On November 23, 2020 Exelixis, Inc. (Nasdaq: EXEL) reported that members of the company’s management team will participate in fireside chats at the following virtual investor conferences in December (Press release, Exelixis, NOV 23, 2020, View Source [SID1234571606]):

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Piper Sandler 32nd Annual Virtual Healthcare Conference: Due to the virtual nature of this year’s conference, presentation sessions were pre-recorded and available on-demand. Exelixis’ fireside chat session is now available to stream on the company’s website.
Evercore ISI 3rd Annual HealthCONx: Exelixis is scheduled to present at 3:05pm EST / 12:05pm PST on Tuesday, December 1, 2020.
To access the webcast links, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentations to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for 14 days.

On November 23, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported the publication of clinical data that provides molecular insight into TRC102’s mechanism of action and patient populations most likely to respond to treatment (Press release, Tracon Pharmaceuticals, NOV 23, 2020, View Source [SID1234571567]). The article, entitled, "Molecular Features of Cancers Exhibiting Exceptional Responses to Treatment," highlights the clinical features and tumor biology of an exceptional responder patient treated with TRC102 at the National Cancer Institute (NCI): View Source

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The patient was diagnosed with metastatic and highly refractory colorectal cancer and received temozolomide (Temodar) and TRC102. Following treatment, the patient was considered an exceptional responder through the achievement of a near compete response lasting 45 months at the most recent follow-up. Detailed molecular analyses of the patient’s tumor showed silencing of DNA repair pathways that may have resulted in sensitivity to the inhibition of DNA base excision repair pathway by TRC102. Specifically, MGMT expression was silenced by promoter methylation, and RAD50, a mediator of DNA double strand break repair, was silenced by genetic mutation and loss of heterozygosity. The publication authors hypothesized that the combination of Temodar and TRC102 was effective because all necessary DNA repair pathways were compromised genetically or through the activity of TRC102. MGMT expression was also assessed in biopsies from 11 colorectal patients who subsequently enrolled in an expansion cohort, one of which demonstrated a partial response. The tumor associated with the partial response did not express MGMT, whereas each of the 10 tumors that did not respond to therapy expressed this enzyme robustly.

TRC102 is being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the NCI through a Cooperative Research and Development Agreement. TRC102 was also evaluated in a Phase 2 trial in combination with Temodar chemotherapy in 19 patients with progressive or recurrent glioblastoma who progressed following Temodar and external beam radiotherapy. Extended survival was observed in two patients for more than two years, both of whom demonstrated activation of the DNA base excision repair pathway and showed hyperactivation of DNA damage response genes prior to treatment with TRC102.

"The Cancer Cell publication supports our belief that patients whose cancers are dependent on the DNA base excision repair pathway to repair DNA damage from chemotherapy may be particularly sensitive to the pharmacologic effects of TRC102," said James Freddo, M.D., Chief Medical Officer of TRACON. "The NCI data are also consistent with the results from the Phase 2 trial of Temodar and TRC102 in refractory glioblastoma. We remain committed to developing TRC102 in collaboration with the NCI and believe that the data generated to date provide strong rationale for studying TRC102 in combination with Temodar and radiotherapy in newly diagnosed patients with malignant glioma."

About TRC102

TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA). TRC102 was granted orphan drug designation by the US FDA for the treatment of malignant glioma in 2020. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical-trials.

About Malignant Glioma and GBM

GBM (also called glioblastoma) is a fast-growing malignant glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is the most invasive type of glial tumors, rapidly growing and commonly spreading into nearby brain tissue. The National Cancer Institute estimates that approximately 22,850 adults (12,630 men and 10,280 women) are diagnosed with brain and other nervous system cancer annually in the U.S. and approximately 15,320 of these diagnoses will result in death. GBM has an incidence of two to three per 100,000 adults per year in the U.S., and accounts for 52 percent of all primary brain tumors.

On November 23, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that highlighted its intellectual property portfolio for apamistamab, a CD45 targeting antibody, and the Antibody Radiation Conjugate (ARC) comprised of apamistamab and the radioisotope iodine-131 used in the Company’s lead Phase 3 candidate, Iomab-B, and its Iomab-ACT programs (Press release, Actinium Pharmaceuticals, NOV 23, 2020, View Source [SID1234571585]). Actinium owns issued or pending patents within the United States and globally covering composition of matter, formulation, methods of use, and methods of administration with potential coverage for 19 years or longer. Importantly, Actinium owns an issued patent in the US covering composition of matter, for which the Company expects validity until 2037. In addition, the Company owns a second issued US patent that further covers composition of matter, methods of use, and methods of administration for Iomab-B. The company has also received a notice of allowance in Europe for this second patent and expects it to be in force until 2036.

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Iomab-B is currently being investigated in the ongoing pivotal Phase 3 SIERRA trial, which is over 75% enrolled, for targeted conditioning prior to potentially curative bone marrow transplant (BMT) for patients with relapsed or refractory Acute Myeloid Leukemia ("R/R AML"). In addition, Actinium is utilizing apamistamab with lower doses of iodine-131, known as Iomab-ACT, for targeted conditioning prior to gene therapy and adoptive cell therapy ("ACT"), namely CAR-T, including in its recently announced collaboration with Memorial Sloan Kettering Cancer Center that is supported by NIH STTR Fast Track grant funding.

"The continued protection of our lead asset Iomab-B, our Iomab-ACT program and apamistamab by a strong patent position is an important component of our development efforts, particularly as we approach the conclusion of our pivotal Phase 3 SIERRA trial for BMT conditioning in R/R AML The growth of BMT, ACT and Gene Therapy has highlighted the importance of conditioning and the need to move beyond non-targeted chemotherapy to increase the number of patients that could benefit from these potentially curative therapies. CD45 is an ideal target for conditioning applications given its unique expression on blood cancer cells and blood forming stem and immune cells and with no expression outside the hematopoietic or blood system," said Dr. Dale Ludwig, Actinium’s Chief Scientific Officer. "Apamistamab is well characterized and its use in conditioning is supported by extensive clinical data across multiple clinical trials and indications. Our robust data shows that apamistamab has a favorable biodistribution profile that, together with our ARC technology, has significant advantages over other approaches such antibody drug conjugates that require payload internalization, making them impractical for targeting CD45. Further, our ARC approach allows us to use varying intensities of targeted radiation to achieve our desired conditioning outcome. With these important patents in place, and continued expansion of our patent portfolio in the US, EU and other select countries, we look forward to continuing to build out our targeted conditioning strategic business unit."

About Iomab-B

Iomab-B is Actinium’s lead product candidate that is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, apamistamab (formerly BC8), labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells. In a Phase 1/2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, Iomab-B produced enabled 100% of patients to proceed to transplant with all patients achieving transplant engraftment by day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 300 patients in a number of blood cancer indications, including acute myeloid leukemia, chronic myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, Hodgkin’s disease, Non-Hodgkin lymphomas and multiple myeloma. Actinium obtained the worldwide, exclusive rights to apamistamab (BC8) and Iomab-B from the Fred Hutchinson Cancer Research Center. Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.

On November 23, 2020 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported they will participate in a fireside chat at the 2020 Evercore ISI HealthCONx Conference on Tuesday, December 1st at 8:20 a.m. PT/11:20 a.m. ET. Dan Faga, Executive Vice President and Chief Operating Officer, will represent Mirati at the event (Press release, Mirati, NOV 23, 2020, https://www.prnewswire.com/news-releases/mirati-therapeutics-to-participate-in-the-2020-evercore-isi-healthconx-conference-301179205.html [SID1234571607]).

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The webcast will be available through the "Investors" section of the Mirati website at View Source, and a replay of the webcast will be made available for 90 days following the event.

On November 23, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and OncoImmune, a privately-held, clinical-stage biopharmaceutical company, reported that the companies have entered into a definitive agreement pursuant to which Merck, through a subsidiary, will acquire all outstanding shares of OncoImmune for an upfront payment of $425 million in cash (Press release, Merck & Co, NOV 23, 2020, View Source [SID1234586359]). In addition, OncoImmune shareholders will be eligible to receive sales-based payments and payments contingent on the successful achievement of certain regulatory milestones. OncoImmune recently announced positive top-line findings from an interim efficacy analysis of a Phase 3 study evaluating its lead therapeutic candidate CD24Fc for the treatment of patients with severe and critical COVID-19.

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"Meaningful new therapeutic options are desperately needed for possibly millions of people around the world who will develop severe or critical COVID-19 disease," said Dr. Roger M. Perlmutter, President Merck Research Laboratories. "Recent clinical investigations support the view that CD24Fc may provide benefit beyond standard of care therapy for COVID-19 patients requiring oxygen support, and hence will represent an important addition to the Merck pipeline of investigational medicines and vaccines designed to address the COVID-19 pandemic."

Interim analysis of data from 203 participants (75% of the planned enrollment) reported by OncoImmune indicated that patients with severe or critical COVID-19 treated with a single dose of CD24Fc showed a 60% higher probability of improvement in clinical status, as defined by the protocol, compared to placebo. The risk of death or respiratory failure was reduced by more than 50%. Detailed results will be submitted for publication in a peer-reviewed medical journal.

"Outstanding work by the OncoImmune team has provided compelling evidence regarding the use of CD24Fc in patients with severe and critical COVID-19 in our Phase 3 Trial," said Yang Liu, PhD, Co-founder and Chief Executive Officer of OncoImmune. "We look forward to working with the scientists and manufacturing engineers at Merck as well as regulators as we seek to accelerate the global development of this potentially important therapy."

Under the agreement, prior to the completion of the acquisition, OncoImmune will spin-out certain rights and assets unrelated to the CD24Fc program to a new entity to be owned by the existing shareholders of OncoImmune. In connection with the closing of the acquisition, Merck will invest $50 million, and become a minority shareholder, in the new entity.

The closing of the acquisition, which is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions, is expected before the end of 2020.

OncoImmune was represented by Goodwin Procter LLP as legal advisor and Guggenheim Securities as financial advisor.

About SAC-COVID Phase 3 Trial

The SAC-COVID Phase 3 clinical trial (NCT04317040) is a randomized, double blind, placebo-controlled trial designed to evaluate the safety and efficacy of CD24Fc in hospitalized patients with COVID-19 requiring oxygen support, including those requiring supplemental oxygen, high flow oxygen, and mechanical ventilation. Participants were randomly assigned into two arms receiving either standard of care plus a single dose of CD24Fc via an intravenous infusion on Day 1 or standard of care plus placebo on Day 1. The multi-center trial was initiated in April 2020 and had enrolled 243 patients when the trial was closed to enrollment in September 2020.

About CD24Fc

OncoImmune’s lead product is CD24Fc, a first-in-class recombinant fusion protein that targets the innate immune system. Prior to the Phase 3 clinical trial for COVID-19 patients, CD24Fc has been studied for safety in healthy volunteers and in Phase 2 clinical trials for the prevention of graft versus host disease (GVHD) following hematopoietic stem cell transplantation in patients with leukemia. A pivotal Phase 3 clinical trial (NCT04095858) for prophylaxis of GVHD has been initiated nationwide.

About Merck’s ongoing Commitment to COVID-19

Merck has been committed to developing an effective response to COVID-19 since the early stage of the pandemic and is exploring multiple paths to advance the understanding of SARS-CoV-2 infection. In collaboration with Ridgeback Biotherapeutics, Merck is evaluating molnupiravir, an investigational orally available anti-viral candidate, in two Phase 2/3 trials, for the treatment of patients with COVID-19 in both the outpatient and inpatient settings.The company is also conducting clinical trials to evaluate two SARS-CoV-2/COVID-19 vaccine candidates: V590, being developed through a collaboration with IAVI, which utilizes a recombinant vesicular stomatitis vector, and V591 which uses a measles virus vector-based platform.