formulations of life-changing medications to the market," commented Daniel Parera, M.D., Partner, Kurma Partners. "We are excited to support Shorla’s growth as an integrated Specialty Pharma company to address shortcomings in patient care and improve outcomes. In particular, the team has shown impressive agility in identifying unmet needs and in operational execution. This matches very well with our focus and expertise as a Growth fund to support the scale-up of emerging champions of the European Healthcare and Life Science ecosystem."

On October 4, 2023 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported the company will present new clinical data for two of its RAS(ON) Inhibitors and other investigational compounds at upcoming oncology conferences, the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) ("Triple Meeting") in Boston, Massachusetts, to be held October 11-15, and the 2023 European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) in Madrid, Spain, to be held October 20-24 (Press release, Revolution Medicines, OCT 4, 2023, View Source [SID1234635647]).

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At the Triple Meeting, the company will present the first report of clinical activity for RMC-6291, its RASG12C(ON) Inhibitor and additional preliminary safety and pharmacokinetic profiles for RMC-6236, its RASMULTI(ON) Inhibitor. At ESMO (Free ESMO Whitepaper), the company will present additional preliminary antitumor activity data for RMC-6236 in patients with non-small cell lung cancer (NSCLC) or pancreatic ductal adenocarcinoma (PDAC) carrying common KRASG12X mutations. The abstract related to this presentation, which will go live on the ESMO (Free ESMO Whitepaper) website at 0:05 CEST on October 16, 2023 (6:05 p.m. ET, October 15), will include data from an April 24, 2023 data extraction, while the Proffered Paper presentation itself will include more recent data from an October data extraction.

Shortly following the company’s ESMO (Free ESMO Whitepaper) data presentation, the company will host an investor webcast to review the clinical data presentations on RMC-6236 and RMC-6291, related clinical development vision, and the company’s overall pipeline and strategy.

Details of the presentations referenced above, as well as other presentations by the company at these conferences, are listed below:

Triple Meeting Oral Presentations:

Title: Targeting RAS-addicted cancers with investigational RAS(ON) inhibitors
Presenter: W. Clay Gustafson, M.D.
Session: Plenary Session 3: KRAS
Date/Time: 8:00 – 9:40 a.m. ET on October 13, 2023

Title: Preliminary safety and pharmacokinetic profiles of RMC-6236, a first-in-class,
RAS-selective, tri-complex RASMULTI(ON) inhibitor in patients with KRAS mutant
solid tumors on the Phase 1 trial RMC-6236-001
Presenter: Alexander I. Spira
Abstract Number: B032*
Session: Plenary Session 4: New Drugs on the Horizon
Date/Time: 9:40 – 11:45 a.m. ET on October 13, 2023
*Also included in Poster Session B on October 13, from 12:30 to 4:00 p.m. ET.

Title: Preliminary safety and anti-tumor activity of RMC-6291, a first-in-class, tri-complex
KRASG12C (ON) inhibitor, in patients with or without prior KRASG12C (OFF) inhibitor
treatment
Presenter: Pasi A. Jänne
Abstract Number: LB_B01*
Session: Spotlight on Proffered Papers 2
Date/Time: 11:50 a.m. – 12:20 p.m. ET on October 13, 2023
*Also included in Poster Session B on October 13, from 12:30 to 4:00 p.m. ET.

Triple Meeting Poster Presentations:

Title: Selective inhibition of the active state of KRASG12V with the non-covalent, tri-complex
Inhibitor RM-048
Presenter: Bianca J. Lee, Ph.D.
Abstract Number: B137
Session: Poster Session B
Date/Time: 12:30 – 4:00 p.m. ET on October 13, 2023

Title: First-in-human phase 1/1b trial of the first-in-class bi-steric mTORC1-selective inhibitor RMC-5552 in patients with advanced solid tumors
Presenter: Alison M. Schram, M.D.
Abstract Number: C020
Session: Poster Session C
Date/Time: 12:30 – 4:00 p.m. ET on October 14, 2023

Additional information on the Triple Meeting is available through the conference website at: View Source

ESMO Oral Presentation:

Title: Preliminary clinical activity of RMC-6236, a first-in-class, RAS-selective, tri-complex RASMULTI(ON) inhibitor in patients with KRAS mutant pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC)
Presenter: Kathryn C. Arbour, M.D.
Abstract Number: 6520
Session: Proffered Paper Session – Developmental Therapeutics
Date/Time: 08:30 – 10:00 a.m. CEST (2:30 – 4:00 a.m. ET) on October 22, 2023

Additional information on the ESMO (Free ESMO Whitepaper) Congress is available through the conference website at: View Source

Investor Webcast
Revolution Medicines will host an investor webcast on Sunday, October 22, 2023, at 12:30 p.m. ET. The presentation will review the clinical data presentations on RMC-6236 and RMC-6291 highlighted above, related clinical development vision, and the company’s overall pipeline and strategy. To participate in the live webcast, participants may register in advance here: View Source A live webcast of the call will also be available on the Investors section of Revolution Medicines’ website at View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

On October 4, 2023 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing immunogenic small molecule approaches in oncology, reported that it will present a poster on lead therapeutic candidate, PT-112, and its early molecular effects culminate in immunogenic cancer cell death (ICD), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) – National Cancer Institute (NCI) – European Organisation for Research and Treatment of Cancer (EORTC) International Conference on Molecular Targets and Cancer Therapeutics (Press release, Promontory Therapeutics, OCT 4, 2023, View Source [SID1234635646]). The AACR (Free AACR Whitepaper)-NCI-EORTC "ENA Triple Conference" will be held from October 11-15, 2023 in Boston.

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The poster will detail PT-112’s ability to cause ribosomal biogenesis inhibition and organelle stress in cancer cells. PT-112 is currently in Phase 2 clinical trials for metastatic castrate-resistant prostate cancer (mCRPC) and thymic epithelial tumors (TETs).

Poster Session Details
Title: PT-112, a novel immunogenic cell death inducer, causes ribosomal biogenesis inhibition and organelle stress in cancer cells
Poster number: C128
Session: Poster Session C
Session date + time: Saturday, October 14, 12:30 p.m.-4:00 p.m. ET
Session location: Hynes Convention Center, Level 2, Exhibit Hall D

For more information about Promontory Therapeutics and PT-112, visit www.PromontoryTx.com.

On October 4, 2023 Orphelia Pharma, a pharmaceutical company dedicated to the development and marketing of pediatric and orphan medicines reported that results from the pediatric TEMOkids clinical trial will be presented at the 55th Société Internationale d’Oncologie Pédiatrique (SIOP) annual congress to be held in Ottawa, Canada, October 11-14, 2023 (Press release, ORPHELIA Pharma, OCT 4, 2023, View Source;utm_medium=rss&utm_campaign=orphelia-pharma-to-present-results-of-the-temokids-study-pharmacokinetic [SID1234635645]). The results will be presented on October 14 during the oral session entitled "novel therapeutic approaches" by Dr. Lucy METAYER, co-investigator of the TEMOkids study and pediatric oncologist at Gustave Roussy, ranked 3rd cancer center worldwide (Villejuif, France).

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TEMOkids (NCT04610736) is a European, multicenter, population pharmacokinetic, acceptability and safety clinical study evaluating KIZFIZO (temozolomide oral suspension, 40 mg/ml) in children from the age of one year and in need of temozolomide. KIZFIZO, formerly known as KIMOZO or Ped-TMZ, has been designed specifically for use in the treatment of children with relapsed or refractory neuroblastoma, an oncology indication of dismal prognosis.

"Forty-three young patients were recruited in TEMOkids across 12 European clinical cancer centers", comments Caroline LEMARCHAND, Chief Pharmaceutical Development Officer at Orphelia Pharma. "TEMOkids is an integral part of the clinical development plan of KIZFIZO and results will be presented at the SIOP conference for the first time".

"Results from TEMOkids are very compelling" adds Dr. Samuel ABBOU, principal investigator of theTEMOkids study and pediatric oncologist at Gustave Roussy. "Not only the population pharmacokinetics show that there is no need for temozolomide dose adjustment in the pediatric population, but KIZFIZO was well accepted by children and its safety profile was similar to that of temozolomide capsules (Temodal), with no specific signal of local intolerance".

About the TEMOkids study (NCT04610736)

TEMOkids is an international, open-label, non-randomized, study evaluating Ped-TMZ oral suspension (KIZFIZO) in 40 pediatric patients aged 1 year and over. The main objective of this study was to determine the pharmacokinetic parameters of KIZFIZO in this population. The secondary objectives were to evaluate its tolerance and acceptability by children, and their response to treatment.

Twelve clinical centers were involved in the TEMOkids study: Gustave Roussy, Villejuif, France (coordinating center); Institut Curie, Paris, France; La Timone Children’s Hospital, Marseille, France; Institute of Pediatric Hematology and Oncology, Lyon, France; Oscar Lambret Center, Lille, France; Charité University Medical Hospital, Berlin, Germany; Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands; Hospital Universitari Vall d’Hebron, Barcelona, Spain; Hospital La Fe, Valencia, Spain; University Pediatric Hospital Niño Jesús, Madrid, Spain; Southampton General Hospital, the United Kingdom and Great Ormond Street Hospital for Children NHS Trust, London, the United Kingdom.

About KIZFIZO 40 mg/ml

KIZFIZO (temozolomide oral suspension, 40 mg/ml) is a ready-to-use oral liquid pediatric formulation of temozolomide developed for use in the treatment of relapsed or refractory neuroblastoma, the most common extracranial solid tumor of childhood carrying a dismal prognosis. This age-adapted and taste-masked formulation delivers an accurate drug load in a small volume, while avoiding drug handling and caregiver exposure to temozolomide. It is the result of a fruitful collaboration between the pharmacists and clinicians of Gustave Roussy Cancer Center and the development team of Orphelia Pharma.

KIZFIZO, under the product name KIMOZO, has been granted Early Access Authorization (Autorisation d’Accès Précoce) by the French authorities in March 2022 for the treatment of refractory and relapsed neuroblastoma.

KIZFIZO received orphan drug designation from the EMA and FDA and its formulation is covered by granted patents and pending applications in Europe and in the US.