On August 28, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted and transformative cancer therapies using its proprietary AI and machine learning (ML) platform, RADR, with multiple clinical stage drug programs, reported a substantial increase in the power and capabilities of RADR focused on improving the drug development process for immune checkpoint inhibitors (ICIs) (Press release, Lantern Pharma, AUG 28, 2023, View Source [SID1234634720]). These capabilities are expected to address the multiple challenges facing the increased usage of ICIs in cancer therapy. Since gaining regulatory approval in 2011, ICIs have improved the lives of tens of thousands of cancer patients as either monotherapies, and more recently, in combination regimens with other therapies. The success of ICIs has resulted in multiple competing ICI molecules, often from the same class, in overlapping cancer indications. Additionally, recent clinical trial failures reveal headwinds to the desired expansion of ICIs for a broader range of cancers and patient groups. Currently, there are over 5,200 ongoing clinical trials involving ICIs, many of these lacking adequate biomarker strategies or guidance from AI enabled approaches to optimize the selection of patient responder populations.

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"We are expanding the functionality of our RADR AI platform in ways that aim to solve the very meaningful and important challenges of future checkpoint inhibitor development. We initially began this effort by identifying meaningful combinations with checkpoint inhibitors that might be the most effective with our LP-184 and LP-284 drug candidates," stated Panna Sharma, Lantern’s CEO and President. "Our latest RADR advancements add a new level of speed, scalability, and precision in the identification of rational combination therapies that have the potential to overcome known shortcomings of ICIs. The current clinical trial landscape of ICIs is at a critical juncture, with dozens of new indications being pursued. Unfortunately, the majority of these trials are unlikely to succeed unless the right cancer subtypes are pinpointed and unless the right combinations with other molecules are pursued. ICIs have the potential to benefit from the ability to predict which patient groups and which cancer subtypes will respond to the drug or drug combination, which is a fundamental part of our AI platform, RADR, as we recently demonstrated in our collaborative 2023 ASCO (Free ASCO Whitepaper) poster."

In a recent study presented at the 2023 ASCO (Free ASCO Whitepaper) meeting, RADR’s algorithms demonstrated an 88% accuracy rate in predicting which melanoma (skin cancer) patients exhibiting resistance to anti-PD1 therapy will respond to Elraglusib, a GSK-3ϐ inhibitor being developed by Actuate Therapeutics, which previously entered into a multi-year research and development collaboration with Lantern Pharma to leverage the RADR platform.

The continued growth of ICIs, especially the approval of new ICIs, will be predicated on: 1) efficiently identifying new biomarker or molecular signatures for optimal patient selection, stratification, and management, and 2) rapidly developing combination regimens that overcome treatment challenges facing current and emerging solid and hematological cancer indications. Lantern’s latest RADR AI developments will focus on addressing these challenges by building automated and highly scalable computational analytics to generate clinically relevant tumor-specific and tumor-agnostic molecular signatures to guide the identification and development of drug combinations that can prolong ICI durability of response and improve patient survival. These developments will leverage RADR to uncover molecular drivers of response and resistance influencing ICI treatment outcomes by coupling pathway and network-based analytics with the simultaneous screening of millions of targets from complex clinical and biological data sets. This capability will be powered by tens of billions of new data points from immunotherapy and checkpoint inhibitor studies that Lantern has begun to add to its RADR platform.

Lantern plans to deploy its new RADR ICI predictive module with biopharma partners and to identify potential combinatorial strategies for LP-184 and LP-284, the first of Lantern’s drug candidates developed internally with the assistance of the RADR AI platform. The ICI market is projected to reach $67.8 billion in annual sales by 2025, according to GlobalData, with future growth dependent on approvals from precision-based approaches guiding the development and positioning of new combination therapies.

On August 28, 2023 Verastem Oncology (Nasdaq: VSTM) (the "Company"), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that the Company has entered into a discovery and development collaboration with GenFleet Therapeutics ("GenFleet") to advance three oncology discovery programs targeting RAS pathway-driven cancers (Press release, Verastem, AUG 28, 2023, https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-enters-discovery-and-development-collaboration [SID1234634719]).

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The collaboration, which builds on the strengths of both Companies in oncology small molecule drug development, enables Verastem Oncology to partner its clinical development and regulatory expertise with GenFleet’s accomplished discovery capabilities. This includes Verastem Oncology’s experience and established network of collaborators, including scientific and clinical experts in RAS biology and RAS pathway-dependent cancers and GenFleet’s accomplishments with its KRAS G12C inhibitor program. The risk-sharing structure of the collaboration is designed to allow Verastem Oncology the flexibility of a milestone-based option to license up to three compounds. The licenses would give Verastem Oncology development and commercialization rights outside of China while GenFleet would retain development and commercialization rights inside of China.

"With the aim of bringing needed therapies to patients where there is high unmet medical need, we are looking forward to working with GenFleet on this important discovery and development collaboration," said Dan Paterson, President and Chief Executive Officer of Verastem Oncology. "This synergistic collaboration augments our research and development pipeline in alignment with our strategy and expertise in RAS pathway-driven cancers. It also may enable new combinations with our lead assets avutometinib and defactinib."

"We are pleased to reach an agreement with Verastem Oncology to develop multiple products based on GenFleet’s proprietary discovery platform and our extensive experience in developing RAS inhibitors. Both Companies have already achieved significant clinical breakthroughs in RAS pathway-driven cancers and we look forward to a synergistic collaboration between GenFleet’s proven R&D capabilities and Verastem Oncology’s clinical and regulatory expertise. This discovery partnership will also enhance GenFleet’s global footprint in delivering potentially life-saving therapies to cancer patients," said Qiang Lu, Ph.D., Chairman of GenFleet.

The terms of the agreement include combined upfront, research support and option payments to GenFleet of $11.5 million for the first program, with potential total deal size across all three programs up to $625.5 million excluding royalties if Verastem Oncology exercises its in-license options. The collaboration provides Verastem Oncology with exclusive rights to obtain a license to each of the compounds after successful completion of pre-determined milestones in Phase 1 trials.

About Avutometinib (VS-6766)

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. Avutometinib is currently in late-stage development.

In contrast to other MEK inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK clamp avutometinib, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Verastem Oncology is currently conducting clinical trials with its RAF/MEK clamp avutometinib in RAS pathway-driven tumors as part of its (Raf And Mek Program). RAMP 201 is a registration-directed trial of avutometinib alone and in combination with defactinib in patients with recurrent LGSOC. Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively. Supported by the "Therapeutic Accelerator Award" Verastem Oncology received from PanCAN, the Company is conducting RAMP 205, a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer.

On August 28, 2023 FogPharma, a biopharmaceutical company committed to transforming the lives of patients through a new precision medicine approach widely applicable to important and challenging intracellular targets, reported that Fierce Biotech has named it as one of 2023’s "Fierce 15" biotechnology companies (Press release, FogPharma, AUG 28, 2023, View Source [SID1234634718]). The annual special report features the most innovative and promising early-stage biotechnology companies in the industry.

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"It is an honor to be among the elite Fierce 15 class of 2023," said Mathai Mammen, M.D., Ph.D. "I am proud of the FogPharma team and the important work that this team has done on behalf of patients with devastating illness using a unique and powerful drug modality capable of modulating important intracellular targets. We are currently advancing our first program, betacatenin inhibitor FOG-001 for the potential treatment of a wide range of cancers, including colorectal cancer."

"For the past 21 years, we have assessed hundreds of early-stage companies for inclusion in the ‘Fierce 15’ special report. To curate this list, we consider a diverse range of factors, including the robustness of their technology, partnerships, venture support and their competitive positioning within the market," said Ayla Ellison, Editor-in-Chief, Fierce Life Sciences and Healthcare. "Our special report celebrates innovation and creativity in the face of intense competition."

On August 28, 2023 Proxygen, a leader in the discovery and development of molecular glue degraders, reported that Fierce Biotech has named it as one of 2023’s "Fierce 15" biotechnology companies (Press release, Proxygen, AUG 28, 2023, View Source [SID1234634717]). The annual special report features the most innovative and promising early-stage biotechnology companies in the industry.

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"It is an incredible honor to be recognized as one of the Fierce 15 biotech companies for 2023," said Bernd Boidol, Ph.D., chief executive officer of Proxygen. "We have seen Proxygen going through an outstandingly successful development over the last three years. Our team of world-class scientists combined with a unique platform has enabled significant progress for both our internal programs and strategic collaborations. We are excited to see these efforts coming to fruition."

Molecular glue degraders redirect the cell’s own quality control machinery towards disease-causing proteins, inducing their selective and complete elimination. Due to the ability of molecular glue degraders to modulate protein classes unamenable to traditional drug discovery approaches, these molecules hold the promise of unlocking a large proportion of the undruggable target space and delivering innovative therapies for diseases with high medical need. However, the lack of scalable discovery strategies has so far hindered the full exploitation of the clinical potential of molecular glue degraders.

By streamlining and fully integrating cutting-edge genomic, proteomic, and biochemical technologies, Proxygen has successfully developed a highly versatile glue degrader discovery engine. The unbiased screening approach enables the specific identification of molecular glue degraders against difficult-to-drug or completely undruggable targets at large scale. The company has generated expansive knowledge and data in the discovery and chemical optimization of degrader molecules, positioning it as a pioneer in this novel modality.

"For the past 21 years, we have assessed hundreds of early-stage companies for inclusion in the ‘Fierce 15’ special report. To curate this list, we consider a diverse range of factors, including the robustness of their technology, partnerships, venture support and their competitive positioning within the market," said Ayla Ellison, Editor-in-Chief, Fierce Life Sciences and Healthcare. "Our special report celebrates innovation and creativity in the face of intense competition."

On August 28, 2023 Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), reported that it will present new clinical and preclinical data for 212Pb-VMT-α-NET, a Targeted Alpha-Particle Therapy, at the upcoming 36th Annual Congress of the European Association of Nuclear Medicine (EANM) (Press release, Perspective Therapeutics, AUG 28, 2023, View Source [SID1234634716]). The conference is being held in Vienna, Austria, from September 9-13, 2023.

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"Our team at Perspective Therapeutics continues to work diligently to advance much needed targeted alpha therapy using 212Pb," said Thijs Spoor, Chief Executive Officer at Perspective Therapeutics. "We are particularly excited about the early clinical results from 212Pb-VMT-α-NET in patients suffering from different types of difficult-to-treat neuroendocrine tumors. These results support our belief that targeted alpha therapies have the potential to revolutionize our approach to eliminating cancers and intractable tumors."

"We are excited to have early results presented by Dr. Dharmender Malik of Fortis Memorial research institute on the safety and efficacy of 212Pb-VMT-α-NET especially in patients with somatostatin receptor positive, metastatic neuroendocrine and medullary thyroid tumors," said Markus Puhlmann, MD, MBA, Chief Medical Officer at Perspective Therapeutics. "Additionally, we will present data from our metastatic mouse model of neuroblastoma exploring the efficacy of 203/212Pb-VMT-α-NET for image-guided treatment in this metastatic neuroblastoma tumor model."

Details about these presentations can be found below and on the EANM website (eanm23.eanm.org). Additionally, copies of the abstracts can be found in the EANM ’23 Abstract Book on the EANM website.

Presentation One:

This presentation will discuss early clinical results from the study of 212Pb-VMT-α-NET in ten patients with somatostatin receptor (SSTR)-expressing progressive neuroendocrine tumors and metastatic medullary thyroid carcinomas. 212Pb-VMT-α-NET demonstrated an encouraging safety profile and treatment resulted in partial responses in a number of patients.

Title: Early results of 212Pb-VMT-α-NET Targeted Alpha Therapy in Metastatic Gastro-entero-pancreatic Neuroendocrine Tumors: First in Human Clinical Experience on Safety and Efficacy
Session: Theranostics Track – What’s New in Endocrine Tumors
Abstract Number: OP-673
Presenter: D. Malik, Consultant Nuclear Medicine and PET-CT, MBBS, DNB, FANMB & RSO-II at Fortis Memorial research institute (FMRI), Gurugram, India at Fortis Healthcare Pvt.
Details: Tuesday, September 12, 2023, 9:45 a.m. CEST
Location: Hall G1

Presentation Two:

This presentation will discuss the effective tumor control of fractionated doses of [212Pb]VMT-α-NET demonstrated in a mouse model of high-risk metastatic neuroblastoma. The data showed that fractionated doses of [212Pb]VMT-α-NET provided greater benefit than single dose administration of [212Pb]VMT-α-NET.

Title: Preclinical Evaluation of [212Pb]VMT-α-NET Targeted Alpha Therapy for High-Risk Metastatic Neuroblastoma
Session: M2M Track: Radioligand Therapy – New and Old Targets
Abstract Number: OP-144
Presenter: D. Liu, Principal Research Scientist, Perspective Therapeutics, Inc.
Details: Session 504, Sunday, September 10, 2023, 3.00 p.m. CEST
Location: Hall E2