Philogen to Attend the Festival of Biologics Basel on November 10, 2021

On August 6, 2021 Philogen reported its attendance at the Festival of Biologics Basel on November 10, 2021 (Press release, Philogen, AUG 6, 2021, View Source [SID1234586008])

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Roberto De Luca, Head of Antibody Therapeutics at Philogen, is giving a lecture entitled "Tripokin: tumor targeted delivery of IL2 potentiated by TNF"

Kaleido Biosciences to Participate in the 41st Annual Canaccord Genuity Growth Conference

On August 6, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported that CFO William Duke will participate in a fireside chat at the Canaccord Genuity Growth Conference at 2:30PM ET on Thursday, August 12 (Press release, Kaleido Biosciences, AUG 6, 2021, View Source [SID1234586005]).

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The webcast of the presentation will be made available in the Investors & Media section of Kaleido’s website at View Source An archived replay will be available for 90 days following the event.

Ichnos Sciences Nominates Innate Modulator ISB 1442 as Next Clinical Candidate for Treatment of Relapsed/Refractory Multiple Myeloma

On August 6, 2021 Ichnos Sciences Inc., a global biotechnology company developing innovative biologics in oncology and autoimmune diseases, reported that it has nominated ISB 1442, a CD38 x CD47 bispecific antibody for the treatment of relapsed/refractory multiple myeloma, as its next clinical candidate (Press release, Ichnos Sciences, AUG 6, 2021, View Source [SID1234586004]). This antibody is the first from Ichnos’ proprietary BEAT 2.0 platform1 to advance to preclinical development, and studies are underway to enable the filing of an investigational new drug (IND) application in the first quarter of 2022. With the BEAT 2.0 platform, Ichnos is able to accelerate the design and advancement of novel bi- and trispecific antibodies by optimizing binding affinity, epitope selection, molecular architecture, and Fc (fragment crystallizable) region function.

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ISB 1442 is a biparatopic bispecific antibody that combines two proprietary anti-CD38 binding arms, each targeting different regions on CD38, with an antagonistic anti-CD47 arm, making it equivalent to a trispecific antibody. The potency and anti-tumor activity of ISB 1442 has been shown in multiple in vitro and in vivo models. Additionally, the ability of ISB 1442 to simultaneously bind to CD38 and block CD47, and its enhanced signaling of FcR (fragment crystallizable receptors) on immune cells, differentiate it from anti-CD38 monospecific targeting therapeutics.

"Ichnos continues to make progress with this novel bispecific approach co-targeting CD38 and CD47 in hematologic malignancies, and we plan to share ISB 1442 preclinical results at a scientific congress later this year," said Cyril Konto, M.D., Chief Executive Officer of Ichnos. "We expect to initiate the first-in-human clinical study in relapsed/refractory multiple myeloma patients in the middle of next year. Despite having numerous products approved for this disease, patients continue to relapse, and more effective therapies are needed. Based on its unique design and mechanism of action, ISB 1442 is anticipated to enhance anti-tumor activity relative to anti-CD38 targeted therapies by overcoming primary and acquired tumor mechanisms of resistance."

GT Biopharma to Host Conference Call to Discuss Second Quarter 2021 Results

On August 6, 2021 GT Biopharma, Inc. ("GT Biopharma" or the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager (TriKE) protein biologic technology platform, reported that the management team will host a conference call to discuss second quarter 2021 financial results and general business updates on August 13, 2021 at 8:30 a.m. EST (Press release, GT Biopharma, AUG 6, 2021, https://ir.gtbiopharma.com/news/detail/230/gt-biopharma-to-host-conference-call-to-discuss-second-quarter-2021-results [SID1234586003]).

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To join the call:

U.S. callers should dial 1-877-870-4263 and international callers should dial 1-412-317-0790.
All participants should ask to be connected to the GT Biopharma conference call.
The call will be available by visiting the "Presentations" page in the "News & Media" section of GT Biopharma’s website at www.gtbiopharma.com/news-media/presentations. A replay of the call will be archived for 30 days following the presentation.

Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for ROLONTIS® (eflapegrastim)

On August 6, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for ROLONTIS (eflapegrastim). The CRL cited deficiencies related to manufacturing and indicated that a reinspection will be necessary. The company is seeking further clarification from the FDA and plans to meet with the agency as soon as possible.

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"We are disappointed with this outcome and look forward to fully understanding the remediation timelines for the program," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We continue to believe in ROLONTIS and plan to diligently complete the regulatory process to bring ROLONTIS to market."

About ROLONTIS

ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.