On September 26, 2022 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) and GenesisCare, the largest provider of integrated cancer care in Australia, reported that a first patient has been enrolled in the Phase II ProstACT TARGET study of Telix’s prostate cancer antibody therapy candidate TLX591 (177Lu-DOTA-rosopatamab), in patients experiencing a first recurrence of prostate-specific antigen (PSA) after initial therapy for prostate cancer (Press release, Telix Pharmaceuticals, SEP 26, 2022, View Source [SID1234621428]).

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Telix’s ProstACT therapeutic program is evaluating the efficacy of the Company’s prostate-specific membrane antigen- (PSMA-) targeting lutetium-177 (177Lu)-labelled therapeutic antibody, TLX591, in various stages of prostate cancer, from first recurrence to advanced metastatic disease. The primary focus of the ProstACT series of studies is to complete the pivotal Phase III ProstACT GLOBAL study in a second-line setting in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing on first-line novel androgen agents.

The TARGET study, a collaboration between Telix and research partner, GenesisCare, is exploring the potential of TLX591 in combination with external radiation in patients at an earlier stage in their prostate cancer, providing direction for future indication expansion. The study, which targets enrolment of 50 patients across multiple Australian sites, enrolled the first patient at GenesisCare’s integrated cancer centre at the St John of God Hospital Murdoch campus in Western Australia. The clinical trial is being run through GenesisCare’s global Contract Research Organisation and its Australian network of dedicated theranostics centres.

The third concurrent study in the ProstACT program, ProstACT SELECT, is a theranostic (imaging and therapy) Phase I radiogenomics study to demonstrate the utility of Telix’s imaging agent Illuccix (kit for the preparation of gallium-68 (68Ga) Glu-urea-Lys(ahx)-hbed-CC, also known as 68Ga-PSMA-11 injection) to select patients for TLX591 therapy given as two doses 14 days apart.

Principal Investigator for the ProstACT TARGET study and GenesisCare Group Medical Director (Theranostics), Professor Nat Lenzo said, "I’m excited to commence this important study that builds on the momentum of ProstACT SELECT. With previous studies having confirmed the preliminary efficacy and safety profile of TLX591, GenesisCare is pleased to partner with Telix to further their therapeutic antibody-based program, which has potential to improve health outcomes for thousands of men living with prostate cancer in Australia and worldwide."

Telix Chief Medical Officer Dr. Colin Hayward added, "Enrolling a first patient in the ProstACT TARGET study is a significant milestone in Telix’s overall clinical mission to support men with prostate cancer at every step in their journey with a PSMA antibody approach to targeted radiation therapy. Alongside ProstACT SELECT, this program will add value and clinical insight to Telix’s antibody therapy candidate TLX591, as we progress global regulatory submissions for the ProstACT GLOBAL Phase III study. We wish to express our gratitude to Professor Nat Lenzo and his clinical team, as well as the patients who will contribute to the study."

About ProstACT

ProstACT is a series of studies of the investigational product TLX591, the Company’s antibody-based, PSMA targeted prostate cancer therapy candidate TLX591 (177Lu-DOTA-rosopatamab).

The three studies running concurrently in the program are:

ProstACT GLOBAL, a Phase III international, multi-centre, randomised controlled trial (RCT) in patients with PSMA-expressing mCRPC, experiencing disease progression following prior treatment with a novel androgen axis drug. The ProstACT trial will enrol up to 390 patients and incorporates patient selection using 68Ga-PSMA imaging with TLX591-CDx (Illuccix). The trial will compare standard of care therapy alone versus standard of care therapy plus TLX591, with a primary endpoint of radiographic progression-free survival (rPFS).
Status: sites in Australia and New Zealand are being prepared to commence patient screening, ahead of initiating global sites.

ProstACT SELECT, a Phase I radiogenomics study with the goal of comparing 68Ga-PSMA (gallium) and 177Lu-PSMA (lutetium), specifically exploring the biodistribution differences between small molecule and antibody-based targeting. The study is designed to inform optimal patient selection for Telix’s antibody-based 177Lu therapy, with the goal of enabling indication expansion for Telix’s PSMA therapeutic portfolio. ProstACT SELECT is a multi-centre study and will enrol up to 50 patients, with a first patient dosed in January 2022.[1]
Status: first cohort of patients dosed.

ProstACT TARGET, a Phase II single arm study in Australia in 50 patients with PSMA-avid[2] biochemically recurrent oligometastatic (five or less metastases) prostate cancer, in combination with external beam radiation therapy (EBRT). The clinical objectives are delaying disease recurrence and thus deferring the commencement of androgen deprivation therapy (ADT) with the primary endpoint biological progression-free survival (PFS BIO). The study is a collaboration with Telix’s strategic partner, GenesisCare. GenesisCare will be enrolling patients at its integrated cancer centres at GenesisCare North Shore, Sydney and GenesisCare at the St John of God Hospital, Murdoch campus, Perth.
Status: patient enrolment has commenced.

On September 26, 2022 Angel Pharmaceuticals Ltd. ("Angel Pharma"), a clinical-stage biopharmaceutical company, reported that the IND application for mupadolimab (formerly CPI-006) has been approved by the Center for Drug Evaluation (CDE) to initiate a Phase 1/1b clinical trial in China. Angel Pharma owns mupadolimab’s rights in Greater China (Press release, Angel Pharmaceuticals, SEP 26, 2022, View Source [SID1234621427]).

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Mupadolimab is a humanized monoclonal antibody directed against CD73 . In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. Compare with other anti-CD73 antibodies and smallmolecule drugs in development, mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine with a proposed unique mechanism of activating B cells to generate immune responses to tumor antigens and viruses. Outside China, mupadolimab has been studied in combination with pembrolizumab in a Phase 1/1b trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy.

Dr. Richard Miller, co-founder of Angel Pharmaceuticals, commented, "We are pleased that mupadolimab has been approved for clinical trial in China. Data from overseas clinical studies has demonstrated its safety and potential to benefit patients with advanced cancers. We look forward to working with clinical experts in China to accelerate its development." Dr. Ted Wang, Co-founder of Angel Pharmaceuticals, commented, "We have completed the local manufacture of mupadolimab in China, and will work closely with top clinical sites to bring it to market to benefit patients in China".

Professor Guo Ye, Deputy Secretary General of the Chinese Clinical Oncology Society (CSCO), Chairman of the Head and Neck Cancer Committee of the Chinese Clinical Oncology Society, and Department of Oncology, Shanghai East Hospital Affiliated with Tongji University, commented, "CD73 plays a key role in the formation of the immunosuppressive microenvironment in cancer, and studies have demonstrated its importance on solid tumors. Mupadolimab is a unique CD73 antibody and we hope its clinical development will progress successfully in China to benefit cancer patients."

On September 26, 2022 KiOmed Pharma, a Belgian biotechnology company with a focus on the development, manufacture and distribution of safe and effective medical devices based on a medical-grade highly pure natural chitosan-derivative, and Hansoh Pharmaceutical Group Company Limited (SEHK: 3692), a leading biopharmaceutical company in Asia, reported a license agreement for the development and commercialization of KiOmedinevsOne, a carboxymethyl chitosan injection that has been launched in Europe for the treatment of knee osteoarthritis, in China’s mainland, Macau and Taiwan (the territory) (Press release, Jiangsu Hansoh Pharmaceutical, SEP 26, 2022, View Source [SID1234621426]).

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Under the terms of the agreement, KiOmed will receive an upfront payment and will be eligible to receive development, regulatory and commercial milestones of up to € 66 million, as well as tiered royalties on future product sales. Hansoh will receive exclusive rights to develop and commercialize KiOmedinevsOne and its future extensions in the territory. KiOmed retains the right to develop and commercialize KiOmedinevsOne in all other global markets.

Osteoarthritis is a progressive and disabling disease affecting about 250 million people worldwide. According to a recent epidemiology report, the prevalence of knee osteoarthritis in China is 8.1%. As the population in China is aging rapidly, disease burden caused by knee osteoarthritis continues to rise while safe and effective treatment options are still lacking.

"We are very excited to partner with Hansoh Pharma, one of the largest biopharmaceutical entities in Greater China. We believe that with Hansoh’s impactful presence in China, their support will be essential to bring this long-acting treatment to the large population of patients suffering from osteoarthritis in China," said Mr. François Blondel, Founder and Executive Chairman of the Board of KiOmed Pharma. "We launched KiOmedinevsOne last year in several regions of Europe, and the feedback we continue to receive from osteoarthritis patients and physicians is great. With just one single injection to the knee, it can provide symptoms relief including pain, stiffness, and function improvement for more than 6-month. It is the world-first next generation non-animal sourced chitosan injection with a potential safety advantage over animal-sourced chitosan," added Dr. Houtaï Choumane, CEO and Managing Director of KiOmed.

"KiOmed is a leader and an expert in developing natural chitosan products to fulfill unmet medical needs in different spaces. Osteoarthritis negatively impacts an individual’s quality of life and creates a large burden for the patients and their families. We are very glad to see KiOmed’s product (KiOmedinevsOne) will help to solve this problem," said Eliza Sun, Executive Director of the Board of Hansoh Pharma. "We are also very excited to partner with them and bring this unique product to much needed patients in China."

About KiOmedinevsOne

KiOmedinevsOne is a new generation single injection for the treatment of knee osteoarthritis based on world-first exclusive animal free KiOmedine CM-Chitosan. KiOmedine CM-Chitosan is a highly purified polysaccharide derived from Agaricus Bisporus (button mushroom) and a patented technology made in Belgium, resulting from years of research and innovation. Different from hyaluronic acid, KiOmedinevsOne has dual mechanism of action to tackle osteoarthritis discomfort and other symptoms by reducing oxidative stress and enhancing joint lubrication. Clinical studies have shown that after a single injection of KiOmedinevsOne, significant pain reduction was observed within 2 weeks and the WOMAC pain score was reduced by 66%, with a long-lasting osteoarthritis symptom reduction for at least 6 months. KiOmedinevsOne is a regulated health product which bears the CE mark under this regulation. It has been launched in Europe in 2021.

On September 26, 2022 Exicure, Inc. (NASDAQ: XCUR) reported plans to restructure the Company and align resources to continue exploring strategic alternatives that maximize stockholder value (Press release, Exicure, SEP 26, 2022, View Source [SID1234621425]). After a strategic review of the Company’s business plans and objectives and its existing cash resources, the Company’s Board of Directors has approved the following:

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A workforce reduction of approximately 66%, expected to be completed by the fourth quarter of 2022;
Cessation of all R&D activities, including suspension of all partnered programs;
Exploration of divesture opportunities for clinical-stage asset in immuno-oncology and preclinical candidates, including the SCN9A product candidates for neuropathic pain; and
Company’s executive team is expected to remain in place following the restructuring and realignment.
The Company estimates that it will incur total expenses relating to the restructuring of approximately $0.5 million, consisting of severance and termination-related costs and expects to record a significant portion of these charges in the third quarter of 2022. This restructuring plan is expected to extend the Company’s cash runway into the second quarter of 2023 based on current operating plans and estimates.

Update Regarding SCN9A Program

For the SCN9A program targeting the Nav 1.7 channel for neuropathic pain, Exicure developed several potential candidates that have shown promising activity in preclinical studies with a significant level of knockdown of the SCN9A mRNA transcript. Unfortunately, results from a recent in-vivo animal study in non-human primates did not meet desired target engagement levels as observed in previous in vitro preclinical studies. Additional preclinical studies would be required to understand recent findings, likely delaying the timing of IND-enabling work. As a result, Exicure has suspended further pre-clinical activities for the SCN9A program as it assesses strategic alternatives for all its assets, including its platform technology, with the goal of maximizing stockholder value.

"These decisions are never easy, and we understand the impact they have on all our stakeholders and stockholders, including our loyal Exicure employees. I want to address our Exicure employees impacted by our workforce reduction by stating that the decision today is in no way a reflection on them. I am so proud and honored to be their colleague at Exicure as I have seen firsthand their tremendous efforts, sacrifices and contributions in following the science, being true to the data and ultimately pursuing treatments in patients with unmet medical needs. Exicure will support them in transitioning to their future endeavors," stated Matthias Schroff, Chief Executive Officer, Exicure.

Private Placement Transaction with CBI, USA

Exicure also reported that it has agreed, subject to customary closing conditions including stockholder approval, to sell an aggregate of 3,400,000 shares of its common stock at a purchase price of $1.60 per share to existing investor, CBI USA, Inc. ("CBI USA"), a subsidiary of CBI, Co. Ltd., in a private placement in public equity ("PIPE") financing. Upon satisfaction of certain closing conditions including approval by Exicure stockholders, CBI USA would hold a controlling position in Exicure equivalent to approximately 50.4% of the total voting power (based on the current number of outstanding shares of common stock). Under the terms of the transaction, assuming stockholders approve the transaction, CBI USA will also receive the right to nominate the number of directors to the Company’s Board equivalent to its proportional equity ownership of shares of the Company’s common stock from time to time, subject to approval by the Board and compliance with the provisions of applicable securities legislation, regulations, rules, policies and Nasdaq rules including, but not limited to, Nasdaq Listing Rule 5640.

Exicure anticipates that the gross proceeds from the PIPE will be approximately $5.4 million, before deducting transaction-related expenses payable by the Company and will be used for working capital and general corporate purposes. The transaction was approved by the Board of Directors of Exicure and Exicure stockholders will receive a proxy statement seeking their approval of the transaction with CBI USA in the coming weeks.

On September 26, 2022 TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapies, reported it has signed a second clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ, USA, for a new clinical trial evaluating TILT-123, its oncolytic adenovirus armed with two human cytokines, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy (Press release, TILT Biotherapeutics, SEP 26, 2022, View Source [SID1234621424]).

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This Phase I, open label, dose escalation trial will include 12 to 24 patients with immune checkpoint inhibitor refractory non-small cell lung cancer (NSCLC). This latest trial builds on the company’s emerging data on the use of its oncolytic immunotherapy candidate TILT-123 currently in trials for several other indications where promising results of intravenous usability has motivated the expansion of the portfolio of trials.

TILT Biotherapeutics’ CEO, Akseli Hemminki, a cancer clinician who has personally treated hundreds of cancer patients, said, "We already have clinical trials running in Europe and the USA in several cancer types, including ovarian cancer, head and neck cancer, and melanoma. We are planning several more, one of which is this new collaboration in NSCLC with our collaborator MSD. Overall, our armed oncolytic viruses are showing potential in the clinic to increase the anti-tumor benefits of checkpoint inhibitors for a range of cancers where there is a pressing need for better therapies."

The heart of TILT’s innovative approach revolves around the use of armed oncolytic adenoviruses, using cytokines and other molecules to boost the patient’s T-cell immune response to better enable it to find and destroy cancer cells.