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]).

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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).

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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 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.

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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.

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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.

On November 29, 2021 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to proceed with a Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG116, in combination with the anti-PD-1 antibody, pembrolizumab (Press release, Adagene, NOV 29, 2021, View Source [SID1234596225]). The global trial (ADG116-P001 / KEYNOTE-C97) will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific (APAC).

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ADG116 utilizes Adagene’s proprietary NEObody platform technology and is designed to target a unique conserved epitope of CTLA-4 with enhanced efficacy by potent Treg depletion in the tumor microenvironment (TME). ADG116 is designed with a soft ligand blocking to address safety concerns associated with existing CTLA-4 therapeutics.

"The FDA clearance of this trial represents a significant milestone for our anti-CTLA-4 program as we advance our evaluation of ADG116 in combination with anti-PD-1 therapy," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "By applying NEObody technology, ADG116 can overcome existing safety limitations of anti-CTLA-4 therapies to achieve improved clinical benefit. Our exploration of ADG116 with pembrolizumab aims to unleash the dual CTLA-4/PD-1 blockade and realize the full potential of this combination therapy approach as a cornerstone of cancer treatment – balancing safety and efficacy."

The ADG116-P001 trial is expected to dose the first patient in early 2022, and is designed to evaluate the safety and tolerability, determine the maximum tolerated dose, and assess preliminary efficacy of the combination of ADG116 and pembrolizumab.

Additionally, the ongoing ADG116-1003 trial is on track to expand with two combination cohorts investigating safety and preliminary efficacy of ADG116 with either toripalimab or ADG106 in patients with advanced/metastatic solid tumors.