On January 4, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the 39th Annual J.P. Morgan Healthcare Conference at 2:00 p.m. Eastern Time on Monday Jan. 11, 2021 (Press release, Neurocrine Biosciences, JAN 4, 2021, View Source [SID1234573407]). Kevin Gorman, Chief Executive Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

On January 4, 2021 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported that the first patient has been dosed with HPN328, a delta like ligand 3- (DLL3) targeting TriTAC, in a Phase 1/2 clinical trial as an investigational treatment of small cell lung cancer (SCLC) and other tumors associated with DLL3 expression (Press release, Harpoon Therapeutics, JAN 4, 2021, View Source [SID1234573406]). The company has presented preclinical data on HPN328 showing that the drug was well tolerated in cynomolgus monkeys at 1 and 10 mg/kg, and pharmacokinetic data supported the potential for once weekly dosing. When administered to mice bearing human SCLC xenografts and human T cells, HPN328 eradicated tumors.

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"We are pleased with the rapid progress of our clinical programs, based on our proprietary TriTAC platform, with patient dosing now underway for our fourth product candidate, HPN328, that targets DLL3," said Natalie Sacks, M.D., Chief Medical Officer of Harpoon Therapeutics. "Treatment options for small cell lung cancer are limited, as are options for other DLL3-associated tumors such as neuroendocrine prostate cancer. Data from preclinical studies suggest that HPN328 has substantial anti-tumor activity, which provides the rationale for investigating its potential benefit in these patients."

"We are excited to participate in this trial of a promising agent that will hopefully benefit patients with small cell lung cancer and other neuroendocrine tumors," said Melissa Johnson, M.D., Program Director of Lung Cancer Research at Sarah Cannon Research Institute. The first patient was treated at Sarah Cannon Research Institute at Tennessee Oncology.

"I am excited that Harpoon’s fourth TriTAC drug candidate, HPN328, has advanced into the clinic focusing on SCLC, an aggressive and deadly disease with a significant unmet need, as its initial indication," said Jerry McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "Each of Harpoon’s four TriTAC clinical programs are progressing well and we expect data to emerge from our clinical trials throughout 2021."

About the Phase 1/2 Trial for HPN328

HPN328 is a TriTAC that binds to human and non-human primate DLL3, CD3e, and albumin with similar affinities. The Phase 1/2 trial is an open-label study of HPN328 as monotherapy to assess the safety, tolerability and pharmacokinetics in patients with advanced cancers associated with expression of DLL3. The first part of the trial is designed to determine a dose for additional clinical investigations. The trial plans to enroll patients with SCLC that have relapsed following at least one line of platinum-based chemotherapy. HPN328 will be administered to patients once weekly by intravenous infusion with dose escalation until a therapeutic dose level has been achieved. The primary outcome measure will be to assess safety and tolerability, and to determine a dose for Phase 2.

Following dose escalation, Harpoon may further evaluate the safety and efficacy of HPN328 in additional parallel cohorts. The primary outcome measure will be to determine efficacy for the Phase 2 dose based on the overall response rate as determined by RECIST. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT04471727.

On January 4, 2021 Genmab A/S (Nasdaq: GMAB) reported the initiation of innovaTV 301 trial, a global phase 3 study to evaluate the efficacy of tisotumab vedotin compared to chemotherapy in patients with recurrent or metastatic cervical cancer who have received one or two prior lines of systemic therapy (Press release, Genmab, JAN 4, 2021, View Source [SID1234573404]). The innovaTV 301 trial is a global, randomized phase 3 trial in which tisotumab vedotin will be compared with physician’s choice single agent chemotherapy.

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"Currently, there is no established standard of care for women with recurrent or metastatic cervical cancer, who have disease progression after first or second line of therapy. There is a need for a novel, safe and effective treatment option that can improve the clinical outcome for these patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to the innovaTV 301 trial which is designed to support potential regulatory applications for marketing approval globally and serve as a confirmatory trial for a potential accelerated approval in the US for patients with metastatic or recurrent cervical cancer."

About the innovaTV 301 Trial
The open label, randomized, global, phase 3 trial of tisotumab vedotin versus chemotherapy will enroll approximately 482 patients with recurrent or metastatic cervical cancer who have received one or two prior lines of systemic therapy for their recurrent or metastatic disease. Eligible patients will be randomized to receive either tisotumab vedotin 2.0 mg/kg every three weeks or investigator’s choice of chemotherapy. The primary endpoint of the study is overall survival. This global study will be sponsored and performed by Seagen Inc. in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT) and the Gynecologic Oncology Group (GOG).

About Tisotumab Vedotin
Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a protein that can promote tumor growth, angiogenesis and metastasis.1 Based on its high expression on many solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

Tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in a range of solid tumors, including recurrent and/or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule.

About Cervical Cancer
Cervical cancer originates in the cells lining the cervix. Over 13,500 women are expected to be diagnosed with invasive cervical cancer in the U.S. in 2020, with approximately 4,200 deaths.2 Cervical cancer remains one of the leading causes of cancer death in women globally, with over 311,000 women dying annually; the vast majority of these women being in the developing world.3 Routine medical examinations and human papillomavirus (HPV) vaccines have lowered the incidence of cervical cancer in the developed world. Despite these advances, women are still diagnosed with cervical cancer, which often recurs or becomes metastatic.

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.

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 (#).