On March 18, 2024 OBI Pharma, Inc. (TPEx: 4174) reported preclinical data for OBI-992, a potential best-in-class anti-TROP2 Antibody-Drug Conjugate (ADC) (Press release, OBI Pharma, MAR 18, 2024, View Source [SID1234641234]). When evaluated against comparative TROP2 ADCs, OBI-992 demonstrated greater antitumor efficacy, superior PK/PD properties, and a favorable safety profile across various preclinical animal models. Additionally, preclinical data will be presented on the novel site-specific proprietary GlycOBI ADC platform, demonstrating improved in vivo efficacy and stability in animal model studies.

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These data will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 5 to 10, 2024 in San Diego, California (USA).

"Our data suggest OBI-992 has the potential to become a best-in-class TROP2 ADC. OBI-992 binds to a TROP2 epitope that is distinct from that of datopotamab and sacituzumab. OBI-992 shows lower non-specific binding, which should lead to decreased off-target cytotoxicity compared to benchmark ADCs. OBI-992 demonstrated remarkable anti-tumor efficacy in several CDX and PDX models. In addition, OBI-992 showed excellent bystander effect and synergistic efficacy in combination with PARP inhibitors or anti-PD1 in animal models. OBI-992 was stable in circulation and well tolerated in cynomolgus monkeys, suggesting a good safety profile" said OBI’s Chief Scientific Officer, Ming-Tain Lai, Ph.D. "In addition, OBI developed a proprietary site-specific conjugation GlycOBI ADC platform to produce homogeneous ADCs. Preclinical studies demonstrated that the ADCs derived from GlycOBI platform showed better anti-tumor efficacy and PK profile. We are excited about the potential of applying this platform to generate novel ADCs to address unmet medical needs and provide cancer patients with better treatment options. These encouraging results warrant further clinical development."

Title: OBI-992, a novel TROP2 targeting antibody-drug conjugate, displayed excellent antitumor efficacy in various animal models 1
Authors*: Wan-Fen Li, Ming-Feng Chiang, Hao-Cheng Weng, Jhih-Jie Yang, Hsin-Shan Wu, Chun-Jung Lin, Ping-Tzu Chiu, and Ming-Tain Lai
Session Title: Antibody-Drug Conjugates and Bispecific Antibodies
Location: Poster Section 23
Poster Board Number: 4
Abstract Presentation Number: 1893
Session Date and Time: Monday April 8, 2024. 9:00 AM – 12:30 PM

Title: In vitro characterization of a novel TROP2-targeting antibody-drug conjugate OBI-992 2
Authors*: Tzer-Min Kuo, Ting-Yu Chang, Jye-Yu Huang, Wei-Chien Tang, Chun-Jung Lin, Yi-Chen Wu, Chi-Huan Lu, Hao-Cheng Weng, Yu-Jung Chen, Yu-Hsuan Tsao, Cheng-Yen Wei, Lifen Shen, Wan-Fen Li, and Ming-Tain Lai
Session Title: Antibody-Drug Conjugates
Location: Poster Section 21
Poster Board Number: 11
Abstract Presentation Number: 3130
Session Date and Time: Monday April 8, 2024. 1:30 PM – 5:00 PM

Title: Development of a novel site-specific ADC glycan platform with potential for improved in vivo efficacy and stability of the ADC in animal studies 3
Authors*: Teng-Yi Huang, Yin-Cheng Hsieh, Ka-Shu Fung, Yu-Chao Huang, Chi-Sheng Shia, Ming-Feng Chiang, Nan-Hsuan Wang, Wan-Fen Li, and Ming-Tain Lai
Session Title: Antibody-Drug Conjugates
Location: Poster Section 21
Poster Board Number: 30
Abstract Presentation Number: 3149
Session Date and Time: Monday, April 8, 2024. 1:30 PM – 5:00 PM

Title: OBI-992, a novel TROP2 targeting antibody drug conjugate demonstrates superior in vivo PK/PD properties and a favorable safety profile 4
Authors*: Chi-Sheng Shia, Shih-Ni Wen, Ren-Yu Hsu, Jyy-Shiuan Tu, Hui-Wen Chang, Wan-Fen Li, and Ming-Tain Lai
Session Title: Pharmacology and Pharmacogenetics
Location: Poster Section 24
Poster Board Number: 20
Abstract Presentation Number: 7179
Session Date and Time: Wednesday April 10, 2024. 9:00 AM – 12:30 PM

* OBI Pharma, Inc., Taipei, Taiwan.
1, 2, 3, 4 : AACR (Free AACR Whitepaper) Annual Meeting 2024 Abstracts online

The e-posters will be available for browsing at the AACR (Free AACR Whitepaper) Annual Meeting beginning at 12:00 PM ET on April 5, as well as on the OBI Pharma website (View Source) beginning on April 11.

About OBI-992

OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill tumor cells. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, and gastric cancer, rendering it an ideal target for cancer therapy.

OBI-992 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. OBI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in animal models. OBI-992 received US IND clearance in January 2024, Phase 1/2 efficacy and safety human studies are planned to commence early Q2, 2024.

The TROP2 targeting antibody was in-licensed from Biosion, Inc. www.Biosion.com, in December 2021. OBI Pharma owns ex-China commercial rights for OBI-992.

About GlycOBI

OBI has developed a unique glycan ADC platform (GlycOBI), which are in a ‘Plug and Play’ format and compatible with any antibodies, linkers, and payloads in various Drug Antibody Ratio (DAR). Utilizing OBI’s proprietary enzymatic technology (EndoSymeOBI), GlycOBI generates site-specific homogenous ADCs with an efficient and scalable process. The conjugation process of GlycOBI avoids disrupting the antibody structure and ensures the ADC has similar biophysical characteristics to the native antibody. Furthermore, OBI’s linker technology has improved conjugation efficiency of the payload and reduced aggregation propensity, and also expanded the half-life of the ADC products. GlycOBI has overcome the limitations of traditional ADCs and achieved better efficacy and stability in various in vivo tests.

GlycOBI and EndoSymeOBI are trademarks of OBI Pharma. Inc.

On March 18, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical-stage drug programs, reported operational highlights and financial results for the fourth quarter and fiscal year ended December 31, 2023 (Press release, Lantern Pharma, MAR 18, 2024, View Source [SID1234641233]).

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"This past quarter and the entire year of 2023 was a period of meaningful and remarkable progress for our programs and our AI platform at Lantern Pharma. Our team demonstrated how combining emerging AI technologies, cancer biology models and experiments, chemical, molecular, and multiomic biomarker data, along with large-scale patient data holds the promise of transforming timelines and costs in drug development for oncology. We are very enthusiastic about 2024 and will be actively focused on meeting and possibly exceeding the milestones ahead of us, which include potential initial data from our LP-184 Phase 1A trial; advancing the new company born from AI – Starlight Therapeutics, which is focused wholly on CNS cancers; and progressing our ADC oncology program." said Panna Sharma, President and CEO of Lantern Pharma."

Sharma continued, "Computational and AI-driven approaches are increasing their value-driving impact on oncology drug development, and our team continues to increase the capabilities and usefulness of our platform while also helping to de-risk and sharpen the focus of our existing clinical drug candidates. Our leadership in the innovative use of AI and machine learning to transform costs and timelines in the development of precision oncology therapies has guided three drug development programs in active clinical trials. We believe this pace of development with our focused team and resources should yield significant future benefits for investors and patients as our industry matures, adopts and accepts a data and AI-centric approach to drug development."

Highlights of AI-Powered Pipeline:

Ø LP-284 – Launched the first-in-human Phase 1 clinical trial with LP-284 targeting recurrent non-Hodgkin’s lymphomas (NHL) and other cancers. Lantern also announced recently that initial patients had been dosed in the LP-284 clinical trial.

LP-284 has shown nanomolar potency across multiple published in vitro and in vivo studies, including mantle cell lymphoma (MCL), double hit lymphoma (DHL), and other advanced NHL cancer subtypes with DNA damage response deficiencies, notably those with compromised functioning of the ataxia-telangiectasia mutated (ATM) gene due to mutations or deletions.

Nearly all MCL, DHL, and High Grade B-Cell Lymphoma (HGBL) patients relapse from the current standard-of-care agents and there is an urgent and unmet need for novel improved therapeutic options for these patients. In the US and Europe, MCL, DHL, and HGBLs are diagnosed in 16,000-20,000 patients each year and have an estimated annual market potential of over USD 3+ billion.

Ø LP-184 – Several cohorts of patients have been dosed in the ongoing Phase 1 clinical trial – a first-in-human Phase 1 basket trial across multiple solid tumor indications that are advanced and refractory to existing standard-of-care therapies. The trial is enrolling patients that have relapsed/refractory advanced solid tumors, such as pancreatic cancer, glioblastoma (GBM), brain metastases (brain mets.), lung cancer, triple-negative breast cancer, and multiple other solid tumor types with DNA damage response deficiencies. Lantern expects to continue Phase 1A enrollment throughout the first half of 2024 across a growing number of US clinical trial sites, including Fox Chase Cancer Center, Johns Hopkins Medicine, and other leading centers, with the potential for an initial readout in Phase 1A during late summer or early fall.

The dosage and safety data obtained in the Phase 1A trial are expected to be used to advance the central nervous system (CNS) indications for a future Phase 1b/2 trial to be sponsored by Lantern’s wholly owned subsidiary, Starlight Therapeutics. Additionally, AI and preclinical studies are ongoing to further refine drug combination studies supporting the use of LP-184 to improve the durability of response and/or the overall response rates in combination with FDA approved drugs that are widely used in cancer treatment. Globally, the aggregate annual market potential of LP-184’s target indications is estimated to be approximately $12+ billion, consisting of $4.5+ billion for CNS cancers and $7.5+ billion for solid tumors.

Ø LP-300 – Twelve sites for the Phase 2 Harmonic trial have been activated in the US, and 3 Asian countries are in various phases of regulatory allowance for clinical trial commencement. This strategy should increase the potential for dosing additional patients in the Phase 2 Harmonic trial during 2024, which should help address the patient enrollment challenges Harmonic has faced in the US. In these Asian countries, Japan, South Korea and Taiwan, the incidence of never-smokers with NSCLC (non-small cell lung cancer) is double or higher than that of patients in the US. The Harmonic trial is assessing the effect of LP-300 in combination with standard-of-care chemotherapy in never-smoker patients with relapsed NSCLC.

Globally, never-smokers with NSCLC are a growing population of patients and do not respond well to PD-1/PD-L1-based therapies, leaving them with reduced treatment options. In the US, there are approximately 20,000-40,000 never-smokers with NSCLC diagnosed annually, representing an estimated US annual market potential of $1.5 billion and a global estimated annual market potential of over $2.6 billion. Additional information on the Harmonic trial can be found at the Harmonic website and clinicaltrials.gov.

RADR Platform Growth and Development:

Ø RADR continues to advance in size, scope, and capabilities and is also progressing towards becoming a standard for AI-driven drug development in oncology – for both early-stage development and later-stage patient biomarker and combination therapy identification. RADR has now surpassed 60+ billion oncology-focused datapoints and is projected to reach over 100 billion datapoints by the end of 2024. The scope of RADR’s data has broadened with a strategic focus on additional classes of compounds, detailed data on chemical and biochemical features and drug-interaction data. Additionally, data from clinical studies such as those being obtained from liquid biopsy, and data from preclinical combination studies that aim to define drug interaction and optimal dosage are being incorporated into the datapoints and data sets powering RADR.

Lantern will potentially focus additional data growth efforts of the RADR platform on: drug sensitivity data, combination treatment outcome data, and biomarker data in rare cancers, and on emerging synthetic lethal targets that are aimed at accelerating the development of new therapies for Lantern and its partners. Additionally, the RADR platform’s generative AI capabilities, focusing on molecular optimization and automated feature extraction to improve understanding and prediction of molecular dynamics, safety, and drug-drug interactions are planned to increase in functionality and scope in the coming quarters.

On March 18, 2024 Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), reported that it will be advancing into an expanded Cohort 6 dose escalation following submission of a protocol amendment to the US Food and Drug Administration (FDA) for its Phase I/IIa study with lead ATAC candidate HDP-101 for the treatment of multiple myeloma (Press release, Heidelberg Pharma, MAR 18, 2024, View Source [SID1234641232]).

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Multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow and can affect more than one part of the body. Plasma cells are a type of blood cell that makes antibodies to fight infection, created by bone marrow. In myeloma, the bone marrow makes lots of abnormal (cancerous) plasma cells. The worldwide incidence of multiple myeloma is currently 160,000 with a mortality of 106,000.

Heidelberg Pharma’s Phase I/IIa clinical study is an ongoing, non-randomised, open label study which is actively enrolling patients with relapsed or refractory multiple myeloma or other plasma cell disorders expressing BCMA. The study is designed to assess the safety, tolerability, pharmacokinetics, and efficacy of HDP-101 in patients with multiple myeloma when treated with intravenous infusion every 3 weeks at agreed dose levels in adult patients.

The Company submitted a protocol amendment to the FDA in February 2024 allowing planned modification and optimization of the medication regimen to lessen the initial transient and reversible reduction of thrombocyte count. Upon ethics committee approval patients will be enrolled in Cohort 6.

Data across the first four Cohorts have demonstrated HDP-101 to be safe and well tolerated. In Cohort 5 at multiple doses of 100 µg/kg HDP-101 objective responses were observed, including three partial remissions out of five patients continuously treated with 100 µg/kg, highlighting the potential of HDP-101 as a highly efficacious treatment option for multiple myeloma. Further data readouts will be reported at upcoming scientific conferences in 2024.

Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, said: "Our proprietary ATAC candidate HDP-101 is showing exciting potential for treating multiple myeloma. First objective responses and partial remissions are highly encouraging with the prospect of HDP-101 becoming a game changer in prolonging life alongside good tolerability for sufferers of this incurable illness worldwide. With our proprietary toolbox of novel payloads, we are building a pipeline across multiple indications that further advances ADCs as a treatment modality for cancer."

Heidelberg Pharma will be presenting data on HDP-101 at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held in San Diego, California on the 5 – 10 April 2024. The Annual Report to be issued on 25 March 2024.

On March 18, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported that the first clinical candidate in its TCB agreement with Astellas has entered into GLP toxicology studies which triggers a $5 million payment to CytomX (Press release, CytomX Therapeutics, MAR 18, 2024, View Source [SID1234641231]). The clinical candidate is the first PROBODY TCB molecule under this alliance to progress into a GLP toxicology study. CytomX and Astellas are also collaborating on additional conditionally activated TCB programs with CytomX eligible to receive future preclinical, clinical and commercial milestones. CytomX retains a cost share and co-commercialization option on a select number of targets.

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"We are excited by the continued momentum towards a potential future IND for the first PROBODY TCB clinical candidate in our collaboration with Astellas, and we continue to partner with Astellas on multiple preclinical programs. The progress with this collaboration highlights the benefits of our strategy to create value through both wholly-owned and partnered programs, as well as the potential of our expanding pipeline of PROBODY T-cell engagers which are designed to localize T-cell activity to the tumor microenvironment," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics.

On March 18, 2024 Bristol Myers Squibb (NYSE: BMY) reported that it has successfully completed its acquisition of Karuna Therapeutics, Inc. ("Karuna") (Press release, Bristol-Myers Squibb, MAR 18, 2024, View Source [SID1234641230]). With the acquisition’s completion, Karuna shares have ceased trading on the Nasdaq Global Select Market and Karuna is now a wholly owned subsidiary of Bristol Myers Squibb ("BMS").

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"We are excited to expand our neuroscience portfolio as we welcome Karuna to Bristol Myers Squibb," said Chris Boerner, Ph.D., Chief Executive Officer, Bristol Myers Squibb. "Importantly, this transaction aligns with our commitment to strengthening BMS’s growth profile in the latter half of the decade and beyond. We look forward to working with Karuna’s talented team to bring KarXT to patients with schizophrenia later this year."

Through this transaction, BMS has added KarXT (xanomeline-trospium), an antipsychotic with a novel mechanism of action and a differentiated efficacy and safety profile, and Karuna’s early-stage and pre-clinical pipeline. KarXT has a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024 for the treatment of schizophrenia in adults. KarXT is also in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease, with potential to expand to additional indications, including Bipolar I disorder and Alzheimer’s disease agitation.

As previously disclosed, the transaction is expected to be dilutive to Bristol Myers Squibb’s non-GAAP diluted earnings per share by approximately $0.30 in 2024 from the financing cost of the transaction, which is primarily from a recently completed new debt issuance. Bristol Myers Squibb expects to offset the operational expenses of the transaction through continued disciplined resource allocation, cost efficiencies and portfolio prioritization. Bristol Myers Squibb’s cash flows and strong financial profile enable continued commitment to strong investment-grade credit ratings and investment for growth through business development opportunities and distributions to shareholders through ongoing dividends and share repurchases.

The transaction will be accounted for as an asset acquisition resulting in an approximately $12 billion one-time, non-deductible Acquired In-Process Research and Development (Acquired IPR&D) charge impacting both 2024 first quarter and full-year GAAP and non-GAAP EPS by approximately $5.93.

Consistent with past practice, Bristol Myers Squibb generally provides updates to its financial outlook once each quarter. When considering Bristol Myers Squibb’s financial outlook issued on February 2, 2024, investors and analysts should take into account the impacts outlined above. Bristol Myers Squibb will provide an update to its financial outlook when it reports first quarter 2024 results on April 25, 2024.

Advisors

Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel. Goldman Sachs & Co. LLC is serving as exclusive financial advisor to Karuna, and Simpson Thacher & Bartlett LLP is serving as legal counsel.