On November 29, 2021 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-centric biotechnology company developing next-generation mental health and oncology treatments by leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, reported that Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences, will participate in the H.C. Wainwright 2nd Annual Psychedelics Conference to be hosted virtually on Monday, December 6, 2021 (Press release, Jay Pharma, NOV 29, 2021, View Source [SID1234596178]).

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Dr. Tucker’s corporate presentation will be available on-demand starting at 7:00 a.m. ET. Register to attend here.

For more information about the conference, or to schedule a one-on-one meeting with Enveric’s management team, please contact your appropriate representative directly, or send an email to H.C. Wainwright at [email protected], or KCSA Strategic Communications at [email protected].

On November 29, 2021 Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, reported that it expects to receive a Complete Response Letter (CRL) after the PDUFA target action date of November 27, 2021 from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for PEDMARKTM (a unique formulation of sodium thiosulfate), for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients ≥1 month to 18 years of age with localized, non-metastatic, solid tumors (Press release, Fennec Pharmaceuticals, NOV 29, 2021, View Source [SID1234596197]).

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The FDA has indicated that, following a recent completion of a pre-approval inspection of the manufacturing facility of our drug product manufacturer, deficiencies have been identified. Once the official CRL is received, the Company plans to request a Type A meeting to discuss the deficiencies and steps required for the resubmission of the NDA for PEDMARKTM.

About PEDMARK (A unique formulation of sodium thiosulfate (STS))

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

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 type of 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.

PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA). PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018.

On November 29, 2021 On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent imaging agents to target and illuminate cancer during surgery, reported that the U.S. Food and Drug Administration (FDA) has approved CYTALUX for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions (Press release, On Target Laboratories, NOV 29, 2021, View Source [SID1234596216]). CYTALUX is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal. CYTALUX, administered by standard IV in as little as one hour before surgery, binds to folate receptors that are overexpressed in most epithelial ovarian cancersi and illuminates intraoperatively under near-infrared light.

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"Complete removal of all malignant tissue is the goal of ovarian cancer surgery, however identifying all lesions can be challenging," said Dr. Janos L. Tanyi, MD, PhD, Associate Professor of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine and Investigator on the Phase 2 and 3 studies. "In the Phase 3 study, additional cancer was detected in 27% of patients, showing great promise in the ability of CYTALUX to help surgeons identify malignant lesions that may otherwise be missed during surgery."

Ovarian cancer is the number one cause of gynecologic cancer death in the United Statesii. Cytoreductive surgery is a well-established treatment for ovarian cancer, however, a study showed that among patients reported to have undergone optimal cytoreduction, 40% were found to have measurable disease on 30-day postoperative imagingiii. CYTALUX serves as an adjunctive tool for surgeons to identify additional malignant ovarian cancer lesions that may have been missed by standard visual inspection and palpation, increasing the detection of more cancer during surgery.

Adverse reactions consisting of nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, and itching were reported during the administration of CYTALUX (see additional Important Safety Information below).

"This FDA approval is a significant milestone towards achieving On Target’s mission to make cancer visible during surgery so it can be removed more completely," said Chris Barys, President and Chief Executive Officer of On Target Laboratories. "We are excited about the potential impact CYTALUX can have for patients in their fight against ovarian cancer. Our goal is to make CYTALUX a standard of care for ovarian cancer surgery and we look forward to exploring the use of our technology for patients suffering from other cancers."

CYTALUX received Priority Review and both Fast Track and Orphan designations from the FDA. Additionally, CYTALUX is being investigated in cancer of the lung in a Phase 3 trial under Fast Track designation.

About Fluorescence-Guided Surgery

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. On Target Laboratories’ targeted fluorescent imaging agents are comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.

On Target’s first novel compound, CYTALUX, targets folate receptors commonly found on many cancers, such as ovarian cancer. A single dose of the agent is administered via intravenous infusion prior to surgery to help the surgeon identify additional malignant tissue during the operation using a near-infrared imaging system.

On November 29, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the granting of US patent 11,141,468, covering methods of treating solid tumors by administering methioninase and asparaginase (Press release, ERYtech Pharma, NOV 29, 2021, View Source [SID1234596258]). In total, ERYTECH’s IP portfolio now includes 16 global patent families with over 310 patents and 45 applications. These patent families protect ERYTECH’s proprietary red blood cell encapsulation technology (ERYCAPS), its therapeutics for Oncology, Rare Metabolic Diseases, and Immune Modulation, as well as its methods for producing Cargo-Loaded Red Cell Extracellular Vesicles (CLRCEV).

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US 11,141,468, entitled "Method of treating a mammal, including human, against cancer using methionine and asparagine depletion", emphasizes ERYTECH’s continuing innovation in the delivery of safe and effective enzymatic activity for depriving tumors of essential nutrients. Corresponding family members have also recently been allowed in Europe, China, and Korea. As disclosed in the patent, ERYTECH scientists determined that certain solid tumors including gastric cancer were unexpectedly sensitized to treatment with asparaginase subsequent to prior treatment with methioninase. And while this finding highlights the complexity of the overarching "tumor starvation" approach, it also demonstrates the potential of the approach to weaken cancer cells, ideally rendering them more susceptible to lower levels of standard of care chemotherapies. Of note, the claims cover the method of treatment irrespective of whether the two enzymes are encapsulated in red blood cells.

ERYTECH currently has a patent portfolio of about 310 issued patents and over 45 pending patent applications worldwide covering 16 patent families. These patent families protect ERYTECH’s proprietary red blood cell encapsulation technology (ERYCAPS), its red cell-based clinical-stage product candidates in oncology, and its preclinical programs in rare metabolic diseases and immune modulation, as well as its methods for producing cargo-loaded red cell extracellular vesicles (CLRCEV).

Red blood cells are the most abundant cell type in the human body and their biology is characterized by a long lifespan and access to all tissues and organs. ERYTECH is a leader in red blood cell-based therapeutics, and its ERYCAPS platform enables the industrial scale encapsulation of active drug substances inside red blood cells using hypotonic loading. The ERYCAPS process maintains robust red blood cell functionality, and red blood cell-encapsulated enzymes have the potential to exhibit substantially improved safety and extended half-life versus non-encapsulated enzymes.

On November 29, 2021 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported the closing of a $15 million financing on November 22, 2021, which brought the Company’s cash reserves above $20 million (Press release, Northwest Biotherapeutics, NOV 29, 2021, View Source [SID1234596198]).

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The Company plans to use the funding to help accelerate its activities related to its brain cancer program. The financing is in the form of a 22-month loan which requires no payments for 8 months, and then provides for a subsequent 14-month amortization period. The loan has a provision for prepayment, an annualized interest rate of 8% and OID of 10%. Upon announcement of the top line data ("TLD") from the Company’s Phase III clinical trial of DCVax-L for Glioblastoma brain cancer, the lender will have a then-springing right to exchange the outstanding balance of the loan for common shares priced at the price of the first private placement transaction following TLD less a 12% discount, and to purchase another 50% of that number of shares at the same price. This then-springing right expires 14 days after that post-TLD private placement.