Vivesto announces that Christer Nordstedt will remain as acting CEO during a transition period

On November 30, 2022 Vivesto AB, an oncology-focused specialty pharma company, reported that the company’s acting CEO Christer Nordstedt will remain in his position part-time until Vivesto’s new permanent CEO Erik Kinnman takes up his position (Press release, Vivesto, NOV 30, 2022, View Source [SID1234624576]).

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On November 21, 2022, Vivesto announced that Erik Kinnman was appointed as the new CEO of Vivesto, effective no later than May 20, 2023. Vivesto has today agreed with Christer Nordstedt that he will remain in his current position as acting CEO of Vivesto on a part-time basis until Erik Kinnman takes office.

"We are very pleased that Christer can remain in his role as acting CEO of Vivesto. During the short time he has been with us, Christer has demonstrated his broad competence and long experience from the industry, and we look forward to a seamless transition until Erik Kinnman takes office. It is also gratifying that Christer will continue to contribute to the company’s development as a senior advisor in R&D," said Peter Zonabend, Chairman of the Board of Vivesto.

As of December 1, 2022, Christer Nordstedt will also hold the position as CEO of Oblique Therapeutics AB.

ISA Completes Enrolment in Randomized Double Blind Phase 2 Clinical Trial of ISA101b in HPV16 induced Oropharyngeal Cancer

On November 30, 2022 ISA Pharmaceuticals B.V., a clinical stage biotech company developing immunotherapies to treat cancers and infectious diseases, reported that it has completed enrolment in its Phase 2 clinical trial named OpcemISA (Press release, ISA Pharmaceuticals, NOV 30, 2022, View Source [SID1234624575]).

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The OpcemISA trial has enrolled 194 patients and is a large randomized, double blind, placebo-controlled Phase 2 clinical trial. The trial will evaluate the efficacy and safety of the addition of ISA101b to checkpoint inhibitor therapy in patients with metastatic/advanced 1st and 2nd line HPV16 positive OPC. Primary endpoints will demonstrate overall response rate (ORR) and safety. Secondary endpoints include duration of response (DOR) and overall survival (OS). This trial is part of an extensive clinical development program of ISA101b in collaboration with US biotechnology company Regeneron.

"This large proof of concept trial of ISA101b has the potential to demonstrate for the first time that the combination of an HPV16-directed therapeutic vaccine with checkpoint inhibitor immunotherapy improves the short-term outcome and longer-term survival of difficult to treat head and neck cancer patients. The completion of enrolment is a major milestone for ISA Pharmaceuticals as it continues development of its SLP technology platform. We look forward to presenting top line interim data from this trial in the third quarter of next year." said Dr. Leon Hooftman, Chief Medical Officer of ISA Pharmaceuticals.

Head-and-neck cancer can be a severe and life-threatening disease. HPV16 is a major cause of head-and-neck cancer. Recurrent and metastatic HPV16 positive OPC is a form of head-and-neck cancer with a high unmet medical need. In September 2021 ISA101b was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent and metastatic HPV16 positive oropharyngeal cancer (OPC).

HOOKIPA to Participate in The JMP Securities Hematology and Oncology Summit

On November 30, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that the company will participate virtually in investor meetings and panel discussions at The JMP Securities Hematology and Oncology Summit, December 6 – 7, 2022 (Press release, Hookipa Pharma, NOV 30, 2022, View Source [SID1234624574]).

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SOTIO Exercises Option for Novel Antibody-Drug Conjugate Program under Agreement with LegoChem Biosciences

On November 29, 2022 SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, reported that it has exercised its first of five exclusive, target-specific options with LegoChem Biosciences for antibody-drug conjugate (ADC) SOT106, which is currently being evaluated in preclinical studies across a multitude of solid tumor indications (Press release, SOTIO, NOV 29, 2022, View Source [SID1234626212]).

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In November of 2021, SOTIO and LCB entered into a multi-target exclusive collaboration and license agreement under which SOTIO obtained the rights to deploy LCB’s ADC technology for up to five ADC programs. SOTIO is responsible for the research, development, manufacturing and worldwide commercialization of the ADC products.

"We are pleased with the progress we have made this year on our innovative antibody-drug conjugate pipeline. We advanced our lead program targeting CLDN18.2, SOT102 into the Phase 1 dose escalation portion of the CLAUDIO-01 trial and have now exercised this option for SOT106. ADCs remain one of the most actively pursued drug classes in oncology and we are encouraged that SOT106, an ADC with the potential to treat some of the most challenging solid tumor indications, continues to show promise in preclinical studies," said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. "The rapid and successful development of this collaboration with LegoChem Biosciences reiterates our commitment to providing patients with efficacious and safe cancer therapeutic options."

"We are very excited that a successful outcome has been achieved in such a short time since the partnership launched a year ago." said Dr. Yong-Zu Kim, the CEO & President of LCB. "This result has come from a combination of SOTIO’s deep antibody discovery expertise and LegoChem’s industry-leading and differentiated ADC platform technology. We look forward to further achieving progress in our efficient and close partnership as this effort continues into generating new drug candidates."

The exercise of the first option triggers an undisclosed milestone payment by SOTIO to LCB.

About SOT106
SOT106 is a novel ADC based on SOTIO Biotech’s proprietary antibodies and LCB’s industry-leading ConjuAllTM ADC platform technology with potential best-in class efficacy, safety and tolerability currently in preclinical development against multiple solid tumor indications.

Theralink® Technologies Announces Closing of Private Placement and Conversion of Existing Convertible Notes and Convertible Preferred Shares

On December 8, 2022 Theralink Technologies (OTC: THER) ("Theralink" or the "Company"), a precision oncology company with a novel phosphoprotein-based assay for breast cancer, reported that it has entered into definitive agreements with certain institutional and accredited investors for the sale of senior secured convertible debentures and warrants to purchase shares of the Company’s common stock, resulting in total gross proceeds of approximately $3.1 million before deducting the placement agent’s fees and other offering expenses (Press release, Theralink Technologies, NOV 29, 2022, View Source [SID1234624962]).

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Under the terms of the securities purchase agreement, the Company has agreed to sell senior secured convertible debentures, with a principal amount of approximately $3.4 million (including OID of 10%), with a 12-month term. The debentures bear an interest rate of 10% per annum and, upon a qualified financing, will be converted into either (a) the securities sold by the Company in such qualified financing, at a price per share equal to the lesser of $0.003 per share or a 30% discount to the price of securities sold in such qualified financing, or (b) newly issued convertible preferred securities, at a price per share equal to the price described in the foregoing clause (a) or the 5-day VWAP on the 181st day following such exchange, subject to a partial redemption right at the time of the qualified offering. The warrants, calculated at 100% of the principal amount of the debentures, are exercisable upon the earlier of the maturity date of the debentures or a qualified financing at an exercise price equal to the price of the securities sold in such qualified financing or, if no qualified financing has occurred prior to the maturity date of the debentures, the lower of $0.003 per share or 70% of the 10-day VWAP prior to such maturity date.

Additionally, in connection with this offering, holders of certain existing convertible notes and convertible preferred shares of the Company agreed to convert their securities into an aggregate of approximately $13.4 million of the senior secured convertible debentures and warrants on the terms described in the foregoing paragraph.

Joseph Gunnar & Co., LLC is acting as the sole placement agent for the offering.

The convertible debentures and warrants (and shares of common stock underlying the convertible debentures and warrants) described above were offered in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (the "SEC") or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to the securities purchase agreement entered into with the investors, the Company has agreed to use its commercially reasonable efforts to file a registration statement with the SEC upon the closing of the qualified financing covering the resale of the shares of common stock underlying the convertible debentures and the shares issuable upon exercise of the warrants.

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.