On March 18, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported that an institutional investor has exercised cash only warrants represented 623,750 American Depository Shares (ADS) at an exercise price of $2.02 (Press release, TC Biopharm, MAR 18, 2024, View Source [SID1234641238]).

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The gross proceeds of the warrant exercise was $1,263,000 with a net cash infusion of $1,168,275 to the Company post fees associated with the exercise to HC Wainwright & Co. There was no additional consideration or inducement paid for the exercise of the Series D warrants in this transaction. The Company intends to use the cash for additional working capital.

"This transaction is further reflective of the promise of TCB-008 and The Company as whole," stated CEO Bryan Kobel. "We will continue to execute on our 2024 plan, driving to human data in AML as well as expanding our platform. This cash infusion further strengthens our balance sheet and is an example of the institutional investor interest the Company is garnering around it’s clinical programs and the therapeutic applications for TCB-008."

On March 18, 2024 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the fourth quarter and year ended December 31, 2023 (Press release, Leap Therapeutics, MAR 18, 2024, View Source [SID1234641237]).

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Leap Highlights:

Presented new clinical data from Part A of the Phase 2 DeFianCe study evaluating DKN-01 in combination with standard of care bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer, at the 2024 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium
Completed enrollment in the randomized controlled Part C of the Phase 2 DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in patients with advanced gastroesophageal junction and gastric cancer
"As we reflect on the fourth quarter and the achievements of the past year, we are proud of the strides we’ve made in advancing DKN-01 and integrating our pipeline of earlier stage biomarker-targeted antibody therapies. The data from Part A of the DeFianCe study, demonstrating a 30% overall response rate and a 93% disease control rate in second-line colorectal cancer patients, showcases a strong foundation as we move into the randomized controlled Part B of the study," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "Additionally, the completion of enrollment in Part C of the DisTinGuish study in first-line gastroesophageal junction and gastric cancer patients positions us to deliver the first randomized controlled data for DKN-01 starting in the middle of the year. As we look ahead to a data rich 2024, we remain focused on our mission to deliver new personalized medicines to patients fighting against cancer."

DKN-01 Development Update

Presented initial clinical data from Part A of the DeFianCe Study of DKN-01 plus bevacizumab and chemotherapy in colorectal cancer (CRC) patients. The Company presented initial data from Part A of the DeFianCe study (NCT05480306), a Phase 2 study evaluating DKN-01 in combination with standard of care (SOC) bevacizumab and chemotherapy in second-line (2L) patients with advanced microsatellite stable (MSS) CRC patients at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, held in San Francisco on January 18-20, 2024 and during the Company’s conference call on January 23, 2024.
Key Findings:
As of the December 6, 2023 data cutoff, across all patients enrolled (n=33):
Overall response rate (ORR) among response-evaluable patients (n=27) was 30% and disease control rate (DCR) was 93%, including 8 partial responses (PR) and 17 patients with a best response of stable disease (SD)
Median progression-free survival (PFS) was 6.3 months
9 patients remained on therapy and were beyond 8.5 months
Enhanced activity in patients with left-sided tumors (n=25), a group that has more frequent activation of the Wnt pathway modulated by DKK1
33% ORR and 100% DCR in response-evaluable population (7 PRs, 14 SDs)
Preliminary median PFS of 8.6 months (9 patients continuing therapy within subgroup)
Compelling ORR, DCR and PFS in patients with rectal/rectosigmoid carcinomas (n=15), a population with increasing incidence among young people and shown to have the highest DKK1 levels:
46% ORR and 100% DCR in response-evaluable population (6 PRs, 7 SDs)
Preliminary median PFS of 9.4 months (6 patients continuing therapy within subgroup)
Higher baseline plasma DKK1 levels correlated with improved responses
DKN-01 plus bevacizumab and chemotherapy was well-tolerated, with a majority of DKN-01 related events being low grade (Grade 1/2)
The Company expects the 130 patient randomized controlled Part B to complete enrollment in mid-2024. As of March 15, 2024, 80 patients have enrolled in Part B.

Announced completion of enrollment in the randomized controlled Part C of the DisTinGuish study evaluating DKN-01 in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, and chemotherapy in patients with advanced gastroesophageal junction and gastric cancer. Part C of the DisTinGuish study (NCT0436380) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal adenocarcinoma. Part C enrolled 170 first-line, HER2-negative patients randomized 1:1 to evaluate DKN-01 in combination with tislelizumab and SOC chemotherapy, compared to tislelizumab and SOC chemotherapy alone. The primary objective is progression-free survival (PFS) in DKK1-high and in all patients. Secondary objectives of Part C include overall survival and objective response rate as measured by RECIST v1.1 in DKK1-high and in all patients. The Company expects to report initial data from Part C of the DisTinGuish study in mid-2024.
Selected Year-End and Fourth Quarter 2023 Financial Results

Net Loss was $81.4 million for the year ended December 31, 2023, compared to $54.6 million for the year ended December 31, 2022. The increase was due to in-process research and development acquired in the Flame merger which was expensed during the year ended December 31, 2023, costs incurred in connection with our research and development programs, and from general and administrative costs associated with our operations.

Research and development expenses were $73.2 million for the full year 2023, compared to $45.0 million for the same period in 2022. Research and development expenses were $11.7 million for the fourth quarter ended 2023, compared to $11.0 million for the same period in 2022. The increases for the full year 2023 were primarily due to in-process research and development acquired in the Flame merger, an increase in clinical trial costs, and an increase in payroll and other related expenses due to an increase in headcount of research and development full-time employees.

General and administrative expenses were $13.8 million for the full year 2023, compared to $11.8 million for the same period in 2022. General and administrative expenses were $3.1 million for the fourth quarter ended 2023, compared to $2.9 million for the same period in 2022. The increases for the full year 2023 were primarily due to costs associated with our business development activities and an increase in payroll and other related expenses due to an increase in headcount of general and administrative full-time employees.

Cash and cash equivalents totaled $70.6 million at December 31, 2023. Research and development incentive receivables totaled $0.8 million at December 31, 2023.

On March 18, 2024 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, reported that it has closed its previously announced private placement, for upfront gross proceeds of approximately $60 million from the issuance and sale of shares of the Company’s common stock and accompanying warrants, before deducting placement agent fees and offering expenses (Press release, Outlook Therapeutics, MAR 18, 2024, View Source [SID1234641235]). Outlook Therapeutics has the potential to receive additional gross proceeds of up to $99 million upon the full cash exercise of the warrants issued in the private placement, before deducting placement agent fees and offering expenses.

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The private placement was led by Great Point Partners, LLC, with participation from existing investor GMS Ventures as well as new investors Altium Capital, Armistice Capital, Caligan Partners LP, Schonfeld Strategic Advisors, Sphera Healthcare, Velan Capital, Woodline Partners LP, and an undisclosed life sciences dedicated investor.

BofA Securities and BTIG acted as co-placement agents in connection with the financing.

About the Private Placement

Pursuant to the securities purchase agreement entered into on January 22, 2024, Outlook Therapeutics issued to purchasers in the private placement an aggregate of 8,571,423 shares of common stock and accompanying warrants to purchase an aggregate of 12,857,133 shares of common stock, at a price of $7.00 per share and accompanying warrant to purchase one and one-half shares of common stock. The warrants have an exercise price of $7.70 per share and are exercisable only for cash until their expiration on the fifth anniversary of the issuance date. The warrants include a feature that allows Outlook Therapeutics to require holders to cash exercise the warrants if certain stock price and milestone conditions are met.

All of the securities in the private placement were offered by the Company.

Outlook Therapeutics intends to use the net proceeds from the private placement to fund its ONS-5010 clinical development programs, including the ongoing NORSE EIGHT clinical trial, and for working capital and other general corporate purposes.

As previously disclosed, Outlook Therapeutics also entered into a securities purchase agreement with Syntone Ventures, another existing stockholder, to purchase $5 million in shares of common stock and warrants on the same terms as the private placement. The closing of the Syntone investment remains subject to receipt of regulatory approvals and other customary closing conditions.

The offer and sale of the foregoing securities were made by Outlook Therapeutics in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and/or Regulation D promulgated thereunder, and such securities have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. Outlook Therapeutics has agreed to file a resale registration statement with the U.S. Securities and Exchange Commission for purposes of registering the resale of the common stock issued or issuable in connection with the private placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About ONS-5010 / LYTENAVA (bevacizumab-vikg, bevacizumab gamma)

ONS-5010/LYTENAVA is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no FDA or European Commission approved ophthalmic formulations of bevacizumab are available currently, clinicians wishing to treat retinal patients with bevacizumab have had to use repackaged IV bevacizumab provided by compounding pharmacies—products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010/LYTENAVA would provide an approved option for physicians to treat wet AMD.

Bevacizumab-vikg/bevacizumab gamma is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

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.