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Amgen To Webcast Investor Call At ESMO 2021

On September 13, 2021 Amgen (NASDAQ:AMGN) reported that it will host a webcast call for the investment community in conjunction with the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Congress (Press release, Amgen, SEP 13, 2021, View Source [SID1234587602]). On Thursday, Sept. 16, 2021, at 8:30 a.m. ET, David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with other members of Amgen’s management team, will discuss clinical data being presented on the Company’s KRASG12C inhibitor LUMAKRAS (sotorasib) in combination with Vectibix (panitumumab).

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Live audio of the investor call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

Celdara Medical Receives $1.7M SBIR to Advance Treatment of Ovarian Clear Cell And Renal Cell Carcinomas

On September 13, 2021 Celdara Medical, LLC reported that the National Cancer Institute (NCI) of the National Institutes of Health (NIH) has awarded a three-year Small Business Innovation Research (SBIR) Fast-Track award to fund the company’s advancement of CM-CX1, a chimeric antigen receptor (CAR) T cell therapy for the treatment of ovarian clear cell and renal cell carcinomas (Press release, Celdara Medical, SEP 13, 2021, View Source [SID1234587601]).

Dr. Jake Reder, Co-founder and Chief Executive Officer of Celdara Medical, remarked, "We are grateful to the NCI for their continued support of this program. The world has learned a lot about how to use CAR T therapies, and we’re now seeing successes against solid tumors as well as hematologic malignancies. Precise selection of target and indication was always part of this particular program, and we’re now keen to translate that potential into the clinic for the benefit of patients."

"The clinical successes of CAR T cells against hematological malignancies have led us to the pursuit of CAR T therapies against multiple targets for the treatment of solid tumors," Dr. Joana Murad Mabaera, Executive Director of Research at Celdara Medical and lead Principal Investigator on this study noted. "I have been working closely with our industry and academic partners to identify ideal targets for cellular therapies and we have created something unique with CM-CX1. The funding by the National Cancer Institute (NCI) provides us with an exciting opportunity to translate our promising research and make this therapeutic option accessible to patients."
Research reported in this press release is supported by the National Cancer Institute of the National Institutes of Health under award number R44CA265424. The content is solely the responsibility of Celdara Medical and does not necessarily represent the official views of the National Institutes of Health.

Dynavax Provides Update on its COVID-19 Collaboration with Valneva

On September 13, 2021 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, reported that Valneva SE has received a termination notice from the United Kingdom Government in relation to Valneva’s supply agreement for its COVID-19 vaccine candidate, VLA2001 (Press release, Dynavax Technologies, SEP 13, 2021, View Source [SID1234587600]). Valneva stated that they intend to continue clinical development of VLA2001 and the pivotal Phase 3 trial for VLA2001, Cov-Compare, remains ongoing at Public Health England. Based on its portfolio of COVID-19 collaborations Dynavax reiterates its belief that its CpG 1018 supply contracts continue to represent an approximately $300 – $400 million dollars aggregate revenue opportunity in 2021.

Valneva recently announced that its Phase 3 results for VLA2001 are expected to be available early in the fourth quarter of 2021 and these results are expected to form part of Valneva’s planned rolling submission for conditional approval of VLA2001 with the UK’s Medicines and Healthcare products Regulatory Agency ("MHRA"). Subject to these data and MHRA approval, Valneva has indicated that it believes initial approval for VLA2001 could be granted in late 2021.

Ryan Spencer, Chief Executive Officer of Dynavax commented, "Valneva is one of a number of companies developing COVID vaccines using CpG 1018 as an adjuvant and we continue to look forward to the upcoming Phase 3 clinical trial results for Valneva’s inactivated COVID-19 vaccine adjuvanted with CpG 1018. The first COVID-19 vaccine that uses CpG 1018 was recently authorized by regulatory authorities and we look forward to the potential authorization of additional Dynavax-enabled COVID-19 vaccines in the months and quarters ahead."

Under Dynavax’s existing supply agreement for CpG 1018, purchase orders submitted by Valneva are cancellable if the UK Government reduces or terminates its order for VLA2001, in which case, Valneva would not be obligated to pay Dynavax the final portion of an outstanding purchase order. Valneva has not yet cancelled any outstanding purchase orders for CpG 1018. Dynavax has the right to retain any portion of the purchase price for CpG 1018 made in advance by Valneva as well as any CpG 1018 manufactured but not yet delivered.

Dynavax intends to continue to monitor the situation but can make no assurances regarding the outstanding orders. If Valneva’s existing purchase orders are cancelled, Dynavax will work to reallocate CpG 1018 inventory to its other COVID-19 collaborators. Dynavax’s revenue opportunity associated with its CpG 1018 commercial supply agreements in 2021, as well as its corresponding profit margin, are contingent on many variables including continued success of each of Dynavax’s partners’ programs and timing of product delivery.

About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used in HEPLISAV-B. Dynavax developed CpG 1018 adjuvant to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 adjuvant provides a well- developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.

Sorrento Therapeutics, Inc. Corporate Presentation

On September 13, 2021, Sorrento Therapeutics, Inc. ("Sorrento") Presented the corporate presentation (Presentation, Sorrento Therapeutics, SEP 13, 2021, View Source [SID1234587599]).

Y-mAbs Announces Priority Review of BLA for DANYELZA® (naxitamab-gqgk) in China

On September 13, 2021 Y-mAbs Therapeutics, Inc. ("Y-mAbs" or the "Company"), NASDAQ: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that its partner SciClone Pharmaceuticals (Holdings) Limited ("SciClone Pharmaceuticals") has been granted priority review of the Biologics License Application ("BLA") for DANYELZA (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma by the Center for Drug Evaluation ("CDE") of China’s National Medical Products Administration ("NMPA") (Press release, Y-mAbs Therapeutics, SEP 13, 2021, View Source [SID1234587598]).

"We are pleased to see SciClone Pharmaceuticals receive priority review of the DANYELZA BLA in China. Priority review in China is intended to expedite review and approval, which means that we could potentially be facing approval and launch of DANYELZA in China as soon as the first quarter of 2022," commented Thomas Gad, founder, Chairman and President at Y-mAbs.

Dr. Claus Moller, Chief Executive Officer, continued, "DANYELZA was recently prescribed for the first time in China, and we were excited to learn that the first patient had received treatment at the Lecheng Branch of Hainan Women and Children’s Medical Center in Hainan Boao Lecheng International Medical Tourism Pilot Zone."

Researchers at MSK developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.