On November 29, 2021 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated compounds and their associated drug formulations with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses reported the Company’s unaudited 3Q2021 condensed interim consolidated Financial Statements ("Financial Statements"), which provides financial information on the previous fiscal quarter and the quarterly Newsletter ("Newsletter") which provides an interim clinical data analysis on the Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("Study II") (Press release, Theralase, NOV 29, 2021, View Source [SID1234597697]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Financial Statements can be found on the Company’s Website at www.theralase.com/financial-filings/

The Newsletter can be found on the Company’s website at www.theralase.com/quarterly-newsletters/

Highlights from the Newsletter:

Leadership Transition

Effective October 25, 2021, Vera Madzarevic, Ph.D. assumed the role of Director of Clinical Development and Quality Assurance. Dr. Madzarevic holds a Ph.D. in both clinical pharmacology and biochemistry and brings over 25 years of global experience in clinical research and quality assurance from the biopharmaceutical and medical device industry to Theralase.

Effective, November 15, 2021, Mr. John Trikola agreed to resign from his positions as the Chief Operating Officer ("COO") and interim Chief Executive Officer ("CEO") of the Company, as a result of certain facts that came to the Company’s attention concerning Mr. Trikola’s background that the Company’s vetting process failed to detect. The Company has taken steps to improve its vetting process for incoming officers and directors.

Effective November 15, 2021, Arkady Mandel, M.D., Ph.D., D.Sc., who is currently the Chief Scientific Officer ("CSO") of the Company, assumed the role of interim CEO, replacing Mr. Trikola.
3Q21 Financial Statement Highlights

Total revenue increased 7%, year over year and is primarily attributed to a recovery in the Canadian and United States ("US") economies from the COVID-19 pandemic, as a majority of healthcare practitioners in 2020 elected to temporarily close their practices and place any purchasing decisions on temporary or permanent hold.

Net loss decreased 34%, year over year and is primarily attributed to the following:
1) Significant delay in patient enrollment and treatment due to the COVID-19 pandemic, resulting in decreased research and development expenses in Study II.
2) Decreased salaries due to the COVID-19 pandemic, resulting in the resignation or termination of certain non-essential administrative, research and production personnel.

The Anti-Cancer Therapy ("ACT") division represented $2,325,340 of this loss (74%) for the nine-month period ended September 30, 2021.

12 CSS’s have been launched in Canada (5) and the US (7) for patient enrollment and treatment for Study II.
Study II Preliminary Results

As of November 29, 2021, Study II has enrolled and provided the primary study treatment for 30 patients (including three patients from the Study treated at the Therapeutic Dose) for a total of 33 patients, demonstrating the following interim results:

Note: Significant clinical data is still pending in Study II and drawing conclusions from this interim clinical data set and assumptions should be done with caution, as Study II is still ongoing and new clinical data collected may or may not continue to support the current trend.
An analysis of the Study II clinical data (with 3 patients from Study Ib) provides the following interim assessments:

1) 7/10 patients (70.0%), who achieved a CR at 90 days continue to demonstrate CR at 180 days

2) In the total population of 33 patients (@ 90 days):

i) 42.4% achieved Complete Response ("CR")
ii) 12.1% achieved Partial Response ("PR")
iii) 21.2% are Pending
iv) 24.2% achieved No Response ("NR")

Hence, the potential for CR is up to 75.8%** for the interim clinical data analysis.

Note**: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date.

3) In the total population of 18 patients (@ 90 days), who received the optimized treatment:

i) 44.4% achieved CR
ii) 11.1% achieved PR
iii) 38.9% are Pending
iv) 5.6% achieved NR

Hence, the potential for CR is up to 94.4%***

Note***: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date for the interim clinical data analysis.

In summary, for patients who received the primary optimized Study II Treatment versus the original Study II Treatment (90 days), there is a 5% increase in CR and a 77% decrease in NR.

On November 29, 2021 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported that members of its senior management team will participate in a fireside chat at the JMP Securities Hematology and Oncology Summit on Monday December 6, 2021 at 1:20 PM ET (Press release, Prothena, NOV 29, 2021, View Source [SID1234596278]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the fireside chat can be accessed through the investor relations section of the Company’s website at www.prothena.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for at least 90 days following the presentation date.

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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, NOV 29, 2021, View Source [SID1234596242]). This programme is part of the overall share repurchase programme of up to DKK 20 billion to be executed during a 12- month period beginning 3 February 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the programme initiated 5 November 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.7 billion in the period from 11 November 2021 to 1 February 2022

With the transactions stated above, Novo Nordisk owns a total of 29,392,732 B shares of DKK 0.20 as treasury shares, corresponding to 1.3% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 20 billion during a 12- month period beginning 3 February 2021. As of 26 November 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 30,639,181 B shares at an average share price of DKK 560.81 per B share equal to a transaction value of DKK 17,182,675,592.

On November 29, 2021 Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development reported positive initial clinical data from its ongoing Phase 2 clinical trials (REBORN©1 and PLENITUDE©) of QIXLEEF for cancer pain (Press release, Tetra Bio Pharma, NOV 29, 2021, View Source [SID1234596226]). QIXLEEF is a botanical inhaled investigational new drug with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The REBORN©1 trial is a head-to-head, open-label, crossover phase 2 study against oral opioids in the management of short and frequent episodes of incapacitating pain (breakthrough pain) in patients with cancer. The REBORN©1 study protocol is assessing the safety and preliminary efficacy of QIXLEEF in onset of pain relief and on pain intensity compared to three types of immediate release oral opioids: oral morphine sulfate immediate release, oral hydromorphone immediate release, and oral oxycodone immediate release. The PLENITUDE© trial is a randomized double-blind phase 2 study assessing the safety and efficacy of QIXLEEF in patients with cancer who have uncontrolled pain. Both studies are conducted across multiple clinical sites located in the United States.

Safety data of the REBORN©1 trial collected up to now confirm QIXLEEF tolerability and good safety profile in patients with cancer with breakthrough pain; no serious adverse events have been reported, only adverse drug reactions of mild intensity have been recorded. Preliminary data of the PLENITUDE© trial also confirm QIXLEEF tolerability and good safety profile in the pool of subjects treated with either QIXLEEF or the placebo in the randomized double-blind 4-week period and in subjects treated with QIXLEEF during the open-label 11-month period. Preliminary analysis of the data shows a positive effect on pain relief in QIXLEEFTM-treated patients. The Company cannot disclose further data on efficacy due to regulatory compliance.

Dr. Guy Chamberland, CEO and CRO commented, "A safe and efficient therapeutic alternative that allows the reduction of opioids is critical now more than ever to support patients in their journey against pain. Preliminary data from both REBORN©1 and PLENITUDE© confirm the safety and pharmacodynamic profile of QIXLEEF reported in the phase I trials. The pharmacokinetic profile of QIXLEEF is well indicated to help manage short episodes of pain such as breakthrough pain and will offer patients and physicians a viable, safer, and non-opioid option for pain management."

Lastly, Tetra’s metabolite profile study in humans showed that intake of QIXLEEF does not lead to significant levels of metabolites associated with toxicity and its pharmacokinetic profile mirrors the temporal characteristics of breakthrough cancer pain episodes, with a transient and fast effect of action. Tetra’s Phase I trials showed that maximal plasma concentration was reached within 5 minutes and that the drug was well tolerated with a good safety profile.

About Breakthrough Cancer Pain

Opioids are the cornerstone of the management of cancer pain. The opioid crisis is serious, and the number of deaths related to overdosing remains elevated (Opioid Basics | CDC’s Response to the Opioid Overdose Epidemic | CDC). Tetra’s cannabis and cannabinoid-derived product pipeline has the potential to play a significant role in opioid use reduction, thus addressing a societal issue of critical proportion.

Current opioids approach to manage breakthrough pain are inadequate to timely relieve pain in patients with cancer. Immediate-release oral morphine produces an analgesic effect in 30-45 minutes, with peak effect at ~1 hour or more (Staahl C. et al., Journal of Clinical Pharmacology, 2008; 48:619-631), in contrast to episodes of breakthrough cancer pain, which typically peak within 3-15 minutes and last ~1 hour. In addition to inappropriate time window of efficacy, immediate-release oral opioids affect the patient’s functioning (e.g., confusion) and quality of life (e.g., constipation, drowsiness, sleep disorders) and may induce life-threatening side effects such as respiratory depression in addition to multiple side effects. More potent opioids such as fast-onset opioids have a higher risk of abuse potential, increasing the risk of misuse and overdose. There is currently no therapeutic solution that offers fast onset of pain relief with an acceptable safety profile and low risk of abuse potential.