Alkermes to Take Part in Cantor Virtual Global Healthcare Conference

On September 9, 2020 Alkermes plc (Nasdaq: ALKS) reported that that its Chief Executive Officer, Richard Pops, will participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on Wednesday, Sept. 16, 2020 at 10:40 a.m. ET (3:40 p.m. BST) (Press release, Alkermes, SEP 9, 2020, View Source [SID1234564903]). The webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alligator Bioscience presents an update regarding the Phase I study with the drug candidate ATOR-1015

On September 9, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported updated timelines indicating 3-6 months delay for the planned Phase Ib study with ATOR-1015, its tumor-localizing, bispecific CTLA-4 and OX40 antibody developed for treatment of metastatic cancer (Press release, Alligator Bioscience, SEP 9, 2020, View Source [SID1234564803]).

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As previously communicated, preliminary data from the ongoing Phase I study have shown that ATOR-1015 is well tolerated at doses up to 600 mg (about 10 mg/kg), which is believed to be a clinically relevant dose range. At the current dose of 750 mg (~12.5 mg/kg), some grade 3 infusion related reactions have been reported which is expected to result in further dose evaluations.

"While the infusion related reactions will lead to the selection of a Phase Ib dose below 750 mg, we are still considerably higher in dose than our competitors and well within clinically relevant dose levels", commented Per Norlén, CEO at Alligator Bioscience.

The ongoing Phase I dose escalation will be completed during the fourth quarter 2020 as previously communicated. The start of the Phase Ib expansion in malignant melanoma will be pushed into 2021 due to study amendments to adjust for the observed reactions. Recruitment will start as soon as regulatory approval has been obtained.

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 1:40 p.m. CEST on September 9, 2020.

About ATOR-1015
ATOR-1015 is a tumor-localizing, bispecific CTLA-4 and OX40 antibody developed for treatment of metastatic cancer. Promising data from the ongoing ATOR-1015 Phase I clinical trial was presented at ASCO (Free ASCO Whitepaper) in June 2020 and dose escalation continued at the higher dose 750 mg. The next step in the ATOR-1015 clinical development plan is a Phase Ib study for demonstration of single-agent activity.

Germany’s first Ethos Therapy Ordered by the German Cancer Research Center

On September 9, 2020 Varian (NYSE: VAR) reported the German Cancer Research Center (DKFZ) in Heidelberg has ordered Germany’s first Ethos therapy, an Adaptive Intelligence solution (Press release, Varian Medical Systems, SEP 9, 2020, View Source [SID1234564824]). This artificial intelligence (AI)-driven holistic solution is designed to increase the capability, flexibility, and efficiency of radiotherapy. Ethos therapy delivers an entire adaptive treatment in a typical 15-minute timeslot, from patient setup through treatment delivery. The first Ethos therapy in Germany is scheduled to be installed and start treating patients by early 2021.

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"Adaptive therapy is one of the most important developments in the field of radiotherapy," said Prof. Dr. Michael Baumann, CEO and scientific director at DKFZ. "At DKFZ, cancer researchers and oncologists are closely cooperating to get the latest research findings rapidly from bench to bedside, as well as transfer the insights gained from the treatment back from clinic to the lab. Ethos therapy will complement both our research and treatment activities at DKFZ, and we are looking forward to applying adaptive radiotherapy in this context."

"We are very proud that DKFZ, the largest biomedical research center in Germany, has selected Ethos to conduct both research into adaptive radiotherapy and to put this research directly into practice," said Chris Toth, president, Varian Oncology Systems. "Since its introduction in September 2019, Ethos therapy has been recognized by leading clinics around the world as a game changer that is unlocking a new era of personalized adaptive radiation therapy."

DKFZ is among the most renowned cancer research facilities in the world, with 3,000 employees working tirelessly to gain a better understanding of cancer and putting their research findings to medical use for patients. Located on the Heidelberg biomedical campus, DKFZ scientists are engaged in a large number of national and international partnerships and research alliances and cooperate closely with several university hospitals in translational networks. The DKFZ Ethos therapy was financed by the Dieter Morszeck Foundation.

Ethos Therapy

The streamlined workflow of Ethos therapy is enabled by its AI-driven planning and contouring capabilities. Physicians define their clinical intent from predefined templates and the initial treatment plan is generated based on the physician’s pre-defined clinical objectives. The treatment is adapted in response to changes in the patient’s anatomy and the tumor’s shape and position, at the time of treatment. The ability of Ethos to deliver on-couch adaptive treatment puts the patient at the center of care.

Ethos therapy offers the use of multimodality images (MR, PET, CT) registered with daily iterative CBCT images at the console. By providing an up-to-date view of the patient’s anatomy, Ethos therapy provides clinicians the confidence to make more informed adaptive treatment decisions. The solution is built on Varian’s latest treatment delivery technology and provides fast imaging and treatment delivery without compromising quality.

Ethos therapy has obtained CE mark, as well as 510(k) clearance. Its availability is rapidly expanding across multiple markets worldwide. For more information on Ethos, visit www.varian.com/ethos.

Scholar Rock Announces First Patient Dosed in Part A2 of DRAGON Phase 1 Proof-of-Concept Trial of SRK-181 to Overcome Primary Resistance to Anti-PD-(L)1 Therapy

On September 9, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that the first patient has been dosed with SRK-181 in combination with anti-PD-(L)1 therapy in Part A2 of the DRAGON Phase 1 proof-of-concept trial (Press release, Scholar Rock, SEP 9, 2020, View Source [SID1234564845]). Part A1 of the DRAGON trial has successfully progressed dose escalation of SRK-181 monotherapy through 800 mg and continues to advance dose escalation . Part A1 and Part A2 are being conducted in a parallel but staggered fashion and will each evaluate doses up to 2400 mg. SRK-181 is a potent and highly selective inhibitor of latent TGFβ1 activation and is being developed to increase responses to immunotherapy by overcoming primary resistance to anti-PD-1 or anti-PD-L1 antibody therapy.

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"We are encouraged by the dose escalation progress-to-date in Part A1 of the DRAGON trial, which has enabled us to begin the evaluation of SRK-181 in combination with anti-PD-(L)1 therapy," said Yung Chyung, M.D., Chief Medical Officer of Scholar Rock. "While checkpoint inhibitor therapies have become standard of care for a large number of cancer patients, there is still significant unmet need as many patients demonstrate resistance to this therapeutic class. It is our belief that SRK-181 could help overcome this immune exclusion and has the potential to increase the therapeutic benefit of this class of drugs."

The DRAGON Phase 1 open-label, dose escalation and dose expansion clinical trial consists of two parts to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRK-181 in adult patients with locally advanced or metastatic solid tumors enrolled across multiple sites in the U.S. The Part A dose escalation portion of the trial is evaluating SRK-181 as both a single agent (Part A1) and in combination with approved anti-PD-(L)1 therapy (Part A2). The Part B dose expansion portion of the trial is expected to initiate in the first quarter of 2021 and will evaluate SRK-181 in combination with approved anti-PD-(L)1 therapy in multiple tumor-specific cohorts, including urothelial carcinoma, cutaneous melanoma, non-small cell lung cancer, and other solid tumors. As is the case in Part A2, Part B of the trial will enroll patients with locally advanced or metastatic solid tumors who had a lack of response to anti-PD-(L)1 therapy. These patients will be treated with SRK-181 in combination with anti-PD-(L)1 therapy to evaluate if they are able to achieve an anti-tumor response. Intravenous (IV) SRK-181 is administered every 3 weeks (Q3W) and additional dosing regimens may be explored. An update on Part A dose escalation is expected in the fourth quarter of 2020 and efficacy and safety data from Part B of the trial is anticipated starting in 2021.

About SRK-181

SRK-181 is a potent and highly selective inhibitor of TGFβ1 activation and is an investigational product candidate being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies. TGFβ1 is the predominant TGFβ isoform expressed in many human tumors, particularly for those tumors where checkpoint therapies are currently approved. Based on analyses of human tumors that are resistant to anti-PD-(L)1 therapy, data suggests TGFβ1 is a key contributor to excluding immune cell entry into the tumor microenvironment, thereby preventing normal immune function. Scholar Rock believes SRK-181 has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy. By specifically targeting the latent TGFβ1 isoform, Scholar Rock hypothesizes that SRK-181 can increase the therapeutic window by potentially avoiding toxicities associated with non-selective TGFβ inhibition. A Phase 1 proof-of-concept clinical trial in patients with locally advanced or metastatic solid tumors is ongoing. The effectiveness and safety of SRK-181 have not been established and SRK-181 has not been approved for any use by the FDA or any other regulatory agency.

Leap Therapeutics to Present at H.C. Wainwright 22nd Annual Global Investment Conference

On September 9, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that Douglas E. Onsi, President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 22nd Annual Global Investment Conference, being held virtually on September 14-16, 2020 (Press release, Leap Therapeutics, SEP 9, 2020, https://www.prnewswire.com/news-releases/leap-therapeutics-to-present-at-hc-wainwright-22nd-annual-global-investment-conference-301126144.html [SID1234564878]).

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Leap Presentation Details:

H.C. Wainwright 22nd Annual Global Investment Conference
Date: Wednesday, September 16
Presentation Time: 3:00 p.m. Eastern Time

The presentation will be webcast live and may be accessed on the Investors page of the company’s website at View Source, where a replay of the event will also be available for a limited time.