On September 29, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported Regulatory approval for the opening of trial sites in Spain, France and Italy for Panbela’s clinical trial in the first-line treatment of metastatic pancreatic cancer (Press release, Panbela Therapeutics, SEP 29, 2022, View Source;utm_medium=rss&utm_campaign=panbela-receives-approvals-to-open-trial-sites-in-spain-france-and-italy-for-aspire-trial-studying-ivospemin-sbp-101-in-combination-with-gemcitabine-and-nab-paclitaxel-in-patients-with-metastatic-p [SID1234621542]). ASPIRE is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. Detailed information on the trial can be located at View Source

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With approximately 95 sites planned throughout the United States, Europe, Australia, and South Korea, we are continuing to focus on site initiation and enrollment in order to ultimately deliver a more effective treatment for pancreatic cancer, a deadly disease with few treatment options. Site initiation can now accelerate, and we are pleased with the current momentum of the ASPIRE trial. We expect that a significant number of global sites will be open by year-end with the full complement of sites open by the first quarter 2023. "We’re excited to have these recent approvals as we move forward towards the interim analysis which is expected to be completed in early 2024," commented Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela.

About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.

SBP-101 Ivospemin

Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial. For more information, please visit View Source .

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.

On September 29, 2022 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported that it has entered into a definitive agreement to merge with Isoray, Inc (NYSE AMERICAN:ISR), a medical technology company and innovator in seed brachytherapy (Press release, Viewpoint Molecular Targeting, SEP 29, 2022, https://viewpointmt.com/viewpoint-molecular-targeting-announces-transformational-merger/ [SID1234621541]).

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Under the terms of the agreement, a newly formed wholly owned subsidiary of Isoray will merge with and into Viewpoint, with Viewpoint continuing as the surviving corporation and a wholly owned subsidiary of Isoray. At the effective time of the merger, each issued and outstanding share of common stock of Viewpoint will be converted into the right to receive 3.3212 shares of Isoray common stock. Other than cash paid in lieu of fractional shares, there will be no cash consideration paid in connection with the merger. Following completion of the merger, the stockholders of Viewpoint will own 49% of the fully diluted outstanding capital stock of Isoray.

The merger is subject to approval by the shareholders of both Isoray and Viewpoint along with other customary closing conditions including receipt by Isoray of a fairness opinion and any necessary governmental or regulatory approvals. Upon closing, the size of Isoray’s board of directors will increase to 5 with 2 directors to be designated by Viewpoint and 3 directors to be designated by Isoray. Lori Woods will be one of the directors appointed by Isoray and will serve as the chairperson. Thijs Spoor, Viewpoint’s current CEO, will be one of the directors appointed by Viewpoint and will serve as Isoray’s CEO.

Additional details along with the merger agreement can be found in Isoray Inc.’s 8-K which was filed with the Securities and Exchange Commission.

Viewpoint Molecular Targeting CEO Thijs Spoor said, "I believe the combination of Isoray, and Viewpoint presents a unique platform company in the precision radiation therapy market. The companies’ shared vision of treating cancer from the inside out and pioneering effective, personalized cancer fighting therapies that aim to minimize unwanted side effects presents a compelling proposition for patients, clinicians, and investors. At Viewpoint Molecular Targeting, we believe this proposed merger brings together two innovative medical technology companies to create a dynamic new force to make cancer care more personalized."

Isoray CEO Lori Woods commented, "The proposed merger with Viewpoint represents a culmination of a long and rigorous process. Throughout our strategic evaluations of opportunities, we have examined the evolving therapies and approaches that signal the future of cancer treatments. In line with our focus on ‘treating cancer from the inside out,’ one therapeutic area that has been of great interest to us is targeted alpha therapy. We have been following it closely and we believe that it has significant potential. It is our belief that the merger with Viewpoint Molecular Targeting represents a solid fit with Isoray’s existing business. It allows us to pursue an enhanced path forward in evolving the technology that we believe will have a significant impact on the future of cancer treatments and the company as we build on our complementary strengths."

On September 29, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed a new drug application for RG6264 today with the Ministry of Health, Labour and Welfare (MHLW) for the treatment of HER2-positive breast cancer, and HER2-positive colorectal cancer that has progressed after chemotherapy (Press release, Chugai, SEP 29, 2022, View Source [SID1234621539]). RG6264 is a fixed-dose subcutaneous combination of antineoplastic agent / anti-HER2 humanized monoclonal antibody, Perjeta [generic name: pertuzumab (genetical recombination)] and anti-HER2 humanized monoclonal antibody / antineoplastic agent, Herceptin [generic name: trastuzumab (genetical recombination)].

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The fixed-dose subcutaneous combination contains the same monoclonal antibodies as Perjeta, Herceptin, and vorhyaluronidase alfa (genetical recombination) in a single vial. Hyaluronidase, an enzyme that breaks down hyaluronic acid, is considered to increase dispersion and absorption of the antibodies. It takes 150 minutes for a sequential infusion of a loading dose of Herceptin and Perjeta using intravenous formulations, excluding follow-up observation, and 60-150 minutes for maintenance infusions.1,2,3) By comparison, in FeDeriCa study it took approximately eight minutes to infuse a loading dose of RG6264 and five minutes for maintenance infusions. The safety of RG6264 shown in FeDeriCa study was comparable to the intravenous administration of Perjeta and Herceptin. In the study, alopecia, nausea, diarrhea, and anemia were reported as adverse events.4) Another clinical study (PHranceSCa study) showed that 85% of patients (N=136/160) evaluated in the study preferred RG6264 injection to the separate IV administration of Perjeta and Herceptin.5)

"We are very pleased that the regulatory application has been filed for the subcutaneous formulation of the combination therapy of Perjeta and Herceptin, the standard therapy for HER2-positive breast cancer," said Chugai’s President and CEO, Dr. Osamu Okuda. "Reduction of administration time is expected to offer better convenience for patients and to reduce the burden on healthcare professionals. In order to deliver new value to patients and healthcare professionals as soon as possible, we will work together with Roche to obtain approval."

The application is based on the results of the global phase III FeDeriCa study and an overseas phase II PHranceSCa study. FeDeriCa study evaluated the pharmacokinetics, efficacy, and safety of RG6264 with patients with HER2-positive breast cancer. PHranceSCa study examined patient preference and satisfaction with subcutaneous administration of RG6264 in HER2-positive breast cancer. Chugai is responsible for the development of RG6264 in Japan and has been participating in FeDeriCa study.

[Reference information]
Roche’s fixed-dose subcutaneous combination of Perjeta and Herceptin comparable to intravenous formulations in people with HER2-positive breast cancer (Press release issued by Roche on December 12, 2019)
View Source

About FeDeriCa study4)
FeDeriCa is an international, multi-center, two-arm, randomized, open-label, phase III study evaluating the pharmacokinetics, efficacy and safety of subcutaneous injection of the fixed-dose combination of Perjeta and Herceptin in combination with chemotherapy, compared with standard intravenous infusions of Perjeta and Herceptin in combination with chemotherapy in 500 people with HER2-positive early breast cancer who are being treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings. The primary endpoint of the study is minimum levels of Perjeta in the blood during a given dosing interval (Ctrough). Secondary endpoints include safety; minimum levels of Herceptin in the blood during a given dosing interval (Ctrough); and pathological complete response (pCR) in the breast and axilla.

About PHranceSCa study5)
PHranceSCa is an overseas phase II randomized clinical study to evaluate patient preference and satisfaction for the fixed-dose combination of Perjeta and Herceptin for subcutaneous injection in 140 patients with HER2-positive early breast cancer. The primary endpoint is patient’s preference for this drug based on responses to the Patient Preference Questionnaire (PPQ). Secondary endpoints include patient satisfaction with this drug and Perjeta and Herceptin intravenous formulations as measured by the Therapy Administration Satisfaction Questionnaire (TASQ), and patient’s selection of this drug during continued treatment.

About Perjeta
Perjeta is a humanized monoclonal antibody that targets human epidermal growth factor receptor type 2 (HER2), which is involved in the growth of tumor cells. Perjeta in combination with Herceptin blocks the HER-signaling system more extensively. The drug was launched in 2013 for "inoperable or recurrent HER2-positive breast cancer." The indication was amended as "HER-2 positive breast cancer," after obtaining regulatory approval for the additional indication of "neoadjuvant and adjuvant therapy in HER2-positive breast cancer" in 2018. In addition, it was approved for the indication of "advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy" in 2022.

About Herceptin
Herceptin, like Perjeta, is a humanized monoclonal antibody that targets human epidermal growth factor receptor type 2 (HER2), which is involved in the growth of tumor cells. Herceptin was launched in 2001 for "metastatic breast cancer overexpressing HER2." Thereafter, the indication was changed to "Breast cancer overexpressing HER2" in 2011 based on the approved postoperative drug therapy and the additional approval of preoperative drug therapy based on a public knowledge-based application. In 2011, it was approved for the treatment of patients with "advanced or recurrent gastric cancer overexpressing HER2 not amenable to curative resection", in 2021 for "advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection" and in 2022 for "advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy."

Trademarks used or mentioned in this release are protected by law.

On September 29, 2022 Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, and Simcere Pharmaceutical Group（2096.HK), an innovation and R&D-driven pharmaceutical company; reported that they have entered into an exclusive licensing agreement for Simcere’s IL-2 mutant fusion protein (IL-2 mu-Fc) autoimmune drug candidate, SIM0278 (Press release, Almirall, SEP 29, 2022, View Source [SID1234621523]).

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Under the agreement, Almirall will be granted an exclusive right to develop and commercialise SIM0278 for all indications outside of the Greater China region (Mainland China, Hong Kong, Macau and Taiwan). Simcere will retain all rights to develop and commercialise SIM0278 within Greater China.

Within the terms of the agreement, Simcere will receive a $15 million upfront payment and up to US$492 million in development and commercial milestone payments considering successful achievements in several indications, with an important part as sales milestones, as well as up to low double-digit tiered royalties based upon future global sales.

"We are very excited to have reached a collaborative agreement with Almirall for the development of SIM0278. This innovative IL-2 mutein is one important molecule of our immune-rebalancing strategy for autoimmune diseases," said Renhong Tang, Ph.D., Co-CEO of Simcere. "SIM0278 is one of the key molecules developed based on Simcere’s in-house protein engineering platform. This partnership also marks a milestone for Simcere’s globalisation effort. We look forward to closely working with Almirall to demonstrate the clinical value of SIM0278."

"At Almirall, we always look for new opportunities to strengthen our R&D pipeline. That is why we are very pleased to close this new development and commercialisation agreement with Simcere," stated Karl Ziegelbauer, Ph.D., Almirall’s Chief Scientific Officer. "SIM0278 has great potential to treat a broad spectrum of immunological diseases, and we expect that its development will allow us to reinforce our biologic pipeline and our leading position in Medical Dermatology."

About SIM0278

SIM0278 is an interleukin 2 mutant fusion protein (IL-2 mu-Fc) that activates regulatory T cells developed in-house by utilizing Simcere’s protein engineering platform. This IND ready subcutaneous injection will potentially be developed to treat various autoimmune diseases. SIM0278 exhibits improved PK profile and selective activation of Treg cells with no activation of effector T cells or NK cells to restore immune balance which has been demonstrated in multiple preclinical disease models.

On September 28, 2022 Biosyngen reported The IND application of BRG01 Therapy has been accepted for review by the Center for Drug Evaluation, China (CXSL2200487)（View Source; (Press release, BioSyngen, SEP 28, 2022, View Source [SID1234621630]). BRG01 Therapy is autologous T cell therapy for relapsed/metastatic nasopharyngeal cancer (NPC) treatment. The principle of the autologous T cell therapy is to genetically modify patients’ own T cells to express the additional receptor for Epstein-Barr virus (EBV) antigen recognition and T cell activation upon EBV+ tumor cell engagement.

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Dr. Han Deping, CEO and CMO of Biosyngen, said, "The acceptance of IND filing for BRG01 Therapy marks a milestone in nasopharyngeal cancer treatment. With its good safety and preliminary efficacy profile, BRG01 Therapy brings hope and gives a second chance to cancer patients and their families."

EBV is a human herpesvirus and has infected ~95% of population worldwide. It has been listed as Group 1 carcinogen ("Carcinogenic to humans") by World Health Organization (WHO) and proved to be associated with a range of diseases including nasopharyngeal cancer, EBV-positive gastric cancers, lymphoma and lymphoproliferative diseases. As one of the most common head and neck tumors, nasopharyngeal cancer, an epithelial carcinoma arising from the nasopharyngeal mucosal lining, is closely related to EBV infection. According to WHO, in 2020, there were about 133,000 new cases of nasopharyngeal cancer worldwide, 50% of which was diagnosed in China. South China provinces like Guangdong and Guangxi provinces makes up for more than 60% of nasopharyngeal cancer patient population.

BRG01 Therapy developed by Biosyngen is an engineered T cell therapy, also known as a type of adoptive immune cell therapy for nasopharyngeal cancer treatment. Patients’ T cells were isolated and genetically modified in the GMP-compliant facility to enhance their ability to recognize and attack specific antigens on cancer cells. The modified T cells are then expanded ex vivo and infused back to the patient. The infused T cells could bind to the specific antigen on the cancer cells to mediate tumor killing.

About Biosyngen

With R&D powered by scientists from Singapore, China, Germany, Australia, France, and America, Biosyngen is dedicated to give cancer patients a second chance by developing first-in-class and best-in-class innovative immunotherapies. Aiming for the global market with dual R&D centers and GMP facilities set in Singapore and China, Biosyngen owns a product portfolio with potential global market of more than 50 billion USD.

Biosyngen possesses exclusive licenses and patented therapies targeting multiple solid tumors and hematological malignancies including nasopharyngeal cancer, gastric cancer, lymphoma and posttransplant lymphoproliferative disorders. We collaborate closely with the world’s leading biomedical research and clinical institutes including A*STAR, Helmholtz Zentrum München, Hannover Medical School, Sun Yat-Sen University Cancer Center to advance our R&D process and conduct clinical trials in Singapore, Australia and China.

Utilizing our strong R&D capability and translational medicine platform, we have been able to engage the end-to-end cycle of drug development including lead identification, preclinical studies cell production and quality control, regulatory filing and clinical studies, thus integrating R&D, manufacturing and commercialization.