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Ichnos Sciences Welcomes Eric Feldman, M.D., as New Chief Medical Officer

On November 8, 2021 Ichnos Sciences Inc., a global biotechnology company developing innovative biologic treatments in oncology and autoimmune diseases, reported the appointment of Eric J. Feldman, M.D., to the position of Chief Medical Officer (CMO), effective immediately (Press release, Ichnos Sciences, NOV 8, 2021, View Source [SID1234594725]).

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Dr. Feldman, who reports to President and Chief Executive Officer Cyril Konto, M.D., will be responsible for all pipeline development activities, including Clinical Development, Clinical Operations, Regulatory Sciences, Pharmacokinetics and Translational Sciences, Biometrics and Drug Safety. Additionally, he will be the Co-Chair of the R&D leadership team and will collaborate closely with the discovery and antibody engineering organizations at Ichnos’ sites in Switzerland to select and set priorities for research targets.

Previously, Dr. Feldman served as Senior Vice President, Chief Medical Officer, at GlycoMimetics, leading the Phase 3 registration study of uproleselan in acute myeloid leukemia, as well as other early-stage assets. He also served as Chief Medical Officer at Amphivena, focusing on bispecific antibody therapies for blood cancers, and directed the myeloid leukemia antibody-drug conjugate (ADC) program at Seattle Genetics, Inc.

"My career has been devoted to developing new and better treatments for people with cancer and I am thrilled to join Ichnos to continue this journey," said Dr. Feldman. "I believe the BEAT platform[1] has immense potential and I look forward to leading the development efforts as we work to provide new options to cancer patients."

"Eric has over three decades of immuno-oncology drug development experience in industry and academia, during which he developed a broad spectrum of antibody-based therapeutics, including novel T-cell bispecific engagers for hematological malignancies and solid tumors," said Cyril Konto, M.D., CEO of Ichnos Sciences. "I am confident Ichnos will benefit from his knowledge and scientific leadership as we continue to advance the oncology portfolio."

Dr. Feldman received a medical degree at New York Medical College, and he holds a B.A. from Tulane University. His broad academic career includes a position as Professor of Medicine and Director of the Hematological Malignancies Service at Weill-Cornell/New York Presbyterian Hospital, and he has authored over 150 scientific articles and served as a former editor-in-chief of the Leukemia Research journal.

iBio to Report Fiscal 2022 First Quarter Financial Results and Provide Corporate Update on Monday, November 15, 2021

On November 8, 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable, plant-based FastPharming Manufacturing System, reported that it will report its fiscal 2022 first quarter financial results after market close on Monday, November 15, 2021 (Press release, iBioPharma, NOV 8, 2021, View Source [SID1234594724]). iBio management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

The live and archived webcast may be accessed on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section. The live call can be accessed by dialing (833) 672-0651 (domestic) or (929) 517-0227 (international) and referencing conference code: 7779281.

Gossamer Bio Announces Third Quarter 2021 Financial Results and Provides Corporate Update

On November 8, 2021 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the third quarter of 2021 and provided a corporate update (Press release, Gossamer Bio, NOV 8, 2021, View Source [SID1234594723]).

Clinical-Stage Product Candidate Updates

Seralutinib (GB002): Inhaled PDGFR, CSF1R and C-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)

Enrollment is ongoing in the TORREY Study, a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance (PVR) from baseline at week 24.
Due to COVID-19 related trial and site delays, topline data from the TORREY study are now expected in the second half of 2022, subject to developments in the ongoing COVID-19 pandemic.
Phase 2 TORREY Study protocol summary manuscript published in Pulmonary Circulation on October 22nd.
GB004: Oral, Gut-Targeted HIF-1α Stabilizer for Inflammatory Bowel Disease (IBD)

Enrollment has been completed in the ongoing SHIFT-UC Study, a Phase 2 clinical trial in patients with active ulcerative colitis (UC) despite treatment with 5-ASAs. The primary endpoint is proportion of patients with clinical remission at week 12.
12-week topline data from the SHIFT-UC study are expected in the second quarter of 2022.
36-week topline data from the treat-through portion of the SHIFT-UC study are expected in the fourth quarter of 2022.
GB5121: Oral, Covalent, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL)

First subject dosed in first-in-human Phase 1 clinical trial in healthy volunteers.
Gossamer expects to initiate a Phase 1b/2 clinical trial of GB5121 in PCSNL patients in the first half of 2022.
GB7208: Oral, Covalent, CNS-Penetrant BTK Inhibitor for Multiple Sclerosis

Gossamer expects to initiate a first-in-human Phase 1 clinical trial of GB7208 in healthy volunteers in the second half of 2022.
Financial Results for the Quarter Ended September 30, 2021

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2021, were $366.0 million. The Company expects the combination of current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into the second half of 2023.
Research and Development (R&D) Expenses: For the quarter ended September 30, 2021, R&D expenses were $43.2 million, compared to R&D expenses of $41.8 million for the same period in 2020.
General and Administrative (G&A) Expenses: For the quarter ended September 30, 2021, G&A expenses were $12.5 million, compared to $11.4 million for the same period in 2020.
Net Loss: Net loss for the quarter ended September 30, 2021, was $60.2 million, or $0.80 per share, compared to a net loss of $57.8 million, or $0.80 per share, for the same period in 2020.
Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 4:15 p.m. ET today, Monday, November 8, to discuss its third quarter 2021 financial results and provide a corporate update.

The live audio webcast may be accessed through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

GENFIT: Third Quarter 2021 Financial Information

On November 8, 2021 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, reported its cash position as of September 30, 2021 and revenues for the first nine months of 2021 (Press release, Genfit, NOV 8, 2021, https://ir.genfit.com/news-releases/news-release-details/genfit-third-quarter-2021-financial-information [SID1234594722]).

Cash Position

As of September 30, 2021, the Company’s cash and cash equivalents amounted to €91.5 million compared with €199.3 million a year earlier.

As of June 30, 2021, cash and cash equivalents totaled €104.4 million.

As a reminder, GENFIT announced on September 29, 2021 that given its cash position as of June 30, 2021 and the payments made to that date, the cost saving plan initiated in the second half of 2020 should allow the Company to reduce its net cash burn to €120 million for both 2021 and 2022 (excluding €47.5 million partial buyback of the OCEANES completed in January 2021).

Revenues2

Revenues for the first nine months of 2021 amounted to €20 thousand compared to €350 thousand for the same period in 2020.

Revenues for the first nine months of 2020 resulted mainly from non-recurring services provided and revenues under the licensing and collaboration agreements signed with Labcorp and Terns Pharmaceuticals.

Q BioMed Bolsters Commercialization of Strontium89 with EVERSANA Partnership

On November 8, 2021 Q BioMed Inc. (OTCQB: QBIO) a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector, reported it has engaged EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, to immediately support the commercialization of Strontium89, an FDA-approved cancer bone palliation radiotherapy (Press release, EVERSANA, NOV 8, 2021, View Source [SID1234594721]).

Strontium89 (Strontium Chloride Sr-89 Injection, USP) is the only approved radiotherapy currently available in the U.S. indicated for metastatic cancer bone pain palliation. In the Strontium89 pivotal trial, as many as 79% of patients had pain relief with Strontium89, and twice as many patients treated with Strontium89 had no pain for three months compared with a placebo. Further, new pain sites were less frequent in patients treated with Strontium89. Strontium89 is administered once every three months via injection, and patients can be re-treated if needed. Please see Important Safety Information below.

To support and accelerate the product’s rollout in the U.S., Q BioMed will leverage the EVERSANA COMPLETE Commercialization model which fully integrates services for: market access, agency services, clinical and commercial field teams, health economics and outcomes research and compliance. Each service is optimized by data and predictive analytics.

"We are pleased to have a partner like EVERSANA leading our commercialization efforts going forward, and I believe this adds tremendous value to what we had already established. The team is passionate about obtaining deep insights into the patient journey and using this knowledge to shape the strategic and creative process needed to maximize commercial successes," said Denis Corin, Chief Executive Officer of Q BioMed.

"Millions of patients are bearing the burden of devastating pain. We are immediately activating our commercial model to create more awareness, faster access and optimized product support for Strontium89 and its potential to change lives," said Jim Lang, CEO of EVERSANA.

The ready-to-deploy commercial platform is complemented by more than 5,500 EVERSANA employees and a dedicated commercialization leadership team, replacing Kristin Keller who is leaving Q BioMed. The EVERSANA field force and commercial team will augment an in-place contract sales force focused on the U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD).