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Altimmune To Announce Year End 2020 Financial Results On February 25, 2021

On February 22, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that it will report its full year 2020 financial results on Thursday, February 25th, 2021 (Press release, Altimmune, FEB 22, 2021, View Source [SID1234575746]).

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Altimmune management will host a conference call for investors beginning at 8:30 am ET on Thursday, February 25th, 2021 to discuss financial results and provide a business update.

Diaprost Announces Promising New Study for Patients with Metastatic PCa

On February 22, 2021 Diaprost reported a publication in the journal of Clinical Cancer Research on PSA-targeted Alpha-, Beta- and Positron Emitting Immuno-Theranostics in Murine Prostate Cancer Models and Non-Human Primates (Press release, Diaprost, FEB 22, 2021, http://diaprost.com/wp-content/uploads/Press-release-mkscc-diaprost_20210222.pdf [SID1234575621]).

The extensive preclinical study was conducted at Memorial Sloan Kettering Cancer Center (MSK) on Diaprost’s propriety antibody (hu5A10) targeting PSA. This rigorous preclinical evaluation of radiolabeled hu5A10-based compounds in prostate cancer (PCa) mouse models and non-human primates, establishes hu5A10 as a promising theranostic (therapy and diagnostic) agent that allows specific and effective delivery of radionuclides to androgen receptor driven prostate tissue. The reported data strongly supports Diaprost’s planned efforts to translate h5A10 to patients.

Diaprost, a private pharmaceutical research and development company based in Lund, Sweden whose principal asset is hu5A10 targeting PSA, previously announced an exclusive license agreement with MSK for intellectual property (IP) related to the use of PSA antibodies for therapeutic and diagnostic purposes for prostate cancer.

"These results clearly show that PSA-targeted alpha-particle therapy is a very promising option for patients with generalized and castration resistant PCa" said Johan Drott, the CEO of Diaprost. "There is an urgent need for therapeutic compounds that result in substantial treatment effects and long-term survival in patients with metastatic PCa. Based on this promising data, we think that hu5A10 is a unique candidate, and we are looking forward to clinical development to be initiated."

This hu5A10 project follows in the footsteps of Diaprost’s successful earlier work in prostate cancer focusing on the hK2 antibody (hu11B6) which led to a sale of the asset to a leading global pharmaceutical company.

Seagen’s Tukysa Combination Garners UK Approval for Advanced HER2-Positive Breast Cancer

On February 22, 2021 Seagen reported the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized its anti-HER2 agent tucatinib (Tukysa) with trastuzumab (Genentech’s Herceptin) and chemotherapy for HER2-positive, locally advanced, or metastatic breast cancer patients who have previously received at least two prior anti-HER2 treatment regimens (Press release, Seagen, FEB 22, 2021, View Source [SID1234575582]).

The MHRA’s decision to approve the combination in the UK comes a week after the European Commission granted approval to the same regimen in the EU. In April 2020, the US Food and Drug Administration approved the combination in the US. Importantly, the drug is approved to treat breast cancer patients whose disease has spread to the brain.

All three approvals are based on data from the randomized, Phase II HER2CLIMB trial, which pitted the tucatinib-trastuzumab-chemo combination against trastuzumab, chemo, and placebo. The median progression-free survival for patients treated with the tucatinib combination was 7.8 months versus 5.6 months for those on the trastuzumab-chemo arm. The median overall survival for patients treated with the three agents was 21.9 months versus 17.4 months for patients treated with just the two.

In September 2020, Seagen, formerly named Seattle Genetics, out licensed tucatinib to Merck for commercialization outside of the US, Canada, and Europe.

Following MHRA’s authorization, bodies such as the UK’s National Institute of Health and Care Excellence (NICE) will appraise the clinical and cost effectiveness of the drug and decide if the National Health Service should fund it for breast cancer patients. "We look forward to further collaborating with the national reimbursement bodies to ensure it is available to adult patients," Seagen CEO Clay Siegall said in a statement.

NovellusDx Establishes Fore Biotherapeutics U.S. as its Operating Company in the United States & Appoints Dieter Weinand as Chairman of the Board & Usama Malik as Chief Executive Officer and Director of the Board

On February 22, 2021 NovellusDx (or the "Company"), a clinical-stage biotechnology company focused on precision oncology, reported that it is establishing Fore Biotherapeutics U.S. as its operating company in the United States to reflect its evolved biotech business model focused on matching patients with unaddressed tumor mutations with the right medicines in the clinic (Press release, Novellusdx, FEB 22, 2021, View Source [SID1234575581]). Using an integrated functional genomics and machine learning drug discovery engine, the Company synthesizes a wide range of mutations across validated oncological targets and in-licenses clinical stage small molecule assets to develop for hyper-targeted populations. As part of the strategic refocus, the Company has appointed therapeutic and business development veterans Mr. Dieter Weinand and Mr. Usama Malik as the Chairman of the Board, and Chief Executive Officer and a director, respectively. The previous Chief Executive Officer of the Company, Dr. Michael Vidne, will continue to work with the Company and has transitioned to Chief Business & Strategy Officer.

The Company is in the process of establishing its headquarters and executive leadership team in the U.S. The Company also anticipates it will complete its Phase 1 dose-finding study in the coming months, which the Company hopes to follow with a launch of a pivotal Phase 2 study of its clinical Class I/II BRAF inhibitor, PLX8394.

"I am excited to embark on the next phase of the Company’s journey with the goal of it becoming a world leader in targeted oncology drug development," said Michael Vidne, Chief Business & Strategy Officer of the Company. "Usama and Dieter bring deep clinical and business development expertise and are recognized biopharma executives. Their expertise will be invaluable as we begin leveraging our functional genomic platform to build our pipeline of clinical development oncology programs. I look forward to working closely with both and contributing to the continued growth of the Company."

Dieter Weinand brings decades of general management and commercial leadership experience with executive management roles at Bayer, Sanofi, Pfizer, and BMS among others. He also sits on the boards of several high-profile biotech companies, including as Chairman of the Board of Directors of Replimune.

Mr. Weinand commented: "The Company represents an exciting story in precision oncology today. With the backing of leading life science funds, and on the strength of its clinical Class I/II BRAF inhibitor, I believe the Company is poised to change the drug development paradigm, and has the potential to deliver tangible benefits to currently underserved populations of cancer patients."

Usama Malik also brings extensive experience from across the healthcare industry into his new role. He has led, grown and transformed pharma and biotech organizations in executive leadership roles, and has been an advisor to the boards and leadership teams of numerous Fortune 100 companies. He most recently led the turnaround of Immunomedics, which was acquired by Gilead Sciences for $21 billion.

Mr. Malik added: "I believe the Company is at the forefront of redefining drug development in precision oncology. Our highly differentiated and proprietary functional genomics platform allows us to characterize a wide range of mutations on target genes and test their response to candidate compounds. This, in turn, enables us to home in on exciting clinical assets that have a higher probability of success for precision populations. It is a real honor and privilege to join this board and executive team, and I look forward to working with my colleagues to establish a world-class precision oncology company."

NovalGen enters strategic partnership with HALIX B.V. to manufacture clinical trial materials

On February 22, 2021 NovalGen Ltd. ("NovalGen"), a biopharmaceutical company developing breakthrough cancer therapies and HALIX B.V. ("HALIX"), a contract development and manufacturing organisation, reported a strategic partnership (Press release, UCLB, FEB 22, 2021, View Source [SID1234575421]). Within the scope of this partnership, HALIX will provide manufacturing of clinical supply of NovalGen’s therapies .

NovalGen’s innovative platform technology has been successfully deployed at HALIX to manufacture clinical trial material for NovalGen’s first clinical program. The program, NVG-111, is a Receptor Tyrosine Kinase Like Orphan Like Receptor 1 (ROR1) targeting bispecific antibody T cell engager for the treatment of hematologic malignancies and solid tumors, is expected to enter the clinic in the first half of 2021. HALIX has supported NovalGen with the successful completion of GMP manufacture of NVG-111 from drug substance up to drug product and final release. The strategic partnership and collective expertise of both organisations has ensured an efficient technology transfer and further development of the process leading to a successful GMP manufacturing campaign.

"This collaboration with HALIX will ensure high quality, rapid and secure manufacture of clinical supplies for our current and future products. Using cutting-edge manufacturing technologies at our partner’s state-of-the-art cGMP facility, we are progressing to become a clinical stage company," said Kieran O’Donovan, SVP Chemistry and Manufacturing Controls at NovalGen."We developed a manufacturing process around the use of transient transfection to accelerate timelines and reduce costs, whilst delivering product of the highest quality. In HALIX we found the ideal partner; experience in transient transfection, modern facilities, strong leadership and a laser focus on delivery to bring NVG-111 from contract signature to vials of clinical drug in less than seven months."

"The partnership with NovalGen has been a great success," said Alex Huybens, Chief Operations Officer at HALIX. "Working closely together and utilizing the collective bispecific antibody expertise of both teams has enabled us to meet the ambitious timelines and efficiently transfer the process and deliver the product to be ready to enter the clinic. We look forward to a long and productive collaboration with NovalGen."