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 6, 2020 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported preclinical findings of ALLO-316, an AlloCAR T therapy targeting CD70, in models of acute myeloid leukemia (AML) (Press release, Allogene, DEC 6, 2020, View Source [SID1234572473]). Data were presented in a poster session today at the 62nd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper).

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The Company also announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for a Phase 1 trial of ALLO-316 for patients with advanced or metastatic clear cell renal cell carcinoma (RCC). The Company’s first solid tumor trial is expected to begin enrolling patients in 2021.

"We are very excited about the potential of ALLO-316, our fourth AlloCAR T investigational therapy, to treat patients with CD70 expressing malignancies across both hematologic and solid tumor indications," said Rafael Amado, M.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. "These preclinical results in AML, coupled with previous findings of ALLO-316 in RCC presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in 2019, reinforce our belief that CD70 may become one of the more important targets across a broad spectrum of cancers."

CD70 is expressed in a number of malignancies ranging from solid tumors such as RCC, lung cancer and glioblastoma to hematologic cancers including AML, diffuse large B-cell lymphoma, multiple myeloma, and chronic lymphocytic leukemia.

In the preclinical studies presented at ASH (Free ASH Whitepaper), CD70 expression was detected on AML cell lines and primary AML samples from patients. No expression of CD70 was identified in hematopoietic stem cells. ALLO-316 demonstrated the ability to mediate efficient killing of leukemic cells in multiple models. This killing activity was specific to CD70 expression on the target cells as ALLO-316 did not kill AML cell lines in which CD70 was knocked out. The preclinical studies also showed that ALLO-316 can mask CD70 on the surface of CAR T cells thereby preventing fratercide and allowing scaled manufacturing of AlloCAR T cells.

On December 6, 2020 IMV Inc. (Nasdaq:IMV; TSX:IMV) ("IMV" or the "Company"), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, today announces that durable clinical benefits induced by combination treatment of IMV’s T cell therapy with Merck’s Keytruda (pembrolizumab) in subjects with PD-L1 positive recurrent/refractory Diffuse Large B Cell Lymphoma (r/r DLBCL) have been presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, IMV, DEC 6, 2020, View Source [SID1234572252]).

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"Compared to currently approved therapies, this combination has demonstrated a promising duration of response with limited adverse events in this difficult-to-treat patient population," said Dr. Neil Berinstein, principal investigator of the SPiReL study and hematologist at Sunnybrook Health Sciences Center. "The improved clinical response in this subset of patients with PD-L1 expression is an exciting scientific finding. The baseline PD-L1 expression is a potential predictor of response to this treatment combination which may not be attributed to the activity of pembrolizumab alone1 and is more likely caused by the complementary mechanisms of action of these two immunotherapies."

"These are exciting early data and the potential synergistic action of these two immunotherapies paves the way for a new treatment paradigm with combination therapeutics," said Dr. Joanne Schindler, Chief Medical Officer at IMV. "We are also evaluating this combination therapy with Merck in other solid tumor indications and we look forward to exploring further the potential of what we have seen in the SPiReL study."

In his presentation during the annual ASH (Free ASH Whitepaper) meeting, Dr. Neil Berinstein describes the results from the SPiReL study:

In the PD-L1+ population (n=7), subjects
Have significantly higher median Progression Free Survival (PFS) of 230 days, compared to the PD-L1 negative subjects (70 days) with a p-value of 0.007, suggestive of a strong predictive biomarker for this treatment combination,
Demonstrated an objective response in six subjects, including three subjects who have completed one-year of study treatment,
Demonstrated an ORR and a DCR at both 85.7%.
Peripheral blood was assessed for survivin-specific ELISpot responses in 15 subjects with available samples. All 3 subjects with a CR, and 3 of 4 subjects with a PR had positive ELISpot responses while only 1 subject with SD and 1 subject with PD demonstrated survivin-specific ELISpot response, suggestive of an association between the clinical responses with the mechanism of action of DPX-Survivac.
Treatment was well tolerated. The majority of treatment-related adverse events were grade 1 and 2 severity. A majority of these were injection site reactions associated with the subcutaneous administration of DPX-Survivac.
The poster presentation by Dr. Berinstein is available under the Scientific Publications & Posters section on IMV’s website and is also available on the ASH (Free ASH Whitepaper) meeting platform.

Biomarkers associated with clinical response were also discussed in a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, and during a webcast hosted by IMV on November 12, 2020.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of immunotherapy that generates targeted and sustained cancer cell killing capabilities in vivo. Treatments with the DPX-Survivac T cell therapy have demonstrated a favorable safety profile across all clinical studies.

IMV’s T cell therapy, DPX-Survivac, consists of survivin-based peptides formulated in IMV’s proprietary delivery platform (DPX). IMV’s lead compound is designed to generate a sustained cytotoxic T cell response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as Orphan Drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

About the SPiReL Study

"SPiReL" is a Phase 2 non-randomized, open label, efficacy, and safety study of a novel immunotherapy combination with DPX-Survivac and pembrolizumab. Intermittent low dose cyclophosphamide is given as an immune modulator. Subjects with r/r incurable DLBCL and survivin expression are eligible for participation. The primary outcome is to document the objective response rate using modified Cheson criteria for the combination treatment. Secondary objectives include safety, duration of response and time to next treatment. Exploratory endpoints include T cell response, tumor immune cell infiltration, and biomarker analysis. To date, 24 subjects have been enrolled.

On December 6, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported the presentation of updated data from its Phase 1b/2 study in relapsed/refractory acute myeloid leukemia (AML) (Press release, Cardiff Oncology, DEC 6, 2020, View Source [SID1234572236]). The data were presented as a virtual oral poster presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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The presentation highlighted the safety, tolerability and anti-leukemic activity of onvansertib in combination with decitabine in patients with difficult-to-treat relapsed/refractory AML. Nine of 45 (20%) patients achieved a complete remission with or without hematologic count recovery (CR/CRi – 5 in Phase 1b and 4 in Phase 2); 55% of responders had a mutation in a splicing factor. Two patients proceeded to transplant following CR and four patients remain on treatment with duration of response of 9, 10, 17 and 20 months, respectively. Together with data demonstrating the safety and tolerability of the combination therapy, these findings highlight onvansertib’s potential to address critical unmet needs in hematologic malignancies.

"The data generated from this ongoing trial are encouraging, particularly considering the very poor prognosis of the relapsed/refractory AML patient population, in whom the median overall survival is generally only a few months," said Dr. Mark Erlander, chief executive officer of Cardiff Oncology. "We believe the over-representation of the splicing factor mutations in patients who achieved a complete response is worthy of further exploration as it may provide a means for identifying patients upfront who have the greatest likelihood of responding to treatment with onvansertib."

Key data and conclusions from the ASH (Free ASH Whitepaper) presentation include:

9 of 45 (20%) evaluated patients achieved CR/CRi (5 in Phase 1b and 4 in Phase 2)
55% of responders had a mutation in a splicing factor
As of the data cutoff, 2 patients proceeded to transplant following CR and 3 patients had ongoing responses
4 patients have achieved a durable response (≥9 months)
Decreases in mutant ctDNA within the first treatment cycle appear to be highly correlated with clinical response; 7 of 7 (100%) patients with CR/CRi showed a decrease in mutant ctDNA after one cycle of treatment, while only 2 of 15 (13%) non-responders showed a similar decrease
Data indicate that onvansertib in combination with decitabine is a safe and well-tolerated treatment regimen
The poster presentation from the 62nd Annual ASH (Free ASH Whitepaper) meeting is available on the "Scientific Presentations" section of the Cardiff Oncology website at View Source

About the Phase 1b/2 Trial of Onvansertib in Relapsed/Refractory AML

Cardiff Oncology’s ongoing Phase 1b/2 trial (NCT03303339) evaluating onvansertib in combination with decitabine in AML patients who are either treatment naïve and not candidates for induction therapy or who have relapsed or refractory disease after treatment with one prior regimen. Patients receive onvansertib, administered orally, on days 1 through 5 of each 21-28-day cycle in combination with decitabine. The primary efficacy endpoint of objective response (CR + CRi) is assessed in patients who complete at least 1 cycle of treatment.