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Shares of Lantern (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 program, closed at $4.93.

On April 22, Lantern announced that – the company has received regulatory approval to expand its Harmonic™ trial, a Phase 2 clinical study evaluating LP-300 in non-small cell lung cancer (NSCLC) in never-smokers in both Japan and Taiwan. Approximately one third of all lung cancer patients in East Asia are never-smokers and the proportion of lung cancer in never smokers (LCINS) has been increasing gradually over time, according to a publication in Translational Lung Cancer Research (1). The approval to proceed with the Phase 2 clinical trials in Japan and Taiwan are expected to accelerate the collection of patient and response data needed for the next-stage of evaluation and development of LP-300, a therapeutic for the treatment of relapsed and inoperable primary adenocarcinoma of the lung given in combination with chemotherapy Additionally, it may also bring a needed therapeutic option for LCINS diagnosed patients in Japan and Taiwan, where one-third of all lung cancer diagnoses are made among those who have never smoked. Finally, Lantern believes that this improves the positioning for drug-candidate LP-300 to develop collaborative and co-development partnerships with global biopharma companies with a primary focus in serving the Asian markets. LCINS are histologically, mutationally, and epidemiologically distinct from smoking-related lung cancers and occur almost exclusively as adenocarcinomas and most commonly in women and individuals of Asian ancestry.(2) LCINS are highly enriched for alterations in the tyrosine kinase (TK) genes, have low tumor mutation burden (TMB) and low rates of PD-L1 expression.(2) Many of these factors may provide clarity on why LP-300 seems to have a distinct mechanism of action and anti-cancer activity in tumors among LCINS patients. Lantern believes that this unique mechanism of action and historically observed anti-tumor activity may ultimately prove to be a useful option for this growing class of patients globally.

Dr. Yashushi Goto, a physician and researcher focused on lung cancer at the National Cancer Center of Japan, has been watching the development of LP-300 and the Harmonic™ trial in the United States with interest. Dr. Goto will now lead the trial in Japan, where the incidence of non-small cell lung cancer (NSCLC) in never-smokers is double or more than that of the United States. Dr. Goto stated, “LP-300 represents a promising new treatment option for never-smokers with advanced NSCLC harboring driver mutations like EGFR, ALK, ROS1, and MET, who have limited choices after progressing on targeted therapies. The Harmonic trial brings renewed hope to those facing this devastating disease, especially in East Asia, where EGFR mutations are highly prevalent. I am deeply gratified to contribute to the development of this innovative therapy that could potentially transform the treatment landscape for never-smokers battling advanced lung cancer.”

The Harmonic™ trial (NCT05456256) is a Phase 2 clinical trial that is assessing the effect of Lantern’s investigational new drug LP-300 in combination with standard-of-care (SOC) chemotherapy, pemetrexed and carboplatin, on the overall and progression-free survival of never smoker patients with advanced NSCLC. The study has been designed as a 90 patient trial with approximately 2/3rds (60) of the patients receiving LP-300 with a chemotherapy doublet and the remaining 1/3rd (30) receiving the standard of care chemotherapy doublet alone. In a previous multi-center Phase 3 clinical trial, a subset of never smoker NSCLC patients who received LP-300 with chemotherapy showed increased overall and two-year survival of 91% and 125%, respectively, compared to patients who only received chemotherapy. In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated. Additional information on the Harmonic™ trial can be found at the Harmonic™ clinical trial website, on ClinicalTrials.gov, or on the first-of-its-kind Harmonic™ trial iPhone app, which is focused on education & awareness for never smoker NSCLC patients and the NSCLC community.

NSCLC presents differently in never smokers, which are defined by the CDC as a person who has smoked 100 cigarettes or less in their life, compared to smokers. These differences are believed to be due to a higher percentage of genetic mutations in a family of cancer-promoting genes called Tyrosine Kinases (TK). Changes in TK genes, such as EGFR, ALK, ROS and MET, can contribute to the development of healthy cells into cancer cells, leading to tumor formation and growth. LP-300’s intended mechanism is to work together with chemotherapy by strongly interacting in the TK gene pathways, interrupting their activity to slow or prevent tumor growth and spread.

According to the American Cancer Society, lung cancer is the second leading cause of cancer in the US, with over 200,000 patients diagnosed annually. Historically, never smokers with NSCLC make up about 15-20% of all lung cancer patients, representing an approximate annual market potential of $1.5 to $2.0 billion. Learn more.

On March 18 after the close, Lantern announced operational highlights and financial results for the fourth quarter and fiscal year ended December 31, 2023. Panna Sharma, President and CEO of Lantern Pharma started, “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. 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.”

On March 7, Lantern presented at a virtual conference being hosted by HCW. Lantern Pharma’s CEO, Mr. Panna Sharma, presentied via a fireside chat format at The 1st Annual Artificial Intelligence Based Drug Discovery & Development Virtual Conference, while addressing AI in drug discovery.  Mr. Sharma spoke about how RADR®, Lantern’s proprietary AI platform, is transforming the cost, pace, and timeline of oncology drug development.   

On March 5, Lantern announced a series of important milestones related to the development, size, and advancement of RADR® — its proprietary AI platform focused on transforming the cost, pace, and timeline of oncology drug development. Lantern highlighted the following:

• The rapid growth of Lantern Pharma’s AI platform could lead to accelerated development of better treatments, greater precision in clinical development, and improved combination regimens with the potential for longer and more durable patient responses.
• Lantern’s RADR® platform recently surpassed 60 billion data points and is planned to exceed 100 billion data points during 2024 and has been crucial in the expansion of the indications for drug candidate LP-184 and in the accelerated development of LP-284.
• Lantern seeks to 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.
• Lantern will also enhance 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.

On Feb. 15, Lantern announced an important milestone in its antibody-drug conjugate (ADC) program. In collaboration with Bielefeld University, Lantern has generated a new class of highly specific and highly potent ADCs with a cryptophycin drug-payload.

This novel approach utilizes cysteine-engineered antibodies which allows for the development of uniform and homogenous ADCs with precise control of the drug to antibody ratio (DAR). The drug-payload, cryptophycin, has the potential to improve upon existing ADCs used in the clinical setting by: 1) improving the anti-tumor potency of the ADC molecule, and 2) overcoming drug resistance tumors can frequently develop to existing drug-payloads such as MMAE (Monomethyl auristatin E). The cryptophycin drug-payload and cryptophycin-ADC (CpADC) averaged an 80% cancer cell kill rate across the tested cancer cell lines and significantly outperformed MMAE.

In a broad range of preclinical studies, the cryptophycin-ADC (Cp-ADC) demonstrated promising picomolar level potency and anti-tumor activity in a wide range of solid tumors, including six cancer indications that are being further evaluated. These six indications include: breast, bladder, colorectal, gastric, pancreatic and ovarian cancer. Initial results (Figure 1) have also shown that in high Her2 expressing tumors, Cp-ADC with a DAR of 8 (Tras(C8)-Cp) and DAR of 4 (Tras(C4)-Cp) is more potent than an MMAE ADC with a DAR of 8. MMAE payloads are used in several commercially available anti-cancer ADCs, including Adcetris®, Polivy® and Enhertu®. Additionally, the Cp-ADC with a lower DAR (Tras(C2)-Cp) provides an equivalent tumor kill-rate to that of an MMAE-ADC with a DAR of 8. In a moderate Her2 expressing cell line, the Cp-ADC with a DAR of 8 (Tras(C8)-Cp) was about 10 times more potent than a DAR 8 MMAE-ADC.

The newly developed Cp-ADC showed highly efficient anti-tumor activity in all six cancer cell lines with EC-50 values in the picomolar to single-digit nanomolar range. Additional studies are now being developed to further validate and expand these findings and to obtain a better understanding of the genomic and biomarker correlates of payload efficacy across these tumors.

Kishor Bhatia, Ph.D., Lantern’s Chief Scientific Officer commented, “Our strategic, data-driven approach of utilizing cryptophycin as a highly potent and novel payload alongside the prioritization of biologically novel and relevant targets with scalable and efficient drug conjugate formats will help expand the repertoire and diversity of ADC opportunities.”

Lantern is also utilizing its AI platform, RADR® to further refine and understand other cancer targets, with a focus on prioritizing targets that are expressed across multiple tumor types or subtypes and have few or no therapeutic ADC options. Given the promise of cryptophycin as a payload, Lantern is also focused on the development and testing of two other cryptophycin-ADC molecules. For these selected targets, Lantern is in advanced discussions with potential partners and collaborators with the goal of generating proof-of-concept data for these additional ADCs and potentially other novel drug conjugate formats. Lantern expects to provide additional details on these studies and collaborations in the coming quarters. These efforts aim to improve ADC development for specific patient populations and potentially guide more effective future clinical treatments with less cost and greater efficiency than historical ADC drug development.

On Jan. 17, Starlight Therapeutics— a Lantern Pharma (Nasdaq: LTRN) subsidiary focused exclusively on the clinical development of therapies for central nervous system and brain cancers with limited or no effective therapeutic options— announced that Marc Chamberlain, M.D. has joined Starlight as its Chief Medical Officer. Dr. Chamberlain will oversee Starlight’s clinical operations, which currently include planned clinical trials for glioblastoma and other high-grade gliomas, brain metastases in adults, and atypical teratoid rhabdoid tumors (ATRT), and diffuse pontine glioma (DIPG) in children. In his role, Dr. Chamberlain will apply his significant medical, clinical, and pharmaceutical development expertise to advance Starlight’s AI-enabled and accelerated drug development portfolio. Dr. Chamberlain is a leading medical oncologist with an extensive and distinct background in therapeutic development, clinical practice, and academic research with a focus in adult and pediatric neurology and neuro-oncology. His experience before joining Starlight has included serving as the co-director of the neuro-oncology programs at 4 NCI designated cancer centers— Moores Cancer Center at UC San Diego, Norris Cancer Center at USC, Moffit Cancer Center at the University of South Florida, and Fred Hutchinson Cancer Center at the University of Washington. He has also served as medical director for Cascadian Therapeutics, Seattle Genetics, SystImmune, Angiochem, and Pionyr Immunotherapeutics. Dr. Chamberlain has published more than 300 neurology-focused papers in peer-reviewed journals. “Starlight Therapeutics and Lantern Pharma are poised to transform oncology with AI-enabled drug development aimed at providing advanced precision therapeutics for cancers in areas of severely unmet need, such as multiple types of pediatric and adult brain cancers, for which there is currently no cure,” said Panna Sharma, CEO and President of Lantern Pharma. “Dr. Chamberlain’s insight and expertise in neuro-oncology and therapeutic development will be invaluable to the further development of treatments already in the pipeline, and the discovery and development of new future treatments that are so desperately needed by cancer patients, especially in neuro-oncology.” Dr. Chamberlain earned his medical degree at the Columbia University College of Physicians and Surgeons, followed by pediatric and neurology residencies at the University of California, Los Angeles, and a neuro-oncology fellowship at the University of California, San Francisco. “Starlight, in collaboration with Lantern Pharma, is poised to advance its novel central nervous system (CNS) penetrant wholly synthetic acylfulvene, LP-184 (referred to as “STAR-001″ for CNS indications), to target tumors in the brain. We are now preparing for two recurrent glioblastoma studies as part of a larger planned expansion study to assess STAR-001 in subjects who have failed standard-of-care temozolomide and involved field radiotherapy. The development of STAR-001 for use in brain tumors has utilized Lantern’s proprietary RADR® platform of in silico modeling as well as extensive preclinical experimentation in multiple in-vitro and in-vivo models,” said Dr. Chamberlain. “I’m looking forward to working alongside the talented researchers and experts at Lantern and its collaborators at Starlight who have already done so much to advance these treatments. I look forward to working together with our collaborators and clinicians to bring these and many more innovative neuro-oncology treatments to the patients who need them.” Formed in Q1 of 2023, Starlight Therapeutics is leveraging RADR®— Lantern Pharma’s proprietary artificial intelligence and machine learning platform focused on transforming the cost, pace and timeline of oncology drug discovery and development— to research, develop and clinically advance therapeutics for CNS and brain cancers.

Shares of Indaptus Therapeutics, Inc. (Nasdaq: INDP) closed at $2.12, +.56% and up +12.64% in the aftermarket at $2.39. Indaptus is a company with the ability to harness both the body’s innate and adaptive immune responses, believes that they are uniquely positioned to revolutionize the treatment of cancer and certain infectious diseases. Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (Nod)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The products are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy products represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts.

 On April 11, Indaptus announced it was proud to unveil its poster at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) in San Diego on Wednesday, April 10th. The poster details mechanism of action data that demonstrates the Company’s Decoy platform successfully induces, matures or activates multiple immune cell types involved in anti-tumor responses. The latest findings significantly enhance the Company’s understanding of its “Decoy” platform technology, which uses killed, non-pathogenic bacteria engineered to activate the immune system to attack tumors. The study highlights the platform’s effectiveness in engaging key innate and adaptive immune cells, including, natural killer cells, natural killer T cells, dendritic cells, CD4+, and CD8+ T cells. In some settings, the platform also produced additive or synergistic activity in combination with IL-2, an approved cancer drug. Additionally, the data reveal that the Decoy platform may not only boost the immune system’s ability to recognize and kill tumor cells, but potentially also overcome a mechanism that suppresses the immune response. The results suggest that the Company’s Decoy bacteria can both directly and indirectly prime the immune system to more effectively fight cancer.

The Company recently initiated the multi-dose cohort of its Phase 1 clinical trial in solid tumors.

Jeffrey Meckler, Indaptus’ Chief Executive Officer, added, “We are encouraged by the promising results observed in our preclinical studies and our ongoing Phase 1 clinical trial. The recognition and validation from prestigious organizations such as the AACR, coupled with the support and insights we are receiving from medical experts, partners and investors at the conference, inspire us to continue advancing our technology and demonstrating its significant therapeutic potential for the treatment of solid tumors.” The full poster can be accessed on the Indaptus Therapeutics website by clicking here.

Indaptus CEO presented in an open Q&A on Tribe Public’s Webinar titled, “Fully Engaging The Human Immune System To Cure Disease” on Wednesday, March 20, 2024. You can now watch the event video at the Tribe Public YouTube Channel at this link. 

On March 13, Indaptus announced financial results for the fourth quarter and fiscal year ended December 31, 2023 and provided a corporate update. Jeffrey Meckler, Chief Executive Officer of Indaptus, commented, “We are thrilled with the progress we made in 2023, which was capped off in November when we announced that our lead candidate, Decoy20, demonstrated a broad immune response in patients following a single dose in the first cohort of our ongoing phase 1 study. More recently, in March 2024, we announced positive results from our second cohort. In close consultation with an independent Safety Review Committee, we are now initiating a multi-dose cohort. Our objective in this next part of the Phase 1 trial is to determine the safety of Decoy20, with multiple doses administered to the same patient, which we believe could also potentially enhance anti-tumor activity across various tumor types. As we are encouraged by these initial findings and by the anti-cancer activity we observed from multi-dosing in our pre-clinical models, we look forward to continuing our efforts to demonstrate safety and efficacy. We remain prudent in managing our cash position and furthering our research in a cost effective and efficient manner.”

On Feb. 8, Indaptus announced the launch of a new social media initiative to provide education and updates about the company. Recognizing the importance of engaging with all stakeholders, Indaptus will generate content on a variety of digital platforms, including X (formerly known as Twitter) and LinkedIn. The launch of these channels signifies Indaptus Therapeutics’ commitment to transparency, knowledge-sharing, and a desire to stay connected with its stakeholders. The company will utilize these platforms to provide updates on its research, share educational content about cancer immunotherapy, and offer a behind-the-scenes look at its team and scientific progress. The company invites all interested parties, including patients, researchers, and the general public, to join the conversation and stay informed about the company’s promising strides in cancer and viral infection treatment.

On Jan. 4, Indaptus announced that the European Patent Office (EPO) has informed the company that it will grant a European patent related to the company’s platform technology, covering a composition that can be used in the prevention or treatment of viral infections. The patent, titled “Methods of Treatment of Infections Using Bacteria,” (Application 19 866 580.4) provides protections for the application of the Company’s Decoy technology platform alone or in combination with standards of care for the prevention or treatment of any viral infection. The EPO patent will be the second patent granted to Indaptus outside the United States for this application. Jeffrey Meckler, Indaptus Therapeutics CEO, commented, “The continued protection of our intellectual property both in the U.S. and abroad will provide a competitive advantage for the Company, which should ultimately drive significant shareholder value over time. We continue to explore the applications of our technology platform beyond solid tumors, for which we are currently engaged in a Phase 1 clinical trial, and look forward to updating our shareholders on scientific progress.”