On February 15, 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, reported the closing of its previously announced initial public offering of 4,117,648 American Depositary Shares (the "ADSs") and warrants (the "Warrants") to purchase up to 8,235,296 ADSs. In connection with the initial public offering, the underwriters have partially exercised their option to purchase an additional 1,235,294 warrants at an exercise price of $4.25 per warrant (Press release, TC Biopharm, FEB 15, 2022, View Source [SID1234608150]). In total, the Company received aggregate gross proceeds of approximately $17.5 million, prior to deducting underwriting discounts, commissions, and other offering expenses. The issuance and sale of these additional ADSs also closed today.

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Each ADS represents one ordinary share, and each Warrant represents the right to purchase one ADS. The ADSs and Warrants will be separately issued but the ADSs and Warrants will be sold to purchasers only in a combination of one ADS and two Warrants, for a combined aggregate offering price of $4.25. Each Warrant will be immediately exercisable for one ordinary share, that will then be deposited with the custodian for the issuance of a corresponding ADS at an exercise price of $4.25 per ADS and expire six years after the issuance date.

The Company intends to use the net proceeds from the offering to finance the cost of treating patients under our proposed clinical trials OmnImmune (TCB 008-001), a phase 2b-into-pivotal (phase 3) trial for the treatment of acute myeloid leukemia) and ImmuniStim (TCB 008-002) (for the treatment of COVID-19 infections) and to continue the research and development of our proposed GD-T CAR therapies to treat sold cancers, as well as financing our operating overhead costs, capital expenditure and limited repayment of convertible loan notes.

EF Hutton, division of Benchmark Investments, LLC, acted as sole book-running manager for the offering.

A registration statement on Form F-1, as amended (File No. 333-260492), was filed with the Securities and Exchange Commission ("SEC") and was declared effective on February 10, 2022. A final prospectus relating to the offering was filed with the SEC and will be available on the SEC’s website at View Source Electronic copies of the final prospectus relating to this offering may be obtained from EF Hutton, division of Benchmark Investments, LLC, 590 Madison Avenue, 39th Floor, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 404-7002.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 15, 2022 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported program updates across its pipeline and anticipated 2022 highlights (Press release, Monopar Therapeutics, FEB 15, 2022, View Source [SID1234608114]).

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Program Developments

Validive – International Phase 2b/3 VOICE Clinical Trial, Actively Recruiting

Severe oral mucositis (SOM) is a painful and debilitating ulceration of the mucosal membranes of the mouth caused by the chemoradiotherapy used to treat patients with oropharyngeal cancer. SOM prevents these patients from being able to drink and/or eat, and can increase hospitalization rates, cause interruption or termination of chemoradiotherapy before completion of treatment, and cause aspiration induced lung injury. SOM results in significant short- and long-term negative impacts on clinical outcomes and quality of life. There is no FDA-approved preventative or treatment option for the estimated >40,000 newly diagnosed individuals with oropharyngeal cancer in the US who may receive chemoradiation each year and are at-risk of developing SOM. Recent trials show that the majority of oropharyngeal cancer patients receiving chemoradiotherapy will develop SOM.

Validive is a once daily self-administered mucoadhesive tablet designed to prevent SOM in oropharyngeal cancer patients who receive chemoradiotherapy. Monopar is evaluating Validive in this patient population in the international Phase 2b/3 VOICE study. Updated highlights of this trial include:

43 clinical sites opened to date, active and enrolling patients in both the US and Europe
Interim analysis is currently anticipated to be reached in mid-2022. Further, based on timely findings extracted from public reporting of recently completed SOM trials, the Company is presently evaluating potential enhancements to and exact timing of the interim analysis
Camsirubicin – Phase 1b Dose-Escalation Trial, Actively Recruiting

Advanced soft tissue sarcoma (ASTS) is a diverse type of cancer that typically develops in the connective tissue of the body and which has metastasized (spread) or is not amenable to surgery. The average life expectancy from time of diagnosis for patients with ASTS is about 12 to 15 months. Doxorubicin is the current 1st line standard of care treatment for most types of ASTS.

Doxorubicin is FDA approved in 14 different types of cancers including soft tissue and bone sarcomas; metastatic stomach, ovarian, thyroid, lung, and breast cancer; acute myeloid and lymphoblastic leukemia; Hodgkin and non-Hodgkin lymphoma; and neuroblastoma, and is one of the most widely used cancer drugs around the world. It is a drug that becomes more effective at higher doses. Unfortunately, due to the potential development of irreversible heart damage, patients stop doxorubicin treatment once a certain cumulative lifetime dose limit threshold is reached. Dosing higher than this lifetime limit sharply increases the rate of irreversible heart damage. As a result, even if patients are responding to treatment, they discontinue doxorubicin treatment typically after only 6 to 8 cycles of doxorubicin.

Monopar is developing a novel proprietary analog of doxorubicin called camsirubicin. Camsirubicin has been designed to retain the anti-cancer activity while avoiding the irreversible heart damage that is seen with doxorubicin. The hypothesis behind the use of camsirubicin is straightforward: modifying doxorubicin in order to reduce cardiac damage could enable higher and longer dosing, resulting in better patient outcomes. The preclinical, Phase 1, and Phase 2 camsirubicin data generated to date support the potential to treat patients with high doses per cycle and for longer periods of time. No irreversible heart damage has been seen to date in any of the camsirubicin clinical trials.

The Company is currently enrolling patients in an open-label Phase 1b dose escalation trial in ASTS patients to evaluate higher doses of camsirubicin than have been used in the previous Phase 1 and Phase 2 trials. Although this Phase 1b is designed to determine the maximum tolerated dose of camsirubicin, given the historical dose-dependent anti-tumor response repeatedly demonstrated with doxorubicin, efficacy measurements are being tracked in these patients as the dose is increased. Updated highlights of this trial include:

Phase 1b dose-escalation trial initiated in September 2021, with first patients dosed in October 2021
First dose level completed in November 2021, with positive recommendation from trial safety review committee to proceed to next higher dose level
Three patients already dosed at the second dose level, which is a higher dose level than tested in any prior camsirubicin clinical trial
"Early signs of clinical benefit are being observed with camsirubicin in this Phase 1b trial, which is quite encouraging. Two of three patients in the first dose level have stable disease, one of which has liver metastases and experienced fairly quickly a reduction in pain and improved liver function tests," said Dr. Sant Chawla, Principal Investigator, Sarcoma Oncology Research Center in Santa Monica, CA. "The second cohort so far is also looking encouraging. We look forward to continuing to escalate the camsirubicin dose level to identify a new, higher recommended Phase 2 dose, and continuing to assess camsirubicin for evidence of antitumor activity."

Radiopharmaceutical Platform and MNPR-101

Monopar and NorthStar Medical Radioisotopes have extended their 50/50 radiopharmaceutical partnership for 2022. This collaboration has generated a radioimmunotherapeutic candidate, MNPR-101-PCTA, that is being evaluated as a potential diagnostic and therapeutic agent in cancer and severe COVID-19. Updated highlights of this program include:

Provisional composition of matter patents filed covering the Actinium-based radiopharmaceutical drug candidate (MNPR-101-PCTA-Ac-225)
Peer-reviewed publications highlighting the utility of MNPR-101 and MNPR-101 fragment conjugates as uPAR-targeted imaging agents in numerous cancers
Currently evaluating pathways to initiating a first-in-human study
MNPR-202

MNPR-202 is a novel analog of camsirubicin currently being evaluated in preclinical studies. It retains the same potentially non-cardiotoxic backbone as camsirubicin but has been modified at other positions, which may enable it to evade doxorubicin drug resistance mechanisms. Updated highlights of this program include:

Entered collaboration and commenced work with Cancer Science Institute of Singapore to evaluate activity of MNPR-202 in preclinical models of multiple cancers
Composition of matter patent covering MNPR-202 has been allowed in the US

On February 15, 2022 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment of cancer and fibrosis, reported that a clinical trial abstract describing the results of its Phase 1 clinical trial of AMP945 has been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting that will be held in New Orleans from April 8th to 13th 2022 (Press release, Amplia Therapeutics, FEB 15, 2022, View Source;[email protected] [SID1234608133]).

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The abstract entitled "A Phase 1 trial of AMP945, a potent and selective focal adhesion kinase inhibitor, in healthy volunteers" describes the results from Amplia’s Phase 1 clinical trial of AMP945 in healthy volunteers which completed in 2021. This trial showed that AMP945 was safe and well tolerated, could be administered orally once a day, and was able to inhibit its intended target, focal adhesion kinase (FAK), in tissue samples taken from participants in the study1. On the back of the successful data from this trial, Amplia intends to initiate a Phase 2 clinical trial in first line pancreatic cancer patients in early Q2 2022. This abstract will be presented at the AACR (Free AACR Whitepaper) Meeting in early April 2022 and also published online in the Proceedings of the AACR (Free AACR Whitepaper).

"The AACR (Free AACR Whitepaper) is one of the most recognised international forums for cancer research and we are delighted that the results of our Phase 1 trial have been selected for presentation at this prestigious meeting," said Dr. John Lambert, CEO of Amplia. "We believe the approach we are taking using AMP945 to potentially improve the current standard of care treatment for pancreatic cancer is well supported by our Phase 1 clinical trial data and the results from a number of nonclinical studies we have conducted."

This ASX announcement was approved and authorised for release by the CEO of Amplia Therapeutics.

On February 15, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2021 fourth quarter and full year financial results on Tuesday, March 1, 2022, after the close of the U.S. financial markets (Press release, Jazz Pharmaceuticals, FEB 15, 2022, View Source [SID1234608151]). Company management will host a live audio webcast at 4:30 p.m. ET / 9:30 p.m. GMT to discuss 2021 fourth quarter and full year financial results and provide a business and financial update.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharma.com.

On February 15, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported the initiation of an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the checkpoint inhibitor, KEYTRUDA, in patients with HPV-associated oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence (Press release, PDS Biotechnology, FEB 15, 2022, View Source [SID1234608115]). The trial is being led by Drs. David Routman, Katharine Price, Kathryn Van Abel, and Ashish Chintakuntlawar of Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck cancers.

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HPV(+)OPSCC is now the most common type of head and neck cancer and has been increasing significantly in recent years. Oropharyngeal cancer is a disease in which cancer cells form in the tonsil tissues of the back (base of tongue) and side (palatine tonsils) of the throat. According to the National Cancer Institute, smoking or being infected with the human papillomavirus (HPV), especially HPV16, can increase the risk of oropharyngeal cancer. The American Cancer Society estimates there are over 54,000 new cases of oral and oropharyngeal cancer and over 11,000 related deaths in the United States, annually.

"We are excited to have a team of doctors at Mayo Clinic conducting a trial to study our novel Versamune-based T cell immunotherapy platform and lead asset, PDS0101 in earlier-stage disease," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "This upcoming trial not only broadens our addressable patient population of those affected by the increasing incidence of HPV(+)OPSCC, but also allows us to better understand the activity of PDS0101 alone or in combination with KEYTRUDA in earlier stages of disease."

The study treatment will be administered before patients proceed to transoral robotic surgery (TORS) with curative intent. Treatment in this setting is referred to as neoadjuvant treatment. PDS0101 has been shown to induce killer T-cells that target and kill HPV-positive cancers, either alone or in combination with checkpoint inhibitors in preclinical studies, and in combination in clinical studies of patients with advanced recurrent/metastatic HPV-associated cancers. This study will explore whether PDS0101 with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic regression, and decreases in circulating tumor DNA (ctDNA).