On February 15, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("AI") and machine learning ("ML") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported expansions and updates to RADR’s product roadmap, which will further enhance its oncology drug discovery capabilities (Press release, Lantern Pharma, FEB 15, 2023, View Source [SID1234627280]). These RADR advancements will focus on additional innovative AI and ML approaches to develop Antibody Drug Conjugates (ADCs), which are highly specific cancer-targeted antibodies linked to potent anti-tumor small molecules and designed for the treatment of cancer.

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"RADR is an integral component for de-risking and powering the progression of Lantern’s drug programs, and our recent advances in moving from program identification through preclinical development have occurred at speeds rarely seen in oncology drug discovery and development," said Panna Sharma, Lantern’s CEO and President. "Globally, ADC drug programs are one of the fastest growing drug development markets and are projected to represent a global market potential of over $14 billion by 2027. The expansion of RADR’s ADC capabilities will not only build on its demonstrated ability to identify synergistic and effective combinations of antibodies and small molecules, but will also facilitate new high-value ADC-focused business development opportunities and collaborations," continued Sharma.

Highlights of RADR’s ADC Development Roadmap:

Lantern’s strategic RADR roadmap for the development of ADCs was implemented this quarter and will include the following expansions and updates:

Development of additional algorithms that can boost prediction of optimal combinations of ADC components including antibodies, antibody linkers, payloads, and ADC combinations with other anticancer small molecules.
Generation of additional ML-based ADC biomarker signatures that can predict a cancer’s sensitivity to an ADC and guide future patient selection for clinical trials.
Use of RADR guided selection of new molecule payloads with features of synergy or properties to overcome resistance from existing ADC payloads.
Creation of AI modules to predict the immunogenicity of ADC antibodies to cancer cell surface antigens.
Expansion of RADR’s 25+ billion oncology-focused data points with the addition of immuno-oncology (IO) datasets.
The advancement of RADR’s product development roadmap will be accelerated using RADR’s library of over 200+ advanced algorithms and automated ML pipelines. This AI strategy will enable the large-scale analysis of thousands of high-performing model features through their SHapley Additive exPlanation (SHAP) scores and can efficiently identify key genes and pathways that are mechanistically important to drug resistance, quality of patient outcomes, and improved delivery of ADC drug payloads. These features can add potential value to ADC programs and prioritize ADC targets. Additionally, this powerful strategy can be leveraged to inform downstream ADC design by identifying ADC components that, when used together, have a high probability of synergy that can lead to therapeutic response.

Lantern’s RADR platform excels at automated, large-scale, biological, and response network analysis, yielding correlations that can be leveraged in both target identification and drug response prediction. This biology-driven AI drug development approach, which leverages over 25 billion oncology focused data points across thousands of data sets, can be used in augmentation with existing structural and bond analysis methodologies to further de-risk ADC drug candidates. This AI-driven approach using RADR is expected to deliver an improved understanding of potential clinical indications and patient stratification approaches for ADC development.

On February 15, 2023 Novocure (NASDAQ: NVCR) reported that the final patient has been enrolled in the pivotal PANOVA-3 study evaluating the efficacy of Tumor Treating Fields (TTFields) together with nab-paclitaxel and gemcitabine for treatment of patients with locally advanced pancreatic cancer (Press release, NovoCure, FEB 15, 2023, View Source [SID1234627279]).

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"There is a severe unmet need for patients with pancreatic cancer," said Asaf Danziger, Novocure’s Chief Executive Officer. "Each year in the U.S. alone, approximately 43,000 people are diagnosed with unresectable pancreatic cancer; however, the five-year survival rate remains stagnant at just 10%. The completion of the PANOVA-3 study marks a critical milestone for our company and potentially for patients suffering from this deadly disease. We are proud to be adding to the evolving clinical research and are excited at the prospect of improving patient survival."

Following the completion of enrollment, an independent Data Monitoring Committee will conduct a pre-specified interim analysis pursuant to the trial protocol. Patients will be followed for a minimum of 18 months.

PANOVA-3 is a randomized, open-label study which was designed to enroll 556 adult patients with unresectable, locally advanced pancreatic adenocarcinoma. Patients have been randomized to receive either the combination of nab-paclitaxel and gemcitabine alone or the combination of nab-paclitaxel and gemcitabine concomitant with TTFields tuned to 150 kHz until progression. The primary endpoint is overall survival. Secondary endpoints are progression free survival, local progression free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.

About Pancreatic Cancer

Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S. While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing. It is estimated that approximately 53,000 patients are diagnosed with pancreatic cancer each year in the U.S. Pancreatic cancer has a five-year relative survival rate of just 10%.

Physicians use different combinations of surgery, radiation and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. For patients with locally advanced pancreatic cancer involving encasement of arteries but no extra-pancreatic disease, the standard of care is surgery followed by chemotherapy with or without radiation. Unfortunately, the majority of locally advanced cases are diagnosed once the cancer is no longer operable, generally leaving chemotherapy with or without radiation as the only treatment option.

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On February 15, 2023 Xilis, a pioneering biotech company advancing its proprietary MicroOrganoSphere (MOS) Platform to enable functional precision medicine and high-confidence drug development for cancer patients, and The University of Texas MD Anderson Cancer Center reported a strategic collaboration to deploy Xilis’s proprietary MicroOrganoSphere (MOS) technology in support of preclinical research to accelerate the development of novel cancer therapies (Press release, Xilis, FEB 15, 2023, View Source [SID1234627278]).

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Under the agreement, the two organizations aim to advance drug development and discovery projects utilizing the MOS platform, which enables translational research on patient-derived micro tumors with new capabilities and at a scale not possible with current in vivo models. If successful, this platform may offer opportunities for third-party collaborations to guide the development of new drugs and cell therapies.

"Our research suggests the MOS platform has the potential to offer new capabilities and to improve the efficiency of developing innovative drugs and cell therapies over current xenograft and organoid models, which we hope will bring medicines to patients more quickly," said Dr. Xiling Shen, CEO and co-founder of Xilis. "We look forward to working with the MD Anderson team to discover and develop the next generation of cancer treatments, and we welcome further conversations with pharmaceutical firms for tripartite drug development opportunities."

The MOS platform at MD Anderson will be run jointly by the Xilis and MD Anderson teams, and the collaboration will be led by three MD Anderson scientists: Timothy Heffernan, Ph.D., vice president of Oncology Research for MD Anderson’s Translational Research to AdvanCe Therapeutics and Innovation in ONcology (TRACTION) platform, Scott Kopetz, M.D., Ph.D., professor of Gastrointestinal Medical Oncology, and Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation & Cellular Therapy.

The MOS technology provides the first reliable platform to rapidly assess how a patient’s tumor responds to a wide variety of cancer drug modalities within 14 days of obtaining harvested tumor cell samples while also sustaining the native tumor microenvironment. This is essential for determining the full spectrum of therapeutic effects, including immuno-oncology, in the clinic.

The platform also is capable of accelerating the development of disease models, enabling new opportunities to further support discovery research, translational science and drug development efforts. The collaborators intend to explore how the MOS platform could be used to establish new patient-derived models underrepresented in the field, such as rare cancers and treatment-resistant disease.

"The ability to rapidly screen many drugs ex vivo and to build an expansive catalog of disease models addressing unmet needs opens new avenues to advance impactful medicines," Heffernan said. "Our collaboration with Xilis will allow us to evaluate this exciting technology as a tool to improve the scale, speed and capabilities of our translational research efforts."

The TRACTION platform, a core component of MD Anderson’s Therapeutics Discovery division, is designed to accelerate the development of innovative cancer therapies and to identify the right treatment for the right patients. MD Anderson’s natural killer (NK) cell therapy program, led by Rezvani, is advancing novel treatments for a variety of cancers using engineered cord blood-derived NK cells.

"Developing impactful cell therapies requires an accurate determination of which cells can produce the desired effect prior to introduction in patients," Rezvani said. "In collaboration with the Xilis team, we aim to deploy the MOS platform to enable rapid screening and increase our chances of clinical success in our NK cell therapy program."

On February 15, 2023 Biotheryx, Inc., a clinical stage company discovering and developing a portfolio of innovative small molecule targeted protein degraders (TPDs) in areas of high unmet medical need, reported that members of its senior management team will participate in two panel discussions at the Wells Fargo 2023 Targeted Protein Degradation Virtual Summit, being held virtually on Tuesday, February 21, 2023 (Press release, BioTheryX, FEB 15, 2023, View Source [SID1234627277]). Details for the panel discussions are as follows:

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Panel Discussion: Overcoming Resistance with Targeted Protein Degradation
Speaker: Aparajita Hoskote Chourasia, M.S., Ph.D., Vice President, Biology
Date and Time: Tuesday, February 21, 2023, at 8:00 a.m. EST
Webcast link: Available here

Panel Discussion: Degradation vs. Inhibition – When does Targeted Protein Degradation Make Sense and When Does It Not?
Speaker: Leah Fung, Ph.D., Chief Scientific Officer
Date and Time: Tuesday, February 21, 2023, at 1:00 p.m. EST
Webcast link: Available here

A replay of the webcasts will be archived for up to 6 months following the event.

On February 15, 2023 Immvira reported that following the recent publication of efficacy data on advanced melanoma, it’s intratumoral injected OV product MVR-T3011 IT has also shown positive efficacy in the treatment of advanced head and neck cancer (Press release, Immvira, FEB 15, 2023, View Source [SID1234627276]). As of January 2023, it achieved a confirmed Objective Response Rate ("ORR") of 25.0% in monotherapy treatment, which is significantly better than standard treatment (ORR: 5.8%/10.1%) and PD-1 immunotherapy (ORR: 13.3%/14.6%) for second-line and above patients.

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This Phase II clinical study commenced in mid-2021 in China. 19 patients with advanced head and neck squamous cell carcinoma ("HNSCC") (except nasopharyngeal carcinoma) received MVR-T3011 IT monotherapy (1*108 PFU/mL), of which 18 patients (94.7%) failed from previous platinum-based chemotherapy and PD-1 immunotherapy, 17 patients (89.5%) had distant metastases, and 6 patients (31.6%) had baseline target lesion diameters of more than 5 centimeters. Median Progression Free Survival ("PFS") was 3.9 months（95%CI: 0.89, NA). Of the 12 evaluable subjects, the confirmed ORR and Disease Control Rate ("DCR") were 25.0% (3/12) and 50.0% (6/12), respectively. Meanwhile, 72.7% (8/11) of injected target lesions and 57.1% (4/7) of non-injected target lesions were observed to have reduced lesion volume, which clinically validated the abscopal effects of MVR-T3011 IT.

As a local single-drug treatment, MVR-T3011 IT’s efficacy on second-line and above subjects after PD-1 and platinum-based chemotherapy is encouraging, with improved ORR and PFS compared to PD-1 monotherapy (see below), and it has shown advantages in subjects that have failed from chemotherapy and immunotherapy in single-agent clinical development.

Results of PD-1 monoclonal antibody as second-line therapy for relapsed and metastatic HNSCC

NO.

Phase

Sample
Size

Drug

Subjects

ORR

Median PFS
(month)

Median
OS
(month)

KEYNOTE-
040

III

247

Pembrolizumab

Second-line or salvage
therapy (failure of platinum-
based chemotherapy)

14.6 %

2.1

8.4

248

PI selected
SOCs

10.1 %

2.3

6.9

CheckMate
141

III

240

Nivolumab

Second-line or salvage
therapy (failure of platinum-
based chemotherapy)

13.3 %

2.0

7.5

121

PI selected
SOCs

5.8 %

2.3

5.1

For advanced HNSCC, patients have limited treatment options after first-line and second-line standard treatment. The efficacy of CSCO-recommended monotherapies cannot meet clinical needs with ORRs generally below 10%. MVR-T3011 IT monotherapy can achieve a significantly improved ORR of 25%, and we expect to see a significant extension of Overall Survival ("OS") with longer follow-up periods. With the fact that patients enrolled all progressed after standard chemotherapy and immunotherapy, we also observed that those patients can receive PD-1/PD-L1 treatment after disease progression from MVR-T3011 and reversed resistance to immunotherapy with significant responses, clinically validated potential breakthrough synergy in combination treatment of MVR-T3011 and immunotherapy.

About Head and Neck Cancer

Head and neck tumors refer to tumors occurring in the mouth, nose, pharynx, throat, etc. More than 90% are squamous cell carcinoma and its variants, collectively referred to as head and neck squamous cell carcinoma (HNSCC). According to the statistics of 2020 GLOBOCAN, it is estimated that the number of new cases of head and neck tumors (except nasopharyngeal carcinoma) in 2020 is about 798,577, accounting for 4.14% of all new cases of malignant tumors. The estimated number of deaths was 387,117, accounting for 3.9% of all malignant tumor deaths, ranking eighth in both the number of new cases and the number of deaths. More than 60% of HNSCCS have progressed to stage III or IV disease at presentation, while 15% to 40% of locally advanced patients will relapse or metastasize after treatment, with a 5-year survival rate of less than 50%.

About MVR-T3011

MVR-T3011, ImmVira’s proprietary 3-in-1 oHSV, is a novel genetic engineered oHSV which aims to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells and highly restricted replication in normal cells. Its incorporation of two latest and well-validated exogenous genes, PD-1 antibody and IL-12, further enhances immune responses in the tumor microenvironment.