On September 9, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate in the following virtual investor conferences in September (Press release, Hookipa Pharma, SEP 9, 2020, View Source [SID1234564804]):

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H.C. Wainwright 22nd Annual Global Investment Conference, September 14-16, 2020
Presentation: Monday, September 14, 2020 at 10:30 AM ET

Morgan Stanley Virtual Global Healthcare Conference, September 14-18, 2020
Presentation: Tuesday, September 15, 2020 at 12:30 PM ET

BofA Global Healthcare Conference 2020, September 16-18, 2020
Presentation: Wednesday, September 16, 2020 at 2:10 PM BST
The live audio webcast of the presentation held at the H.C. Wainwright 22nd Annual Global Investment Conference, Morgan Stanley Virtual Global Healthcare Conference and BofA Global Healthcare Conference will be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

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.

On September 9, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan for Annamycin, including the clinical study design and dosing strategy for the initial phase 1b/2 protocol for soft tissue sarcomas with lung metastases (Press release, Moleculin, SEP 9, 2020, View Source [SID1234564802]).

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Moleculin submitted a proposed clinical protocol for FDA review entitled, "Phase 1b/2 Study of Liposomal Annamycin (Annamycin) in Subjects with Previously Treated Soft-Tissue Sarcomas with Pulmonary Metastases." The proposed study is an open-label, multicenter, single-arm, dose escalation and expansion study to evaluate single-agent Annamycin in up to 55 patients with soft tissue sarcoma (STS) with lung metastases for whom chemotherapy is considered appropriate. The primary objectives of the dose escalation phase are to evaluate the safety of Annamycin and identify the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D).

In summary, the FDA, among other items:

did not object to the proposed clinical study design while providing guidance on additional assessments

agreed the proposed dose escalation schedule appeared reasonable

commented regarding the consideration for including adolescents in oncology clinical trials

stated that a repeat dose toxicology study of 3 months is required before initiating a registration study

recommended an EOP1 meeting after completion of the RP2D.

"We are pleased to complete the pre-IND meeting with the FDA, and will move forward with our plans to file the IND by the end of 2020 and initiate a Phase 1b/2 trial of Annamycin for the treatment of soft tissue sarcomas metastasized to the lungs," said Wally Klemp, Chief Executive Officer of Moleculin. "We appreciate the FDA’s guidance as we endeavor to find a cure for certain cancers metastasized to the lungs."

On September 9, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), reported that Michael Bonney, Executive Chair, will participate in the following upcoming conferences in September (Press release, Kaleido Biosciences, SEP 9, 2020, View Source [SID1234564801]). Each conference will involve a fireside chat presentation.

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Event: Morgan Stanley 18th Annual Global Healthcare Conference
Date: Wednesday, Sept. 16, 2020
Time: 12:30 p.m. EDT

Event: Cantor 2020 Virtual Global Healthcare Conference
Date: Thursday, Sept. 17, 2020
Time: 3:20 p.m. EDT

A live webcast of each event will be available in the Investors & Media section of the Kaleido website at View Source Archived replays will be accessible following each event.

On September 9, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that its chief executive officer, Dr. Gerrit Dispersyn, will present at the upcoming H.C. Wainwright 22nd Annual Global Investment Conference, held virtually this year from September 14 – 16, 2020 (Press release, Phio Pharmaceuticals, SEP 9, 2020, View Source [SID1234564800]).

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Dr. Dispersyn is scheduled to present on Wednesday, September 16th, at 11:30 a.m. ET. Interested parties may access a live webcast of the presentation at View Source

An archived version of the webcast and the slides used in the presentation will be made available on the "Investors – Events and Presentations" section of the Company’s website after the live event.