On December 7, 2022 Aarvik Therapeutics reported a global license and assignment Agreement with NJ Bio, Inc. to secure a class of novel proprietary payloads with a wide range of potencies (Press release, Aarvik Therapeutics, DEC 7, 2022, View Source [SID1234624920]).

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Aarvik has an exclusive license to commercialize the novel proprietary payloads from NJ Bio, as well as any materials or products containing the payloads, and can acquire ownership and all rights upon completion of option payments. As part of the agreement, Aarvik will pay NJ Bio an upfront payment, option payments, as well as future success-based milestone and royalty payments for products utilizing the payloads. NJ Bio will also provide all conjugation services for the payloads. Aarvik will partner with NJ Bio to manufacture materials for preclinical studies and clinical trials.

"We are excited to secure a set of novel payloads for our ADC programs from NJ Bio and to benefit from NJ Bio’s deep chemistry and bioconjugation expertise with ADCs," said Jagath Reddy Junutula, Ph.D., Co-founder, President, and CEO of Aarvik Therapeutics. "NJ Bio will be an excellent research, development, and manufacturing partner for Aarvik. The payloads from NJ Bio complement the novel therapeutic antibodies from Aarvik."

"We are thrilled to provide Aarvik with a class of novel payloads for their next-generation ADC program. The ADC development experience and innovative antibodies from Aarvik combined with our bioconjugation and novel linker-payload synthesis expertise can be synergistic. We look forward to a very exciting time with Aarvik to revolutionize ADC therapies for patients with cancer," said Nareshkumar Jain, President, and CEO of NJ Bio.

On December 7, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported updated findings from the Translational Breast Cancer Research Consortium (TBCRC) Trial 022 at the ongoing 2022 San Antonio Breast Cancer Symposium in San Antonio, Texas (Press release, Puma Biotechnology, DEC 7, 2022, View Source [SID1234624919]). The poster (PD7-03), entitled "Neratinib and ado-Trastuzumab-Emtansine (T-DM1) for HER2+ Breast Cancer Brain Metastases (BCBM): Translational Breast Cancer Research Consortium (TBCRC) Trial 022," was presented by Rachel A Freedman, MD, MPH, Breast Oncology Center, Susan F. Smith Center for Women’s Cancers, Dana Farber Cancer Institute, at Spotlight Poster Session 7 on December 7 from 5:00 p.m. – 6:15 p.m. CT.

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TBCRC-022 is a prospective, multicenter, Phase II study to evaluate the effect of neratinib plus T-DM1 in patients with HER2-positive breast cancer brain metastases. This presentation outlined updates from three cohorts: 4A – patients with previously untreated BCBM; 4B – patients with BCBM progressing after prior local CNS-directed therapy without prior T-DM1 exposure; and 4C – patients with BCBM progressing after prior local CNS-directed therapy with previous T-DM1 exposure. Data from previous cohorts from this study were reported at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting. Patients with measurable HER2-positive BCBM received neratinib 160 mg orally once daily plus T-DM1 3.6 mg/kg intravenously every 21 days in the three parallel-enrolling cohorts. Diarrhea prophylaxis with colestipol and loperamide was required during cycle 1. All enrolled patients underwent a brain MRI plus CT scan of the chest/abdomen/pelvis every 6 weeks for 18 weeks, followed by every 9 weeks thereafter.

The primary endpoint, Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM), was evaluated in each cohort separately. The efficacy results from the trial showed that CNS Objective Response Rate by RANO-BM was 33.3% of patients in cohort 4A, 29.4% in cohort 4B, and 28.6% in cohort 4C. Rates of response + stable disease greater than or equal to 6 months were 50% in cohort 4A, 35.3% in cohort 4B, and 33.3% in cohort 4C.

Intracranial activity was observed for the combination of neratinib plus T-DM1 in all three cohorts, including in patients with prior T-DM1 exposure, suggesting a reversal of resistance to T-DM1. Overall, the most frequently observed adverse event was diarrhea, grade 2 (32%) and grade 3 (23%). These data provide additional evidence for the consideration of neratinib-based combinations in patients with HER2-positive BCBM.

"Neratinib given in combination with T-DM1 showed promising activity in patients with heavily pre-treated HER2-positive disease metastatic to the CNS including patients with prior T-DM1 exposure, which may suggest that neratinib is playing a role in reversing resistance to T-DM1," said Rachel A. Freedman, MD, MPH, Breast Oncology Center, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute. "Despite the introduction of several new treatments for patients with HER2-positive metastatic breast cancer, CNS progression events remain a major source of patient morbidity and mortality. The data from this study provide additional evidence for consideration of neratinib- based combinations in patients with HER2-positive breast cancer brain metastases."

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are pleased with the results from the TBCRC-022 trial on the combination of neratinib and T-DM1. As a small molecule that can cross the blood brain barrier, neratinib potentially offers patients with HER2-positive metastatic breast cancer that has metastasized to the CNS a novel HER2 targeted treatment option. This data adds to the existing body of data that we have from the other previously presented arms from the TBCRC-022 trial that continue to demonstrate that neratinib is active in patients with HER2-positive breast cancer brain metastases."

On December 7, 2022 Kite Pharma, Inc., a Gilead Company, (hereafter Kite) and Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo) jointly reported the revision of their 2017 partnership agreement, which gave Daiichi Sankyo exclusive rights to develop, manufacture and commercialize Yescarta (axicabtagene ciloleucel) in Japan (Press release, Kite Pharma, DEC 7, 2022, https://www.businesswire.com/news/home/20221207005859/en/Kite-and-Daiichi-Sankyo-Announce-Changes-to-YESCARTA%C2%AE-CAR-T-Cell-Therapy-Licensing-Agreement-in-Japan [SID1234624918]). Kite was acquired by Gilead Sciences, Inc. later in 2017 after the Daiichi Sankyo partnership agreement. Daiichi Sankyo and Kite have now agreed that the Marketing Authorization for Yescarta will be transferred to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc., in 2023. A Kite Cell Therapy Business Unit at Gilead Sciences K.K. will manage the sales and promotion activities of the product in Japan after the Marketing Authorization transfer.

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Kite’s manufacturing facility in El Segundo, California, U.S., has been approved by Japanese regulatory authorities to manufacture Yescarta for the Japanese market, and it is expected that supply will commence in early 2023. The first axicabtagene ciloleucel treatment center in Japan was authorized in December 2021, and there are now six hospitals in Japan authorized to administer the therapy.

"We are confident that these changes will benefit patients in Japan by increasing capacity and support broader patient access to this important treatment for blood cancer patients and we remain committed to working together with Kite to ensure a smooth transfer during this transitional period," said Shoji Hirashima, Senior Executive Officer, Head of Japan Business Unit of Daiichi Sankyo.

"As the global leader in cell therapy, we are pleased that our partnership with Daiichi Sankyo has brought this innovative therapy to patients in Japan. We look forward to building on the momentum to accelerate efforts in Japan to maximize access and impact for patients as part of Gilead and Kite’s expansion into oncology in Japan," said Christi Shaw, CEO of Kite.

About YESCARTA

YESCARTA (axicabtagene ciloleucel) is a CAR T-cell therapy directed against CD19 (a cell membrane protein), which harnesses a patient’s own immune system to fight cancer. Axicabtagene ciloleucel is made by removing a patient’s T cells from their blood and engineering them in the lab to express chimeric antigen receptors so that they can recognize and destroy cancer cells when they are infused back to the patient’s body. The CAR T therapy is manufactured specifically for each patient and administered only once. Axicabtagene ciloleucel received Orphan Drug Designation from the Japan Ministry of Health, Labour, and Welfare in 2018 for the treatment of diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma and high-grade B-cell lymphoma. Yescarta was approved in Japan for the treatment of patients with relapsed or refractory large B-cell lymphomas1, a type of non-Hodgkin lymphoma, in January 2021. Japan has the second-largest number of people diagnosed with non-Hodgkin lymphoma globally2.

YESCARTA is approved in the U.S. and Europe for patients with certain types of relapsed or refractory B-cell lymphoma, where it is developed, manufactured and commercialized by Kite.

Please see full U.S. Prescribing Information, including BOXED WARNING and Medication Guide.

Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. (1.1)
Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. (1.1)

Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2)
For the full European Prescribing Information, please visit: View Source

On December 7, 2022 Pimera Therapeutics, Inc., a clinical-stage biotechnology company focused on developing breakthrough medicines for cancer and other diseases with high unmet medical need, reported that Pimera’s President and CEO, Mustapha Haddach, Ph.D., will present a corporate overview at the Biotech Showcase 2023 meeting on Monday, January 9, 2023, at 5:15 PM (Press release, Pimera Therapeutics, DEC 7, 2022, View Source [SID1234624917]). The Biotech Showcase Conference is taking place in San Francisco in parallel to the J.P. Morgan (JPM) 41st Annual HealthCare Conference.

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The Company will be available to meet potential partners, collaborators, and investors. One-to-one appointments may be requested as follows:

The Biotech Showcase partnering platform: https://informaconnect.com/biotech-showcase/
Biotechnology Innovation Organization (BIO) partnering platform: View Source

On December 7, 2022 Oncopeptides AB (publ) (NASDAQ Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported that the US Food and Drug Administration, FDA, has requested a withdrawal of the US marketing authorization for Pepaxto (melphalan flufenamide, also called melflufen) (Press release, Oncopeptides, DEC 7, 2022, View Source [SID1234624916]). The request is based on the outcome of the confirmatory phase 3 OCEAN study, which demonstrated an ITT overall survival HR of 1.1, but with significant survival result differences for both melflufen and the comparator drug pomalidomide for large relevant patient groups.

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"We respect FDA´s accelerated approval regulations," says Jakob Lindberg, CEO of Oncopeptides. "Multiple myeloma remains an incurable disease, and the treatment options for patients with triple class refractory disease will ultimately become exhausted. The OCEAN study demonstrated clinical benefit for multiple myeloma patients, in particular for non-transplanted elderly patients where the unmet medical need remains very high."

Pepaxto was granted accelerated approval in the U.S., on February 26, 2021, and is indicated in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. At the FDA’s request, Oncopeptides stopped marketing Pepaxto in the US on October 22, 2021, and Pepaxto is currently not commercially available for US patients.

The commercialization of Pepaxti in Europe is ongoing. Pepaxti has a full approval from the European Medicines Agency, EMA, since August 18, 2022, and was approved by the Medicines and Healthcare Products Regulatory Agency, MHRA, in the UK on November 11, 2022. Both approvals take the large OCEAN study overall survival differences across relevant patient groups into account. Pepaxti is indicated in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.

The Company is developing its preclinical pipeline, including the next generation of drug candidates from the PDC platform, as well as an NK-cell engager, built on the technology platform of "Small Polypeptide based Killer Engagers," SPiKEs.