On November 15, 2021 T-knife Therapeutics, Inc., a biopharmaceutical company dedicated to developing novel therapeutics to fight cancer, reported preclinical data demonstrating that its novel MAGE-A1-specific T cell receptor (TCR) induced meaningful anti-tumor activity and enhanced engraftment as compared to human donor derived TCRs (Press release, T-Knife, NOV 15, 2021, View Source [SID1234595592]). In vivo data presented at the SITC (Free SITC Whitepaper) annual meeting highlight the potential of T-knife’s lead product candidate TK-8001, a TCR engineered T cell therapy (TCR-T) that is being developed to treat MAGE-A1 positive solid tumors. The company plans to initiate a first-in-human, Phase 1/2 trial in early 2022.

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T-knife has used its proprietary HuTCR platform to discover multiple naturally optimized high-affinity TCRs specific for the cancer-testis antigen MAGE-A1. These MAGE-A1-specific TCRs were isolated from the HuTCR platform and in vitro and in vivo activity were compared to different human-derived MAGE-A1-specific TCRs. T-knife’s TCRs, including the TCR incorporated in TK-8001, were found to be of higher affinity than human derived TCRs and resulted in superior anti-tumor activity, as shown in a syngeneic preclinical model. In addition, TK-8001 exhibited enhanced engraftment rates, as measured by TCR+ cells in peripheral blood. The data generated in these preclinical evaluations highlight the potential therapeutic benefit of TK-8001.

In a separate trial-in-progress poster at the conference, the company provided detail on its planned IMAG1NE Phase 1/2 trial of TK-8001 to evaluate the safety, tolerability, and clinical activity of TK-8001 in advanced-stage, metastatic, MAGE-A1 positive solid tumors. The trial will be conducted in two phases, including a dose escalation phase designed to select the optimal dose to be utilized in a subsequent open-label expansion cohort. A supporting translational poster validating MAGE-A1 as an attractive solid tumor target was also presented.

"It is gratifying for our R&D team to present this exciting preclinical efficacy data in solid tumors expressing MAGE-A1," said Elisa Kieback, Ph.D., founder and Chief Technical Officer of T-knife Therapeutics. "Advancing this program toward the clinic and clinical proof of concept for our TCR platform is an important corporate milestone and highlights the substantial progress we have been making over the past year. We look forward to generating clinical data with TK-8001 with the initiation of our IMAG1NE Phase 1/2 study in select patients with MAGE-A1 expressing solid tumors.

About TK-8001 TCR-T

TK-8001 is a CD8 TCR-T specific for the Melanoma-associated Antigen Gene-A1, or MAGE-A1. MAGE-A1 is associated with hallmarks of aggressive cancers and poor clinical prognosis, and there is an emerging body of evidence indicating its involvement as a potential driver of tumorigenesis. MAGE-A1 represents an attractive therapeutic target given the high unmet need in MAGE-A1 expressing cancers, no reported protein expression in healthy tissues other than testis and significant consistency of expression between the primary tumor and metastases. As high affinity TCRs specific for MAGE-A1 peptides in humans are eliminated through central tolerance, we believe our HuTCR platform is a differentiated means to discover and select MAGE-A1 specific TCRs with an optimal affinity and high specificity profile.

About the IMAG1NE Phase 1/2 Trial

The IMAG1NE Phase 1/2 trial is an open-label, multi-center Phase 1/2 trial designed to evaluate the safety and efficacy of TK-8001 in patients with MAGE-A1 positive solid tumors. The first phase of the IMAG1NE trial is planned to enroll approximately 6 to 18 patients to assess the initial safety and tolerability of ascending dose levels of TK-8001. A key outcome of the first phase of the trial is to select a dose to be evaluated in an open label expansion phase of the study. The open label expansion phase of the IMAG1NE trial is designed to enroll approximately 30 additional participants to assess the efficacy of TK-8001 across a range of tumor indications

On November 15, 2021 MimiVax LLC, a clinical-stage biotechnology company in Buffalo, NY, USA, developing immunotherapeutics for cancer and autoimmune diseases, reported that the company has received a "Study May Proceed" notification from the United States Food and Drug Administration (FDA) to begin a Phase 2b trial, for SurVaxM in newly diagnosed glioblastoma entitled "SURVIVE (Press release, MimiVax, NOV 15, 2021, View Source;utm_medium=rss&utm_campaign=mimivax-llc-receives-fda-approval-to-initiate-a-new-phase-2b-clinical-study-for-the-treatment-of-newly-diagnosed-glioblastoma [SID1234595591])." MimiVax has been operating through Covid related delays but is excited to now be able to launch a new clinical trial in 2021. The "SURVIVE" trial will evaluate SurVaxM in a randomized, blinded, placebo-controlled, multi-center study designated to compare standard of care (temozolomide) with or without the addition of SurVaxM. The primary objective and endpoint for the study will be overall survival. Additional objectives will evaluate molecular predictors of response, including MGMT methylation status, IDH1 mutation and survivin-specific responses.

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About Glioblastoma

Glioblastoma is the most deadly and unfortunately the most common adult brain tumor affecting approximately 14,000 people/year in the USA. Only 25% of patients generally survive 1 year and less than 5% survive longer than 5 years, while standard of care has remained largely unchanged over the last 15 years.

About SurVaxM

SurVaxM is the first of its kind patented peptide vaccine, developed at Roswell Park Comprehensive Cancer Center. SurVaxM targets survivin, a cell-survival protein present in glioblastoma and many other cancers. A multi-center Phase 2a open label study in newly diagnosed glioblastoma was completed in 2020 (NCT02455557). Data from this study indicated a median overall survival of 25.8 months with a range of 19.5 to 43.5+ mos. Those survival statistics compare favorably with current standard of care, where patients are expected to have a median overall survival of 16 months, with a range of 14-18.4 mos.

MimiVax is collaborating and partnering for SurVaxM in several other indications; multiple myeloma in combination with Revlimid (BMS) (fully enrolled); recurrent glioblastoma in combination with Keytruda (Merck) (fully enrolled); and Neuro-endocrine Tumors (NET) (recruiting at Roswell Park).

The SurVaxM project has been graciously supported by donations to the Roswell Park Comprehensive Cancer Center and by private investors, including Buffalo Capital Partners and Varia Ventures.

On 5 November 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 15, 2021, View Source [SID1234595590]). 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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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

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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.

Since the announcement of the programme, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com. The appointed lead manager makes its trading decisions concerning the timing of the purchases of the shares independently of Novo Nordisk.

Transactions related to Novo Nordisk’s incentive programmes have resulted in a net transfer from Novo Nordisk of 2,894 B shares in the period from 8 November 2021 to 12 November 2021. The shares in these transactions were not part of the Safe Harbour repurchase programme.

With the transactions stated above, Novo Nordisk owns a total of 28,399,732 B shares of DKK 0.20 as treasury shares, corresponding to 1.2% 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 12 November 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 29,646,181 B shares at an average share price of DKK 554.87 per B share equal to a transaction value of DKK 16,449,867,345.

On November 15, 2021 Scandion Oncology A/S reported that it will publish its Q3 interim report on Thursday, November 18, 2021 before 09:00 CET (Press release, Scandion Oncology, NOV 15, 2021, View Source;2021,c3454064 [SID1234595589]).

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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

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Scandion Oncology’s executive management will host a webcast and conference call the same day at 10:00 CET presenting the results and a company update.

At the end of the presentation there will be a Q&A session.

On November 15, 2021 Palatin Technologies, Inc., (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems, reported results for its first fiscal quarter ended September 30, 2021 (Press release, Palatin Technologies, NOV 15, 2021, View Source [SID1234595588]).

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"I am excited with the significant advancement of our melanocortin agonist programs and their differentiating product profiles, which include the expected initiation of a Phase 3 pivotal study of PL9643 in patients with dry eye disease next month, and a Phase 2 clinical trial of PL8177 for ulcerative colitis in the first half of calendar year 2022," stated Carl Spana, Ph.D., President and CEO of Palatin.

"Regarding Vyleesi, our measured plan is showing positive trends for our targeted value metrics with net revenue up 98% and net revenue per prescription up 45% over the prior quarter ended June 30, 2021," concluded Dr. Spana.

Recent Highlights and Upcoming Events

Anti-Inflammatory / Autoimmune Programs
PL9643 melanocortin agonist for the treatment of dry eye disease (DED):
Palatin remains on track to initiate its pivotal Phase 3 clinical program in DED patients in December 2021, with data readout expected in the second half of calendar year 2022.
Presented Phase 2 clinical trial results for PL9643 in DED at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.
Presented Phase 2 clinical trial results for PL9643 in DED and preclinical data in retinal disease, at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting.
PL8177 melanocortin agonist for the treatment of ulcerative colitis:
A Phase 2 oral formulation study of PL8177 in ulcerative colitis is currently scheduled to start in the first half of calendar year 2022, with data readout expected in the second half of calendar year 2022.
Conducted a Featured Speaker presentation on Vyleesi and two poster presentations of PL9643 and PL8177 at the TIDES USA hybrid conference.
Hosted a Key Opinion Leader webinar on melanocortin agonists for treating ocular indications, with a primary focus on PL9643 and data from the Company’s recently completed Phase 2 clinical trial for dry eye disease. Introduced the Company’s growing portfolio of melanocortin agonists to treat the harmful effects of inflammation in the eye.
Presented the protective effects of PL8331 and PL9654 in mouse models of retinopathy, at the 2021 Annual Meeting of the American Society of Retina Specialists (ASRS). Awarded "Top Ten Poster" Designation.
Research and Development Infrastructure: Strengthened R&D department with key appointments who have demonstrated a high-level of expertise in their fields to support the advancement of our development programs.
Vyleesi (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Goal of the Vyleesi program is to demonstrate product value in the marketplace with an objective of re-licensing the U.S. rights to a committed women’s healthcare company.
For the quarter ended September 30, 2021:
Gross product sales increased 18%, net revenue increased 98%, net revenue per prescription dispensed increased 45%, despite a 13% decrease in total prescriptions dispensed, over the prior quarter ended June 30, 2021.
Market access, reimbursement coverage, and refill rates increased over the prior quarter ended June 30, 2021.
Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com
First Quarter Ended Fiscal Year 2022 Financial Results

Revenue

Total net revenues consist of gross product sales of Vyleesi, net of allowances and accruals.

Vyleesi gross product sales for the quarter ended September 30, 2021, amounted to $1.4 million, with net product revenue of $159,482, compared to gross product sales for the period July 25 (the date Palatin regained North American rights to Vyleesi) to September 30, 2020, of $809,100, with negative net product revenue of $(288,560).

Operating Expenses

Total operating expenses for the quarter ended September 30, 2021, were $7.4 million, compared to $3.7 million for the comparable quarter of 2020.

The increase in operating expenses was primarily due to the gain of $1.6 million (which reduced expenses) recorded during the quarter ended September 30, 2020, as a result of the Vyleesi Termination Agreement with AMAG Pharmaceuticals, and secondarily to increased commercial expenses related to Vyleesi.

Cash Flows

Palatin’s net cash used in operations for the quarter ended September 30, 2021, was $6.4 million, compared to net cash provided by operations of $3.8 million for the same period in 2020. The difference is due to the cash received in excess of the gain on termination of the Vyleesi agreement with AMAG.

Net Loss

Palatin’s net loss for the quarter ended September 30, 2021, was $7.1 million, or $0.03 per basic and diluted common share compared to a net loss of $3.9 million or $0.02 per basic and diluted common share for the same period in 2020.

The difference between the quarter ended September 30, 2021, and the quarter ended September 30, 2020, was primarily due to the gain of $1.6 million recorded during the quarter ended September 30, 2020, as a result of the Vyleesi Termination Agreement with AMAG Pharmaceuticals and secondarily to increased commercial expenses related to Vyleesi.

Cash Position

As of September 30, 2021, Palatin’s cash and cash equivalents were $53.4 million with $0.9 million of accounts receivable, compared to cash and cash equivalents of $60.1 million with $1.6 million of accounts receivable, as of June 30, 2021.

Based on its current operating plan, Palatin believes that existing cash and cash equivalents will be sufficient to fund currently anticipated operating expenses through calendar year 2022.

Conference Call / Webcast

Palatin will host a conference call and audio webcast on November 15, 2021, at 9:30 a.m. Eastern Time to discuss the quarter ended September 30, 2021, results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-877-614-0009 (US/Canada) or 1-856-344-9283 (international), conference ID 3594800. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 3594800. The webcast and telephone replay will be available through November 22, 2021.

About Melanocortin Receptor Agonists and Inflammation

The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.

Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.