On September 26, 2022 Qu Biologics Inc., a clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel immunotherapy platform designed to restore innate immune function, reported it has received Health Canada clearance (No Objection Letter) and institutional-level ethics approval to proceed with a randomized placebo-controlled Phase II multicenter trial to assess the effectiveness of QBECO SSI in reducing postoperative immune suppression and improving cancer outcomes in patients with late-stage colorectal cancer undergoing surgical resection of liver metastases (Press release, Qu Biologics, SEP 26, 2022, View Source [SID1234621417]). QBECO SSI is a first-in-class innate immune modulator specifically designed to restore innate immune function in the gastrointestinal (GI) tract, including the liver. The study, which is led by gastroenterology (GI) oncology surgeons Dr. Rebecca Auer (Ottawa Hospital Research Institute) and Dr. Paul Karanicolas (Sunnybrook Health Sciences Centre) and managed by the Centre of Clinical Trial Support at the Sunnybrook Research Institute, will enroll patients through a minimum of six academic oncology centers in Ontario.

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Major surgery results in immune paralysis in the days following surgery that can contribute to cancer growth and metastases, leading to poor outcomes for cancer patients undergoing surgical treatment. By programming immune cells to remain functionally active to deal with any postoperative remnants of cancer and targeting that response to the liver and GI tract, QBECO SSI is singularly positioned to overcome surgery-induced immune suppression and its negative consequences on patient outcomes.

Dr. Hal Gunn, CEO of Qu Biologics, stated, "A majority of patients diagnosed with cancer undergo surgery in the hope of cure. However, surgery profoundly suppresses immune function in the postoperative period, enabling residual cancers cells to grow and spread. This exciting study is designed to test whether we can prevent that postoperative immune suppression resulting in improved outcomes and survival." Immunologist Dr. Shirin Kalyan, Qu’s VP of Scientific Innovation, noted, "Proof-of-concept studies have shown that QBECO SSI treatment overcomes both cancer-induced and the more profound surgery-induced immune suppression through innate immune training and natural killer cell (NK cell) activation resulting in clearance of cancer cells in the targeted organ. This trial will assess whether perioperative QBECO SSI treatment can serve as a unique multi-pronged approach to transform outcomes for cancer patients undergoing surgery." Dr. Paul Karanicolas, study co-lead investigator noted, "Patients with late-stage colorectal cancer with liver metastases can potentially be cured by surgical excision of those metastases. Unfortunately, the majority of patients go on to have cancer recurrence and disease progression following surgery. There aren’t any current treatments that have been shown to improve overall survival in these patients; new effective treatments that improve survival are urgently needed." Dr. Rebecca Auer, co-lead investigator of the study and leading researcher in the field of postoperative immune suppression added, "As surgeons we recognize the significant impact of surgery on the immune system and, given the central role that the immune system plays in the clearance of cancer cells, it is paramount to find a therapeutic strategy to enhance postoperative immune function. Preclinical studies suggest that QBECO SSI could be that therapy for colorectal cancer surgery."

On September 26, 2022 CatalYm reported that it has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA) to expand its ongoing Phase 2 clinical program to include clinical trial centers in the U.S. The ongoing GDFATHER-2 program (GDF-15-neutralizing antibody-mediated human effector cell relocation) is evaluating the company’s lead candidate, visugromab in combination with an anti-PD1 antibody in patients with advanced solid tumors that are relapsed/refractory to prior anti-PD1/-PD-L1 treatment (Press release, Catalym, SEP 26, 2022, View Source [SID1234621416]). Visugromab is a monoclonal antibody that neutralizes GDF-15, a key immunosuppressor, which has been shown to prevent T cell migration into tumors, enabling cancerous cells to evade the immune system.

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"Adding trial sites in the U.S. is a critical component of our clinical development strategy for visugromab and we appreciate receiving this IND approval," said Prof. Dr. Eugen Leo, Chief Medical Officer at CatalYm. "Our focus is to rapidly advance the GDFATHER-2 program and we have now gained the opportunity to enroll a more diverse set of cancer patients. We are planning to further maximize the potential of this program with additional cohorts and trial modalities in the future."

Dr. Phil L’Huillier, Chief Executive Officer at CatalYm added: "The IND clearance demonstrates our ability to execute on our clinical objectives and heralds the next stage of our journey toward developing visugromab as a new class of anti-cancer immunotherapeutic treatment. We look forward to working with our clinical partners in the United States and to announcing initial results from the first ongoing Phase 2a cohorts by mid 2023."

The multi-center, open-label, cohort expansion GDFATHER-2 trial (NCT04725474) investigates the treatment of advanced stage cancer patients that are relapsed/refractory to prior anti-PD-1/-PD-L1 treatment with the GDF-15 neutralizing antibody, visugromab, in combination with the anti-PD-1 checkpoint inhibitor nivulomab. The GDFATHER-2a program will enroll up to 164 participants aged 18 years or older, who are relapsed or refractory to prior anti-PD-1/-PD-L1 treatment, at clinical centers across Europe and the United States. Phase 2a is currently recruiting at locations in Germany, Spain and Switzerland. Recruitment in the United States is expected to begin before end of 2022.

The full data readout from the visugromab Phase 1 trial, GDFATHER-1, was recently presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 and demonstrated encouraging signs of efficacy in a last-line patient setting with a favorable safety profile.

On September 26, 2022 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported that it has completed the second closing of $20 million of senior secured promissory notes under our previously announced investment agreement with Petrichor Healthcare Capital Management (Press release, Fennec Pharmaceuticals, SEP 26, 2022, View Source [SID1234621415]). Under the terms of the original investment agreement, the second closing of $20 million was to be funded upon the U.S. Food and Drug Administration (FDA) approval of PEDMARK (sodium thiosulfate injection) by September 30, 2022 and satisfaction of other closing conditions. On September 20, 2022, the FDA approved the Company’s New Drug Application (NDA) for PEDMARK to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors. Further, Fennec upon mutual agreement with Petrichor, may draw up to $20 million of additional financing under the investment agreement.

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Further information concerning the investment agreement will be set forth in the Current Report on Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission (the "SEC") on or about September 26, 2022. The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes, if any, have not been registered under the Securities Act of 1933, as amended, or the securities laws of any other jurisdiction, and the notes and such shares may not be offered or sold absent registration with the SEC, or an applicable exemption from registration requirements, or in a transaction not subject to, such registration requirements. Fennec is relying upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

No regulatory authority has either approved or disapproved the contents of this press release. This press release is neither an offer to sell nor a solicitation of an offer to buy the notes or the shares of common stock issuable upon conversion of the notes, if any, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum compounds are essential chemotherapeutic agents for the treatment of many pediatric malignancies. Unfortunately, platinum-based therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.i

The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.ii Infants and young children that are affected by ototoxicity at critical stages of development lack speech and language development and literacy, and older children and adolescents often lack social-emotional development and educational achievement.iii

About PEDMARK (sodium thiosulfate injection)

PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients.iv PEDMARK is also the only therapeutic agent with proven efficacy and safety data with an established dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

In the U.S. and Europe, it is estimated that, annually, more than 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult, and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

Indications and Usage

PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use

The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information

PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

On September 26, 2022 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic liver diseases, reported that its Chief Medical Officer, Todd Hobbs, MD, will participate in the "Novel Targets in Oncology: Risk vs. Reward" panel at the Cantor Oncology, Hematology & HemeOnc Conference on Wednesday, September 28, 2022 at 9:00 a.m. Eastern Time at the New York Palace Hotel (Press release, Hepion Pharmaceuticals, SEP 26, 2022, View Source [SID1234621414]).

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During the panel alongside other industry peers, Dr. Hobbs will focus his discussion on Hepion’s upcoming Phase 2 clinical trial of rencofilstat in the treatment of HCC. Due to the format of the event, no webcast will be available.

On September 26, 2022 VECT-HORUS S.A.S. reported that it will participate in the next event dedicated to Imaging and organized by CERIMED: "R&D Seminar IMAGING 2022" from Monday, 26th September to Friday 30th September (Press release, Vect-Horus, SEP 26, 2022, View Source [SID1234621413]).

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Cedric Malicet will give a talk, « From bench to Clinic », Thursday, 29th September in the workshop intitled "NUCLEAR MEDICINE Imaging".
It will be the occasion to present Vect-Horus technology, the last imaging results generated by in vitro and in vivo TEP with our #LDLR vectors currently in clinical study for the Glioblastoma with our partner Radiomedix.