On March 3, 2021 Century Therapeutics, a leading cell therapy company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported the closing of a $160 million Series C financing (Press release, Century Therapeutics, MAR 3, 2021, View Source [SID1234576045]). The financing was led by Casdin Capital and brought together a syndicate of new investors including Fidelity Management & Research LLC, the Federated Hermes Kauffmann Funds, RA Capital, Logos Capital, OrbiMed, Marshall Wace, Qatar Investment Authority, Avidity Partners, and Octagon Capital. Founding investors Versant Ventures and Leaps by Bayer also participated. Eli Casdin, Founder and Chief Investment Officer of Casdin Capital will be joining the Century Therapeutics Board of Directors.

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"We are fortunate to be surrounded by such a top-tier group of investors, whose support will enable the acceleration of Century’s technology platform into the clinic," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "With this new investor partnership, we are well-positioned to capitalize on the tremendous potential of our integrated iPSC, cell engineering and manufacturing capabilities to develop safer, more effective and more affordable next generation allogeneic cancer therapies."

Funds raised will help advance Century’s rich pre-clinical pipeline, which includes multiple iPSC-derived CAR-iT and CAR-iNK cell products. These products are designed to resist host rejection, enhance cell persistence, and allow repeat dosing to provide durable responses in all patients. The team anticipates beginning clinical testing of its first products in 2022, as well as generating multiple INDs annually in the coming years.

"It’s a remarkable and transformative time in the field, with the ability to engineer cells for therapeutic impact now a commercial reality. At the same time, iPSC technology has matured and is now leading the transition from bespoke autologous products to off-the-shelf allogeneic ones." said Eli Casdin CIO of Casdin Capital. "We could not be more excited to partner with the expert team at Century Therapeutics and do our part to help them leverage and accelerate their deep technical expertise in cellular reprogramming, differentiation, genetic engineering and manufacturing to deliver on this next phase of cellular therapy."

On March 3, 2021 Protagonist Therapeutics, Inc. (Nasdaq: PTGX), reported it will host a conference call and webcast on Wednesday, March 10 at 4:30 pm ET/1:30 pm PT to discuss its fourth quarter and full year 2020 financial results (Press release, Protagonist, MAR 3, 2021, View Source [SID1234576044]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Conference Call and Webcast Information

To access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (International) and refer to conference ID #: 7756175. A live webcast of the call will also be accessible on the Investors section of the Company’s website at www.protagonist-inc.com. The replay will be available on the Company’s website approximately two hours after the call.

On March 3, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that it will report financial results for the full year ended December 31, 2020 before the market opens on Monday, March 29, 2021, and host a conference call to discuss the results and provide a corporate update at 8:00 a.m. ET (Press release, I-Mab Biopharma, MAR 3, 2021, View Source [SID1234576043]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Conference Call and Webcast Information

I-Mab will host a live conference call and webcast on March 29, 2021 at 8:00 a.m. ET. Participants must register in advance of the conference call. Details are as follows:

Registration Link:

View Source

Conference ID:

4848159

Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.

A webcast replay will be archived on the Company’s website for one year after the conclusion of the call at View Source

A telephone replay will be available approximately two hours after the conclusion of the call. To access the replay, please call +1-855-452-5696 (U.S.), +61-2-8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 4848159.

On March 3, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported that Viracta will participate at the H.C. Wainwright Global Life Sciences Conference, being held March 9-10, 2021 (Press release, Viracta Therapeutics, MAR 3, 2021, View Source [SID1234576042]). A pre-recorded presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 7 a.m. ET on March 9, 2021. Viracta’s management team will also be available for one-on-one investor meetings at the conference.

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On March 3, 2021 Blueprint Medicines Corporation (NASDAQ: BPMC) reported that the European Medicines Agency (EMA) has validated the company’s Type II variation marketing authorization application for AYVAKYT (avapritinib) for the treatment of advanced systemic mastocytosis (SM) (Press release, Blueprint Medicines, MAR 3, 2021, View Source [SID1234576041]). Validation of the application confirms that the submission is sufficiently complete to begin the formal review process. The European Commission has granted orphan medicinal product designation to AYVAKYT for the treatment of mastocytosis.

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"AYVAKYT represents a promising approach to address the needs of patients with advanced systemic mastocytosis, a rare, life-threatening disease characterized by severe organ damage," said Paul Beresford, Senior Vice President and General Manager, International, at Blueprint Medicines. "In robust datasets across our registrational trials, AYVAKYT has shown complete and durable remissions not typically observed in this patient population, and a generally well-tolerated safety profile. We look forward to working closely with the EMA during the review process, and aim to bring the first precision therapy to patients in Europe that targets the primary driver of the disease."

AYVAKYT, a potent and selective inhibitor of D816V mutant KIT, is being developed to treat advanced and non-advanced forms of SM. Last month, Blueprint Medicines announced that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental new drug application and granted priority review for AYVAKIT (avapritinib) for the treatment of advanced SM.

About SM

SM is a rare disease driven by the KIT D816V mutation. Uncontrolled proliferation and activation of mast cells result in chronic, severe and often unpredictable symptoms for patients across the spectrum of SM. The vast majority of those affected have non-advanced (indolent or smoldering) SM, with debilitating symptoms that lead to a profound, negative impact on quality of life. A minority of patients have advanced SM, which encompasses a group of high-risk SM subtypes including aggressive SM, SM with an associated hematological neoplasm and mast cell leukemia. In addition to mast cell activation symptoms, advanced SM is associated with organ damage due to mast cell infiltration and poor survival.

Debilitating symptoms, including anaphylaxis, maculopapular rash, pruritis, diarrhea, brain fog, fatigue and bone pain, often persist across all forms of SM despite treatment with a number of symptomatic therapies. Patients often live in fear of severe, unexpected symptoms, have limited ability to work or perform daily activities, and isolate themselves to protect against unpredictable triggers. Currently, there are no approved therapies for the treatment of SM that selectively inhibit D816V mutant KIT.

About AYVAKYT (avapritinib)

AYVAKYT (avapritinib) is a kinase inhibitor approved by the European Commission for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring the PDGFRA D842V mutation. This medicine was approved by the FDA for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, under the brand name AYVAKIT.

AYVAKIT/AYVAKYT is not approved for the treatment of any other indication, including SM, in the U.S. by the FDA or in Europe by the European Commission, or for any indication in any other jurisdiction by any other health authority.

Blueprint Medicines is developing AYVAKIT globally for the treatment of advanced and indolent SM. The FDA granted breakthrough therapy designation to AYVAKIT for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematological neoplasm and mast cell leukemia, and for the treatment of moderate to severe indolent SM.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of AYVAKIT in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for AYVAKIT in the rest of the world.