On December 7, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported data from two ongoing Phase 2 studies evaluating parsaclisib, an Incyte-discovered, potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), for the treatment of patients with relapsed or refractory follicular (CITADEL-203) and marginal zone (CITADEL-204) lymphomas (Press release, Innovent Biologics, DEC 7, 2020, View Source [SID1234572379]). These data were accepted for presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2020), held virtually from December 5–8, 2020.

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The primary endpoint for the CITADEL-203, and -204 studies is objective response rate (ORR); duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety and tolerability are among the secondary endpoints. All radiology-based endpoints are based on independent review committee (IRC) assessment.

Eligible patients received parsaclisib 20 mg once daily for eight weeks followed by either 20 mg once weekly (weekly-dosing group [WG]) or 2.5 mg once daily (daily-dosing group [DG]). Subsequently, daily dosing was selected as the preferred regimen and patients initially enrolled in the WG were allowed to switch to DG. Data are presented for the DG and all patients.

Key results from the CITADEL studies include:

ORR(95%CI), %

mDOR(95%CI),
months

mPFS(95%CI),
months

CITADEL-203: R/R Follicular Lymphoma

DG (N=95)

75(65-83)

14.7(12.0-17.5)

15.8(13.8-19.1)

All (N=118)

73(64-81)

15.9(12.0-NE)

15.8(13.2-19.3)

CITADEL-204: R/R Marginal Zone Lymphoma

DG (N=72)

56.9(44.7-68.6)

NR(8.1-NE)

NR(11.0-NE)

All N=100)

57.0(46.7-66.9)

12.0(9.3-NE)

19.4(13.7-NE)

R/R: relapsed or refractory; ORR: objective response rate; mDOR: median duration
of response (reported for responders); mPFS: median progression-free survival;
DG:daily dosing group.

Parsaclisib was generally well tolerated in all studies with a manageable safety profile.

"We are glad that data from the CITADEL studies presented at ASH (Free ASH Whitepaper) 2020 appear promising, and they highlight the potential of parsaclisib to become a meaningful treatment for patients with relapsed or refractory B-cell non-Hodgkin lymphomas," said Dr. Hui Zhou, Vice President of Oncology Strategy and Medical Sciences of Innovent, "A pivotal Phase 2 registrational trial to evaluate the efficacy and safety of parsaclisib in patients with recurrent and refractory follicular lymphoma or marginal zone lymphoma in China is also recruiting now, and, if successful, the results of this study may help benefit patients with recurrent or refractory indolent B-cell lymphoma and potentially provide more treatment options to the clinicians that treat them."

Presentations are available on the ASH (Free ASH Whitepaper) website at
View Source; #338 (Oral presentation, CITADEL-204), #2935 (Poster, CITADEL-203).

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib (PI3Kδ inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan. Currently Innovent is conducting a pivotal Phase 2 registrational trial in China to evaluate the efficacy and safety of parsaclisib in patients with recurrent and refractory follicular lymphoma or marginal zone lymphoma.

About Follicular and Marginal Zone Lymphomas

Follicular lymphoma is a B-cell cancer that originates from the uncontrolled division of specific types of B-cells known as centrocytes and centroblasts. Although it is classified as indolent lymphoma, and the current immunochemotherapy has achieved good efficacy, it still often relapses following by aggressive diseases, which may lead to death within 1 to 2 years. There is an unmet medical need for treatment options for recurrent/refractory follicular lymphoma.

Marginal zone lymphoma is also a group of indolent B-cell lymphoma. Although BTK inhibitors have been approved in the United States to treat recurrent/refractory marginal zone lymphoma, the reported disease free survival after treatment with BTK inhibitors is short, so new treatments need to be developed on the basis of BTK inhibitors.

About Parsaclisib

Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). It is currently under evaluation as a monotherapy in several ongoing Phase 2 trials as a treatment for non-Hodgkin lymphomas (follicular, marginal zone and mantle cell); and autoimmune hemolytic anemia. Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are underway; and there are plans to initiate a trial to evaluate parsaclisib in combination with tafasitamab for B-cell malignancies.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib (PI3Kδ inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.

On December 7, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, reported that it has commenced an underwritten public offering of $150,000,000 of shares of its common stock (Press release, Atara Biotherapeutics, DEC 7, 2020, View Source [SID1234574478]). In connection with the proposed offering, Atara Biotherapeutics expects to grant the underwriters a 30-day option to purchase up to an additional $22,500,000 of shares of its common stock at the public offering price, less the underwriting discounts and commissions. All of the shares in the proposed offering will be sold by Atara Biotherapeutics. The proposed offering is subject to market and other conditions, and there can be no assurances as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

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Citigroup, Evercore ISI and Mizuho Securities are acting as joint book-running managers for the proposed offering.

The securities described above are being offered by Atara Biotherapeutics pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Atara Biotherapeutics with the Securities and Exchange Commission (the "SEC") and that became automatically effective on February 27, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering, when available, may be obtained from: Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 800-831-9146; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at [email protected]; or Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY 10020, by telephone 212-205-7600, or by email: [email protected]. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On December 7, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases reported that the company will host a webcast on Wednesday, December 9th, 2020, at 14:00 (CET) to provide an update regarding the data presented December 4-8 at the American Society Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2020 (Press release, Oncopeptides, DEC 7, 2020, View Source [SID1234572282]).

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At ASH (Free ASH Whitepaper) Oncopeptides has presented twelve abstracts, including one oral presentation. Key clinical abstracts focused on new data from the ongoing phase 1/2 ANCHOR combination study and new data from the pivotal phase 2 HORIZON study. The preclinical abstracts further explored the mechanism of action of the proprietary peptide-drug conjugate platform in multidrug resistant models of multiple myeloma.

The webcast will be hosted by CEO Marty J Duvall, CSO Jakob Lindberg and CMO Klaas Bakker.

About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release an entrapped hydrophilic alkylator payload. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.

On December 7, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will hold a conference call on Wednesday, December 9, 2020 at 10:00 a.m. ET to discuss clinical data from ongoing studies evaluating eganelisib in triple negative breast cancer (TNBC) which will be presented during the San Antonio Breast Cancer Symposium (SABCS) being held virtually, December 8-11, 2020 (Press release, Infinity Pharmaceuticals, DEC 7, 2020, View Source [SID1234572346]).

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Conference Call Information

A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 2088322. An archived version of the webcast will be available on Infinity’s website for 30 days.

Presentation Details:

Title: MARIO-3 phase II study initial data evaluating a novel triplet combination of eganelisib (IPI-549), atezolizumab (atezo), and nab-paclitaxel (nab-pac) as first-line (1L) therapy for locally advanced or metastatic triple-negative breast cancer (TNBC)

Presenter: Erika Hamilton, M.D., Tennessee Oncology

Date: Wednesday, December 9, 2020, 8:00 a.m. CT

Abstract: PS11-32

Poster Session: 11

Title: ARC-2: Efficacy and safety of etrumadenant (AB928) + pegylated liposomal doxorubicin (PLD) ± eganelisib (IPI-549) in participants with metastatic ovarian and triple negative breast cancer

Date: Wednesday, December 9, 2020, 8:00 a.m. CT

Abstract: PS12-12

Poster Session: 12

On December 7, 2020 CIBMTR reported that Initial results from a recent study indicate that for patients between the ages of 50 and 75, overall survival nearly doubled when patients with myelodysplastic syndrome (MDS) received allogeneic hematopoietic cell transplantation (alloHCT) when compared to other treatments (Press release, CIBMTR, DEC 7, 2020, View Source [SID1234572361]). Additionally, patients age 65 and older saw a similar benefit to overall survival as those between the ages of 55 and 64. The majority of patients received transplant using matched unrelated donors, and outcomes were similar to those of patients using matched related donors.

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These findings from a Blood and Marrow Transplant Clinical Trials Network (BMT CTN) study were presented during the 62nd ASH (Free ASH Whitepaper) Annual Meeting & Exposition.

The initial results of a separate observational study currently being run by the CIBMTR (Center for International Blood and Marrow Transplant Research)—which is a research collaboration between the National Marrow Donor Program (NMDP)/Be The Match and the Medical College of Wisconsin—also demonstrate the patients 65 and older experience similar benefit from allogeneic HCT to patients 55-64 years of age. In addition, the initial analysis of the CIBMTR observational study showed similar non-relapse mortality between these two age groups. The initial results were published in JAMA Oncology.

"In both studies of older adults with MDS, we found that transplantation using either an HLA-matched related or HLA-matched unrelated donor is feasible even in older patients and in the BMT CTN study, provides significant survival benefit relative to non-transplant therapies. This supports the early referral of all patients with MDS to a transplant center for consultation, regardless of age," said Steven Devine, MD, Chief Medical Officer, NMDP/Be The Match, and Associate Scientific Director, CIBMTR.

Early referral to a transplant center for all patients is critical as it allows the search for a donor to start early for those patients who are eligible for transplant. This increases the likelihood a patient will find a suitable donor and proceed to transplant earlier in their disease, which can lead to better outcomes.

"While alloHCT is the only known cure for MDS, many older adults did not receive HCT in the past because the benefits for older adults had not been sufficiently proven for CMS to provide payment coverage. Taken together, these studies support allogeneic HCT for older patients with MDS based on survival improvements," said J. Douglas Rizzo, MD, MS, Senior Scientific Director, CIBMTR.

Currently, the Centers for Medicare and Medicaid Services (CMS) does not cover alloHCT for adults over age 65 unless the patient is enrolled in a qualified Coverage with Evidence Development (CED) study. The NMDP/Be The Match and CIBMTR will provide CMS with the data from these two studies for its use in making coverage policy decisions.

In the meantime, the current CIBMTR observational study meets CED requirements and qualifies for payment under CMS. The study remains open for enrollment for a broad range of clinically eligible Medicare recipients. By enrolling patients in this study, more older patients across the U.S. with MDS will have access to HCT.

Access the BMT CTN study abstract presented by senior study author Corey Cutler, MD, MPH, Dana-Farber Cancer Institute, during the ASH (Free ASH Whitepaper) Annual Meeting:

A Multi-Center Biologic Assignment Trial Comparing Reduced Intensity Allogeneic Hematopoietic Cell Transplantation to Hypomethylating Therapy or Best Supportive Care in Patients Aged 50-75 with Advanced Myelodysplastic Syndrome: Blood and Marrow Transplant Clinical Trials Network Study 1102

Access the initial results of the CIBMTR observational study published in JAMA Oncology:

Comparison of Patient Age Groups in Transplantation for Myelodysplastic Syndrome: The Medicare Coverage With Evidence Development Study

About the BMT CTN

The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) conducts rigorous multi-institutional clinical trials of high scientific merit, focused on improving survival for patients undergoing hematopoietic cell transplantation and/or receiving cellular therapies. The BMT CTN has completed accrual to 43 Phase II and III trials at more than 100 transplant centers and enrolled over 12,800 study participants. BMT CTN is funded by the National Heart, Lung, and Blood Institute and the National Cancer Institute, a part of the National Institutes of Health (NIH) and is a collaborative effort of 20 Core Transplant Centers/Consortia, the CIBMTR (Center for International Blood and Marrow Transplant Research), the National Marrow Donor Program/Be The Match and the Emmes Company, LLC, a clinical research organization.