On March 9, 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 new data for its product candidate LP-100 supporting the development of LP-100 in combination with the class of anticancer agents known as PARP inhibitors (PARPi) (Press release, Lantern Pharma, MAR 9, 2023, View Source [SID1234628483]).

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In prostate cancer mouse xenograft studies, LP-100 demonstrated synergistic potency when used in combination with the FDA-approved PARP inhibitor Olaparib. LP-100 also demonstrated synergy with the FDA-approved PARP inhibitors Olaparib, Rucaparib, and Niraparib in ovarian cancer cell line studies. The observations from these studies are further supported by in-silico evaluation of LP-100 in combination with PARP inhibitors using Lantern’s AI platform, RADR.

"The combined anti-tumor potency of LP-100 in combination with PARP inhibitors, strongly supports the pursuit of this development pathway for LP-100," stated Panna Sharma, Lantern’s President and CEO. "We also believe this development focus will enhance the potential to position LP-100 in earlier lines of therapy, while also opening the door to pursue treatment indications with larger market sizes," continued Sharma. "Exposure to LP-100 results in double-strand DNA breaks and PARP inhibitors prevent the repair of these types of breaks. We believe this mechanistic combination provides a potent and highly synergistic method to eradicate tumors."

LP-100 and PARP inhibitors act by complementary mechanisms. LP-100 acts by a synthetically lethal mechanism of action that preferentially damages DNA in cancer cells lacking nucleotide excision repair (NER) capabilities. Sensitivity to LP-100 is also higher in tumors with homologous recombination repair (HRR) deficiency, suggesting that this pathway is also involved in the repair of DNA damage from LP-100. PARP inhibitors have been shown to be effective in the treatment of tumors with HRR deficiencies. Lantern believes the simultaneous exploitation of both these mechanisms will enhance the development opportunities for LP-100, while also expanding potential market opportunities for existing PARP inhibitors.

LP-100 has previously been in a genomic signature guided Phase 2 clinical trial in Denmark where the drug candidate was used without PARP inhibitors for patients with metastatic castration-resistant prostate cancer (mCRPC). In this trial 9 patients (out of a targeted enrollment of 27) were treated and had a median overall survival (OS) of approximately 12.5 months, which is an improvement over other similar fourth-line treatment regimens for mCRPC.

"Based on these results, the synergies of LP-100 with PARPi, along with the increasingly narrow field of patients in mCRPC due to the emergence of radio-ligand based therapies, we believe that the positioning of LP-100 in an earlier and more genomically defined setting is the best use of our resources and can lead to improved patient outcomes," continued Sharma.

In conjunction with its evaluation work on LP-100 with PARP inhibitors, Lantern has been collaborating with the Danish Cancer Society Research Center (DCSRC) to explore the future clinical potential of LP-100 across 9 different solid tumor types that have known deficiencies in DNA repair pathway mechanisms. This work has included an examination of the role of NER deficiency in breast, ovarian, prostate, lung, kidney, bladder, stomach, pancreatic, and esophageal cancers, with the aim of identifying the most promising patient populations for future LP-100 therapy. Lantern expects to present additional details on the results of its collaboration with DCSRC later this year.

Based on Lantern’s evaluation of the synergies of LP-100 with PARP inhibitors, and the industry’s development of entirely new classes of radio-ligand based therapy for mCRPC, the decision has been made to close the Phase 2 clinical trial in Denmark, to allow the focus of LP-100-directed resources on positioning the molecule for development in earlier lines of therapy with potentially larger market opportunities. Earlier line treatment indications where Lantern believes LP-100 in combination with PARPi could have potential future treatment benefits include prostate cancer indications such as HRR gene-mutated metastatic castration-resistant prostate cancer, ovarian cancer indications such as first line platinum-responsive advanced ovarian cancer, and breast cancer indications such as germline BRCA-mutated metastatic breast cancer. The total U.S. market size of these and other potential target development indications for the LP-100 and PARPi combination is estimated at between $700 million and $2 billion.

On March 9, 2023 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported its financial results and provides an update on operational progress for the fourth quarter and year ended December 31, 2022 (Press release, Summit Therapeutics, MAR 9, 2023, View Source [SID1234628482]).

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Operational & Corporate Updates

Our Collaboration and License Agreement with Akeso Inc. ("Akeso") for ivonescimab:
On December 5, 2022, Summit and Akeso entered into a Collaboration and License Agreement for ivonescimab, Akeso’s breakthrough, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.
Summit received the rights to develop and commercialize ivonescimab (SMT112) in the United States, Canada, Europe, and Japan. Akeso retained development and commercialization rights for the rest of the world, including China.
In exchange for these rights, Summit committed to an upfront payment of $500 million to be paid in two installments.
The first installment worth $300 million was paid in January in conjunction with the closing of the transaction. Of the $300 million paid to Akeso by Summit, Akeso opted, in accordance with the Collaboration and License Agreement, to receive 10 million shares of Summit common stock valued at $25.1 million; the remaining $274.9 million was paid by Summit to Akeso in cash.
The second installment of $200 million was paid on March 6, 2023 in cash.
Going forward, Akeso will be eligible to receive regulatory and commercial milestones of up to $4.5 billion. In addition, Akeso will receive low double-digit royalties on net sales in the Summit territories.
Summit is initiating development activities for SMT112 and will do so first in non-small cell lung cancer (NSCLC) indications. Summit intends to start treating patients in clinical studies during the second quarter of 2023.
Summit is in communication with and has planned multiple meetings with health authorities, including the US Food & Drug Administration ("FDA") in order to align on our approach for multiple potential late-stage trials for SMT112.
The deal closed on January 17, 2023 following customary waiting periods. At this time, Michelle Xia, Ph.D., Co-Founder, Chairwoman, and CEO of Akeso, was appointed to our Board of Directors.
Dr. Xia has exceptional experience in leadership across scientific discovery, R&D, building and scaling manufacturing, and overall leadership through her experience at companies in the US. Prior to founding Akeso, Dr. Xia held roles of increasing leadership at Celera Genomics, Bayer, and Crown Biosciences. Dr. Xia has approximately 20 years of experience in the pharmaceutical industry and academic research in the US and the UK alone, in addition to her deep experience in China leading Akeso.
Akeso has a rich and diversified antibody drug pipeline with over 30 internally discovered drug candidates in various stages of development, including six bispecific antibodies. Akeso has taken part in over 80 clinical trials for 17 drug candidates, including 14 pivotal trials. Akeso has two drugs approved for oncology indications in China: a PD-1 inhibitor, and novel PD-1 / CTLA-4 bispecific antibody. Akeso has over 2,300 employees.
In October 2022, we announced the appointment of renowned biotech executive and scientific leader, Dr. Robert Booth, PhD, to our Board of Directors. Dr. Booth initiated the BTK inhibitor program at Celera Genomics, Inc. that ultimately became Pharmacyclics, Inc.’s IMBRUVICA (ibrutinib), the blockbuster drug that changed the paradigm of treatment for many hematological cancers. In addition to his scientific breakthrough discoveries, Dr. Booth was an adjunct professor at Stanford University School of Medicine. He is the co-founder of CuraSen Therapeutics and its former Executive Chairman, and was the co-founder and CEO of Virobay Inc. in addition to his previous role as a Senior Vice President at Roche. Dr. Booth previously served on the boards of Pharmacyclics and CymaBay Inc.
In November 2022, we appointed experienced clinical leader, Dr. Alessandra Cesano, MD, to our Board of Directors. Dr. Cesano is the Chief Medical Officer (CMO) at Essa Pharma Inc. (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer. Previously, she was the CMO at NanoString Inc. and Cleave Biosciences. She has 25 years of experience in the biopharmaceutical industry focused in oncology, including extensive experience at Biogen, Amgen, and GSK. She was instrumental in the development and approval of two marketed drugs including Vectibix (panitumumab), an anti-EGFR antibody for the treatment of certain colorectal cancers. Dr. Cesano currently serves on the board of Puma Biotechnology Inc. (NASDAQ: PBYI), a clinical stage oncology company focused on solid tumors.
Financial Highlights

Aggregate cash and cash equivalents, restricted cash, accounts receivable, and tax credits receivable on December 31, 2022 totaled $654.7 million as compared to $89.0 million on December 31, 2021. Our cash and cash equivalents and restricted cash balance on December 31, 2022 was $648.6 million as compared to $71.8 million on December 31, 2021. Accounts receivable and research and development tax credits receivable on December 31, 2022 were $6.1 million as compared to $17.2 million on December 31, 2021.
Net loss for the three months ended December 31, 2022 and 2021 was $19.2 million and $27.1 million, respectively. Net loss for the year ended December 31, 2022 and 2021 was $78.8 million and $88.6 million, respectively.
Operating cash outflow for the year ended December 31, 2022 and 2021 was $41.6 million and $72.6 million, respectively.
On December 6, 2022, the Company entered into a Note Purchase Agreement with the Company’s Chairman and CEO, Robert W. Duggan, and the Company’s Co-Chief Executive Officer, President, and a member of the Company’s Board of Directors, Dr. Maky Zanganeh, in the aggregate amount of $520.0 million. Interest due and payable through February 15, 2023 was prepaid in shares of the Company’s common stock.
On February 15, 2023, Dr. Zanganeh’s $20.0 million note became due and the Company repaid the outstanding principal balance.
On December 6, 2022, the Company announced a Rights Offering for its existing shareholders to participate in the purchase of additional shares of its common stock. The Rights Offering commenced on February 7, 2023, and the associated subscription rights expired on March 1, 2023. Through the fully subscribed Rights Offering, the Company raised $500.0 million in gross proceeds through the issuance and sale of 476.2 million shares of its common stock at a price per share of $1.05. Issuance costs associated with the Rights Offering were approximately $0.5 million, resulting in net proceeds of approximately $499.5 million.
In connection with the closing of the rights offering, a $400 million note payable with Mr. Duggan, matured and became due, and the Company repaid all principal and accrued interest of $401.3 million using a portion of the proceeds from this Rights Offering.
Based on our current cash balance, including the net proceeds received from our Rights Offering, repayments of certain notes, and payments to Akeso in accordance with our Collaboration and License Agreement during the first quarter of 2023, we believe that we have sufficient capital resources to fund our operating costs and working capital needs, including our planned clinical trials for ivonescimab, into the second half of 2024.
After accounting for the information described above, as of February 28, 2023, we have a current aggregate cash and cash equivalents, accounts receivable, and tax credits receivable balance of approximately $240 million, inclusive of approximately $100 million in notes payables due in September 2024.
Q4 and Year-end 2022 Earnings Call

Summit’s management team will host an earnings call to discuss its fourth quarter 2022 financial results and provide an operational update for the Company today, March 9, 2023, at 9:00am ET. It will be accessible through Summit’s website www.smmttx.com or through the following link: View Source An archived version of the webcast will be available on our website.

On March 9, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), reported it has signed an agreement with the University of Iowa (UI) Pharmaceuticals for formulation development and clinical batch manufacture of drug capsules of Ropidoxuridine (Press release, Shuttle Pharmaceuticals, MAR 9, 2023, View Source [SID1234628481]). This is expected to be the final step required in the drug manufacturing process for use in Shuttle Pharma’s upcoming Phase II clinical trial evaluating Ropidoxuridine in combination with radiation therapy for the treatment of glioblastoma.

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Shuttle Pharma has worked with TCG GreenChem, Inc. to complete the campaign to manufacture 25 kg of the drug product for Ropidoxuridine, and approximately 10,000 capsules, to complete the Phase II trial. Shuttle Pharma is preparing the Investigational New Drug application for the study with an expectation of final submission to the FDA at the end of the second quarter of 2023.

UI Pharmaceuticals is a university-affiliated CDMO offering pharmaceutical product development, manufacturing (sterile and non-sterile products), and analytical services. As an FDA-registered Drug Product Manufacturing and Testing Facility, UI Pharmaceuticals can produce and test products intended for both clinical studies and commercial sales.

"We continue to execute on the necessary steps to advance Ropidoxuridine, our lead clinical sensitizer drug candidate, towards the commencement of our upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy," commented Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. "We look forward to working with TCG GreenChem and UI Pharmaceuticals going forward to advance our clinical work."

Shuttle Pharma’s platform of sensitizers offers a pipeline of product candidates designed to address the urgent clinical need for new radiation sensitizer agents. The Company’s pipeline includes Ropidoxuridine, its lead clinical sensitizer drug candidate, to sensitize rapidly growing cancer cells and selective histone deacetylase inhibitors to sensitize cancer cells and stimulate the immune system. In addition, the Company has also pursued research related to the development of human cell cultures for health disparities studies and predictive biomarkers of radiation responses and late effects through awards received from the National Institutes of Health’s National Cancer Institute for Phase I and II Small Business Innovation Research contracts.

More than 800,000 patients are treated with radiation therapy for their cancers in the US on a yearly basis. According to the American Society of Radiation Oncologists, about 50% are treated with curative intent and the balance for palliative care. The market opportunity for radiation sensitizers lies with the 400,000 patients treated with curative intent.

On March 9, 2023 PathAI, a global leader in AI-powered pathology, reported the launch of AISight, PathAI’s digital pathology platform, and the AIM-PD-L1 NSCLC RUO algorithm1, which quantitates the percent of PD-L1 positive tumor and immune cells in non-small cell lung cancer (NSCLC) samples across the whole slide image (WSI), in 13 leading academic medical centers, health systems, reference laboratories, and independent pathology organizations across the United States (Press release, PathAI, MAR 9, 2023, View Source [SID1234628480]). These organizations are part of PathAI’s Early Access Program to gather real-world evidence about the use of digital pathology tools to advance precision medicine for the benefit of patients around the world.

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"We’re pleased to bring our technology and the advantages of a digital pathology workflow directly to some of the country’s leading laboratories," said Andrew Beck, MD, PhD, co-founder and CEO of PathAI. "This network of laboratories will serve as pioneers in transforming anatomic pathology and will be the first to access PathAI’s extensive and growing menu of algorithm products across oncology and non-oncology indications."

AISight is a digital pathology platform that was designed with input from more than 200 pathologists and can be used by physicians, academic institutions, biopharma companies, and CROs to support AI-driven research. The AIM-PD-L1 NSCLC RUO algorithm was built using a series of convolutional neural networks, each trained on a diverse real-world dataset consisting of more than 5,000 samples with inputs from 350,000+ cell and tissue-level annotations from 50+ pathologists. The algorithm analyzes NSCLC surgical specimens stained with any of the four major clones and provides quantification and visualizations of PD-L1 positivity on tumor and immune cells for use in immune oncology research applications.

"We recognize the benefits that digital pathology will provide to pathologists, oncologists and other clinicians, but there are still barriers to its adoption that need to be overcome such as cost and confidence in algorithm performance," said Douglas Hartman, MD, Vice Chair of Pathology Informatics at The University of Pittsburgh Medical Center (UPMC), a world-renowned health system headquartered in Pittsburgh, Pennsylvania that operates 40 hospitals and more than 700 doctors’ offices and outpatient centers. "PathAI has a deep understanding of these obstacles, as shown by their significant investment in creating a simple and intuitive user interface to easily interpret the outputs of their algorithms. We’re pleased to be part of this first cohort of leading institutions to help advance the understanding and use of this technology."

PathAI previously published validation data for the AIM-PD-L1 NSCLC Algorithm that was presented at the 2022 AACR (Free AACR Whitepaper) Annual Meeting. As part of the AISight Early Access Network, participating laboratories will be building on this work to test the performance of the AIM-PD-L1 NSCLC algorithm on real-world data. These labs will also be able to access a suite of additional immunohistochemistry (IHC) quantitation algorithms across Breast Cancer, Urothelial Carcinoma, Head and Neck Squamous Cancer, and Melanoma. PathAI has previously published data in Modern Pathology highlighting the potential for AI-powered PD-L1 algorithms to identify more patients who would benefit from treatment with immuno-oncology therapy compared with current guidelines using manual assessment.

"As a leader in precision medicine and digital pathology, PathGroup is committed to transforming patient care and providing our clients with cutting-edge technology," stated Derek Welch, MD, FCAP, Chief Medical Officer of Anatomic Pathology at PathGroup, one of the largest independent anatomic pathology laboratories in the United States serving more than 200 hospitals and 15,000 referring physicians. "Our partnership with PathAI allows us to deploy their AI-powered algorithms in our work to enhance our industry-leading efficiency and accuracy and improve outcomes for the patients who are at focus of everything we do."

Reference Laboratories

Caris Life Sciences (National)
NeoGenomics Laboratories (National)
TriCore Inc. (New Mexico)
Independent Pathology Laboratories

Celligent Diagnostics (North and South Carolina)
PathAI Diagnostics (National)
PathGroup (National)
Academic Medical Centers & Health Systems

Baylor Scott & White Health (Texas)
Cleveland Clinic (Ohio)
Inova Health (Virginia)
Medstar Health (District of Columbia)
Penn State Health (Pennsylvania)
SUNY Upstate Medical University (New York)
University of Pittsburgh Medical Center (Pennsylvania)
To learn more about PathAI, AISight, and the AIM-PD-L1 NSCLC Algorithm, stop by Booth #639 at USCAP or register for an upcoming webinar on March 22nd, 2023. For more information regarding the AISight Early Access Network, please contact [email protected].

On March 9, 2023 Servier, a global pharmaceutical group, reported it has entered into a strategic partnership with QIAGEN, a leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life, to develop a companion diagnostic test that detects IDH1 mutations (Press release, Servier, MAR 9, 2023, View Source [SID1234628479]). This test will be for use with Servier’s marketed and investigational targeted treatments in Acute Myeloid Leukemia (AML).

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QIAGEN and Servier are collaborating to develop a PCR-based companion diagnostic test that can be used to rapidly identify AML patients with IDH1 gene mutations. This partnership comes in the light of the published pivotal clinical phase 3 data of the AGILE study which showed that ivosidenib in combination with azacitidine as a first-line treatment for intensive chemotherapy ineligible AML patients with IDH1 gene mutations shows superior results compared to treatment with azacitidine alone.1 The partnership with QIAGEN will lead to the development of a specific diagnostic test for IDH1 gene mutations with a rapid turnaround time.

Brian Lockhart, Global Head of Companion Diagnostics at Servier, said: "In order to expand the global access for ivosidenib for patients, it is imperative that we leverage a partner such as QIAGEN with an established global footprint in oncology-driven diagnostics, and a proven expertise in companion diagnostics development and approvals."

Jonathan Arnold, Vice President, Head of Partnering for Precision Diagnostics at QIAGEN, said: "We are pleased to support Servier with a companion diagnostic in their mission to propose innovative treatment for IDH1 mutated AML patients. At the same time, we are further strengthening our role in developing companion diagnostics for the ever-growing number of biomarkers being discovered in onco-hematology."

Under the Master Collaboration Agreement, QIAGEN will develop and validate a real-time PCR-based in vitro diagnostic test that can be used to detect IDH1 gene mutations in whole blood and bone marrow aspirates in AML.

The companion diagnostic will run on the QIAGEN Rotor-Gene Q MDx device, which is widely used by labs worldwide. QIAGEN’s experienced regulatory teams will support clinical validation of the companion diagnostic and its approval in the US, the European Union and Japan.

Fabien Schmidlin, Global Head of Translational Medicine at Servier, concluded: "Early biomarker testing for an IDH1 mutation has grown in importance for targeted therapies and can play a critical role in the treatment of acute myeloid leukemia (AML). This partnership with QIAGEN will help us further our mission to improve outcomes for patients with AML who test positive for an IDH1 mutation in both the relapsed/refractory and newly diagnosed intensive chemotherapy ineligible setting and for investigational purposes in AML patients in the front-line setting."

Press contact

Sonia Marques (France): [email protected] I Tel. +33 (0)1 55 72 40 21
Julia Ferreira (U.S.): [email protected] I Tel. 857 262 3852