On February 23, 2021 Day One Biopharmaceuticals, a clinical-stage biopharmaceutical company focused on accelerating new, promising targeted therapies for children and adults with cancer, reported that it has entered into a global licensing agreement with Merck KGaA, Darmstadt, Germany, for an exclusive license to develop and commercialize pimasertib as well as a second compound, MSC2015103B (Press release, Day One, FEB 23, 2021, View Source [SID1234575482]). Pimasertib and MSC2015103B are oral, highly-selective small molecule allosteric inhibitors of MEK 1/2, a key enzyme in the MAPK signaling pathway. Dysregulation of the MAPK pathway has been shown to occur in many cancers.

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Pimasertib has been studied in more than 10 Phase 1/2 clinical trials in approximately 900 patients with various tumor types. Day One plans to initiate a Phase 1/2 study to evaluate the safety, tolerability, and preliminary efficacy of combining pimasertib with DAY101, the Company’s potential first-in-class, oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor, in patients ≥12 years of age with recurrent, progressive, or refractory solid tumors with MAPK pathway aberrations.

"Day One is purpose-built to accelerate innovative targeted therapies designed to help both children and adults with cancer," said Jeremy Bender, Ph.D., chief executive officer of Day One. "This license agreement with Merck KGaA, Darmstadt, Germany, exemplifies our core strategy to identify investigational potential treatment options such as pimasertib and leverage our expertise to rapidly advance them in patients who we believe will benefit the most. We are excited that a leading pharmaceutical company like Merck KGaA, Darmstadt, Germany recognizes the importance of our mission and look forward to the advancement of pimasertib in combination with our pan-RAF kinase inhibitor, DAY101."

"There is strong scientific and clinical rationale for targeting multiple nodes of the MAPK signaling pathway to drive deeper and more durable tumor responses," said Samuel Blackman, M.D., Ph.D., co-founder and chief medical officer of Day One. "DAY101 demonstrated encouraging single agent anti-tumor activity in pediatric low-grade glioma, and we believe the combination of pimasertib and DAY101 will be well-suited for adult patients with solid tumors given their greater heterogeneity. Further, data have shown DAY101 to selectively inhibit both RAF monomers and dimers which may broaden its potential clinical application in combination with MEK inhibition in solid tumors driven by non-BRAF V600 mutations and RAF fusions. We look forward to initiating a Phase 1/2 combination study later this year."

Under the terms of the agreement, Day One will make an upfront payment to Merck KGaA, Darmstadt, Germany plus additional regulatory, approval and sales-based milestone payments. Merck KGaA, Darmstadt, Germany will also receive royalties on potential net sales of pimasertib and MSC2015103B. Specific financial details are not disclosed.

About Pimasertib

Pimasertib is designed as a highly selective, oral, small molecule inhibitor of mitogen‐activated protein kinase kinases 1 and 2 (MEK1/2), of the MAPK signaling pathway. Dysregulation of the MAPK pathway has been shown to occur in many cancers. Pimasertib has been studied in more than 10 Phase 1/2 clinical trials in approximately 900 patients with various tumor types and has demonstrated a safety and efficacy profile comparable to other MEK inhibitors.

On February 23, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported that members of its senior management team are scheduled to participate in three virtual investor conferences in March (Press release, Repare Therapeutics, FEB 23, 2021, View Source [SID1234575481]). Details are as follows:

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Cowen 41st Annual Health Care Conference
Panel Discussion Title: Ovarian Cancer
Date: Tuesday, March 2, 2021
Time: 12:50 p.m. Eastern Time

H.C. Wainwright Annual Global Life Sciences Conference
Date: Tuesday, March 9 – Wednesday, March 10, 2021

Morgan Stanley Virtual Healthcare Corporate Access Day
Date: Tuesday, March 16, 2021

The prerecorded H.C. Wainwright presentation will be available on Tuesday, March 9, 2021, at 7:00 a.m. Eastern Time in the Investor section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 30 days.

On February 23, 2021 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that CEO David Giljohann will present at the 2021 H.C. Wainwright Global Life Sciences Conference, March 9-10, 2021 (Press release, Exicure, FEB 23, 2021, View Source [SID1234575480]).

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The presentation will be available to registered conference attendees for on-demand viewing beginning March 9, 2021 at 7:00AM EST via the virtual conference link, and will be archived for 90 days.

Exicure will be taking 1×1 investor meetings with registered conference attendees.

Replays of the presentation will be available on Exicure’s website for 30 days following the presentation.

On February 23, 2021 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for a pilot study evaluating the company’s lead drug candidate, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in progressive multifocal leukoencephalopathy (PML) (Press release, NeoImmuneTech, FEB 23, 2021, View Source [SID1234575479]). PML is a rare, aggressive, opportunistic brain infection caused by the reactivation of John Cunningham virus (JCV) in immunocompromised individuals. The investigator-initiated study will be led by Irene Cortese, M.D., of the National Institute of Neurological Disorders and Stroke (NINDS)/National Institute of Health (NIH).

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"With no anti-viral therapies available to treat PML, the only possibility for survival is to restore the antiviral immune response," said Dr. Cortese. "Unfortunately for many people who develop PML this is not easily achieved – and this is why we have strong interest in strategies that can facilitate and effectively speed up immune reconstitution, such as NT-I7."

PML is characterized by progressive damage of the white matter of the brain at multiple locations resulting from lytic infection of glia cells, leading to permanent damage of the affected nervous system, and in some cases can be fatal. Common conditions predisposing PML are hematologic and solid malignancies, rheumatologic disorders, primary immune deficiencies, and HIV infection. Currently, there is no specific prophylaxis for PML and no effective anti-JCV treatment.

"Following NT-I7’s FDA Orphan Drug Designation for the treatment of PML in June 2020, this IND clearance is an important step in developing a new treatment option for PML, a serious and potentially fatal infection of the brain," said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. "PML chiefly affects immunocompromised individuals. We believe that NT-I7’s ability to amplify T cells as well as increase their functionality could enhance the recovery of the immune system, bolster the immune response in PML patients, and thereby provide assistance to patients in fighting this devastating disease."

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On February 23, 2021 GenesisCare, a leading provider of integrated cancer care globally, and Prelude Corporation (PreludeDxTM), a leader in molecular diagnostics and precision medicine, reported a new strategic partnership aimed at increasing access to personalized breast cancer treatment and improved patient outcomes (Press release, GenesisCare, FEB 23, 2021, View Source [SID1234575478]).

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DCISionRT is a precision medicine test for women diagnosed with DCIS (Ductal Carcinoma in situ) or Stage 0 breast cancer who are treated with breast-conserving surgery. The DCISionRT test, developed by PreludeDx, assesses a woman’s 10-year risk of recurrence of DCIS or development of invasive breast cancer. The test provides predictive information regarding recurrence risk, allowing physicians to better select those patients who will benefit from radiation therapy in addition to surgery.

Patients with DCIS have abnormal cells lining the milk ducts of the breast that have not spread into surrounding breast tissue. According to a March 2020 report from the National Center for Biotechnology Information in the United States, 20 percent of all breast carcinomas are DCIS.1 In Australia, women who are diagnosed with DCIS are, on average, 3.9 times more likely to develop invasive breast cancer than Australian women of a similar age without DCIS.2 With the help of DCISionRT, doctors are able to better identify patients with elevated scores and provide patients with information on whether receiving radiation therapy, in addition to surgery, will reduce the risk of DCIS recurrence or invasive disease.3

The new partnership between GenesisCare and PreludeDx will make DCISionRT testing available in Australia, where the test is currently not offered, as well as increase patient access in the United States through GenesisCare’s network of integrated cancer treatment centers. Australian-headquartered GenesisCare is one of the largest networks of integrated oncology care in the world, with more than 440 treatment centers and clinics across the US, Australia, the UK, and Spain.

Through the partnership GenesisCare and Prelude will also investigate the clinical development of precision medicine tests, for breast or other cancers, with global real-world evidence. GenesisCare will draw on its global network of physicians and clinical research expertise through its Contract Research Organization to extend Prelude’s existing US based registry to Australia to advance and further evaluate DCISionRT’s impact on treatment decision-making for women with DCIS.

GenesisCare’s Founder and Global Chief Executive Officer, Dan Collins, said: "GenesisCare is delighted to be bringing this much-needed test to early-stage breast cancer patients in Australia and the United States."

"Over the last decade, we have witnessed the profound positive impact of precision medicine on the quality of life of cancer patients, through personalizing the therapeutic journey to an individual’s tumor and risk factors."

"The innovative DCISionRT test heralds a new era in the delivery of precision cancer care, and we are thrilled to be at the forefront of bringing this latest evolution in personalized medicine to early-stage breast cancer patients around the globe."

"Our new global partnership with PreludeDxTM will empower thousands of women with information about their own biological risk factors, enabling doctors and patients to make better-informed decisions about their treatment options," said Mr. Collins.

PreludeDx’s President and Chief Executive Officer, Daniel Forche, said: "We share GenesisCare’s mission to treat every cancer patient as an individual and we are thrilled to be partnering with GenesisCare to increase patient access to DCISionRT."

"This partnership is an important milestone as it means that for the first time, DCIS patients in Australia will have access to personalized information to better inform decisions about whether surgery alone or surgery with radiation therapy is appropriate."

"This partnership will also leverage GenesisCare’s international network outside of the US to rapidly expand our real-world data registry and we are excited about the clinical evidence we will be able to provide to patients, physicians, governments and payers," said Mr. Forche.

GenesisCare’s Global Chief Medical Officer, Dr. Wally Curran, said: "Historically, physicians have relied on clinical information and pathology to determine treatment plans for women with DCIS, but we can now employ molecular information from each patient’s cancer to personalize treatment plans with unrivaled confidence. We know that globally there are significant variations in the management of DCIS patients with radiotherapy in conjunction with surgery."

"This test levels the diagnostic playing field for DCIS patients and will empower physicians and patients to make better-informed decisions about treatment options based on a patient’s individual biological risk profile," said Dr. Curran.