On November 19, 2020 Lantern Pharma reported that it has reached a significant milestone by surpassing one billion curated data points on its RADR platform, a total it believes is the most amassed by any company in the biotech sector (Press release, Lantern Pharma, NOV 19, 2020, https://www.ddw-online.com/lantern-pharma-ai-platform-milestone-will-cut-cost-time-and-risk-in-developing-new-drug-therapies-8292-202011/#new_tab [SID1234571458]). The milestone, which was reached well ahead of schedule, enables new opportunities in Lantern’s work to identify and suggest combination cancer therapy programs, and the ability to compare and contrast biomarker signatures generated by a variety of machine learning algorithms.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The significance of one billion data points provides Lantern Pharma the opportunity to transform the pace, risk, and cost of oncology drug discovery and development. Current failure rates and prolonged processes have led to high developmental costs that are not sustainable for cancer patients. Utilising the RADRplatform, one billion data points brings real-world oncology data together with large-scale biomarker analytics to establish a sustainable route in oncology drug development.

The one billion data points are composed of genomic, transcriptomic and drug sensitivity data points that have been curated from both Lantern’s internal studies as well as relevant published studies and cancer datasets. These data points collected on the RADR platform allow Lantern to predict combinations of drugs that can be used together, such as Lantern’s pipeline of drug therapies, an existing drug already on the market, or an existing drug with a new type of compound that can improve efficacy in cancer patients.

"Since our IPO in June, our proprietary RADR platform has quadrupled its collection of curated data points and allowed us to meet our goal a year ahead of schedule," said Panna Sharma, CEO of Lantern Pharma. "Our growing AI platform will be pivotal in uncovering potential new therapeutic opportunities and developing insights into the creation of combination-therapy programs."

Achieving more than one billion data points in RADR enables Lantern to reduce the timeline in identifying new cancer therapies and in discovering how existing compounds can be aimed at the right subtypes of cancer. This is a process that can typically take years, but now, with large scale data and powerful new algorithms this process can be cut down to weeks. The growth in data points also positions Lantern for increased research activity in key cancer indications that the company is pursuing, including glioblastoma, lung cancer, prostate cancer, pancreatic cancer, and most recently, ovarian cancer. In fact, RADRis already beginning to predict how Lantern’s drugs will work with these types of cancer. The one billion, and counting, data points have saved months of time for Lantern’s team in understanding how their targeted therapies could be used with cancer patients.

The RADR platform has already provided Lantern with their three current drug compounds as well, where genomics and data-driven methods have been used to refine and accelerate the development process. These include: LP-100 in a Phase II trial for the treatment of metastatic, hormone-refractory prostate cancer (MHRPC) which is partnered with an European biotech; LP-300 which is preparing to enter into a Phase II trial for non-small cell lung cancer (NSCLC) as a combination therapy; and LP-184 which is in preclinical development for genomically-defined cancers, including prostate, pancreatic and glioblastoma multiforme (GBM).

On November 19, 2020 IntraOp Medical Corporation and the University of Verona in Italy reported the enrollment of the first patient in the PancFORT Trial: A phase II study of primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma (Press release, IntraOp Medical, NOV 19, 2020, View Source [SID1234571454]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Globally, over 460,000 patients are diagnosed with pancreatic cancer every year. Approximately 30% of those patients are diagnosed as having borderline resectable disease with an expected five-year survival rate of less than 15%.

The Pancreas Institute of the University of Verona is a world-renowned center of excellence for the treatment of pancreatic cancer with a dedicated multidisciplinary team that includes Gastroenterologists, Radiologists, Pathologists, and Oncologists. The General and Pancreatic Surgery Unit is led by Professor Claudio Bassi, MD, FRCS, FACS, FEBS, FASA (Hon.) and comprises a team of surgeons highly experienced in the treatment of all the inflammatory and neoplastic diseases of the pancreas, with a yearly operative caseload exceeding 400 pancreatic resections.

The PancFORT Trial is a prospective clinical trial led by principle investigators Salvatore Paiella, MD, PhD and Giuseppe Malleo, MD, PhD, that will explore the clinical benefits of delivering IORT in patients who’ve been diagnosed with borderline resectable pancreatic cancer and have undergone "total neoadjuvant" treatment including FOLFIRNOX and SBRT with a primary endpoint of three-year disease-specific survival. With the addition of electron beam IORT, the researchers anticipate the escalated dose will potentially improve survival with reduced likelihood of local recurrences and minimal side effects to the patients.

"Despite recent improvements in oncologic treatments, the prognosis for patients diagnosed with borderline resectable pancreatic cancer remains quite poor." stated Professor Claudio Bassi, MD, Chairman of the Surgery Unit of the Pancreas Institute of the University of Verona in Italy. "However, based on early results from PREOPANC trial, we see a promising opportunity to further improve clinical outcomes by combining a total neoadjuvant approach with an ablative dose of electron IORT delivered after resection or as an in situ treatment."

"The overall radiotherapy dose administered in this study corresponds to an ablative biologically effective dose, which could significantly increase the tumor local control rate and finally improve patients’ survival." stated Renzo Mazzarotto, MD, PhD, Chairman of the Radiation Oncology Department at the University Hospital of Verona, "Moreover, for patients whose tumors are determined to be not operable at the time of surgery, delivering IORT as in situ treatment could prevent possible disorders related to tumor progression, such as pain, duodenal/stomach infiltration and bleeding, thus improving patient’s quality of life."

"We are honored to be joining forces with Professor Bassi, Dr Mazzarotto, Drs Paiella and Malleo, and the rest of the team at the University Hospital of Verona to bring new treatment options to patients suffering from pancreatic cancer," said Derek T. DeScioli, Chief Executive Officer of IntraOp Medical Corporation. "As one of the most experienced and innovative pancreatic centers in Europe, they are a perfect partner for advancing the science and clinical evidence supporting the role of IORT in treating this dreadful disease. We look forward to the ongoing collaboration."

On November 19, 2020 NeoDynamics AB (publ, (Spotlight Stock Market: NEOD), a MedTech company dedicated to advancing diagnosis and care of breast cancer, reported that the Company has received the first UK order from the Buckinghamshire Healthcare NHS Trust, London, of its pulse biopsy system, NeoNavia (Press release, NeoDynamics, NOV 19, 2020, View Source [SID1234571453]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Product demonstrations at several centres have gained significant interest, and the company has now received the first commercial order of its pulse biopsy system including three needle options for all ultrasound led biopsy procedures. The UK team of NeoDynamics has managed to introduce physicians at key centres to the new pulse biopsy system, despite the difficulties to accessing hospitals and key staff following the pandemic.

"The first order of NeoNavia from a London based Hospital Trust is an important milestone for NeoDynamics, and we will be working closely with the centre to ensure a timely delivery and successful use. The consolidated feedback from the physicians who have participated in hands-on workshops, is very positive. Our long-term goal by introducing the pioneering pulse biopsy technology for ultrasound guided biopsy in breast and axilla is to advance the way biopsies are taken and ultimately improve patient outcomes. Over time, we believe that the versatile pulse biopsy system could transform standard practice", says Ian Galloway, Country Manager UK & Ireland, Neodynamics,

The information in this press release is information that NeoDynamics is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above on November 19, 2020 at 08.44 (CET).

Breast cancer in UK

Breast cancer is the most common cancer among women in the UK. With around 55,000 cases, it represented 15% of all new cancer cases in 2017. It is critical that new biopsy technologies can offer a controlled way for lesion targeting as well as accurate and reliable diagnosis through high quality tissue samples.

On November 19, 2020 NeoDynamics AB reported that (publ) Third Quarter 2020 (Press release, NeoDynamics, NOV 19, 2020, View Source [SID1234571452])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The proposed financing strengthens NeoDynamics ahead of pivotal period

Third quarter 2020

There were no sales during the period. Revenue amounted to SEK 2.643 m (4.581 m) including capitalized costs of SEK 2.051 m (4.469 m).
Loss after tax amounted to SEK -6.731 m (-4.416 m).
Loss per share amounted to SEK -0.19 (-0.29).
9 months 2020

There were no sales during the period. Revenue amounted to SEK 15.175 m (16.329 m), whereof capitalized costs SEK 14.140 m (16 214 m).
Costs for product development contuned to be higher than expected.
Loss after tax amounted to SEK -18.011 m (-12.498 m).
Loss per share amounted to SEK -0.71 (-0.82).
Equity per share was SEK 2.52 (3.63 at year-end).
Equity ratio was 94 (60 per cent at year-end)
Significant events during the third quarter

Reference centers established in Germany to support the introduction of the new pulse biopsy system NeoNavia and optimize the diagnosis of breast cancer.
An Extraordinary General Meeting on 13 August resolved on an incentive program for employees with a maximum of 1,021,900 warrants, where each warrant entitles to subscribe to one new share at SEK 4.71 per share during the period 1 Aug – 30 Sep 2023.
The directed share issue of 2,561,339 shares, SEK 7,684,017 announced in April, was registered with the Swedish Companies Registration Office in September. Hence, the share capital is SEK 3,600,695.10 distributed on 36,006,951 shares.
In September, the NeoNavia biopsy system was very well received at the international senology congresses in Vienna and Lucerne, and for the first time, physicians gained practical experience of the finished product.
Significant events after the period

An Extraordinary General Meeting on November 19 will resolve on a directed share issue to a limited group of investors. The subscription price in the share issue is proposed to be SEK 3.71 per share and was determined through an accelerated bookbuilding procedure. The share issue can provide the company with close to SEK 90 million before transaction costs.
On November 2, the company announced that its CFO, Jörgen Vrenning, has decided to leave the company after eight years to retire. Jörgen will continue in an advisory role until the end of May 2021 to ensure a smooth transition.
The company joined a scientific partnership to evaluate the NeoNavia pulse biopsy system for knee and bone tissue sampling in a new potential indication, osteoarthritis.
Neodynamics gets first order for the pulse biopsy system NeoNavia from the Buckinghamshire Healthcare NHS Trust, London.
CEO’s comments

Proposed new financing strengthens NeoDynamics ahead of pivotal period

During the autumn, the Board discussed various ways to strengthen the company’s cash flow in order to be able to carry out the forthcoming market introduction of NeoNavia in a successful manner. These discussions, which have also involved the company’s main owners, led to the Board’s proposal for a directed issue of approximately SEK 90 million. The company’s owners will decide on the matter at an extraordinary general meeting on 19 November. The share issue provides much-needed room for manoeuvre to create value. The Board’s assessment is that the funding benefits both old and new shareholders.Through the proposed raising of capital, the ownership circle will be expanded with competence and experience in MedTech, a significant stamp of quality for a company such as NeoDynamics The Dutch investment firm Nyenburgh and Swedish Cardeon Futuring Finance have thoroughly analysed the company prior to investing in NeoDynamics. Both appreciate the solid preparation for the launch of NeoNavia, and state it as one of the most important reasons why they have chosen to invest in NeoDynamics.

First order

NeoNavia is now launched in the UK, Germany and Sweden, somewhat delayed compared to plan as the announced product development dragged on and the pandemic further delayed the project in the critical verification and validation phase. Covid-19 currently also limits the possibility of physical meetings on site with radiologists, but many activities are now underway thanks to our specialist sales staff in the UK, Germany and Sweden.It is gratifying to note that after a short introduction, the first centre in the UK was able to place an order. A strong symbolism that we are now up and running. Other centres will want to follow suit.The cancer area remains a priority in hospitals and there is a backlog when it comes to caring for breast cancer patients. Our studies have familiarized doctors with our product and built knowledge on how to use it. This provides benefits when NeoNavia now becomes commercially available.Due to the pandemic, the study in the UK has not been able to be conducted normally and therefore we are expanding with more centres for faster results that can be used in sales work.

The United States is the next step

Work on our registration application to the Federal Drug Administration (FDA) is ongoing, as is the dialogue with the authority. We expect to submit the documentation at the beginning of 2021, in order to get the go-ahead to start selling NeoNavia in the USA during the year as well. Covid-19 has led to the closure of several states where we have planned user tests with American physiciansThe work in the USA also lays the foundation for the regulative application in China, which is next on the agenda. We will also perform a local study in China to get a strong basis, both in the dialogue with the authority and with future customers in the Chinese market.

Scale up of production

The company works continuously to optimize its production processes to keep manufacturing costs at a level that enables a long-term good profit margin. We have been collaborating for just over a year with a well-established FDA-approved Thai manufacturer who, together with us, is preparing the transfer of our disposable probes (needles) to serial / commercial production. The first delivery is expected to take place in mid-2021. Until then, the company’s Swedish partner Sanmina in Örnsköldsvik will be used, which will continue to manufacture the reusable system parts (base unit and driver) which are built with a significantly larger technical content.Finally, we have recently started an international research collaboration to evaluate the NeoNavia pulse biopsy system for knee and bone tissue sampling in osteoarthritis, which is also a large indication. Here we collaborate with William Hunter Revisited, a research consortium consisting of six universities as well as academic hospitals, which specialize in osteoarthritis. We know that our pulse technology is attractive to develop in other indications as well, which we have confirmed by being approached by this research team

NeoDynamics is finally on its way to the market. We look forward to in-depth relationships with cancer clinics in Europe, to roll out NeoNavia in the US and to receive feedback on how the products will be received by doctors and patients.

CEO Anna Eriksrud

The information was submitted for publication through the agency of the contact person set out below, at 08:55 CET on November 19, 2020

On November 19, 2020 Phosplatin Therapeutics LLC, a clinical stage pharmaceutical company focused on oncology therapeutics, reported that data from a Phase I Dose Escalation Study of its lead candidate PT-112, an immunogenic cell death (ICD) inducer, in patients with relapsed or refractory multiple myeloma will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place virtually from December 5-8, 2020 (Press release, Phosplatin, NOV 19, 2020, View Source [SID1234571451]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Title:

A Phase I Dose Escalation Study of PT-112 in Patients with Relapsed or Refractory Multiple Myeloma

Abstract availability:

Saturday, December 5 through Monday, December 7, 2020, from 7:00 a.m. to 3:30 p.m. (Pacific Time), on the ASH (Free ASH Whitepaper) Annual Meeting and Exposition site and the Phosplatin Therapeutics web site

Session:

653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster I

Lead Author:

Taxiarchis Kourelis, M.D., Division of Hematology, Assistant Professor of Medicine, Mayo Clinic College of Medicine Rochester, Minnesota

Under this year’s virtual meeting format, Dr. Kourelis will present a pre-recorded, narrated slide presentation on the multi-center dose escalation study of PT-112 in multiple myeloma patients who are relapsed or refractory to available therapy (NCT03288480). The study was designed and launched following non-clinical work conducted in the Cancer Genetics Laboratory of P. Leif Bergsagel, M.D. at the Mayo Clinic in Scottsdale, Arizona.

About PT-112

PT-112 is a novel small molecule conjugate of pyrophosphate that possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents the best-in-class small molecule inducer of this immunological form of cancer cell death and is currently under Phase II development. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase Ib study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress. The Phase I study in patients with relapsed or refractory multiple myeloma to be presented at ASH (Free ASH Whitepaper) is the third completed Phase I study of PT-112.