Lantern Pharma Announces Abstract on Effectiveness of LP-184 in Pancreatic Cancers Accepted for Presentation at the AACR Virtual Special Conference: Pancreatic Cancer

On August 16, 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 that Lantern Pharma’s abstract titled ‘LP-184, a novel alkylating agent, is highly effective in pancreatic cancers with DNA damage repair defects‘ has been accepted as a virtual poster at the upcoming AACR (Free AACR Whitepaper) Virtual Special Conference on Pancreatic Cancer being held on September 29-30, 2021 (Press release, Lantern Pharma, AUG 16, 2021, View Source;utm_medium=rss&utm_campaign=abstract-on-effectiveness-of-lp-184-in-pancreatic-cancers [SID1234586631]).

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The abstract submitted by Lantern Pharma and researchers at Fox Chase Cancer Center describes work demonstrating promising efficacy of LP-184 in multiple in vitro and in vivo pancreatic cancer models. The abstract also highlights the increased efficacy and synthetic lethality of LP-184 in pancreatic cancers with DNA damage repair deficiencies.

Virtual posters will be available on-demand to attendees starting on September 29, 2021 and will remain accessible for 90 days after the live program ends. Accepted abstracts will be published as an online-only proceedings supplement to an AACR (Free AACR Whitepaper) journal after the completion of the meeting.

LP-184 is a small molecule drug candidate and next generation alkylating agent that preferentially damages DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. LP-184 is being developed for several targeted indications in cancer, including pancreatic cancer. LP-184 has recently been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of pancreatic cancer.

Turning Point Therapeutics Initiates TRIDENT-2 Clinical Study Investigating Repotrectinib-Trametinib Combination in KRAS G12D Mutated Advanced Solid Tumors

On August 16, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported initiation of the first cohort of its Phase 1b/2 TRIDENT-2 combination study of lead investigational drug repotrectinib (Press release, Turning Point Therapeutics, AUG 16, 2021, View Source [SID1234586647]). The initial cohort will investigate repotrectinib in combination with MEK-inhibitor trametinib in KRAS G12D mutated advanced solid tumors.

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"We are pleased to initiate the TRIDENT-2 study and explore a potential new treatment option for patients with KRAS-driven solid tumors," said Mohammad Hirmand, executive vice president and chief medical officer. "With preclinical studies demonstrating repotrectinib’s ability to inhibit JAK2, SRC and FAK, our goal is to help improve the effectiveness of KRAS-targeting agents by suppressing known pathways of tumor resistance."

The Phase 1b portion of the study will examine the safety, tolerability, pharmacokinetics, and any early signals of efficacy of repotrectinib in combination with trametinib in patients with KRAS G12D mutated advanced solid tumors. After determination of a recommended Phase 2 combination dose, the study includes a Phase 2 dose expansion portion with the primary endpoint of objective response rate.

Results from preclinical studies presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting found that repotrectinib in combination with trametinib was more effective than single-agent trametinib in patient-derived KRAS mutant G12D lung cancer models. The repotrectinib-trametinib combination suppressed a broad range of downstream mutant KRAS G12D signaling, increased cell cycle arrest and induction of apoptosis, and was more active in multiple KRAS G12D dependent models compared to either single-agent treatment.

The frequently mutated Kirsten Rat Sarcoma (KRAS) viral oncogene is associated with a broad range of human cancers, including approximately 30% of non-small cell lung, 40% of colorectal and more than 90% of pancreatic cancers. KRAS G12D mutations are known to occur across multiple tumors types, including an estimated 30% of pancreatic, 15% of colorectal and 5% of both endometrial and non-small cell lung cancers.

Therapeutic targeting of KRAS has proven challenging, in part due to resistance and adaptive upregulation of alternative signaling pathways that promote tumor cell survival, as well as concurrent secretion of various cytokines and growth factors.

Cellectar Announces Manufacturing and Supply Agreement with Evergreen Theragnostics for CLR-131, now known as iopofosine I-131

On August 16, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported that it has entered into a commercial manufacturing and supply agreement with Evergreen Theragnostics, a global radiopharmaceutical contract development and manufacturing organization (CDMO) based in Springfield, NJ (Press release, Cellectar Biosciences, AUG 16, 2021, View Source [SID1234586671]). The company also announced that the United States Adopted Names Council (USAN) has approved the use of "iopofosine I-131" as the generic name for CLR-131.

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The agreement with Evergreen provides long term commercial supply of iopofosine I-131 and supply of clinical study material for Cellectar’s pivotal study in Waldenstrom’s macroglobulinemia (WM) as well as ongoing Phase 1 and Phase 2 clinical studies. Evergreen will conduct process development and validation of additional large scale commercial quantities of iopofosine I-131 at its newly constructed, state-of-the-art manufacturing facility designed specifically for radiopharmaceutical manufacturing, including therapeutic and diagnostic radiopharmaceuticals.

"Establishing a collaboration with a strong partner capable of supplying clinical and commercial scale quantities of iopofosine I-131 is another important advancement in our iopofosine I-131 product development and commercialization plan," said James Caruso, president and CEO of Cellectar. "Evergreen has tremendous expertise as a leading radiopharmaceutical contract manufacturer, and their location in New Jersey provides strategic logistical advantages including favorable distribution for both the U.S. and ex-U.S. markets. Importantly, this collaboration expands upon our current supply capabilities with our existing CDMO, allows future development and supply of additional radiotherapeutic programs in development and continues to pave the way for Cellectar to meet the potential market demand for iopofosine I-131 upon approval."

James Cook, CEO of Evergreen Theragnostics stated that, "We welcome this new collaboration with Cellectar Biosciences. Iopofosine I-131 represents a unique and novel class of radiotherapeutics and Evergreen is excited to participate in its continued development and long-term supply to patients. We look forward to working with Cellectar on this and future programs."

Iopofosine I-131 is currently being investigated in a global, pivotal expansion cohort in WM patients who have received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitor failed or suboptimal response. The WM cohort will enroll up to 50 patients to evaluate the efficacy and safety of iopofosine I-131 for marketing approval. The company is also evaluating iopofosine I-131 in highly refractory multiple myeloma patients in its Phase 2 CLOVER-1 study in hematologic malignancies.

Kumquat Biosciences and Eli Lilly have reached a partnership to jointly develop tumor immune small molecule drugs

On August 16, 2021 Recently, Loxo Oncology, a research and development group of Eli Lilly, and Kumquat Biosciences (Kumquat) reported that the two parties have reached an exclusive collaboration agreement to jointly discover, develop and commercialize a series of innovative small molecule drug candidates that cause tumor-specific immune responses (Press release, Shanghai Medicilon, AUG 16, 2021, View Source [SID1234586598]).

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As a collaborative partner of Kumquat, Shanghai Medicilon Inc. (Medicilon) congratulates the Kumquat Biosciences on the new progress of small molecule immuno-oncology (IO) platform.

Kumquat Biosciences and Eli Lilly have reached a partnership to jointly develop tumor immune small molecule drugs
According to the agreement, Kumquat will use its small molecule immuno-oncology (IO) platform to discover the innovative clinical drug candidates, from which Eli Lilly could select a certain number of drug candidates for further development and commercialization of global market except Greater China Region. Kumquat reserves the right to develop and commercialize each drug candidate selected by Eli Lilly in the Greater China region, however Eli Lilly has the right to participate in the joint commercialization of these drugs in the Greater China region. In addition, Kumquat could choose to jointly develop and commercialize certain drug candidates selected by Eli Lilly in the United States.

The collaboration between the two parties is the starting point after Kumquat has focused on small-molecule tumor immunotherapy. As a collaborative partner, Medicilon has the honor to witness the growth of Kumquat. Currently, Medicilon has over 50 researchers providing chemical FTE services for Kumquat. Medicilon is continuing to empower Kumquat with the flexibly adjustable solutions, controllable project progress, and customizable synthesis lines.

Guided by customer needs with the mission of innovative drug research, the FTE team of Medicilon is committed to providing high-quality emerging compounds for new drug research and development organizations. The pharmaceutical service includes medicinal chemistry, compound library design and synthesis, synthetic chemistry and synthetic process research and development. This collaboration model is cost effective and could be flexibly adjusted based on customer and project needs.

"Congratulations to Kumquat and Eli Lilly for reaching collaboration," Medicilon Founder & CEO Dr. Chunlin Chen said, "Medicilon wishes Kumquat shine in the field of tumor immunotherapy, achieve more innovative research and development results, and bring hope to the tumor patients around the world."

Vyant Bio Reports Second Quarter 2021 Results and Provides Strategic Business Updates

On August 16, 2021 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), an emerging global drug discovery company, reported that it is rapidly identifying small and large molecule therapeutics to treat central nervous system (CNS) and oncology-related diseases (Press release, Cancer Genetics, AUG 16, 2021, View Source [SID1234586632]). Today, Vyant Bio reports its Second Quarter 2021 strategic and business updates in a conference call scheduled for 4:30 p.m. ET.

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"We have achieved a tremendous amount of momentum in the first 90 days since launching the Vyant Bio brand and completing the merger we announced at the end of March 2021. Vyant Bio is committed to transforming the way drugs are discovered by quickly adapting to exciting new technologies and combining capabilities in ways that leverage their strengths," stated Jay Roberts, CEO of Vyant Bio. "Our internal teams of scientists, data scientists and engineers, coupled with the capabilities of select strategic partners that are now integrated into our platform, allow us all to work together to design and develop superior therapeutics and position us to build a robust pipeline of novel therapeutics targeting degenerative and developmental neurological disorders and cancers with high unmet needs."

Vyant Bio’s drug discovery platform uses both human-induced pluripotent stem cell-derived (hiPSC) and primary human cell organoids as proprietary disease models combined with analysis of human genetics and the use of machine learning algorithms for the identification of new targets, validation of known targets, and high-throughput screening for drug discovery. Vyant Bio’s drug discovery platform is intended to overcome the shortcomings of traditional drug discovery efforts that rely more heavily on insights from animal models to identify targets and to develop therapies intended for human disease. The Company is currently focused on the specific utility for the identification of targets and therapies in CNS and Oncology.

The Company filed its quarterly report for the Second Quarter 2021 on Form 10-Q today with the Securities and Exchange Commission. Please refer to our Form 10-Q for more detailed information with respect to our financial results for the three and six months ended June 30, 2021.

SECOND QUARTER 2021 FINANCIAL RESULTS1

As StemoniX, Inc. was deemed to have acquired Cancer Genetics, Inc. for accounting purposes and the Merger closed on March 30, 2021, the Company’s Second Quarter 2021 financial results include the post-merger results of the combined companies, now known as Vyant Bio. The analysis below excludes the Second Quarter 2020 results as they are based solely on StemoniX’s historical stand-alone operations and therefore do not reflect the post-merger enterprise.

Cash and cash equivalents totaled $26.5 million as of June 30, 2021.

Total revenues were $1.9 million for the three months ended June 30, 2021. Cost of goods sold – service aggregated to $1.0 million for the three months ended June 30, 2021 resulting in a cost of goods sold of 56% of service revenues. Cost of goods sold – product aggregated to $345 thousand for the three months ended June 30, 2021 resulting in a cost of goods sold gross margin deficit of $229 thousand. Our product manufacturing capabilities currently have excess capacity to support future growth. Research and development expenses were $910 thousand for the three months ended June 30, 2021. Selling, general and administrative expenses, which include public company costs and non-cash expenses of $620 thousand, were $3.7 million for the three months ended June 30, 2021.

While the Company executes its drug development strategy for long-term growth, the Company currently generates revenue from its vivoPharm and StemoniX subsidiaries. On a pro forma basis, assuming the Merger occurred on January 1, 2020, revenues for the three and six-month ended June 30, 2021 were $1.9 million and $3.8 million, respectively, as compared with $1.5 million and $3.1 million for the respective prior-year periods. On a pro forma basis, revenues increased by 26% and 21% in the current-year three and six-month periods as compared with the same prior-year periods.

1Pro forma information gives effect to the Merger between Cancer Genetics, Inc. and StemoniX, Inc. as if the Merger had occurred as of January 1, 2020. The pro forma information is presented solely for informational purposes and is not necessarily indicative of the combined results of operations or financial position that might have been achieved for the periods or dates indicated, nor is it necessarily indicative of the future results of the Company.

Vyant Bio’s Conference Call and Webcast and Information

Vyant Bio’s management will host a conference call on Monday, August 16, 2021 at 4:30pm ET to discuss the Second Quarter 2021 results and provide strategic business updates, as well as answer questions. Event information is below: