On December 26, 2023 LegoChem Biosciences, Inc. (KOSDAQ: 141080) reported on December 22 that it has entered into a license agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company, to develop and commercialize LCB84, a Trop2 directed antibody drug conjugate (ADC) (Press release, LegoChem Biosciences, DEC 26, 2023, View Source [SID1234638818]).

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Under the terms of the agreement, LCB will grant Janssen an exclusive, worldwide license for the development and commercialization of LCB84. LCB is eligible for up to potentially USD 1.7 billion in total consideration including an upfront payment of USD 100 million, an option exercise payment of USD 200 million as well as potential development, regulatory, and commercial milestone payments, plus tiered royalties on net sales. The companies will collaborate during the ongoing Phase 1/2 clinical trial, with Janssen solely responsible for clinical development and commercialization after option exercise.

LCB84, a Trop2 directed ADC applying LCB’s next-generation ADC platform technology and Trop2 antibody licensed from Mediterranea Theranostic, S.r.l, is being studied in a recently initiated Phase 1/2 clinical trial in the U.S. The ADC has a distinctive targeted mechanism, binding a unique cleaved form of the Trop2 antigen, which is highly expressed in cancer cells. Preclinical data demonstrated a differentiated safety and efficacy profile compared across multiple cancers, showing LCB84’s promise as a Trop2-targeting ADC.

"We are very pleased to collaborate with Janssen on LCB84, our first wholly in-house developed clinical stage ADC," said Yong-Zu Kim, President and CEO of LCB. "We look forward to continuing to build our global clinical development capabilities and advance other ADC programs into the clinic."

On December 26, 2023 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that it entered into a definitive asset purchase agreement with Atreca, Inc. (Nasdaq: BCEL) to acquire a collection of antibody-related assets and materials (Press release, Immunome, DEC 26, 2023, View Source [SID1234638800]).

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"We believe that novel and underexplored targets will drive the next generation of transformative ADCs. These antibody-related assets will expand our toolbox, complementing our existing programs as we advance our mission of developing innovative treatments for cancer patients," stated Clay B. Siegall, Ph.D., Chairman and Chief Executive Officer of Immunome.

Under the terms of the asset purchase agreement, Immunome would pay Atreca a $5.5 million upfront payment and up to $7.0 million in clinical development milestones. Completion of the transaction is subject to customary conditions including Atreca obtaining a required stockholder vote.

On December 26, 2023 Jemincare, a leading pharmaceutical company from China, reported that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer, kidney and anti-infectious diseases, including 4 approvals from National Medical Products Administration (NMPA) and 2 approvals from the U.S. Food & Drug Administration (FDA) (Press release, Jemincare Therapeutics, DEC 26, 2023, View Source [SID1234638799]).

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On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria. Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year. Preclinical studies on its mechanism show that JMKX003801 can overcome carbapenem resistance with very broad antibacterial spectrum.

On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema. There are about 120 million patients of chronic kidney disease (CKD) in China. The rise of proteinuria during the late stage of CKD will cause edema. Research has shown that JMKX003142 can improve patients’ quality of life with minor side effects as a novel diuretic drug.

On November 28, NMPA has approved a clinical trial for JMKX003948 to treat renal cell carcinoma. In China, the number of newly diagnosed patients suffered from renal cell carcinoma is around 60 to 80 thousand each year. Since the failure of TKI and/or PD-1 immunotherapy, there is no other drug with new mechanism. Preclinical studies indicate that JMKX003948 show significant effect in animal models with a different mechanism of action.

On December 12, FDA has approved a clinical trial for JMKX000197 to treat BCG-unresponsive non-muscle-invasive bladder cancer, and earlier on October 19, NMPA has approved the clinical trial. Bladder cancer is the most common malignant tumor in bladder system and the number of newly diagnosed patients with bladder tumor is around 80 thousand each year in China. Preclinical studies indicate that JMKX000197 can regulate the immune system and show significant anti-tumor effect in BCG-unresponsive animal models.

Earlier on November 9, FDA has approved a clinical trial for JMKX003002 to treat hyperphosphatemia in end-stage kidney disease patients on dialysis. There are about 120 million patients of CKD in China and CKD causes hyperphosphatemia and CKD-mineral and bone disorder. As a novel drug to reduce phosphorus, JMKX003002 is expected to reduce phosphorus with a long-lasting effect and better oral compliance to improve the patients’ quality of life.

On December 26, 2023 Nectin Therapeutics Ltd., (Nectin), a biotechnology company developing novel targeted immunotherapies that address resistance to approved immune oncology treatments, reported that it has progressed its Phase 1 clinical trial of NTX1088 to include a combination therapy arm with the immune-oncology drug KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, and expanded the trial to four additional global sites to include Sheba Medical Center, Hadassah Medical Center, Ochsner Health, and City of Hope along with flagship site, MD Anderson Cancer Center (Press release, Nectin Therapeutics, DEC 26, 2023, View Source [SID1234638798]).

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NTX1088 is Nectin’s First-in-Class lead candidate – a highly potent monoclonal antibody directed against PVR (CD155), a transmembrane protein expressed on cancer cells and associated with resistance to PD1 and PDL1 immune checkpoint inhibitors. PVR blockade by NTX1088 is the first and only therapeutic approach aimed at restoring the antitumor immune activity of DNAM1 (CD226). DNAM1 is a cell surface glycoprotein, central to the function of T and NK cells, that is degraded by PVR on tumor cells. Restoring the expression and activation of DNAM1 by blocking PVR results in increased antitumor activity from T and NK cells. PVR blockade by NTX1088 further stimulates an antitumor immune response by preventing the suppressing signaling of several immune checkpoint receptors, including TIGIT and CD96. NTX1088 is currently being clinically evaluated as a monotherapy and in combination with KEYTRUDA (pembrolizumab).

"We are very pleased to treat Israeli patients as part of NTX1088’s clinical trial," said Dr. Raanan Berger, Director of the Cancer Center at the Sheba Medical Center. "We are impressed by the pre-clinical data and the novel mechanism of action of PVR blockade and are looking forward to collaborating with Nectin Therapeutics to evaluate the impact of this first-in-class therapy for cancer patients."

"Nectin’s innovative pipeline holds a therapeutic promise for patients with hard-to-treat cancers. This transformational potential is proudly driven by dedicated research efforts in Israel, making it very compelling for Nectin to establish trial sites close to home," said Dr. Keren Paz, Chief Development Officer of Nectin Therapeutics. "We are encouraged by the rapid progress of our NTX1088 clinical program and are excited to expand it globally."

About NTX1088

NTX1088 is a first-in-class monoclonal antibody directed against a key immune checkpoint, PVR (CD155), currently in a Phase I clinical trial. NTX1088 blocks the interaction between PVR and DNAM1(CD226), a transmembrane molecule, involved in the activation of anti-cancer T and NK cells. By preventing internalization and degradation of DNAM1, NTX1088 leads to restoration of DNAM1 expression on the surface of immune cells, resulting in robust antitumor activity. NTX1088 also blocks PVR interactions with its other ligands, such as TIGIT and CD96, preventing their immune inhibitory signaling. NTX1088 demonstrates superior antitumor activity compared to approved and investigational immune checkpoint inhibitors in preclinical models and had a favorable safety profile in non-human primates. NTX1088 is currently being clinically evaluated as a monotherapy and in combination with KEYTRUDA (pembrolizumab).

On December 26, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the status of its dose escalation/dose expansion Phase 1/2 Study ONCT-808-101, evaluating the company’s ROR1-targeting autologous CAR T cell therapy ONCT-808 for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T treatment (Press release, Oncternal Therapeutics, DEC 26, 2023, View Source [SID1234638797]).

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At the initial dose of 1×106 CAR T cells per kg, two of the three patients achieved complete metabolic response (CMR) and the third achieved a partial response (PR) by FDG PET-CT. Common adverse events in this dosing cohort included decreased blood counts, pneumonia and Grade 1-2 cytokine release syndrome (CRS) as of a 4 December 2023 data cutoff.

The first patient treated at the second dose level of 3×106 CAR T cells per kg, an 80-year-old with bulky disease who had received four previous lines of therapy including CD19 CAR T, experienced a Grade 5 (fatal) serious adverse event consistent with CRS and immune effector cell-associated neurotoxicity syndrome (ICANS). No evidence of his lymphoma was found histologically, based on the patient’s initial autopsy report.

Oncternal has been in communication and is aligned with the Food and Drug Administration (FDA) on our proposed protocol changes that include modified eligibility criteria and testing lower doses of ONCT-808 for future patients in the study.

Salim Yazji M.D., Chief Medical Officer at Oncternal Therapeutics, commented, "The safety of every patient who participates in our studies is of the utmost priority for us. We believe these early disease response data indicate that ONCT-808 is a particularly potent autologous CAR T product with the potential to address significant unmet needs for patients with aggressive B-cell malignancies. With this clear path forward, we plan to implement the protocol amendment as rapidly as possible."