On October 27, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported a collaboration that will power A.I.-driven computational research for oncology-focused drug discovery and development with Code Ocean, the leading computational research environment for sharing scientific discoveries (Press release, Lantern Pharma, OCT 27, 2021, View Source [SID1234593961]). By leveraging Code Ocean’s Compute Capsule technology, the strategic approach is expected to further power Lantern Pharma’s RADR platform for faster, more collaborative discoveries from billions of RADR data points, as well as data and insights from Lantern’s network of collaborators.

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Computational researchers today are challenged with analyzing big data due to too many disparate tools, lack of specialized coding experience, and challenging, cumbersome DevOps processes required to organize and securely share research. Through this collaboration, Lantern Pharma is expected to benefit from significant efficiencies in development time and cost, as well as increased reproducibility from Code Ocean’s platform. The Code Ocean platform will offer an easy to use, collaborative research experience with an integrated development environment, secure repository, and portable Compute Capsule technology for guaranteed reproducibility.

"I’m thrilled to be working with a leading-edge technology partner like Lantern Pharma," said Simon Adar, Co-Founder and CEO of Code Ocean. "This collaboration truly enables large-scale, high-throughput collaboration both internally at Lantern and also with their leading research partners to accelerate the pace of oncology drug discovery."

"It’s clear that science and discovery need to be fully integrated using the latest tools and technologies to reduce costs, speed-up development, and increase probability of success," said Panna Sharma, President & CEO of Lantern Pharma. "We selected Code Ocean as we believe this collaboration will provide our scientists, researchers, data engineers and collaborators with a best-in-class, reproducible and highly secure platform environment to maximize the power and usability of our RADR A.I. platform to improve and enhance the research experience. Bringing together our proprietary A.I. with Code Ocean’s Compute Capsule technology we believe will allow us and other researchers to take collaborative drug development further and faster than ever before."

Lantern leverages advances in machine learning, genomics and artificial intelligence to develop oncology therapies by using its proprietary A.I. platform, RADR, to discover biomarker signatures aimed at helping identify patients more likely to respond to its pipeline of cancer therapeutics. Working within the Code Ocean platform is expected to help increase team productivity and enhance Lantern Pharma’s ability to collaborate more rapidly with industry leading partners, such as the National Cancer Institute, Georgetown University, Johns Hopkins and Fox Chase Cancer Center, within a secure and agile research environment.

The Code Ocean platform does not require the user to be an IT expert to utilize the software properly. By integrating the essential triplet– code, data and a computing environment– Code Ocean offers the most complete platform for computational research that’s on the market. Code Ocean’s unique Compute Capsules provide a fundamentally easier and more efficient way for researchers to create and safely share their work, which is essential to moving science forward. This, combined with Lantern Pharma’s billions of data points and growing library of algorithms designed for oncology drug development, will allow researchers to have faster access to more data than ever before, without being overwhelmed by massive amounts of data management or computational structure.

On October 25, 2021 Theseus Pharmaceuticals, Inc. (the "Company") reported that exercised their option to purchase an additional 1,171,990 shares of common stock from the Company (Press release, Theseus Pharmaceuticals, OCT 27, 2021, View Source [SID1234592030]). The partial exercise of the over-allotment option closed on October 27, 2021, resulting in additional gross proceeds to the Company of approximately $18.8 million, before deducting underwriting discounts, commissions and other offering expenses payable by the Company. After giving effect to this partial exercise of the over-allotment option, the total number of shares of common stock sold by the Company in the initial public offering increased to 11,172,190 shares and total gross proceeds increased to approximately $178.8 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

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On October 27, 2021 ZAP Surgical Systems, Inc. reported an agreement to bring its advanced ZAP-X Gyroscopic Radiosurgery platform to the Centre de Cancérologie de la Porte de Saint-Cloud (CCPSC) in Boulogne, France (Press release, ZAP Surgical Systems, OCT 27, 2021, View Source [SID1234592055]). As part of the renown American Hospital of Paris, CCPSC will be the first in France to offer the latest advance in radiosurgical brain tumor treatments. First patient treatments with ZAP-X at CCPSC are estimated to begin the Fall of 2022.

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Stereotactic radiosurgery (SRS) is a well-established procedure for the non-invasive treatment of many primary and metastatic brain tumors, as well cranial functional and vascular disorders including trigeminal neuralgia and arteriovenous malformations. Often considered an alternative to costly and invasive surgical procedures, SRS is a non-invasive outpatient procedure that often provides superior outcomes, yet requires no surgical incision, and little to no patient recovery period.

"A significant percentage of cancer patients develop brain metastases during the course of their disease," said Eric Duret, General Manager of CCSPC. "As this population continues to grow with improving cancer survival, having the most advanced radiosurgery option available to our patients was imperative."

The ZAP-X system uses unique gyroscopic mobility to direct radiosurgical beams from hundreds of angles to precisely concentrate radiation on the tumor target. This pioneering approach supports the clinical objective of protecting healthy brain tissue and patient cognitive function, and when needed, enable future potential SRS re-treatments without the unnecessary risks associated with other radiation delivery techniques.

ZAP-X is additionally recognized for being the first and only vault-free and cobalt-free dedicated SRS delivery system, thereby eliminating the costs to build expensive shielded radiation treatment rooms, and removing the need to maintain, secure and regularly replace live radioactive isotopes.

For more about the ZAP-X Gyroscopic Radiosurgery platform, please visit: View Source Detailed system overview animations can be found at View Source

On October 27, 2021 Monteris Medical, the leader in MR-guided laser interstitial thermal therapy (LITT or laser ablation), reported that Cigna, a global health services company and one of the largest commercial payors in the United States, has released a national coverage policy supporting the use of LITT for people with brain tumors and drug-resistant epilepsy (Press release, Monteris Medical, OCT 27, 2021, View Source [SID1234592020]).

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The medical coverage policy by Cigna considers LITT medically necessary in the treatment of drug-resistant epilepsy and symptomatic brain tumors and radiation necrosis when medical necessity is met, and the patient is not suitable for open brain surgery.

"Many patients with brain tumors face situations in which traditional, open surgery is neither possible, nor the preferred approach. This policy decision by Cigna offers appropriate patients greater access to a targeted, minimally invasive technology that can positively impact their care and improve their quality of life," said Dr. Peter Fecci, director of the Brain Tumor Immunotherapy Program and the Center for Brain and Spine Metastasis at Duke University School of Medicine in Durham, N.C.

A growing body of peer-reviewed clinical evidence continues to show medical advantages of minimally invasive, MR-guided laser ablation technology due to decreased morbidity, faster recovery time, shorter hospital and intensive care stay, and an ability to access lesions not amenable to open surgery. Laser ablation also represents an alternative to surgery for patients with significant comorbidities.

"Cigna and other national payors have progressively widened access to care for the patients we serve. This policy announcement is the latest in a continuum of advancements for LITT, establishing its position in the care pathway for patients and their families afflicted by brain tumors and epilepsy," said Martin J. Emerson, president and chief executive officer of Monteris Medical.

The Cigna coverage policy follows recently issued position statements on the use of LITT for epilepsy and brain tumors, respectively, by the major neurosurgical societies, inclusion of LITT in guidelines issued by the National Comprehensive Cancer Network, and Category Level 1 CPT codes approved by the American Medical Association with an effective date of January, 2022.

On October 27, 2021 The Medicines Patent Pool (MPP) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported the signing of a voluntary licensing agreement to facilitate affordable global access for molnupiravir, an investigational oral COVID-19 antiviral medicine for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization (Press release, Merck & Co, OCT 27, 2021, View Source;and-Middle-Income-Countries/?feedref=JjAwJuNHiystnCoBq_hl-SZsvSFSeS2k6e-jDETKtk7rEQumBjqILHhqiwHg7GoJnkvYMqDDYxFrLs-oQ2BHQ-mJCMFkCosC_NGzuJ8TW18j0KvNpL5ik-rnXyj1_o5vU-QF2vCj0ELWlPt_oGwViA== [SID1234593962]). This agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries (LMICs) following appropriate regulatory approvals. Merck and Ridgeback Biotherapeutics are jointly developing molnupiravir.

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Under the terms of the agreement, MPP, through the license granted by Merck, will be permitted to further license non-exclusive sublicenses to manufacturers ("MPP License") and diversify the manufacturing base for the supply of quality-assured or WHO-prequalified molnupiravir to countries covered by the MPP License, subject to local regulatory authorization. Merck, Ridgeback Biotherapeutics and Emory University will not receive royalties for sales of molnupiravir under this agreement for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.

Charles Gore, MPP, executive director, said, "The interim results for molnupiravir are compelling and we see this oral treatment candidate as a potentially important tool to help address the current health crisis. This transparent, public health-driven agreement is MPP’s first voluntary license for a COVID-19 medical technology, and we hope that Merck’s agreement with MPP will be a strong encouragement to others."

Frank Clyburn, executive vice president and president of Human Health, Merck, said, "Merck’s mission to save and improve lives is a truly global commitment. This agreement with MPP is another important element in our multi-faceted strategy to accelerate broad, affordable access to molnupiravir, if approved or authorized, for patients no matter where they live, including in countries where governments face greater challenges to finance healthcare."

Dr. Philippe Duneton, executive director, Unitaid, co-lead of the ACT-A Therapeutics Pillar, said, "Effective, easy to administer, oral treatments that can help to reduce the risk for progression to severe illness may be an important tool to help get the pandemic under control. We encourage further efforts in voluntary licensing to ensure that people in low- and middle-income countries can access COVID-19 treatments once authorized by WHO or a stringent regulatory authority."

Molnupiravir was invented at Emory University and licensed to Ridgeback Biotherapeutics by Drug Innovation Ventures at Emory (DRIVE), LLC, which was formed by Emory to advance the development of early-stage drug candidates for viral diseases of global concern. Emory received research funding from the U.S. Defense Threat Reduction Agency and the U.S. National Institute of Allergy and Infectious Diseases.

Gregory L. Fenves, president, Emory University, said, "The license for molnupiravir to the Medicines Patent Pool will support global public health and address unmet medical needs – reflecting Emory’s mission to serve humanity. Innovative research and collaboration across organizations have been vital in the fight against COVID-19."

Wendy Holman, chief executive officer, Ridgeback Biotherapeutics, said, "We are pleased to collaborate with MPP to ensure that quality-assured generic versions of molnupiravir can be developed and distributed quickly following regulatory authorization. This agreement is another great example of how partnerships and collaboration can do more to address global health challenges than any organization could do on its own."

Merck and Ridgeback Biotherapeutics recently announced the submission of an Emergency Use Authorization application for molnupiravir to the U.S. Food and Drug Administration and are actively working with additional regulatory agencies worldwide. If authorized, molnupiravir could be the first oral antiviral medicine available for COVID-19 therapy. The submission is based on positive results from a planned interim analysis of the Phase 3 MOVe-OUT study, a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild-to-moderate COVID-19 and at least one risk factor for progression to severe disease or death. Additionally, Merck announced the European Medicines Agency has initiated a rolling review for molnupiravir for the treatment of COVID-19 in adults.

Access the license agreement.

MPP invites Expressions of Interest (EoI) from potential sublicensees based anywhere in the world for sublicenses to manufacture and sell molnupiravir in the licensed territory:

Access the EoI portal
More information about the EoI process
About Molnupiravir

Molnupiravir (MK-4482 and EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants.

Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. For more information, please visit View Source