On November 17, 2024, HCW Biologics Inc. (the "Company") entered into an exclusive, worldwide License, Research, and Co-Development Agreement (the "License Agreement") with WY Biotech Co., Ltd. (the "Licensee") for one of the Company’s preclinical, proprietary molecules (the "Licensed Molecule"). Under the terms of the License Agreement, the Company will receive an upfront fee of $7.0 million, to be paid in two tranches (Filing, 8-K, HCW Biologics, NOV 17, 2024, View Source [SID1234648468]). Within 90 days after the effective date of the License Agreement, which may be extended by an additional 30 days, if required, the Licensee will pay the Company $4.0 million; and within 30 days of completing the technology transfer to the Licensee, the Company will receive $3.0 million. All payments under the License Agreement will be made in U.S. Dollars.

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Upon the completion of a Phase 1 clinical trial in any jurisdiction, the Company has an "Opt-In Right," which gives the Company the option to assume all control and responsibility for the development, manufacture and commercialization of the Licensed Molecule in the Opt-In Territory. The "Opt-In Territory" is North America, South America, and Central America. Upon the completion of the exercise of the Opt-In Right, the Company will be responsible for all costs associated with research and development, manufacturing, clinical development, regulatory approval, and commercialization for the Licensed Molecule in the Opt-In Territory.

The Licensee will pay the Company milestone payments as the Licensed Molecule advances through clinical trials and the first marketing approval is granted for the first territory in which the Licensee retains exclusive rights. Upon commercialization, the Company will receive double-digit royalties on a product-by-product basis in each jurisdiction in which the Licensee retains exclusive rights, subject to adjustment in the event the Company exercises the Opt-In Right. In addition, the Company will share a substantial portion of the net proceeds from any future transactions entered into by the Licensee, involving an exclusive license for the Licensed Molecule, an assignment of the License Agreement or the sale of the Licensee’s business that would permit the buyer to assume exclusive rights under the License Agreement, excluding transactions in the Greater China market. The Company and the Licensee have expressed their intent to work cooperatively with respect to the Licensed Molecule in the development stage, with a global focus for clinical development and partnering. The License Agreement contains various representations, warranties, affirmative and negative covenants, events of default and related remedies as well as other customary provisions.

The foregoing summary of the terms of the License Agreement does not purport to be complete.

On November 17, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported a new Investigator-Initiated Trial (IIT), evaluating the performance of Clarity’s diagnostic product, 64Cu-SAR-bis-PSMA, in comparison to standard-of-care (SOC) 68Ga-PSMA-11 product for the detection of prostate cancer recurrence (Press release, Clarity Pharmaceuticals, NOV 17, 2024, View Source [SID1234648447]).

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The trial, named Co-PSMA, stands for "Comparative performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy". It is led by Prof Louise Emmett at St Vincent’s Hospital, Sydney.

The Co-PSMA trial is a prospective, Phase II comparative imaging trial in 50 patients with biochemical recurrence (BCR) post-radical prostatectomy who are being considered for curative salvage radiotherapy. The primary objective of the study is to compare the detection rate of sites of prostate cancer recurrence, as determined by number of lesions per patient, between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT).

Prof Louise Emmett has been a member of Clarity’s Scientific Advisory Board since 2022 and is deeply embedded in Australia’s multidisciplinary clinical development and cancer research efforts. She is passionate about translational science, collaborating with biotechnology companies to bring promising theranostic agents into the clinic. Prof Emmett was Lead Principal Investigator in Clarity’s successfully completed Phase I diagnostic 64Cu-SAR-bisPSMA trial in patients with untreated prostate cancer, PROPELLER1, which led to the registrational Phase III CLARIFY trial (NCT06056830)2, currently recruiting patients in the U.S. and Australia. She also led 2 IITs with Clarity’s SAR-Bombesin product in prostate and breast cancer indications, BOP3 and C-BOBCAT4 trials, respectively.

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented: "We are excited to deepen our collaboration with Prof Louise Emmett and St Vincent’s Hospital, Sydney, through this new investigator-initiated Phase II trial. We pride ourselves on good Australian science and adhering to the highest standard for clinical research, so we look forward to working with Prof Emmett on generating data to highlight the benefits of our bisPSMA molecule over the current-generation diagnostics, such as the generic 68Ga-PSMA-11. Through this IIT we also look to provide access to what we consider to be the best-in-class diagnostic to more men suffering from prostate cancer in Australia, and particularly in our home city of Sydney.

"The head-to-head comparison between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 PET presents a significant opportunity to continue demonstrating the superior diagnostic capabilities of our proprietary copper-based and bis-PSMA platforms. 64Cu-SAR-bisPSMA’s excellent performance has already been demonstrated in the COBRA trial5, where we were able to image lesions more than 6 months prior to other standard of care imaging, identifying lesions with a diameter smaller than 2 millimetres. We know very well that early detection of cancer provides the best opportunities for better treatments, and this capability, coupled with the extended imaging window and logistical advantages, make it an ideal candidate to revolutionise care in these patients."

Prof Louise Emmett (St Vincent’s Hospital Sydney), Principal Investigator in the Co-PSMA trial, commented: "Men with BCR after radical prostatectomy have a window of opportunity for a cure with the use of external beam radiotherapy. In order to achieve that, we need to use highly sensitive imaging techniques that can accurately detect the site of disease recurrence when the prostate-specific antigen (PSA) levels start to rise. This could really help improve patients’ lives, and I am really looking forward to seeing whether the use of 64Cu-SAR-bisPSMA has a significant management impact over the current standard 68Ga-PSMA-11 PET CT, detecting sites of disease recurrence more accurately."

On November 17, 2024 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily for malignancies, reported that a New Drug Application (NDA) for its inhouse developed investigational novel Bcl-2 selective inhibitor, lisaftoclax (APG-2575), for the treatment of patients with relapsed or refractory (r/r) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) has been accepted and recommended the Priority Review designation by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) (Press release, Ascentage Pharma, NOV 17, 2024, View Source [SID1234648450]). This NDA, the first for a domestically developed Bcl-2 inhibitor in China, could potentially lead lisaftoclax to become the second Bcl-2 inhibitor approved anywhere in the world.

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This NDA is based on results from a pivotal registrational Phase II study in China (APG2575CC201) that evaluated the efficacy and safety of lisaftoclax in patients with r/r CLL/SLL. The primary endpoint of the study is the overall response rate (ORR).

CLL/SLL is a hematologic malignancy caused by mature B-cell neoplasms. It primarily affects older populations and is among the most common leukemia subtypes in the Western World, with over 100,000 new diagnoses reported globally each year1. In China, where the incidence rate of CLL/SLL is lower than that of the western countries, the disease is occurring at a rapidly rising rate, with a younger age of onset and higher aggressiveness2. SLL and CLL are two different manifestations of the same disease and approximately 20% of all SLL cases would progress to CLL3. Treatments such as immunotherapies and Bruton’s tyrosine kinase inhibitors (BTKis) have significantly improved patients’ responses to initial treatment. However, due to the limitations of existing treatment options, the poor prognosis of patients, severe impact on patients’ quality of life and high complexity of the disease, patients with r/r CLL/SLL are in desperate need for new treatment options that are safe and effective.

The introduction of Bcl-2 inhibitors has further revolutionized the treatment of CLL/SLL. Bcl-2 is an apoptosis suppressor factor that regulates cell survival by controlling mitochondrial membrane permeability. It suppresses apoptosis by inhibiting the release of cytochrome C from mitochondria or by binding to apoptotic activators to inhibit the activity of caspase. The overexpression of Bcl-2, found in a variety of hematologic malignancies, particularly CLL/SLL, is a key mechanism by which tumor cells evade apoptosis.

However, the development of Bcl-2 as a therapeutic target is challenging mainly because its mechanism of action is based on the protein-protein interaction (PPI). The binding interface of Bcl-2 is relatively large, making it difficult for small-molecule inhibitors to exert blocking effects. Additionally, the Bcl-2 protein is located on the mitochondrial membrane, and mitochondria, with its double-membrane structure, is among the most complex and challenging cellular components. Drugs must first penetrate the cell membrane before they can further act on the mitochondrial membrane. In nearly 40 years since the discovery of this target, only one Bcl-2 inhibitor has been approved globally, a reality highlighting the immense difficulty and challenges in this field of research and development. In western countries, the treatment of CLL/SLL has entered a new era of chemotherapy-free and fixed-duration regimens, while no Bcl-2 inhibitor has been approved in China in this therapeutic area. Therefore, patients in China have an urgent unmet need for such novel therapies that can offer both efficacy and safety.

Lisaftoclax is a novel, investigational orally administered small-molecule Bcl-2 selective inhibitor being developed by Ascentage Pharma to treat patients with malignancies by selectively blocking the antiapoptotic protein Bcl-2 and hence restoring the normal apoptosis process in cancer cells. Lisaftoclax is the first Bcl-2 inhibitor in China and the second anywhere globally that has demonstrated compelling clinical benefit and entered a pivotal registrational study. Lisaftoclax has broad therapeutic potential for a variety of hematologic malignancies and solid tumors, particularly as a single agent and in combinations in CLL/SLL. Lisaftoclax is a potential drug that may offer patients a safe, effective, and easy to use treatment option.

Lisaftoclax is being evaluated in multiple registrational Phase III studies, including a global registrational Phase III study of lisaftoclax in combination with a BTKi in previously treated patients with CLL/SLL (cleared by the US FDA); a global registrational Phase III study of lisaftoclax in combination with acalabrutinib for the first-line treatment of treatment-naïve patients with CLL/SLL; a global registrational Phase III study of lisaftoclax in combination with azacitidine (AZA) for the first-line treatment of elderly/unfit treatment-naïve patients with acute myeloid leukemia (AML) who were intolerant of standard induction chemotherapies; and a global registrational Phase III study of lisaftoclax in combination with AZA for the first-line treatment of newly-diagnosed patients with higher-risk myelodysplastic syndrome (MDS).

"Ascentage Pharma’s founding team has over 20 years of deep experience in developing apoptosis-targeted therapies and has made significant strides with the Bcl-2 target," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "To date, only one Bcl-2 inhibitor has been approved globally, which is a reality underscoring the immense difficulty and challenges in this field of research and development. This NDA submission for lisaftoclax could potentially pave the way for lisaftoclax to become the first approved China-developed Bcl-2 inhibitor, thus marking another major milestone that is a culmination of the Ascentage Pharma’s deep commitment and perseverant work in the past 15 years."

Dr. Yang continued, "Globally, r/r CLL/SLL represents an area of urgent unmet clinical needs. To have successfully advanced lisaftoclax to this point, it is a true testament to Ascentage Pharma’s robust capabilities in global pharmaceutical innovation. Moving forward, we will accelerate the global development of lisaftoclax in other indications to bring benefit to patients as quickly as possible. Remaining steadfastly committed to our mission of addressing unmet clinical needs in China and around the world, we will strive to develop more novel therapeutics for patients in need."

On November 16, 2024 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), reported that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved toripalimab (UK trade name: LOQTORZI) for the treatment of two indications (Press release, Shanghai Junshi Bioscience, NOV 16, 2024, View Source [SID1234656133]):

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Toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC);
Toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (ESCC).
In UK, toripalimab is the first and only drug for the treatment of NPC and the only first-line treatment for advanced or metastatic ESCC, regardless of PD-L1 status.

NPC is a malignant tumor that occurs in the nasopharyngeal mucosal epithelium and is one of the most common types of head and neck cancers globally. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. Due to the location of the primary tumor, surgery is rarely an option. The latest European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Guidelines recommend immunotherapy combined with chemotherapy as the first-line treatment for recurrent or metastatic NPC.

The approval of the NPC indication is primarily based on the results from the JUPITER-02 study (a randomized, double-blind, placebo-controlled, multinational multi-center Phase 3 clinical study, NCT03581786). JUPITER-02 is the first international multi-center, double-blind, randomized Phase 3 clinical study in NPC immunotherapy with the largest sample size, and the world’s first Phase 3 clinical study with preset statistical verification (Type I error control) for overall survival ("OS") in first-line immunotherapy combined with chemotherapy for NPC compared to chemotherapy alone that demonstrated a survival benefit. The study results were presented in an oral report during the Plenary Session of the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#LBA2) and were subsequently featured on the cover of Nature Medicine. The results were also published in full in the Journal of the American Medical Association (JAMA). Results showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. The median progression-free survival ("PFS") in the toripalimab plus chemotherapy group was prolonged by 13.2 months compared to chemotherapy alone, from 8.2 months to 21.4 months. In addition, patients treated with this combined therapy achieved a higher objective response rate (ORR) and longer duration of response (DoR), with a complete response (CR) rate of 26.7%, and no new safety signal was identified. Long-term survival follow-up data, presented at ASCO (Free ASCO Whitepaper) 2024, reported a 5-year survival rate of 52.0%.

EC is one of the most common malignant tumors in the alimentary tract. According to GLOBOCAN 2022 statistics, esophageal cancer is the 11th most commonly diagnosed cancer and the seventh leading cause of cancer death worldwide, with over 511,000 new cases and over 445,000 deaths in 2022. ESCC and esophageal adenocarcinoma are the two main histological subtypes of esophageal cancer.

The approval of the ESCC indication is primarily based on the results from the JUPITER-06 study (a randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical study, NCT03829969). The study aimed to evaluate the efficacy and safety of toripalimab in combination with paclitaxel/cisplatin (TP) for the first-line treatment of advanced ESCC compared with placebo in combination with chemotherapy. The results were first presented in an oral session during the ESMO (Free ESMO Whitepaper) Congress 2021 and later published in Cancer Cell and Journal of Clinical Oncology, two leading international oncology journals. Study findings showed that toripalimab in combination with chemotherapy resulted in superior PFS and OS in patients with advanced or metastatic ESCC, the median OS was prolonged by 6 months to 17 months and the risk of disease progression or death in patients was significantly reduced by 42%. Futhermore, there was a significant improvement in survival benefits regardless of PD-L1 status.

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, "The approval of toripalimab by MHRA marks another significant milestone for toripalimab in Europe, not only making toripalimab the first and only drug in UK for the treatment of NPC, but also the only first-line treatment for ESCC, regardless of PD-L1 status. We are extremely proud to introduce innovative Chinese biopharmaceuticals to Europe that can address longstanding unmet medical needs of the patients there. Moving forward, we will remain committed to our globalization strategy, ‘In China, For Global.’ We will continue working towards the commercialization of toripalimab, and offer high-quality, innovative, domestically developed medicines to benefit more patients around the world."

On November 15, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported its financial results for the third quarter 2024 (Press release, AIM ImmunoTech, NOV 15, 2024, View Source [SID1234648435]). Also, the Company will host a conference call and webcast today, November 15, 2024 at 8:30 AM ET (details below).

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AIM Chief Executive Officer Thomas K. Equels stated, "We are driving significant momentum across multiple clinical programs and studies that are demonstrating Ampligen’s significant potential to address high value and high need indications, especially in the pancreatic cancer space. Over the course of 2024, our team has made important progress in executing our clinical strategy, facilitating potential partnerships with big pharma and leveraging commercialization opportunities to create value. Our Board of Directors is dedicated to helping patients in need and delivering enhanced value for our shareholders."

Recent Highlights

Pancreatic Cancer:
Reported positive preliminary data in Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer.
Announced further positive findings from a study evaluating Ampligen in the treatment of pancreatic cancer.
Long-COVID:
Announced that analysis of AMP-518 complete clinical patient data underscores Ampligen’s potential to improve the post-COVID condition of fatigue.
Endometriosis: Company granted U.S. patent for Ampligen for composition of matter and method of treatment of endometriosis.
Please refer to previously released CEO Corner segments for additional highlights around the Company’s news and programs.

Summary of Financial Highlights for Third Quarter 2024

As of September 30, 2024, AIM reported cash, cash equivalents and marketable securities of $7.2 million.
Research and development expenses for the three months ended September 30, 2024 were $1.4 million, compared to $2.7 million for the same period in 2023.
General and administrative expenses were $3.1 million for the three months ended September 30, 2024, compared to $5.4 million for the same period 2023.
The net loss from operations for the three months ended September 30, 2024 was $3.7 million, or $0.06 per share, compared to $7.8 million, or $0.16 per share, for the three months ended September 30, 2023.
Please refer to the full 10-Q for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a conference call and webcast to discuss the Company’s Q3 2024 operational and financial results on November 15, 2024 at 8:30 AM ET.

The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.