On January 18, 2022 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 and research agreement with The Danish Cancer Society Research Center (DCRC) to support clinical development of Lantern’s acylfulvene class drug candidates, LP-100 and LP-184, as well as the development of improved diagnostic methods to identify nucleotide excision repair (NER) deficient tumors (Press release, Lantern Pharma, JAN 18, 2022, View Source [SID1234605540]). LP-100 and LP-184 have both shown synthetically lethal impact in tumors that are lacking NER capabilities. The DCRC is a cancer research institute within the Danish Cancer Society. The Danish Cancer Society is Denmark’s largest non-government organization and dedicates more than 60% of its budget to research, with the remainder shared between prevention and patient support initiatives. Lantern expects the data, genomic signatures and biological models generated from this collaboration to add millions of data points to RADR and help accelerate the development of new indications for LP-100 and LP-184. This collaboration, together with the growing power of the RADR platform, can potentially uncover new drug combinations using LP-100 and LP-184 for cancer treatments at a fraction of the cost of traditional drug development.

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The overall aim of the collaboration is to determine the most promising patient populations for future LP-100 (irofulven) and LP-184 therapy. The collaboration will focus on developing improved diagnostic tools to detect NER deficiency patient profiles more accurately. The research study conducted as part of the collaboration will use expanded mutational signature-based analyses to achieve this objective. The study will include a comprehensive analysis of breast, ovarian, prostate, lung, kidney, bladder, stomach, pancreatic and esophageal cancer. This collaboration will help determine how many patients and which patients can benefit for targeting NER deficiency and also help assess the overall market size for both LP-100 and LP-184 across multiple solid tumors.

"Inherent DNA repair deficiencies characterize a subset of many of our common tumor types and are increasingly relevant as markers of therapeutic responses. The focus on defining NER deficiencies as a potential marker for irofulven use is in line with our strategies on drug repurposing as well as personalized oncology," says Mef Nilbert, medical oncologist and research director at the DCRC.

The collaboration research will be led by Dr. Zoltan Szallasi, MD as principal investigator at DCRC. Dr. Szallasi serves joint appointments as Group Leader of the Translational Cancer Genomics department at DCRC and as Faculty, Computational Health Informatics Program (CHIP) and Assistant Professor of Pediatrics at Boston Children’s Hospital affiliated with Harvard Medical School.

"Through our breakthrough approach of collaborating with internationally recognized research centers such as DCRC, we are able to leverage and grow our proprietary RADR A.I. platform with millions of additional data points to further our ability to rapidly discover biomarker signatures aimed at helping identify patients more likely to respond to cancer therapies, which we believe will significantly reduce development timelines and cost of treatment," commented Panna Sharma, CEO and President of Lantern Pharma Inc. "We are assembling a growing body of data supporting LP-184 and LP-100’s synthetic lethality to tumor cells with either NER or HR deficiency, and our collaboration with DCRC will further accelerate our path to clinical trials as well as provide opportunities for new trials and additional targeted indications."

LP-184 is a DNA-damaging small molecule drug candidate currently in preclinical development for certain genomically defined solid tumors, including pancreatic cancer and glioblastoma. As a next-generation acylfulvene class agent that preferentially damages DNA in cancer cells overexpressing certain biomarkers, LP-184 has the potential to be used as both monotherapy as well as a synergistic agent in combination with other drugs. LP-184 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of malignant gliomas, as well as pancreatic cancer.

LP-100 exploits cancer cells’ deficiency in DNA repair mechanisms. LP-100 has the potential to be an important compound — either as monotherapy or in combination — for several challenging cancers that are impacting patients globally. LP-100 is in an existing genomic-signature guided phase 2 clinical trial in Denmark for patients with metastatic castration resistant prostate cancer (mCRPC). 9 patients (out of a targeted enrollment of 27) have been treated in the trial. The median overall survival (OS) for the initial group of 9 patients has been approximately 12.5 months, which is an improvement over other similar fourth-line treatment regimens for mCRPC.

On January 18, 2022 Exact Sciences reported performance data for a second-generation Cologuard (multi-target stool DNA) test showing overall sensitivity of 95.2% for colorectal cancer (CRC) at specificity of 92.4% for negative samples confirmed by colonoscopy (Press release, Exact Sciences, JAN 18, 2022, View Source [SID1234605599]). Subgroup analyses showed 83.3% sensitivity for high-grade dysplasia, the most dangerous precancerous lesions, and 57.2% for all advanced precancerous lesions. These data will be presented January 22 at ASCO (Free ASCO Whitepaper) GI in a poster titled, "Second-generation Multi-target Stool DNA Panel Reliably Detects Colorectal Cancer and Advanced Precancerous Lesions."

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Cologuard is the first and only FDA-approved, non-invasive stool DNA test used to screen average-risk people for CRC. Exact Sciences is developing a second-generation Cologuard to improve the specificity and precancer sensitivity of the test, decreasing the false positive rate and increasing the detection rate of precancerous lesions. The study shows the potential of a highly discriminate panel of methylated DNA markers and fecal hemoglobin to accomplish both in a real-world setting. If approved, the second-generation Cologuard test could help increase screening rates while sending fewer people to follow-up colonoscopies unnecessarily and identifying more advanced precancers before they progress to cancer, helping prevent the disease.

"The Exact Sciences team is constantly innovating to help make earlier cancer detection a routine part of medical care," said Kevin Conroy, chairman and CEO. "These data demonstrate our commitment to patients and the power of our research and development teams, scientific platform, and expertise in colorectal cancer screening."

The study was carefully designed to simulate a true screening population and better predict real-world, prospective performance of the marker panel. It included non-advanced precancers, samples collected prospectively across all precancer types and sizes, and colorectal cancer samples weighted heavily towards early stages. The study consisted of 777 stool samples collected in the United States and Canada across 134 sites, including 112 cancers – 78% in stages I and II, 98 prospectively collected advanced precancerous lesions, 176 non-advanced precancerous lesions, and 391 negative controls.

"Exact Sciences and Mayo Clinic scientists worked together to discover these new methylation markers, which demonstrate improved performance over first-generation Cologuard markers," said Paul Limburg, MD, MPH, AGAF, Chief Medical Officer for Screening at Exact Sciences. "In particular, the observed increased specificity suggests that false positive screening results can be reduced, which has important implications for clinical practice and decision-making."

Colorectal cancer is the second deadliest cancer impacting both men and women in the United States. It’s also treatable if caught in early stages.1 Despite the benefits of CRC screening, approximately 45 million average-risk people in the United States remain unscreened.2 A multi-center pivotal trial evaluating second-generation Cologuard markers is ongoing, and results are expected late 2022 or early 2023. Exact Sciences plans to use results of the ongoing trial to support an FDA submission and approval and make the enhanced Cologuard test available broadly.

Conference call and webcast details

Exact Sciences management and Mayo Clinic will host a conference call and webcast on Wednesday, Jan. 19, 2022, at 11 a.m. ET to discuss results of the second-generation Cologuard study. The webcast will be available at www.exactsciences.com. Domestic callers should dial (833) 952-1519 and international callers should dial +1 236-714-2125. The access code for both domestic and international callers is 3972189.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or +1-416-621-4642 internationally. The access code for the replay of the call is 3972189. The webcast, conference call, and replay are open to all interested parties.

Additional data presented at 2022 ASCO (Free ASCO Whitepaper) GI Cancers Symposium

Four additional Exact Sciences abstracts were accepted and will be shared at ASCO (Free ASCO Whitepaper) GI. Details for each are included below and all abstracts can be found on the conference website.

Cologuard abstracts

Title: Patterns of Colorectal Cancer (CRC) Screening Rates Among the Average Risk US Population
Authors: Fisher, D., et al.
Date/Time: Jan. 22, 2022, 9:30 a.m. ET

Title: Preferences for Colorectal Cancer Screening of Physicians and Individuals at Average Risk in the United States: A Discrete Choice Experiment
Authors: Heidenreich, et al.
Date/Time: Jan. 22, 2022, 9:30 a.m. ET

Oncoguard Liver abstracts

Title: A Prospective Trial to Evaluate the Performance of the Multi-Target Hepatocellular Carcinoma Blood Test (mt-HBT) for Screening At-Risk Patients: The ALTUS Study
Authors: John, B., et al.
Date/Time: Jan. 21, 2022, 3:05 p.m. ET

Title: Multi-Target Blood Test Can Improve the Performance of Hepatocellular Carcinoma Surveillance Programs: A Modeling-Based Virtual Trial
Authors: Chhatwal, J., et al.
Date/Time: Jan. 21, 2022, 3:05 p.m. ET

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On January 18, 2022 BioLineRx Ltd. (NASDAQ-CM: BLRX) (TASE: BLRX) a late clinical-stage biopharmaceutical company focused on oncology, reported that the Company has completed a successful pre-New Drug Application (NDA) meeting with the US Food and Drug Administration (FDA) regarding Motixafortide as a novel stem-cell mobilization agent for autologous bone marrow transplantation in multiple myeloma patients (Press release, BioLineRx, JAN 18, 2022, View Source [SID1234605524]).

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The purpose of the meeting was to obtain agreement from the FDA on the content of the proposed NDA and, in particular, to confirm that the Company’s single Phase 3 pivotal study, GENESIS, is sufficient to support an NDA submission. During the pre-NDA meeting, the FDA agreed that the proposed data package is sufficient to support an NDA submission, which the Company continues to anticipate will occur in H1 2022.

"We are highly encouraged by the collaborative pre-NDA meeting that we held with the FDA, and having confirmed alignment with the agency, our NDA submission remains on track for the first half of this year," stated Philip Serlin, Chief Executive Officer of BioLineRx. "This successful meeting continues the positive momentum generated from the compelling results of our GENESIS Phase 3 study, which demonstrate a highly significant improvement over the current standard of care, alongside the positive results of the pharmacoeconomic study that we reported more recently. As a result, Motixafortide, if approved, has the potential to become the standard-of-care mobilization therapy for all multiple myeloma patients undergoing autologous stem cell transplantation, especially in light of new and more intense induction treatment regimens given to these patients, which make stem-cell mobilization more difficult than ever before," concluded Mr. Serlin.

In May 2021, BioLineRx announced positive top-line results from its GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients. The study met all primary and secondary endpoints with a very high degree of statistical significance (p<0.0001). Importantly, ~90% of patients went directly to transplantation after mobilizing the optimal number of stem cells following only one administration of Motixafortide and in only one apheresis session.

On January 18, 2022 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that the Company will be presenting updated data from the DisTinGuish study, a Phase 2a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, in patients with gastric or gastroesophageal junction cancer (G/GEJ), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium being held on January 20-22, 2022 (Press release, Leap Therapeutics, JAN 18, 2022, View Source [SID1234605541]).

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The Company will host a conference call with Dr. Samuel Klempner of Harvard Medical School and Massachusetts General Hospital on Friday, January 21, 2022 to discuss results from the study.

The latest results from Part A of the DisTinGuish study will be presented, representing first-line advanced G/GEJ patients treated with DKN-01 in combination with tislelizumab and chemotherapy. New data demonstrate compelling efficacy from this combination regimen, driven by enhanced clinical responses and survival benefit associated with high tumoral DKK1 expression that is independent of PD-L1 expression. Also to be presented are initial findings from the still-enrolling Part B of the clinical trial, studying DKN-01 and tislelizumab in second-line advanced G/GEJ patients with high tumoral DKK1 expression, showing the treatment is well tolerated with encouraging objective responses observed.

"The combination of DKN-01 with tislelizumab continues to demonstrate encouraging results in patients with gastric and gastroesophageal junction cancer, especially those in the DKK1-high subpopulation," said Samuel Klempner, MD, Associate Professor at Harvard Medical School who leads the gastric and esophageal cancer program at Massachusetts General Hospital Cancer Center and is a principal investigator on the DisTinGuish study. "The updated front-line results are encouraging in a difficult to treat cohort of primarily PD-L1 low patients, who are less likely to benefit from anti-PD-1 therapy. Together with encouraging initial findings from Part B, where DKN-01 and tislelizumab are used as a chemo-free second-line treatment of DKK1 high-expressing tumors, these results continue to support the therapeutic potential of DKN-01 and warrant exploration in a randomized clinical trial in first-line gastric and gastroesophageal junction patients."

About the DisTinGuish Study

The DisTinGuish study (NCT04363801) is a Phase 2a study of DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. The study is being conducted in two parts in the United States and the Republic of Korea. Enrollment of Part A has been completed with 25 first-line HER2- G/GEJ cancer patients whose tumors express either high levels of DKK1 (DKK1-high) or low levels of DKK1 (DKK1-low). Part B of the study has enrolled 30 patients with second-line DKK1-high G/GEJ cancer and will continue to enroll up to 48 patients. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 in Asia (excluding Japan), Australia, and New Zealand.

First-Line Part A Key Findings

· Overall preliminary median progression-free survival (PFS) was 10.7 months
o PFS was longer in DKK1-high patients at 11.9 months, compared to 10.7 months in DKK1-low patients
· Preliminary median duration of response (DoR) was 10.7 months in DKK1-high patients, compared to 7.9 months in DKK1-low patients
· Median overall survival has not been reached
· Among patients who received a full first cycle of DKN-01 (modified intent to treat, n=22), the objective response rate (ORR) was 68%, including one complete response (CR) and 14 partial responses (PR)
o 90% ORR in DKK1-high patients (n=10)
o 56% ORR in DKK1-low patients (n=9)
· Activity was independent of PD-L1 expression
o 79% ORR in PD-L1-low (vCPS < 5) and 67% ORR in PD-L1-high (vCPS > 5) patients
o 100% ORR in DKK1-high, PD-L1-low patients (n=6)
· Combination was well tolerated, safety profile consistent with previous update and reflecting the underlying patient population

Second-Line Part B Key Findings

· DKN-01 and tislelizumab administered in DKK1-high, PD-1 naïve patients was well tolerated at both 300mg and 600mg DKN-01 doses
· Among evaluable patients who received a full first cycle of DKN-01 (response evaluable modified intent to treat, n=20), the objective response rate (ORR) was 25%, including 5 PRs and 4 stable disease (SD). One additional patient has had an irPR by iRECIST criteria.
· PD-L1 expression is low overall in the study population and not correlated with DKK1 expression
· The study is ongoing and enrolling in the 600mg DKN-01 cohort. Twelve patients were on study at the time of the data cut, four of whom had not yet had their first imaging assessment.

Leap Presentation Details:

Title: DKN-01 and Tislelizumab ± Chemotherapy as a First-Line (1L) and Second-Line (2L) Investigational Therapy in Advanced Gastroesophageal Adenocarcinoma (GEA): DisTinGuish Trial

Session Type: Poster Session

Presenter: Samuel J. Klempner, Harvard Medical School

Date and Time: Thursday, January 20, 2022 at 3:00 p.m. Eastern Time

Conference Call

Leap will host a conference call on Friday, January 21, 2022 at 1:00 p.m. Eastern Time to further discuss the data. In addition to Leap’s executive management team, Dr. Samuel Klempner of Harvard Medical School and Massachusetts General Hospital will be on the call. The call can be accessed by dialing (866) 589-0108 (U.S. and Canada) or (409) 231-2048 (international). The passcode for the conference call is 3323348. The presentation will be webcast live and may be accessed on the Investors page of the Company’s website at View Source, where a replay of the event will also be available for a limited time.

About DKN-01

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways and has an important role in promoting tumor proliferation, metastasis, angiogenesis, and in mediating an immune suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells. The U.S. Food and Drug Administration has granted DKN-01 Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer and Fast Track Designation in combination with tislelizumab for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1 protein, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy.

On January 18, 2022 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported that Scott Carmer, Chief Executive Officer, will participate in the LLS TAP panel discussion entitled "Expanding the Possible with Next Generation Cell Therapies" on Friday, January 21, 2022 at 12:00 p.m. Eastern Time (Press release, NexImmune, 18 18, 2022, View Source [SID1234605598]).

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The webcast will be accessible on the Investor Relations page of NexImmune’s website at Events and Presentations | NexImmune, Inc. Participants may also register at LLS TAP: Expanding the Possible with Next-Generation Cell Therapies.

LLS and NexImmune have a long history of working together. In October 2017, NexImmune benefitted from an initial TAP investment and in 2021 received a second investment as part of the Company’s initial public offering to support NexImmune’s ongoing Phase 1/2 studies in AML/MDS and multiple myeloma.

"We are excited with our continued support of NexImmune and their participation in this panel. The LLS track record in accelerating lifesaving blood cancer treatments is unparalleled," said Lee Greenberger, Ph.D., LLS Chief Scientific Officer. "The continuity of our funding from preclinical through clinical research demonstrates our commitment to supporting innovative therapies as they move from the laboratory into practice."