Medivir has determined the starting dose for the next part of the phase Ib study with MIV-818

On April 19, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that the last patient has undergone the safety follow-up to identify potentially dose-limiting toxicity from the first part of the phase Ib study with the company’s leading candidate drug, MIV-818, against liver cancer (Press release, Medivir, APR 19, 2021, View Source [SID1234578206]). The results were positive and the recommended dose for the next phase has thus been determined.

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At present, three patients continue to be active on treatment within the study, and they will continue treatment until intolerable side effects or disease progression occur. The second part of the phase Ib study, where MIV-818 is given together with standard treatment, is planned to be initiated during the second half of 2021.

The results continue to be promising and show a good safety and tolerability profile. The study is proceeding according to plan and now the recommended starting dose has been set for the next study where we combine MIV-818 with standard treatment. We now look forward to initiating that study during the second half of 2021, said Yilmaz Mahshid, CEO of Medivir.
Details of the coming study are planned to be presented during the second quarter of 2021. Detailed results from the first part of the phase Ib study are expected to be presented at an upcoming scientific conference.

For further information, please contact:
Yilmaz Mahshid, CEO, Medivir AB, phone: +46 (0)8 5468 3100.
[email protected]

About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug for patients with HCC and other forms of liver cancer.

About liver cancer
Liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. HCC is a very diverse disease with multiple cancer cell types and without specific mutations seen in other tumor types. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

PharmAbcine announces Clinical Trial Collaboration with MSD for the Phase II study in mTNBC

On April 19, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, reported that the company has entered into an agreement with MSD to initiate a Phase II combination trial of olinvacimab, an anti-VEGFR2 antibody, and KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in metastatic Triple-Negative Breast Cancer(mTNBC) (Press release, PharmAbcine, APR 19, 2021, View Source [SID1234578205]).

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The phase II clinical trial, an open-label, multicenter trial, will enroll immuno-oncology drug naïve mTNBC patients regardless of their PD-L1 expression level to evaluate the clinical efficacy, safety, pharmacodynamics, and the expression level of VEGFR-2 and PD-L1 after administering 16mg/kg of olinvacimab and 200mg of pembrolizumab.

The companies have entered this collaboration based on the promising clinical data obtained from the phase Ib olinvacimab and pembrolizumab study in mTNBC which is currently ongoing in Australia. According to the interim result as of September 2020, the combo therapy showed a manageable safety profile with 50% ORR (Overall Response Rate) and 67% DCR (Disease Control Rate) in patients who received olinvacimab plus pembrolizumab at the recommended phase 2 dose (RP2D) (N=6pts). In addition, 1 patient in PR (Partial Response) showed CR (Complete Response) in the target lesion and another PR patient showed CR in a non-target lesion.

Under the terms of the agreement, PharmAbcine will sponsor a phase II clinical trial that will take place in both Australia and South Korea, and MSD will supply KEYTRUDA.

"Helping cancer patients is core to our mission. Based on the safety profile and early clinical efficacy observed in the phase Ib trial, we feel we have a responsibility to explore olinvacimab in combination with pembrolizumab in mTNBC patients further in phase II," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We will try our best so the multinational clinical study can begin in the first half of 2021."

About Metastatic Triple Negative Breast Cancer (TNBC)
mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 15-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike some other breast cancers, mTNBC does not express estrogen receptor, progesterone receptors and human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is still very difficult to treat, and there are very few FDA approved treatment options for these patients.

About Olinvacimab

PharmAbcine’s leading pipeline, olinvacimab, an anti-VEGFR2 neutralizing fully human IgG, is currently in a phase II study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients in both US and Australia. In addition to the combination of olinvacimab and pembrolizumab trial in mTNBC, another olinvacimab plus pembrolizumab Phase Ib trial for rGBM is ongoing in Australia.

ViewRay Announces Conference Call for First Quarter 2021 Financial Results to be Held After Market on May 6, 2021

On April 19, 2021 ViewRay, Inc. (Nasdaq: VRAY) reported details relating to the release of its first quarter 2021 financial results (Press release, ViewRay, APR 19, 2021, View Source [SID1234578204]).

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ViewRay will hold a conference call to discuss results on Thursday, May 6, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (888) 771-4371 for domestic callers and (847) 585-4405 for international callers. The confirmation number is 50150605. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until May 13, 2021. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 8484107.

Jazz Pharmaceuticals to Report 2021 First Quarter Financial Results on May 4, 2021

On April 19, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2021 first quarter financial results on Tuesday, May 4, 2021 after the close of the financial markets (Press release, Jazz Pharmaceuticals, APR 19, 2021, View Source [SID1234578203]). Company management will host a live audio webcast at 4:30 p.m. ET/9:30 p.m. IST to discuss first quarter 2021 financial results and provide a business and financial update.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. A replay of the webcast will be archived on the website for at least one week.

AACR 2021-ImmVira presents the preclinical study results of MVR-T3011 via intravenous administration

On April 19, 2021 ImmVira reported the preclinical study results of MVR-T3011 via intravenous administration through publication in a virtual poster at the AACR (Free AACR Whitepaper) annual meeting (Press release, Immvira, APR 19, 2021, View Source [SID1234578202]). MVR-T3011 is a replication competent and genetically modified oncolytic herpes simplex virus-1 expressing human interleukin-12 and anti-PD-1 antibody. ImmVira owns the global right for development and commercialization of MVR-T3011 via intravenous administration.

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Oncolytic virus(OV) has been proven to inhibit tumor growth in a number of superficial tumors through intratumoral injection. From clinical studies, intratumoral injection of OV has been proved to provide effective treatment against tumor via its abscopal effect, transitions from immunologically cold to hot tumor and combination with other cancer therapies. However, to advanced tumors, especially the lesions of multiple metastasis are ideally treated via a systemic route. At present, common types of viruses that have been studied clinically for intravenous administration are Vaccinia virus, Coxsackie virus and Reovirus etc. However, for various reasons, most virus types used in developing oncolytic viruses including HSV-1 and adenoviruses, have not been fully studied for intravenous administration preclinically and clinically.

In the preclinical study conducted by ImmVira, intravenous administration of MVR-T3011 demonstrated enrichment of viral DNA in tumor tissue. MVR-T3855, the surrogate of MVR-T3011 for mouse, was shown to significantly extend the survival time of several mouse with orthotopic tumors including primary and metastatic lung cancer and primary liver cancer, and repeated dose via intravenous administration has clearly enhanced antitumor effect. Furthermore, intravenous administration or intra-cavity of MVR-T3855 significantly delayed or prevented the formation of malignant ascites in mouse liver model. In terms of safety, the three-month pre-clinical study showed that the intravenous administration of MVR-T3011 and MVR-T3855 did not cause significant adverse reactions and had clinical significance. After administration, no histopathological change was found in non-target organs.

ImmVira submitted an IND application for MVR-T3011 intravenous administration to the U.S. FDA in January 2021 and expects to recruit patients in five leading U.S. research cancer centers within the next few weeks.