On July 11, 2023 Ratio Therapeutics Inc. (Ratio), a pharmaceutical company that employs a suite of innovative technologies to develop best-in-class radiopharmaceuticals for the monitoring and treatment of cancers reported that in partnership with Lantheus, a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, and in collaboration with PharmaLogic, a world-class contract development and manufacturing organization (CDMO) specializing in radiopharmaceuticals, that it has initiated dosing in a Phase I study evaluating the pharmacokinetics, biodistribution and radiation dosimetry of a novel fibroblast activation protein-alpha (FAP)-targeted radiopharmaceutical, Copper-64[Cu-64]-labeled RTX-1363S, for PET imaging in adult healthy volunteers (Press release, Ratio Therapeutics, JUL 11, 2023, View Source [SID1234633180]).

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FAP is a membrane-bound dipeptidyl peptidase that is specifically expressed in activated fibroblasts. The ubiquitous expression of FAP in cancer-associated fibroblasts across nearly all epithelial-derived cancers paired with the low abundance in normal tissues, makes it a unique target to exploit for tumor imaging for a wide variety of cancers such as breast, pancreatic, lung and stomach cancer.

"Today marks a major milestone for Ratio as we take a crucial step forward in the development of our FAP-targeted imaging agent," said Dr. John Babich, Ratio’s President and Chief Scientific Officer. "Cancer-associated fibroblasts selectively expressing FAP comprise up to 90% of the tumor mass in highly desmoplastic cancers, including pancreatic, breast, and colorectal. RTX-1363S has the potential to transform the way we detect and monitor various epithelial-derived cancers."

"We are delighted by our collaboration with Ratio Therapeutics in advancing the clinical development of RTX-1363S as a FAP-targeted diagnostic to the clinic," stated Etienne Montagut, Lantheus’ Chief Business Officer. "By leveraging our expertise in radiopharmaceuticals, we aim to contribute to the early detection and accurate monitoring of epithelial-derived cancers. This partnership exemplifies our commitment to Find, Fight and Follow disease by delivering innovative solutions to improve cancer care, ultimately leading to better patient outcomes."

"PharmaLogic is honored to contribute its manufacturing expertise in radiopharmaceuticals to this clinical trial, advancing diagnostics for epithelial-derived cancers," said Scott Holbrook, Chief Strategy Officer, General Manager PET & Precision Medicine at PharmaLogic, the manufacturing partner involved in the trial. "This further strengthens our commitment to production and development of novel radiopharmaceuticals to advance cancer treatments and quality of life for cancer patients."

Ratio’s clinical candidate, RTX-1363S, is a highly selective, high affinity FAP inhibitor that will be radiolabeled with copper-64 (Cu-64), a positron-emitting radionuclide with a half-life of 12.7 hr. In the first study, biodistribution and pharmacokinetics will be evaluated following a single injection of [Cu-64]-labeled RTX-1363S in a small subset of adult healthy volunteers. Study subjects will be screened within 28 days of administration and up to 6 eligible subjects will be enrolled, including 3 female and 3 male subjects. Results from the study will inform further development of [Cu-64]-labeled RTX-1363S as a FAP-targeted tumor imaging agent.

About Trillium and Macropa
Ratio Therapeutics’ fully integrated proprietary R&D platforms, Trillium and Macropa, harness the tumor-killing power of alpha particles. The tunable nature of the platforms enables the efficient and timely development of numerous novel radiopharmaceuticals for a broad range of high unmet need in solid tumors, while addressing the trifecta of typical challenges seen with most radiopharmaceuticals: delivery, safety and efficacy. Trillium is a pharmacokinetic modulation platform that can be altered to bind to any antigen-specific target, while Macropa is a best-in-class Actinium-225 chelator. The combination of these platforms enables the tumor-killing power of alpha particles with potential for first- and best-in-class radiopharmaceuticals.

On July 11, 2023 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that it has collected the previously announced arbitration award from I-Mab Biopharma (Press release, Tracon Pharmaceuticals, JUL 11, 2023, View Source [SID1234633175]).

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"We are pleased to collect the award. As we previously announced in April, the net proceeds extend our cash runway into early 2024 and past expected full accrual of the ENVASARC pivotal trial," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "We look forward to reporting the interim efficacy assessment from ENVASARC in the third quarter of 2023, which includes a futility analysis that we have already met based on responses seen to date."

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. ENVASARC is enrolling patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. A total of 80 patients will receive treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

On July 11, 2023 Silence Therapeutics plc, Nasdaq: SLN ("Silence" or "the Company"), an experienced and innovative biotechnology company committed to transforming peoples’ lives by silencing diseases through precision engineered medicines, reported that it will receive a $4.0 million cash payment from Hansoh Pharmaceutical Group Company Limited ("Hansoh") following the achievement of two undisclosed preclinical milestones (Press release, Silence Therapeutics, JUL 11, 2023, View Source [SID1234633174]).

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"We are very pleased with the continued progress being made in our Hansoh Pharma collaboration," said Craig Tooman, President and CEO of Silence. "Today’s news follows the $10.0 million milestone payment we achieved in our AstraZeneca collaboration in May and reflects our ongoing efforts to advance our partnered pipeline. We continue to be excited about the advancement of our siRNA technology in both partnered and proprietary programs."

Silence and Hansoh entered a collaboration in October 2021 to develop siRNAs ("short interfering RNAs") leveraging Silence’s proprietary mRNAi GOLD platform for three undisclosed targets. Under the terms of the agreement, Silence has exclusive rights to the first two targets in all territories except the China region. Hansoh has the exclusive option to license rights to those two targets in Greater China, Hong Kong, Macau and Taiwan, and global rights to the third target.

Hansoh made a $16 million upfront payment to Silence and the Company is eligible to receive up to $1.3 billion in development, regulatory and commercial milestones. Silence is also eligible to receive royalties tiered from low double-digit to mid-teens on Hansoh net product sales. Today’s announcement represents the second and third research milestone payments achieved under the collaboration. The Company achieved the first milestone payment for $2.0 million in April 2022.

On July 11, 2023 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported the completion and data maturity of its Phase 1 dose escalation study of CM24, a first-in-class anti-CEACAM1 monoclonal antibody addressing multiple tumor types (Press release, Purple Biotech, JUL 11, 2023, View Source [SID1234633173]).

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In the dose escalation part of the study, 11 refractory, pancreatic ductal adenocarcinoma (PDAC) patients whose cancer progressed following two lines of prior therapies were treated with CM24 at 10, 15 and 20mg/kg once every two weeks (q2w) and nivolumab at 480mg once every four weeks (q4w).

The investigational immunotherapy combination was well tolerated across all dose levels with no recorded Drug Limiting Toxicities (DLTs). Grade 3 adverse events were reported in 6 of the patients and none was considered related to the study drugs. No Grade 4 or deaths were reported.

Overall Survival (OS) data across all dose levels from this study with Purple’s chemo free CM24 in combination with nivolumab, demonstrated comparable OS rate in comparison to historical data of third line patients treated with chemotherapy, which demonstrate an OS median rate in a range of 3 to 4 months1.

Among the patients who demonstrated a response or disease control from the CM24 + nivolumab treatment, one third line patient has survived for 14.6 months. The patient had Microsatellite Stable (MSS) and PDL-1 IHC 2+ and 5% staining, features not expected to respond to immuno-oncology therapy.

Based on the study’s safety, tolerability, efficacy, pharmacokinetic and pharmacodynamic data, the recommended Phase 2 dose of CM24 in combination with nivolumab was determined to be 20mg/kg. We believe that these encouraging and confirmed final results provide additional support to the rationale for conducting the already initiated Phase 2 randomized study of CM24 in combination with nivolumab and standard of care chemotherapy vs. standard of care chemotherapy alone, in the second line PDAC setting. This randomized Phase 2 study (NCT04731467) is being conducted as part of Purple Biotech’s clinical collaboration with Bristol Myers Squibb.

"We are highly encouraged by these latest Phase 1 data and plan to provide further details from this study at an upcoming medical conference," said Isaac Israel, Purple Biotech’s Acting Chief Executive Officer. "As we continue the Phase 2, which is enrolling as planned across multiple sites in the U.S., Europe, and Israel, we expect to share initial Phase 2 data by the end of 2023 and topline results later in 2024."

Efficacy of the third-line chemotherapy in patients with advanced pancreatic cancer.

Bomi Kim, Jinwoo Ahn, Jae Hyup Jung, Kwangrok Jung, Jong-Chan Lee, Jin-Hyeok Hwang, and Jaihwan Kim, Journal of Clinical Oncology 2023 41:4_suppl, 711-711

On July 11, 2023 PharmaMar (MSE:PHM) reported that its licensing partner, Lotus Pharmaceutical CO., Ltd. (TWSE:1795), has received accelerated marketing approval for Zepzelca (lurbinectedin) by the Taiwan Food and Drug Administration (TFDA), for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy (Press release, PharmaMar, JUL 11, 2023, View Source [SID1234633172]). It had been more than 10 years since a drug had been approved in Taiwan for this therapeutic indication.

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This new approval of lurbinectedin is based on the data from the open-label, multi-center, single-arm monotherapy clinical trial in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive and platinum-resistant disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the US.

In November 2021, PharmaMar and Lotus Pharmaceutical signed a licensing agreement for lurbinectedin in Taiwan. Under the terms of the agreement PharmaMar will retain production rights and will sell the product to Lotus for its clinical and commercial use, while Lotus will pursue the marketing approval in Taiwan and have the right to market the compound exclusively.

The approval is subject to confirmation with a Phase III clinical trial. With this approval in Taiwan, lurbinectedin is now approved in 12 countries around the world.

About 15% of all lung cancers are Small Cell Lung Cancer (SCLC). This type of lung cancer tends to grow and spread faster than Non Small Cell Lung Cancer. In most people with SCLC, the cancer has already spread beyond the lungs at the time it is diagnosed.