On November 25, 2021 APIM Therapeutics (APIM), a clinical stage biotech company, focusing on the development of novel peptide therapeutics targeting PCNA (Proliferating Cell Nuclear Antigen), reported that the first patient has been treated in a clinical Phase 1b/2a study in ovarian cancer (Press release, APIM Therapeutics, NOV 25, 2021, View Source,c3460072 [SID1234605478]).

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The clinical study (ClinicalTrials.gov Identifier: NCT04814875) investigates ATX-101, the lead compound of APIM’s development program, in combination with platinum-based chemotherapy in patients suffering from recurrent, platinum sensitive ovarian, fallopian tube and primary peritoneal cancer. The study consists of 2 parts; Part 1 is a safety part with dose limiting toxicity as primary endpoint, Part 2 is an efficacy part with progression free survival as primary endpoint. Approximately 72-78 patients will be treated.

The study started recruitment in Australia; further APAC sites will be opened soon. Prof Tarek Meniawy is the Coordinating Investigator of this study. "Although a lot of progress has been made in the treatment of ovarian cancer over the last years, it remains a life-threatening disease and new treatment approaches are needed." Dr. Meniawy said. "ATX-101 is a first-in-class compound with the potential to boost the effect of standard of care chemotherapy."

"This proof-of-concept study is an important step for APIM Therapeutics. Preclinical data have shown that ATX-101 can potentiate the effect of a wide range of anticancer therapies." said Dr. Kostas Alevizopoulos, CEO of APIM. "In particular, the combination of ATX-101 with platinum-based therapies has shown very promising data. This clinical study is the logical next step in our development program."

ATX-101 has been investigated as single agent in a Phase 1 study which has been finished recently. "Data have shown that ATX-101 infusions are well tolerated and indicate clinical activity in late-stage solid tumors." Dr. Jens-Peter Marschner, CMO of APIM Therapeutics, said. "Ovarian cancer is an appropriate indication to investigate the combination of ATX-101 with platinum-based chemotherapy. We have discussed this development step with experts and authorities, including the FDA. A proof-of-concept for this combination could open the doors for further cancer indications with high medical need."

About ATX-101

ATX-101 is a first-in-class, cell penetrating peptide featuring a novel PCNA-interacting motif (AlkB homolog 2 PCNA Interacting Motif or APIM). In preclinical experiments, it was shown that APIM-containing proteins bind to PCNA and mediate processes of escape mechanisms and survival of cancer cells. ATX-101 competitively inhibits interaction of PCNA with APIM-containing protein complexes resulting in cancer cell death and altered cellular signaling. These properties translate in anticancer effects of ATX-101 as demonstrated in several preclinical models in vitro and in vivo.

About ovarian cancer

The term "ovarian cancer" also covers cancer of the fallopian tubes and primary peritoneal cancer. Epithelial ovarian cancer (90% of all ovarian cancers) is the gynecological cancer with the highest death rate. 75% of patients treated with initial standard platinum-based chemotherapy are platinum sensitive, i.e., they show a relatively long stabilization of disease. But almost all patients experience tumor progression after some time. New drugs have been approved over the last years which extend the disease stabilization, but ovarian cancer remains a life-threatening disease with a high unmet medical need.

On November 25, 2021 Elekta (EKTA-B.ST) reported that its latest African order for Elekta Unity MR-Linac comes less than six months after the company introduced its ACCESS 2025 strategy, which includes giving more than 300 million people access to radiation therapy with the addition of 800 to 1,000 additional Elekta linacs in underserved markets (Press release, Elekta, NOV 25, 2021, View Source [SID1234596093]).

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In addition to the Unity system, the Eugene Gasana Jr. Foundation signed an agreement on behalf of the International Children’s Cancer Research Centre (ICCRC) to also acquire two Elekta Versa HD linear accelerators as well as Elekta Studio* including the ImagingRing, a brand-new mobile imaging device for brachytherapy treatments, and a Flexitron afterloader.

As a member of the Elekta MR-Linac Consortium, ICCRC will actively investigate the potential benefits of magnetic resonance-guided radiation therapy (MRgRT) in pediatric oncology. In addition, ICCRC will join hospitals around the world in providing high precision radiation therapy to treat cancer in children.

"We are very excited that Ghanaians will have access to the same cancer care as the best hospitals in the U.S., Europe or Asia," said Habib Nehme, Executive Vice President Turkey, India, Middle East, Africa, APAC & Japan. "And while a focus on children’s’ health is especially appreciated; I know that having the tools to treat advanced-stage cervical cancer is welcome as rates for the indication are particularly high in Africa. We are also proud to collaborate with partners of the Eugene Gasana Jr. Foundation in providing comprehensive training for the hospital staff."

Of the more than 24,000 new cancer cases recorded in Ghana each year1, approximately 1,200 are estimated to be children under the age of 152. Cervical and prostate cancers are the most common among women and men respectively and are regularly treated with brachytherapy. Versa HD is a system designed to treat a spectrum of tumors throughout the body using both conventional and highly sophisticated techniques. And Elekta Unity uses dynamic real-time adaptation to tailor treatment based on changes in the shape, size and position of the tumor and surrounding anatomy.

Construction of the new hospital will begin in the first quarter of 2022 calendar year, with deliveries at the end of 2023. The equipment is scheduled to be clinical during 2024.

*Elekta Studio is comprised of multiple medical devices, some of which may not yet be available in all markets. Confirm availability with your local Elekta representative.

On November 25, 2021 Priothera Ltd, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, reported the appointment of Elisabeth Kueenburg, M.D., as Chief Medical Officer (Press release, Priothera, NOV 25, 2021, View Source [SID1234596092]). Dr. Kueenburg will lead the advancement of mocravimod into Phase 2b/3 clinical trials as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving hematopoietic stem cell transplantation (HSCT), and expansion of Priothera’s pipeline.

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"The breadth of knowledge Elisabeth has gained working at Celgene, alongside her extensive clinical experience, makes her a crucial addition to our team," said Florent Gros, Co-Founder and CEO of Priothera. "We are delighted to welcome Elisabeth during this exciting time as we look to progress mocravimod, into a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia receiving hematopoietic stem cell transplantation. The study is expected to begin in 2022."

"I am pleased to join Priothera at such an important stage of its development," said Dr. Kueenburg. "Mocravimod has the potential to address the significant unmet need of AML patients undergoing HSCT. I look forward to guiding mocravimod and future programs into the clinic and making an important contribution to Priothera’s future success."

Dr. Kueenburg brings significant drug development and medical affairs experience from her years at Celgene where she most recently served as Clinical Development Lead. At Celgene she developed deep clinical development and medical affairs expertise, providing strategic insight and overseeing the coordination of multiple clinical trials, in the area of hematology and specifically in multiple myeloma. Furthermore, Dr. Kueenburg has supported the successful global launch of Celgene’s Revlimid.

Prior to her numerous roles at Celgene, Dr. Kueenburg spent more than 15 years in clinical practice and academic research specializing in oncology and hematology.

Dr. Kueenburg gained her Doctor of Medicine from the University of Vienna in Austria.

On November 25, 2021 Lunit, a leading medical AI provider, reported it has raised $61 million in its Pre-IPO fundraising round ahead of the company’s planned public offering on the South Korean stock market (KOSDAQ) early next year (Press release, Lunit, NOV 25, 2021, View Source [SID1234596091]). A number of new investors have joined the round including leading US healthcare investors HealthQuest Capital, Casdin Capital, and American Cancer Society BrightEdge, as well as Asia-based global healthcare investors Tybourne Capital Management, and NSG Ventures.

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HealthQuest Capital invested $20 million of the total funding amount. HealthQuest Capital is a leading healthcare growth equity firm with funding from a number of major US healthcare systems and has extensive experience partnering with global pharmaceutical companies including Roche-Genentech, Merck, AstraZeneca, Johnson & Johnson, and Pfizer. It also has a broad network of healthcare payers such as Kaiser Permanente, Humana, and United Healthcare. Lunit is the HealthQuest Capital’s first investment in Asia.

"At HealthQuest, we’re highly interested in AI advancement and its application to complex diagnostic procedures to improve accuracy and reduce complexity," said Garheng Kong, Managing Partner at HealthQuest Capital. "Lunit stands out as best-in-class for its state-of-the-art solutions (which uses a paired modality approach) across multiple products, and has significant initial commercial traction around the world. We’re excited to partner with Lunit through this exciting stage of growth."

Casdin Capital, a New York based life science focused investment firm, has invested in well over 100 biotechnology companies including Loxo Oncology, Spark Therapeutics, Foundation Medicine, and Flatiron Health, which were recent acquisition targets for major pharmaceutical companies Eli Lilly and Roche.

Tybourne Capital Management is a global growth investor in public and private equity markets, focusing on investments in the Healthcare, Consumer, Financials and TMT sectors. The firm was founded in 2012 and is headquartered in Hong Kong with an office in San Francisco. Tybourne manages long duration capital on behalf of prominent non-profits, university endowments, sovereigns, corporate pensions and family offices. Notable investments in healthcare include Zentalis Pharmaceuticals/Zentera Therapeutics, WuXi Biologics, Tigermed, and SK Biopharmaceuticals.

BrightEdge is a recently established venture capital arm of American Cancer Society, and NSG Ventures is a global healthcare venture capital which Tim Lu, a serial entrepreneur and world-renowned expert in systems biology at MIT, co-founded as founding partner.

The list further adds Naver, one of the leading IT companies known to be the Google of Korea, and its affiliate Naver Cloud, as well as Asia’s leading venture capitals including Softbank Ventures Asia, Legend Capital, IMM Investment, Kakao Ventures, and Mirae Asset Venture Investment.

"It is a great pleasure to be successfully closing this round, consisting of major biotech investors. It is a result of hard work throughout the years to establish ourselves as one of the leading medical AI companies in the world," said Brandon Suh, CEO of Lunit.

Prior to this latest round, Lunit closed a strategic investment of $26 million from Guardant Health last July. Combined with the pre-IPO round, the company has secured more than $135 million in total to date. "Our purpose of the last few investment rounds has been to find partners who would bring strategic value for our future endeavours. Through these partnerships we look forward to reinforcing our journey to conquer cancer through AI," added Suh.

Lunit, based in Seoul, Korea, was founded in 2013. With a mission to conquer cancer through AI, Lunit develops AI-powered diagnostic tools for cancer screening, as well as biomarkers that can accurately predict and guide which patients respond to specific cancer therapy. Its radiology solutions for chest x-ray and mammography, Lunit INSIGHT, in active partnership with various medical device giants including GE Healthcare, Philips, and FujiFilm, is commercial in 30+ countries and will also be offered in the US with its recent FDA approval.

On November 25, 2021 IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company focusing on discovering, developing, and manufacturing innovative medicine reported on Oct 26, 2021 that the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) has granted the Orphan Drug Designation (ODD) to the company’s in-house developed fully human CD19/CD22 dual-targeted chimeric antigen receptor (CAR)-T cell therapy for the treatment of acute lymphoblastic leukemia (ALL) (Press release, IASO BioMed, NOV 25, 2021, View Source [SID1234596089]).

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The ODD is expected to accelerate the registration and launch of CT120 in the United States, where the product will be eligible to several preferential policies, including FDA support for clinical research, a waiver or reduction of certain fees, and seven years marketing exclusivity upon product approval.

The ODD is based on the proven clinical safety and efficacy of CT120. In an investigator-initiated clinical study (Registration No: ChiCTR2000038641), all 4 subjects with B-cell ALL achieved complete response (CR) after treatment with CT120 treatment, with a complete remission rate (CRR) of 100%. No Grade 3 or higher cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. Based on these results, CT120 is expected to become an innovative treatment for patients with relapsed/refractory B-ALL.

Dr. Wen (Maxwell) Wang, CEO of IASO Bio said, "CT120 is the first dual-targeted CAR-T cell therapy. The ODD granted to CT120 demonstrates the FDA’s recognition and expectation of the product. CT120 has obtained two IND approvals for B-NHL and B-ALL in China, and the clinical trial for the treatment of B-NHL is going well. The company is advancing the development of the product in China and United States. We look forward to the launch of this innovative therapy to cure more patients."

About the FDA’s Orphan Drug Designation

The Orphan Drug Designation (ODD) is granted by the FDA’s Office of Orphan Products Development (OOPD) to eligible drugs (including biologic agents) for the prevention, treatment, and diagnosis of rare diseases. The FDA defines rare diseases as those which affect fewer than 200,000 people in the United States. Due to the small number of patients, low market demand and huge R&D costs, pharmaceutical companies were less inclined to invest in the development of these drugs without specific policy support. In 1983 however, the United States Congress passed the Orphan Drug Act (ODA), stipulating that all drug candidates granted the ODD will have access to a series of supporting policies.

About ALL

Acute lymphoblastic leukemia (ALL) is a rapidly progressing form of leukemia and is a cancer of the blood and bone marrow, which can occur in both adults and children. According to the SEER in the United States, the annual incidence of ALL is 1.8 per 100,000, the mortality rate is 0.4 per 100,000, and the five-year survival rate is 69.9%. Based on these figures, the number of patients with ALL in the United States in 2021 is estimated at 115,000. According to the Frost & Sullivan report, the five-year survival rate of leukemia patients in China is only 25.4%, which is significantly lower than that in the United States. In 2020, the number of new ALL cases in China was 12,800, and the total number of patients with ALL was 143,900, and it is expected to rise to 150,300 in 2025.

About CT120

CT120 is an autologous dual-target CAR-T therapy. Its extracellular domain contains two fully human single-chain fragment variable (scFv) sequences that can specifically bind to CD19 and CD22, identifying tumor cells with CD19 and CD22 expressions, thereby reducing the tumor escape caused by the loss of target antigen. Adopting a fully human design, CT120 has low immunogenicity, reduces the ADA effect, and improves CAR-T cells’ viability.

Compared to the intracellular costimulatory signal CD28, CT120’s intracellular costimulatory signal 4-1BB and CD3ζ have lower neurotoxicity and improved viability of CAR-T cells, thus more durable efficacy. Upon binding with CD19/CD22 antigens on the tumor cells, CT120 eliminates targeted tumor cells through the release of granzyme and perforin while simultaneously releases cytokine to promote the proliferation of CAR-T cells, thus achieves its durable antitumor activity.