On June 1, 2022 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported a corporate reorganization to extend its cash runway through 2023, including a workforce reduction of more than 25% (Press release, Atreca, JUN 1, 2022, View Source [SID1234615417]). Atreca will remain focused on the development of ATRC-101, ATRC-301, and its other preclinical oncology programs, and will continue efforts to generate new lead antibodies against tumor specific targets utilizing its proprietary discovery platform.

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"While we are taking steps to significantly streamline our operations, we remain committed to the development of ATRC-101 and ATRC-301, the advancement of earlier-stage assets, and the discovery of additional novel tumor-targeting lead antibodies using our platform," said John Orwin, Chief Executive Officer of Atreca. "We look forward to sharing additional monotherapy and combination data from the ongoing Phase 1b clinical trial of ATRC-101, as well as key preclinical toxicology data from the ATRC-301 program, later this year. While it is difficult to part with so many talented and valued members of our team, we view this as a necessary step to ensure we have the capital required to execute on our mission to deliver novel therapeutics to patients in need. I’d like to thank those leaving Atreca for their important contributions to the Company."

Corporate Updates and Revised Guidance

Atreca has extended its guidance on cash runway through the end of 2023 as a result of revisions to its operating plan and a workforce reduction of more than 25%, including both current employees and open positions.
Atreca still plans to present updated monotherapy and pembrolizumab combination data from the Phase 1b clinical trial of ATRC-101 in the second half of 2022.
Initial non-human primate toxicology data in the ATRC-301 development program remains expected in the second half of 2022.
Based on the efficiency of its discovery platform, Atreca continues to target one additional investigational new drug, or IND, filing per year beginning with ATRC-301 in 2023.
The chemotherapy combination arm of the ATRC-101 Phase 1b clinical trial is no longer expected to initiate enrollment in 2022.
"In 2022 so far, we’ve not only named our next clinical candidate, ATRC-301, an antibody drug conjugate targeting EphA2, but we’ve disclosed multiple lead-stage oncology programs, all generated via our discovery platform," said Tito A. Serafini, Ph.D., Chief Strategy Officer and Founder of Atreca. "Given the productivity of our platform, and the validation provided by ATRC-101 clinical activity reported earlier this year, we remain committed to leveraging the platform for the continued growth of our pipeline, while also supporting the development of existing programs. We sincerely thank our team, including those who are leaving Atreca, for working so creatively and diligently to build a highly efficient and scalable platform in service of delivering potential medicines to patients with unmet needs."

On June 1, 2022 Regeneron Pharmaceuticals, Inc., a New York corporation ("Regeneron" or the "Company"), and Sanofi Biotechnology SAS, a société par actions simplifée organized under the laws of France ("Sanofi Biotechnology"), reported that entered into the Amended and Restated Immuno-Oncology License and Collaboration Agreement (the "A&R IO LCA"), which amends the Immuno-Oncology License and Collaboration Agreement, dated as of July 1, 2015 and executed as of July 27, 2015 (as amended), by and between the Company and Sanofi Biotechnology (the "Original IO LCA") (Filing, 8-K, Regeneron, JUN 1, 2022, View Source [SID1234615411]). The A&R IO LCA is subject to and will become effective on the first day of the first month following receipt of all necessary authorizations and expiration of all necessary waiting periods applicable to the consummation of the A&R IO LCA (such date, the "A&R Effective Date").

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The Original IO LCA provides for Regeneron and Sanofi Biotechnology to collaborate on the development and commercialization of certain immuno-oncology products, including Libtayo (cemiplimab). From and after the A&R Effective Date, Regeneron will have the sole right to develop and commercialize Libtayo worldwide and no other products will be subject to the A&R IO LCA; and Regeneron will also obtain a license under certain intellectual property rights of Sanofi Biotechnology to develop and commercialize Libtayo worldwide and Sanofi Biotechnology will transfer to Regeneron certain regulatory, promotional, and other rights relating to the commercialization of Libtayo outside the United States. The parties have also entered into a transition services agreement, a transitional distribution agreement, and a manufacturing services agreement, pursuant to which, during certain transitional periods, Sanofi Biotechnology will perform for Regeneron certain transition, distribution, and manufacturing services, respectively.

Under the A&R IO LCA, the quarterly period ended March 31, 2022 is the last quarter for which Sanofi Biotechnology and Regeneron share net profits and losses for Libtayo under the Original IO LCA. From and after April 1, 2022 (after giving effect to certain true-up payments as set forth in the A&R IO LCA), Regeneron will be entitled to all profits from Libtayo and will pay Sanofi Biotechnology an 11% royalty on net product sales of Libtayo through March 31, 2034. In addition, the A&R IO LCA provides for the following payments by Regeneron to Sanofi Biotechnology: (i) a $900 million upfront payment, payable within 10 business days after the A&R Effective Date; (ii) a $100 million development milestone payment upon the first marketing approval from the U.S. Food and Drug Administration or the European Commission of Libtayo in non-small cell lung cancer in combination with chemotherapy; and (iii) sales milestone payments of up to $100 million in the aggregate upon achieving certain amounts of worldwide net product sales of Libtayo in 2022 or 2023.

Under the A&R IO LCA, the amount of development costs incurred under the Original IO LCA for which Regeneron is obligated to reimburse Sanofi Biotechnology is $35 million. Regeneron will reimburse Sanofi Biotechnology for such development costs by paying Sanofi a 0.5% royalty on Regeneron’s net product sales of Libtayo until Regeneron has reimbursed Sanofi Biotechnology for all such development costs.

Fifth Amendment to Antibody LCA. On June 1, 2022, Regeneron, Sanofi Biotechnology, and Sanofi, a société anonyme organized under the laws of France ("Sanofi Parent"), entered into the Fifth Amendment to Amended and Restated License and Collaboration Agreement (the "Fifth Amendment"), which amends the Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended), by and between the Company, Sanofi Biotechnology (as successor in interest to Aventis Pharmaceuticals Inc.) and Sanofi Parent (the "Antibody LCA") and will become effective on the A&R Effective Date. Pursuant to the Fifth Amendment, the parties amended the Antibody LCA, among other matters, to, from and after April 1, 2022, increase from 10% to 20% the percentage of Regeneron’s share of profits used to reimburse Sanofi Biotechnology for the remaining development costs incurred under the Antibody LCA subject to reimbursement by Regeneron.

The foregoing description of the A&R IO LCA and the Fifth Amendment is qualified in its entirety by reference to the full text of the A&R IO LCA and the Fifth Amendment, a copy of each of which will be filed with the U.S. Securities and Exchange Commission as an exhibit to the Quarterly Report on Form 10-Q to be filed by the Company for the quarterly period ending June 30, 2022.

On June 1, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT) reported entry into agreements that include a $25 million investment by G42 Investments AI Holding RSC Ltd ("G42 Investments") (Press release, vTv Therapeutics, JUN 1, 2022, View Source [SID1234615402]). Under the terms of the agreements, G42 Investments acquired 10,386,274 shares of Class A Common Stock of vTv at an issue price of $2.407 per share, with $12.5 million paid in cash at closing, and the remaining amount of $12.5 million payable on May 31, 2023. The agreements also provide for the potential issuance of $30 million in additional shares of Class A Common Stock to G42 Investments (or cash in lieu of such issuance at the option of G42 Investments) if the United States Food and Drug Administration (the "FDA") approves the marketing and sale of a pharmaceutical product containing TTP399, a liver selective glucokinase activator, as the active ingredient for treatment of type 1 diabetes in the United States. The agreements set forth the terms under which vTv and an affiliate of G42 plan to collaborate on clinical trials for pharmaceutical products that contain TTP399, including G42’s affiliate funding a portion of the Phase 3 clinical trials for TTP399, and vTv granting G42’s affiliate an exclusive license to develop and commercialize pharmaceutical products containing TTP399 in certain territories outside of the United States and the European Union.

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"We have focused substantial energy and resources on TTP399 since obtaining Breakthrough Therapy designation from the FDA in April 2021 and are thrilled to welcome a partner to work with us to accelerate the development and potential approval and commercialization of this treatment. G42 Healthcare brings a unique combination of strong commitment to the development of new impactful drugs and treatments, as demonstrated by their success and their leadership on COVID-19 testing and other product and service offerings in the healthcare spectrum, and substantial resources, making them an ideal partner for this program. This investment into vTv will fund a substantial portion of our Phase 3 clinical trials for TTP399 in the United States and the collaboration with G42 will fund certain of the Phase 3 clinical trials that will be conducted in other territories. We are excited to partner with the G42 Healthcare team as we launch our Phase 3 clinical trials and work together towards approval and commercialization of this treatment for type 1 diabetes," said Rich Nelson, Interim Chief Executive Officer of vTv.

Dr. Fahed Al Marzooqi, the Chief Operating Officer of G42 Healthcare, noted that "We have a deep commitment to collaborating with international organizations to share our knowledge and expertise in the consumer and clinical health spectrum and we look forward to working together with vTv to further develop and commercialize this important treatment. As we move ahead, we will continue to join forces with the world’s best to innovate and invest in science and create the next wave of medicines to future-proof the health of nations."

A more detailed description of the agreements is set forth in vTv’s Current Report on Form 8-K filed with the SEC. The Stock Purchase Agreement is attached to the Current Report on Form 8-K and the Collaboration and License Agreement will be filed with vTv’s Quarterly Report on Form 10-Q for the second quarter.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor will there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.

About TTP399

TTP399 is a novel, oral, small molecule, liver selective glucokinase activator being developed as an adjunct therapy to insulin in patients with type 1 diabetes. In a recent phase 2 clinical trial, TTP399 showed a 40% reduction in hypoglycemic episodes compared to placebo. In April 2021, the FDA granted Breakthrough Therapy designation to TTP399 for the treatment of type 1 diabetes. This past October, vTv announced results of a mechanistic study of TTP399 in patients with type 1 diabetes demonstrating no increased risk of ketoacidosis. TTP399 has now been tested in almost 600 subjects. TTP399 is still in the development phase; the FDA has not reviewed or approved TTP399 for use in the United States.

On June 1, 2022 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported the pricing of an underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $4.75 per share (Press release, Concert Pharmaceuticals, JUN 1, 2022, View Source [SID1234615398]). The gross proceeds to Concert, before deducting underwriting discounts and commissions and estimated offering expenses payable by Concert, are expected to be approximately $47.5 million. Concert has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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All shares in the offering are being sold by Concert. The offering is expected to close on or about June 6, 2022, subject to the satisfaction of customary closing conditions.

Concert intends to use the net proceeds from the offering, together with its current cash and cash equivalents, to complete clinical development supporting the filing of its New Drug Application for CTP-543 for the treatment of moderate to severe alopecia areata in adults, conduct pre-commercial activities related to CTP-543 and support its pipeline development, working capital needs and other general corporate purposes.

Jefferies and Truist Securities are acting as joint book-running managers for the offering. JMP Securities, A Citizens Company, and Mizuho Securities are acting as lead managers, and H.C. Wainwright & Co. is acting as co-manager for the offering.

The offering is being made only by means of a written prospectus supplement and prospectus forming part of a shelf registration statement previously filed with the Securities and Exchange Commission (SEC) and declared effective on November 16, 2020. A preliminary prospectus supplement relating to the offering was filed with the SEC. The final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected] or Truist Securities, Inc., Attention: Prospectus Department, 3333 Peachtree Road NE, 9th floor, Atlanta, Georgia 30326, by telephone at (800) 685-4786, email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On June 1, 2022 Servier, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that data will be presented from multiple studies across its oncology portfolio during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 3-7 and the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress, June 9-12 (Press release, Servier, JUN 1, 2022, View Source [SID1234615395]). Data highlighted at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) include multiple company-sponsored and investigator-initiated trials, which underscore the breadth of Servier’s oncology portfolio and commitment to improving outcomes for patients with difficult-to-treat cancers, including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), cholangiocarcinoma (CCA), colorectal cancer, pancreatic cancer and lung cancer.

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At both congresses, new data will be presented from Servier’s phase 3 AGILE study, a global, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy and safety of TIBSOVO (ivosidenib tablets) in combination with azacitidine compared with placebo in combination with azacitidine, in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy (≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy). These data build on the efficacy and safety results presented at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition. Patients with IDH1-mutated AML have a poor prognosis and have fewer treatment options, especially for newly diagnosed patients who are not eligible for intensive chemotherapy. This new AGILE data presentation comes on the heels of the U.S. Food and Drug Administration approval of TIBSOVO in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated AML.

Ivosidenib monotherapy has breakthrough therapy designation in IDH1 mutated R/R MDS and Servier will be presenting updated efficacy and safety results at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper).

"Several of the studies being presented at this year’s ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) highlight the potential role of IDH inhibition and the company’s overall innovative research portfolio in generating new therapies based on precision approaches," said David K. Lee, CEO, Servier Pharmaceuticals. "Servier Pharmaceuticals has made immense progress since we’ve launched our oncology program in 2018, and we will continue to move the needle for patients with difficult-to-treat cancers."

In the short time the company has been in the U.S., Servier Pharmaceuticals has established a presence in oncology. The company has tripled its oncology portfolio since 2021 with 21 oncology assets at varying stages of clinical development, and 20 research projects.

"Our significant presence at these key congresses demonstrates our long-term commitment to developing innovative therapeutic solutions to meet the needs of patients with difficult-to-treat cancers," said Claude P. Bertrand, Executive Vice President of Research and Development, Servier Group. "We look forward to presenting to the scientific community data across our diverse portfolio, including research on the potential of IDH inhibition in the treatment of cancers with high unmet needs."

Key highlights of data from Servier and its partners at ASCO (Free ASCO Whitepaper) are listed below and are available online on the ASCO (Free ASCO Whitepaper) website: View Source

Abstract #7042/Poster #273: Hematologic improvements with ivosidenib + azacitidine compared to placebo + azacitidine in patients with newly diagnosed acute myeloid leukemia.

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: H. Dohner
Abstract #7019/Poster #250: Molecular characterization of clinical response in newly diagnosed acute myeloid leukemia patients treated with ivosidenib + azacitidine compared to placebo + azacitidine

Date & Time: Saturday, June 4 at 1:15 p.m. CDT; poster will be on display in the poster hall from 8 – 11 a.m.
Poster Discussion: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: S. de Botton
Abstract/Publication Only: Changes in health-related quality of life in patients with newly diagnosed acute myeloid leukemia receiving ivosidenib + azacitidine or placebo + azacitidine.

Author: A. Schuh
Abstract #7053/Poster #284: Ivosidenib in patients with IDH1-mutant relapsed/refractory myelodysplastic syndrome (R/R MDS): Updated enrollment and results of a phase 1 dose escalation and expansion substudy

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: D. Andrew Sallman
Abstract #7005/Oral Presentation: Overall survival by IDH2 mutant allele (R140 or R172) in patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia treated with enasidenib or conventional care regimens in the phase 3 IDHENTIFY triali

Date & Time: Tuesday, June 7 at 11:33 a.m. CDT
Oral Abstract Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: S. de Botton
Abstract #7032/Poster #263: Health-related quality of life (HRQoL) with enasidenib vs conventional care regimens in older patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML)i

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: C. Dinardo
Abstract #3568/Poster #362: Trifluridine/tipiracil plus bevacizumab (FTD/TPI + BEV) and trifluridine/tipiracil (FTD/TPI) monotherapy in metastatic colorectal cancer (mCRC): results of a meta-analysisii

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Gastrointestinal Cancer—Colorectal and Anal
Presenting Author: T. Yoshino
Abstract/Publication Only: Characterizing Platinum Sensitivity among Medicare FFS Patients with Limited vs Extensive Stage Small Cell Lung Cancer Receiving NCCN Category 1 Regimensiii

Presenting Author: G. Dieguez
Abstract/Publication Only: Patient Characteristics and Outcomes Associated with Small Cell Lung Cancer by Treatment Status in a U.S. Medicare Populationiii

Presenting Author: P. Cockrum
Abstract/Publication Only: Treatment Patterns and Outcomes Associated with Small Cell Lung Cancer by Platinum Sensitivity Status in a U.S. Medicare Populationiii

Presenting Author: P. Cockrum
Abstract #8584/Poster #210: Trends in Treatment Patterns Associated with Small Cell Lung Cancer in a U.S. Medicare Populationiii

Date & Time: Monday, June 6 at 8 a.m. CDT
Poster Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Presenting Author: R. Ramirez
Abstract #7018/Poster #249: A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1-mutated hematologic malignancies

Date & Time: Saturday, June 4 at 8 a.m. CDT
Oral Abstract Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: C. Lachowiez
Abstract #3612/Poster #406: Phase II, multicenter, open-label, non-randomized study of neoadjuvant chemotherapy NALIRINOX (5-FU/LV + oxaliplatin + nal-IRI) followed by chemoradiotherapy in patients with rectal cancer in a watch-and-wait program

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Gastrointestinal Cancer—Colorectal and Anal
Presenting Author: C. Gregorio Muñoz
Abstract #TPS4185/Poster #157b: A randomized phase II study of gemcitabine and nab-paclitaxel compared with 5-fluorouracil, leucovorin, and liposomal irinotecan in older patients with treatment-naïve metastatic pancreatic cancer (GIANT): ECOG-ACRIN EA2186—Trials in progress

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Presenting Author: E. Dotan
Abstract #4005/Oral Presentation: NET-02: A multi-centre, randomised, phase II trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients (pts) with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma (PD-EP-NEC)

Date & Time: Sunday, June 5 at 9 a.m. CDT
Oral Abstract Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Presenting Author: M. McNamara
Servier will be hosting a continuing medical educational program at ASCO (Free ASCO Whitepaper) focused on hematology:

"Advantage with Innovation in AML: Guidance on Developing and Delivering Effective and Highly Personalized Care," administered by PeerView, June 3, 2022
In addition, encore presentations from ASCO (Free ASCO Whitepaper) will be presented at EHA (Free EHA Whitepaper):

Poster #2209: Hematologic improvements with ivosidenib + azacitidine compared to placebo + azacitidine in patients with newly diagnosed acute myeloid leukemia

Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: H. Dohner
Poster #2374: Changes in health-related quality of life in patients with newly diagnosed acute myeloid leukemia receiving ivosidenib + azacitidine or placebo + azacitidine

Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: A. Schuh
Poster #2356: Molecular characterization of clinical response in newly diagnosed acute myeloid leukemia patients treated with ivosidenib + azacitidine compared to placebo + azacitidine

Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: S. de Botton
Poster #P765: Updated enrollment and results from the phase 1 substudy of ivosidenib in patients with IDH1-mutant relapsed/refractory myelodysplastic syndrome (R/R MDS)

Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: C. DiNardo