Lantern Pharma Announces Launch of Antibody Drug Conjugate (ADC) Program through Agreement with Califia Pharma

On January 4, 2021 Lantern Pharma (Nasdaq: LTRN), a clinical-stage biopharma company using its proprietary RADR artificial intelligence ("A.I.") platform to transform cancer drug development and identify patients who will benefit from its targeted oncology therapeutics, reported that it will be launching the development of its ADC (Antibody Drug Conjugate) program through an evaluation and potential development agreement with Califia Pharma along with other key internal development and computational initiatives (Press release, Lantern Pharma, JAN 4, 2021, View Source;utm_medium=rss&utm_campaign=antibody-drug-conjugate-adc-program-califia-pharma [SID1234573403]). Lantern will potentially leverage the patent-protected linker library, conjugation processes and payloads, including its own DNA damage causing compounds, LP-100 and LP-184, for development as ADC-based therapies for a range of solid tumors and blood cancers. In addition, Lantern intends to utilize its proprietary A.I. platform, known as RADR, to help determine the cancer types, targets, and cancer biomarker signatures believed most likely to respond to and benefit from this ADC approach. According to industry analysts, the global antibody drug conjugate cancer therapy market is expected to exceed $10 billion USD by 2026, and $15 billion USD by 2030, driven by innovations in protein targeting, linker technologies and conjugation processes.

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"At Lantern we are focused on uncovering and accelerating new advances that can make a meaningful impact on personalizing cancer treatment and that can leverage our A.I. and data driven model for precision cancer drug development. The Califia portfolio of technologies and library of linkers has been meaningfully progressed with a specific focus on the class of drugs represented by LP-100 and LP-184. We believe that this optimization coupled with our identification of cancer sub-types should enable us to target very specific cancers quickly, creating the potential to enter into clinical trials at a speed that we believe has not been achieved in the ADC category," said Panna Sharma, CEO of Lantern Pharma. ADCs bring together the ability to target specific antibodies on specific cancer cells and then link that antibody targeting capability to delivering specific potent molecules or toxic payloads to the targeted cancer cell. ADCs are an emerging class of highly potent biological drugs that have seen five FDA approvals over the last two years. ADCs can use the specificity of antibodies and antigens to focus cytotoxic small molecules on target cells "precisely" and then kill them based on releasing the "payload" by designing and controlling the linker element. "Pioneering development by Califia has yielded novel linkers and chemistries that we believe have significantly improved the therapeutic index of specific DNA damage compounds and alkylating agents in early pre-clinical studies, and have also minimized the manufacturing steps involved in conjugation of the ADC structure," added Panna Sharma

"Working closely with innovators and world-leading drug developers is an essential part of our strategy to leverage and develop new platforms that can transform the timeline and effectiveness of cancer drug development. By implementing ADC approaches, we aim to offer cancer patients an additional, highly-targeted platform that can make meaningful contributions in advancing the personalization of treatment, while also benefitting from synergies with our A.I. drug development platform," continued Panna Sharma, CEO of Lantern Pharma.

The ADC program will begin immediately and initially focus on evaluating Califia’s novel, patented linker technologies with DNA damaging small molecules, LP-100 and LP-184, in select solid tumors. Lantern also expects to use RADR to guide the selection and prioritization of certain tumors and cancer subtypes and also to uncover cancer sub-types where there is significant unmet patient need, especially in rare tumors and orphan indications where there have not been recent meaningful improvements in the standard of care. The ADC development program is at the forefront of translational cancer medicine and will be optimizing target indications and design during 2021, with the intent to launch IND and clinical programs in 2022. Subject to positive results of the evaluation and early development process, Lantern expects to further a license(s) that cover the intended targets, payloads and linkers to be brought into the clinical development process. This rapid approach is intended to be done in collaboration with leading cancer research centers and will attempt to also implement the use of precision medicine tools, such as biomarker driven targeting and analysis, companion diagnostics, and large-scale analytics to fully leverage the precision power of ADCs.

GT Biopharma (OTCQB: GTBP) Announces Corporate Update Conference Call

On January 4, 2021 GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company’s proprietary NK cell engager (TriKE) technology platform reported that it will be holding a shareholder update call on Thursday, January 7, 2021 (Press release, GT Biopharma, JAN 4, 2021, View Source [SID1234573402]).

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Management will host the conference call on Thursday, January 7, 2021 at 4:15 pm Eastern Time, to review past events and provide an update on its clinical programs and corporate highlights. Following management’s formal remarks, Anthony Cataldo, Chairman and Chief Executive Officer of GT Biopharma will answer submitted questions. Please email your questions prior to the call to [email protected].

Conference Call Information

To join the conference call, live via telephone, interested parties should dial 712-775-7031 approximately 10 minutes before the start of the call. Use confirmation number 576-591-822 followed by the pound sign (#).

Boston Scientific to Participate in J.P. Morgan Healthcare Conference and Announces Conference Call Discussing Fourth Quarter 2020 Results

On January 4, 2021 Boston Scientific Corporation (NYSE: BSX) reported that it will participate in the virtually held 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 (Press release, Boston Scientific, JAN 4, 2021, View Source [SID1234573401]). Mike Mahoney, chairman and chief executive officer, will present at 8:20 a.m. EST. At approximately 8:40 a.m. EST, Mahoney will be joined by Dan Brennan, executive vice president and chief financial officer, Dr. Ian Meredith, AM, executive vice president and global chief medical officer, and Susie Lisa, vice president, Investor Relations, in a question-and-answer session with the host analyst.

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On Wednesday, February 3, 2021 Boston Scientific will webcast its conference call discussing financial results and business highlights for the fourth quarter ended December 31, 2020. The call will begin at 8:00 a.m. EST, hosted by Mike Mahoney and Dan Brennan. The company will issue a news release announcing financial results for the fourth quarter on February 3 prior to the conference call.

A live webcast and replay of the webcast for each event will be accessible at investors.bostonscientific.comView Source The replay will be available beginning approximately one hour following the completion of each event.

IMV to Participate in Two Upcoming Investor Events

On January 4, 2021 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported that IMV’s executive management team will participate at two upcoming virtual investor events (Press release, IMV, JAN 4, 2021, View Source [SID1234573400]).

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BTIG Fireside Chat with IMV
Date: Thursday, January 7, 2021
Time: 12:15 PM ET

H.C. Wainwright Fireside Chat with IMV (Bioconnect 2021 Conference)
Date: Monday January 11, 2021 (on demand for one week)
Time: Starting at 6:00 AM ET

A webcast of these events will be available under "Events, Webcasts and Presentations" in the investors section of IMV’s website and a replay will be available shortly afterwards for approximately 30 days.

Estimated FY’21 Q1 Revenues

On January 4, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported that it expects revenues for the first fiscal quarter of 2021 ended December 31, 2020, to be in the range of $1.3 million to $1.6 million compared to revenues of $314,000 in the fourth quarter of fiscal 2020 (Press release, Applied DNA Sciences, JAN 4, 2021, View Source [SID1234573398]). The strong sequential growth in quarterly revenues is driven principally by demand for safeCircle, the pooled COVID-19 surveillance testing program offered by the Company’s wholly-owned subsidiary, Applied DNA Clinical Laboratories, LLC (ADCL), and from sales of its LineaCOVID-19 Assay Kit under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).

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"Fiscal first-quarter revenues surged over fiscal fourth quarter, reflecting the first full quarter of revenue contribution from our safeCircle program. New client acquisitions drove a sequential improvement in ADCL revenues during each month of the quarter. We believe we are tapping into an unmet need for an accurate, painless, and fast COVID-19 risk mitigation option that can deliver ongoing, consistent, and highly accurate COVID-19 surveillance testing proactively. We expect continued uplift to revenues over the coming weeks as new clients ramp up their testing volumes, including Suffolk County (N.Y.) Government that signed on just two weeks ago with a six-month contract valued at up to $2.0 million, and as we onboard more new clients," said Dr. James A. Hayward, president and CEO, Applied DNA.

"Interest in our pooled surveillance testing modality is strong and growing. In the months ahead, our ADCL team is intensely focused on increasing testing throughput, developing new COVID-19 assays to detect mutations in SARS-CoV-2, offering expanded services via the Cleared4 return-to-work health safety platform, and client acquisition and retention through direct sales efforts and channel partners," concluded Dr. Hayward.

These preliminary unaudited results are based on management’s initial analysis of operations for the first fiscal quarter of 2021 ended December 31, 2020, and are subject to review and revision. The Company expects to issue full financial results for the first fiscal quarter of 2021 in mid-February.

About safeCircle
ADCL’s pooled surveillance testing program, known as safeCircle, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides 24-hour results using real-time PCR (RT-PCR) testing.

Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle

About the LineaCOVID-19 Assay Kit and Pooled Surveillance Testing
The LineaCOVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the LineaCOVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the LineaCOVID-19 Assay Kit.