On October 5, 2020 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to improve drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, reported the advancement of its collaboration with Georgetown University for LP-184, a small molecule drug candidate currently in preclinical development for certain genomically defined solid tumors, including prostate and pancreatic cancers (Press release, Lantern Pharma, OCT 5, 2020, View Source [SID1234568098]).

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The first phase of the joint research activities with Georgetown which began in the 4th quarter of 2019 generated strong evidence of the efficacy of LP-184 in certain solid tumors and linked the anti-tumor activity to the presence of specific biomarkers. Phase one of the collaboration was a proof of concept study that demonstrated LP-184 had nanomolar potency across a wide variety of cell lines specifically engineered to study prostate cancer. LP-184 demonstrated increased efficacy in killing prostate cancer cells that overexpress PTGR1, a gene that is often upregulated in aggressive cancer tumors as well as higher anti-cancer activity in cells lines that had targeted DNA damage repair gene mutations. LP-184 was further tested in 3D organoid cultures, which are derived from patient tumor samples and more closely represent the actual biology of human tumors than cell lines, resulting in dose-dependent cell death in multiple patient-derived xenograft (PDX) prostate cancer models. Additional genomic, transcriptomic and drug sensitivity data from the cell lines and 3D organoids was also obtained, which is helping to refine the response signature, and is providing insights into which DNA repair deficiencies are more likely to be highly sensitive to LP-184. Since aggressive cancers can frequently over express PTGR1, this important insight regarding the observed efficacy of LP-184 in such tumors will be further validated in the next phase of the collaboration.

Mr. Sharma added: "I am very excited about the results of the first phase of our collaboration with Georgetown University as it validates that LP-184 is a highly potent agent in cancers that exhibit certain molecular features. This fact is highly significant as it suggests LP-184 could develop into a first-in-class compound for the treatment of certain prostate and pancreatic cancers and potentially other solid tumors. Moreover, LP-184 seems to work specifically by damaging and blocking a pathway critical for cancer cell proliferation; it could potentially be a perfect drug for use in combination with existing therapies for these prostate and pancreatic cancers as well as other solid tumors where we can exploit this molecular feature. We will be working alongside Dr. Banerjee to further elucidate this mechanism and generate a signature that we can use for future patient selection in trials and patient treatment."

The next phase of the collaboration and research program with Georgetown will focus on a larger set of PDX models and help pinpoint the specific mechanism of action, and seek confirmatory validation of the role of PTGR1 and the genetic mutations driving the DNA damage repair pathways that make the drug highly potent in these cancers. Research will also focus on completing the acquisition of detailed genomic information in prostate cancers, which will involve work in animal models and cell lines that have been edited to under and over express key driver genes.

Dr. Partha Banerjee, a world-renowned expert in molecular oncology and prostate cancer, and lead investigator for LP-184 at Georgetown University, commented: "There is currently a lack of approved therapeutic options for metastatic castration resistant prostate cancer (mCRPC), which affects ~33,000 men per year in the U.S. alone. It is a highly lethal disorder with increasing incidence in the US and a 5-year survival rate of 26%, as compared to 91% for localized prostate disease. LP-184 has the potential to preferentially target DNA damage repair pathway in cancer cells that express certain biomarkers, like PTGR1. Thus, if LP-184 is able to demonstrate efficacy in future human clinical trials and meaningfully increase the survival rate, this would be extremely important for patients." In addition to Dr. Partha Banerjee, Dr. Shiv Shrivastava, who previously served as the Co-Director of the Center for Prostate Disease Research at Walter Reed National Military Medical Center is also advising Lantern Pharma in the development strategy in this precision oncology approach for LP-184.

LP 184 has been advanced using Lantern’s proprietary RADR A.I. platform that uses machine learning, genomics, and computational biology to accelerate the discovery of potential mechanisms of action and genomic and biomarker signatures that correlate to drug response in cancer patients.

The goal of phase two of the collaboration is to create a more biologically relevant and robust gene signature in preparation for clinical trials, with the objective of allowing future prostate cancer patients to experience the benefit of a more personalized cancer treatment approach. Ultimately, Lantern’s A.I. driven approach could save millions of dollars in drug development costs while significantly accelerating the path to commercialization.

Panna Sharma, CEO of Lantern Pharma, said: "I am excited about the potential of LP-184, particularly as it relates to a more targeted therapy for patients with prostate cancer. If we can further develop this potent compound as a novel therapeutic agent, it would constitute an important breakthrough in the treatment of this deadly form of prostate cancer. I look forward to our continued collaboration with Dr. Banerjee and Georgetown University."

On October 5, 2020 ImmunoGen, Inc., (Nasdaq: IMGN) a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, ImmunoGen, OCT 5, 2020, View Source [SID1234568093]).

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"We are pleased FDA has granted Breakthrough Therapy designation for IMGN632, our novel CD123-targeted ADC, as it underscores the urgent need for effective and well-tolerated treatments for patients with this rare and aggressive cancer," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "We look forward to continuing to work with FDA to further define the development path for IMGN632 in BPDCN, in addition to pursuing our ongoing evaluation of IMGN632 in AML and other hematological malignancies."

According to FDA guidelines, Breakthrough Therapy designation is designed to expedite the development and review of drugs that are intended to treat a serious condition and have generated preliminary clinical evidence that the drug may demonstrate substantial improvement over available therapy. Breakthrough Therapy designation was granted for IMGN632 based on the findings from the BPDCN cohort of the first-in-human study of IMGN632, for which initial data were presented in an oral session at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in 2019. Updated data from the IMGN632 monotherapy BPDCN dose expansion cohort will be presented at ASH (Free ASH Whitepaper) this December.

ABOUT IMGN632
IMGN632 is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and acute lymphocytic leukemia (ALL). IMGN632 is currently being evaluated in multiple cohorts, including monotherapy for patients with BPDCN and minimal residual disease positive (MRD+) AML following frontline induction therapy and in combinations with Vidaza (azacitidine) and Venclexta (venetoclax) for patients with relapsed/refractory AML. IMGN632 uses one of ImmunoGen’s novel indolino-benzodiazepine (IGN) payloads, which alkylate DNA without crosslinking. IGNs have been designed to have high potency against AML blasts, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads.

ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM
BPDCN is a rare form of blood cancer that has features of both leukemia and lymphoma, with characteristic skin lesions, lymph node involvement, and frequent spread to the bone marrow. This aggressive cancer requires intense treatment often followed by stem cell transplant. Despite the recent approval of a CD123-targeting therapy, the unmet need remains high for patients, particularly in the relapsed/refractory setting.

On October 5, 2020 Unum Therapeutics Inc. ("Unum") (NASDAQ: UMRX), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported its name change to Cogent Biosciences, Inc. ("Cogent") (Press release, Unum Therapeutics, OCT 5, 2020, View Source [SID1234568092]). Beginning on October 6, 2020, Cogent will trade on NASDAQ under the ticker symbol "COGT", and Cogent’s common stock will trade under a new CUSIP number, 19240Q102. The new name reflects Cogent’s mission to design rational precision therapies that treat the underlying cause of disease and improve the lives of patients. Cogent is also pleased to provide an update on recent scientific and operational progress since its July acquisition of Kiq LLC, including the announcement of an upcoming oral presentation of Phase 1/2 clinical data in gastrointestinal stromal tumors (GIST) with Cogent’s lead asset, PLX9486, at the 2020 Connective Tissue Oncology Society (CTOS) Annual Meeting to be held virtually November 18 – 21. In connection with the change of the Company’s corporate name, Cogent anticipates that the name of PLX9486 will be changed to CGT9486.

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"Our new name reflects the evolution of our company to focus on developing precision therapies for genetically defined diseases and paves the path forward as we strive to deliver real solutions for patients in serious need of new treatment options," said Chuck Wilson, PhD, President and CEO of Cogent. "Over the past three months, we have made significant progress in shifting the focus of the company to align with our future vision, and we look forward to presenting additional data on our lead program PLX9486 at CTOS 2020 as we continue to make progress in advancing the program for the treatment of patients suffering from Systemic Mastocytosis and GIST."

Cogent remains on track to advance PLX9486 as a single agent in Advanced Systemic Mastocytosis patients in the first half of next year and Indolent Systemic Mastocytosis patients in the second half of 2021. Additionally, Cogent plans to further develop PLX9486 in combination with sunitinib in GIST patients and plans to initiate an additional clinical study in GIST in the second half of 2021.

An updated corporate presentation, which includes additional preclinical data highlighting the potency of PLX9486 against KIT D816V, is now online at Cogent’s new website, www.cogentbio.com.

PLX9486 + Sunitinib Combination data to be presented in Oral CTOS Abstract

Cogent’s lead precision therapy is PLX9486, a potent and selective precision kinase inhibitor that is designed to target KIT mutations present in Systemic Mastocytosis and GIST. New details of the open-label Phase 1/2 clinical study testing the combination of PLX9486 with sunitinib in 18 adult patients with advanced GIST, will be presented as an oral presentation at the upcoming 2020 CTOS Annual Meeting.

Title: The Potent and Selective Kit Inhibitor PLX9486 Dosed in Combination with Sunitinib Demonstrates Promising Progression Free Survival (PFS) in Patients with Advanced Gastrointestinal Stromal Tumor (GIST): Final Results of a Phase 1/2 Study

Date: Friday, November 20, 2020 from 11:30 a.m. – 12:30 p.m. ET

Presenter: Jonathan Trent, M.D., Ph.D., University of Miami Health System, Sylvester Comprehensive Cancer Center

The oral presentation will contain detailed results from the combination of PLX9486 and sunitinib in patients with advanced GIST. Previously announced topline results demonstrated 11 months median progression free survival with the combination of PLX9486 and sunitinib in heavily treatment-experienced patients with advanced GIST, with two-thirds of patients having previously received three or more lines of therapy. PLX9486 was well-tolerated, and the most commonly occurring treatment emergent adverse events (TEAEs) were predominantly £ Grade 2. PLX9486 has been dosed in more than 50 patients both as a single agent and as part of a combination therapy. Based on the data, Cogent believes the combination of PLX9486 and sunitinib has the potential to address an unmet medical need in patients living with GIST.

Operational Update

Cogent’s current cash balance includes gross proceeds of a $104.4 million private placement concurrent with the Kiq acquisition, as well as $8.1 million from the BOXR sale with potential near-term milestones of up to $3.4 million. This funding provides Cogent with runway into 2023. More details on Cogent’s cash position will be provided in November in the Q3 earnings call.

Cogent has retained senior personnel from Unum who bring critical expertise in clinical science, clinical operations, regulatory affairs, and project management, and the company has continued to grow the team over the past three months with new hires following the completion of the Kiq acquisition.

On October 5, 2020 Invitae Corporation (NYSE: NVTA), a leading genetics company, reported that on October 2, 2020, it completed the transaction to bring ArcherDX, a leading genomics analysis company, into Invitae to create a comprehensive offering that provides testing services for disease risk, therapy optimization and personalized cancer monitoring to enable precision approaches to cancer treatment (Press release, Invitae, OCT 5, 2020, View Source [SID1234568091]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"With the addition of ArcherDX’s technologies, capabilities and team, Invitae is now well positioned to accelerate the utilization of genetic information throughout a cancer patient’s journey. Starting from risk profiling and diagnostic testing, moving to therapy optimization, monitoring and recurrence surveillance, Invitae can deliver the information needed to enable best-in-class personalized cancer care," said Sean George, Ph.D., co-founder and chief executive officer of Invitae. "Invitae is on a mission to increase access to molecular medicine to all who can benefit, and the addition of the ArcherDX platform builds out an important segment serving the current and future oncology landscape."

In connection with the closing of the acquisition, Jason Myers, Ph.D., has been appointed to Invitae’s Board of Directors, effective October 2, 2020, and will serve as president of oncology.

Transaction Details
Under the terms of the Agreement and Plan of Merger and Plan of Reorganization, Invitae acquired ArcherDX for upfront consideration consisting of 30.0 million shares of Invitae common stock and $325.0 million in cash, subject to certain adjustments. In addition, up to an additional 27.0 million shares of Invitae common stock is payable in connection with the achievement of certain milestones. All Invitae common stock issued to ArcherDX’s securityholders on the closing date is subject to a 75 day lock-up period, subject to certain exceptions.

In connection with the acquisition, Invitae entered into a credit agreement and guaranty with Perceptive Credit Opportunities Holdings III, LP providing for a senior secured term loan facility, and on October 2, 2020, borrowed an aggregate principal amount of $135.0 million under the credit agreement and guaranty. In addition, Invitae issued to Perceptive warrants to purchase 1.0 million shares of Invitae common stock.

In connection with the acquisition, Invitae sold $275.0 million of common stock to certain accredited investors in a private placement.

On October 5, 2020 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX:TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has received Notices of Allowance from the United States Patent and Trademark Office for two patent applications covering the use of SIRPαFc for the treatment of cancer, U.S. Patent Application No. 13/320,629 (the "629 Application", exclusively licensed to Trillium) and U.S. Patent Application No. 15/962,540 (the "540 Application") (Press release, Trillium Therapeutics, OCT 5, 2020, View Source [SID1234568090]). Trillium has two SIRPαFc biologics, TTI-621 and TTI-622, in clinical development. Both therapeutics target CD47, a "don’t eat me" signal that cancer cells use to evade immune destruction.

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The ‘629 method of use Application provides coverage for the use of SIRPαFc biologics to treat all CD47+ cancer cells and tumours, including hematologic and solid cancers. Counterparts of this application have already been granted in Japan, Canada and Australia.

The ‘540 Application has claims that cover TTI-622 composition of matter comprising human SIRPα linked to an IgG4 Fc region, as well as claims covering pharmaceutical compositions that contain TTI-622. A composition of matter patent for TTI-621 (SIRPα linked to an IgG1 Fc) has already been granted in the U.S. (US 9,969,789) and other countries.

"Intellectual property remains a top priority for Trillium, and the allowance of these two important patents further strengthens our position in the SIRPαFc CD47 space," said Jan Skvarka, President and Chief Executive Officer of Trillium. "In addition to our specific composition-of-matter claims covering both of our CD47-targeting agents, we have expanded our coverage to embrace the use of the SIRPαFc class of biologics to treat cancer. We are particularly pleased that the method of use patent also covers treatment of solid tumors."