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]).

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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.

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.

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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."

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 .

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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."

On February 22, 2021 Enlivex Therapeutics Ltd., (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, reported that the China National Intellectual Property Administration (CNIPA) issued a notice of allowance for a new patent application (number 201680029277.4) covering AllocetraTM, the Company’s immunotherapy product candidate (Press release, Enlivex Therapeutics, FEB 22, 2021, View Source [SID1234575419]). Upon issuance, the new patent will provide added intellectual property protection in China, with respect to methods, uses and pharmaceutical compositions for AllocetraTM. The company expects that this new patent will be issued in China in the coming months.

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AllocetraTM is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, AllocetraTM has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

On February 22, 2021 Cullinan Management, Inc. (Nasdaq: CGEM) ("Cullinan"), a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies, reported the following business updates (Press release, Cullinan Oncology, FEB 22, 2021, View Source [SID1234575418]):

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Portfolio Overview and Updates:

Cullinan Pearl
Based on pre-specified efficacy criteria, Cullinan recently initiated Phase 2a Dose Expansion at the 100 mg BID dosing level in the ongoing Phase 1/2a study evaluating CLN-081 in adult NSCLC patients with EGFRex20ins mutations. This expansion will enable enrollment of up to 36 patients, inclusive of 13 previously enrolled patients, at this dosing level. Cullinan is contemplating additional expansion cohorts and intends to provide updated safety and efficacy data in mid-2021.
Cullinan Florentine
In January 2021, Cullinan submitted an IND to the U.S. Food and Drug Administration (FDA) for a Phase 1/2a clinical trial evaluating CLN-049, a bispecific antibody targeting FLT3 and CD3, in relapsed or refractory AML patients. The FDA subsequently provided feedback, including a request to consider alternative trial designs that would enable the collection of exploratory pharmacokinetic and pharmacodynamic data before dose escalation. Based on this information, Cullinan elected to withdraw the IND to determine the most efficient path forward.
Cullinan MICA
Cullinan is completing the production of GMP drug product to support an IND submission and subsequent clinical trial for its investigational product CLN-619, a monoclonal antibody designed to stimulate natural killer (NK) and T cell responses by engaging a unique target, MICA/B. Consistent with prior guidance, Cullinan intends to submit an IND in the second quarter of 2021.
SVB Leerink Global Healthcare Conference Event Details:

Chief Executive Officer, Owen Hughes, will provide a company overview and update at the 10th Annual SVB Leerink Global Healthcare Conference.

Event: 10th Annual SVB Leerink Global Healthcare Conference
Location: Virtual
Date: Friday, February 26, 2021
Time: 4:20 PM ET/1:20PM PT
Members of the Cullinan management team will also host investor meetings during the SVB Leerink Global Healthcare Conference.

A webcast of the SVB Leerink presentation will be available in the Investors section of the Cullinan website at View Source

About CLN-081
CLN-081 is an orally available, irreversible EGFR inhibitor that is designed to selectively target cells expressing mutant EGFR variants, including EGFR exon 20 insertion mutations, with relative sparing of cells expressing wild type EGFR. CLN-081 is currently in a Phase 1/2a dose escalation and expansion trial evaluating oral, twice-daily administration of various doses in patients with NSCLC harboring EGFRex20ins mutations who have had at least one prior treatment with platinum-based chemotherapy or another approved standard therapy. CLN-081 is being developed in Cullinan Pearl, a Cullinan subsidiary.

About CLN-049
CLN-049 is a humanized bispecific antibody targeting FLT3 on target leukemic cells and CD3 on T cells, triggering cancer cell lysis via T cell cytolytic mechanisms. FLT3 is expressed frequently on AML cells and leukemic blasts but minimally on healthy blood cells, unlike other tumor surface antigens such as CD33 and CD123. CLN-049 is being developed in Cullinan Florentine, a Cullinan subsidiary.

About CLN-619
CLN-619 is MICA/B-targeted, humanized IgG1 monoclonal antibody that Cullinan intends to develop in patients with advanced solid tumors. MICA/B are stress-induced ligands that innate and adaptive immune cell populations recognize via the NKG2D receptor. To evade potential cytotoxic destruction by NK cells and T cells, tumors shed MICA/B from the cell surface. CLN-619 is designed to promote an antitumor response through multiple mechanisms of action, including shielding the proteolytic cleavage sites of MICA/B on cancer cells. CLN-619 is being developed in Cullinan MICA, a Cullinan subsidiary.