Crescendo Biologics Announces Humabody® Evaluation in CAR-T by Takeda

On January 3, 2019 Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T-cell enhancing therapeutics, reported that Takeda Pharmaceutical Company Limited (Takeda) is planning to evaluate the application of recently licensed Humabodies from Crescendo for the development of novel CAR-T therapeutics (Press release, Crescendo Biologics, JAN 3, 2019, View Source [SID1234553819]).

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This research will investigate the unique properties of the Humabody VHs for tumour targeting of CAR-Ts. Unlike single-chain variable fragments (scFvs), Humabody VHs do not require a light chain for high specificity and affinity, and can be easily configured for multi-specific target binding. Takeda’s decision to license these Humabodies provides an opportunity to evaluate a large number of different VHs directed to the same target, in order to identify a format that delivers both enhanced safety and functionality.

Crescendo’s global, strategic, multi-target collaboration and license agreement with Takeda was first announced in October 2016. Under this agreement, Crescendo’s proprietary transgenic platform and engineering expertise is being used to identify and configure Humabody-based therapeutics against certain targets selected by Takeda.

Dr Peter Pack, CEO of Crescendo, commented:
"We’re pleased to see the research Takeda is undertaking with our Humabody technology. Their desire to explore the Humabody technology in a CAR-T setting presents an exciting opportunity to evaluate whether Humabodies can address the issues that exist with other CAR-T targeting approaches."

Adlai Nortye Announces Clinical Collaboration with Merck to Evaluate Adlai Nortye’s AN0025 (EP4 Antagonist) in Combination with KEYTRUDA® (pembrolizumab) in Patients with Solid Tumors

On January 3, 2019 Adlai Nortye Ltd. ("Adlai Nortye"), a global clinical-stage biopharmaceutical company reported that it has entered into a clinical collaboration with Merck (known as MSD outside the US and Canada) to evaluate the combination of Adlai Nortye’s AN0025 (EP4 Antagonist) and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with solid tumors (Press release, Merck & Co, JAN 3, 2019, View Source [SID1234553811]).

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Under the terms of the agreement, Adlai Nortye and Merck will collaborate in a clinical trial to evaluate the safety and preliminary efficacy of the combination of AN0025 (EP4 Antagonist) and KEYTRUDA in patients with solid tumors.

"We are excited to announce this collaboration with Merck, to help bring innovative cancer treatments to patients with unmet medical needs. AN0025 is an investigational, oral EP4 antagonist – potentially first-in-class – with high activity and high selectivity," said Carsten Lu, CEO of Adlai Nortye. "Based on preliminary results, it is well tolerated in patients with solid tumors. This collaboration is supported by our recent preclinical data demonstrating the potential ability of AN0025 (EP4 Antagonist) to rescue patients who do not initially respond to anti-PD-1 therapy alone or who are resistant to PD-1 inhibitors with solid tumors."

"With its proposed mechanism of action and observed preclinical results, we believe that AN0025 (EP4 Antagonist) will become a key component in furthering the development of our oncology pipeline," said Dr. Lars Birgerson, CDO and CEO of Adlai Nortye USA. "In preclinical studies, AN0025 (EP4 Antagonist) combined with radiotherapy, chemoradiotherapy and with immune checkpoint inhibitors demonstrated antitumor activity in different malignancies, we are optimistic that the combination of AN0025 (EP4 Antagonist) with KEYTRUDA may provide meaningful clinical benefit in patients with solid tumors."

Tragara Pharmaceuticals Appoints Scott Megaffin as Chief Executive Officer and Changes Name to Adastra Pharmaceuticals

On January 3, 2019 Tragara Pharmaceuticals Inc. reported the appointment of Scott Megaffin as Chief Executive Officer and a member of the Board of Directors effective immediately (Press release, Tragara Pharmaceuticals, JAN 3, 2019, View Source [SID1234539282]). Megaffin brings extensive leadership experience in clinical stage companies in oncology, specialty and critical care. He replaces Tom Estok, who will remain active with the company as an advisor and continue in his role on the Board of Directors.

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The addition of Megaffin comes at the time of a strategic pivot for the company that includes a change of name to Adastra Pharmaceuticals Inc. As part of this strategy, Adastra has expanded its operations beyond San Diego with the opening of an office in Princeton, N.J. This is consistent with the Adastra strategy to grow and attract new pharmaceutical talent in the New Jersey area. Adastra, which is derived from the Latin phrase "to the stars," is a name that reflects the boundless motivation and dedication of each team member to the development of best-in-class therapeutics for patients with cancer.

"Scott has the right experience to drive forward all of the Adastra strategic imperatives and continued program advancement of TG02," said Dennis Podlesak, Adastra Chairman and Partner of Domain Associates. "The Board would like to acknowledge and thank Tom for his vision and dedication in getting us to this point. We have advanced TG02 in clinical studies in collaboration with healthcare providers in the United States and Europe for adult patients diagnosed with glioblastoma multiforme (GBM). Furthermore, we have prepared for the start of an exploratory study in pediatric patients with diffuse intrinsic pontine glioma (DIPG). Between now and the first quarter of next year, Adastra will have a series of clinical milestones and data read-outs that we expect will enable the company to explore multiple development and business paths forward."

Prior to joining the company, Megaffin was President of Churchill Pharmaceuticals LLC, where he successfully marshalled the company through a transaction that resulted in the sale of company assets before an FDA approval, while simultaneously preparing the company for its own possible commercialization activities. Before this, he held numerous global strategic and operational positions of increasing responsibility with Onconova Therapeutics Inc., Cephalon Inc., Adolor Corp., Yamounchi and Bristol-Myers Squibb Co. He has led six global product launches and clinical development programs in a variety of therapeutic categories, including oncology, hematology, virology, critical care, anti-infectives, pain and inflammation. Megaffin earned a B.S. in Biology from Pittsburg State University.

TG02 is a highly differentiated orally delivered inhibitor of cyclin-dependent kinase 9 (CDK9) with high penetration of the blood brain barrier, overcoming a major challenge in GBM drug development. TG02 exerts inhibitory effects on RNA Polymerase II phosphorylation, leading to depletion of the key cancer cell survival protein, Myc, thus committing cancer cells to apoptosis. TG02 has demonstrated broad anti-tumor activity across cell lines and shows a positive synergistic effect when added to standard of care treatments for GBM. Currently, the National Cancer Institute (NCI) and European Organisation for Research and Treatment of Cancer (EORTC) are enrolling patients in trials of TG02 in GBM. In addition, Adastra will initiate a study of TG02 in DIPG in the second quarter of this year.

Megaffin added, "I am very happy to take on this role at Adastra during this transformational year for the company. The TG02 trials in GBM are progressing nicely, and we are entering into the start of the DIPG study in the pediatric patient population. When evaluating the opportunity to join the company, I reviewed the data in hand for TG02 and became excited by its potential for the benefit of patients. GBM and DIPG are both devastating brain cancers and represent high unmet treatment needs. TG02 presents Adastra with regulatory opportunities of rapid advancement into registrational studies in the near future. We look forward to reporting our progress in 2019 as we focus sharply on clinical programs as well as exploring possible pipeline expansion opportunities."

Mavupharma Selects First Immuno-Oncology Clinical Candidate MAVU-104, an Oral STING Pathway Enhancer

On January 3, 2019 Mavupharma (Mavu) reported that it has selected its first immuno-oncology clinical development candidate, MAVU-104, a novel innate immune modulator (Press release, Mavupharma, JAN 3, 2019, View Source [SID1234537639]).

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MAVU-104 is a first-in-class, orally active, small molecule inhibitor of ENPP1, a phosphodiesterase that negatively regulates the STING (Stimulator of Interferon Genes) pathway. STING signaling plays a crucial role in the generation of an immune response directed at the tumor, and enhancing STING signaling has been shown to induce cures in multiple preclinical cancer models. Inhibiting ENPP1 activity with MAVU-104 allows for highly-controlled enhancement of STING signaling in all tumors and lymph nodes without any injections.

"With our approach, which focuses on blocking a key negative regulator of the STING pathway, as opposed to directly stimulating STING itself, the degree and duration of innate immune activation are tunable, which avoids both overstimulation of the pathway and high levels of cytokine release," stated Mike Gallatin, Ph.D., Mavu’s president and co-founder. "Having selected our first immuno-oncology drug candidate, we are now focused on the path to IND for MAVU-104, which we expect to file in the second half of 2019."

Mavu’s approach may have significant advantages over other developmental therapies that stimulate the STING pathway. Published studies on the direct STING agonists in clinical development show that these therapies are administered via direct injection into the tumor(s) and may induce release of pro-inflammatory cytokines into systemic circulation, which has been associated with side effects.

Previously, Mavu presented data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2018 meeting showing that ENPP1 inhibition leads to tumor shrinkage and can be combined with other immunotherapies to induce long-term cures and durable immunologic memory in mouse models of cancer.

Chongqing Jingdong Pharmaceutical and Athenex announce a strategic partnership and licensing agreement to develop and commercialize KX2-391 in China

On January 3, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it, through its subsidiary, has entered into a licensing and partnership agreement with Chongqing Jingdong Junzhuo Pharmaceutical Co., Ltd. ("Chongqing Jingdong Pharmaceutical") on December 30, 2018 to exclusively develop and commercialize KX2-391 for the treatment of actinic keratosis and oncology indications in humans in China (Press release, Athenex, JAN 3, 2019, View Source [SID1234534523]).

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KX2-391, also known as KX-01, is a first-in-class dual Src kinase and tubulin polymerization inhibitor. KX2-391 ointment is a topical medicinal product for the treatment of actinic keratosis that is in late stage Phase III development. Actinic keratosis is a common skin condition that is induced through ultra-violet light damage, resulting in patches of thick, scaly, or crusty skin. Left untreated, the lesions have risk of progression to squamous cell carcinoma and consequently treatment by a dermatologist is recommended. Other drug candidates with KX2-391 as the compound are also being developed for oncology indications.

Pursuant to the terms and conditions of the arrangement, Athenex will grant to Chongqing Jingdong Pharmaceutical an exclusive license under Athenex’s intellectual property to commercialize topical and oral products containing KX2-391 in mainland China, excluding Hong Kong, Macau and Taiwan. Athenex is expected to receive an upfront payment of an aggregate amount of US$14.5 million. Athenex will also be eligible to receive other development milestone payments of up to US$15 million. In addition, the agreement provides for tiered royalties based on annual net sales starting at 15%, and with incremental increases of royalties with increases in sales.

Athenex will be responsible for conducting all preclinical and clinical studies, as well as regulatory submissions, required for approval in China. Chongqing Jingdong Pharmaceutical will employ its expertise to plan and prepare for the commercialization of the products in China. Athenex announced on July 26, 2018 that statistical significance (p < 0.001) was achieved in two Phase III studies conducted in the United States to support the registration of KX2-391 ointment for the treatment of actinic keratosis. Athenex has submitted an abstract to the American Academy of Dermatology for potential presentation of top-line data from Phase III studies at the AAD meeting in March 2019.

Bin Li, Chief Executive Officer, Chongqing Jingdong Pharmaceutical, commented, "We are pleased to enter into this strategic collaboration with Athenex. We are excited with the very encouraging results generated from the two Phase III studies of KX2-391 ointment, and are impressed by the Athenex team in their innovation and execution of drug development efforts. KX2-391 ointment has the potential to change the standard of care for treatment of actinic keratosis and there is a large unmet medical need in China. We look forward to bringing this promising product to market in China, as well as other potential drug candidates. Our strength and capabilities in drug commercialization and our relationships with key stakeholders in both the pharmaceutical industry and healthcare system in China will complement Athenex’s drug development expertise."

Johnson Lau, Chief Executive Officer, Athenex, added, "Athenex is excited to partner with Chongqing Jingdong Pharmaceutical to develop and commercialize KX2-391. Chongqing Jingdong Pharmaceutical is a pioneer in pharmaceutical drug sales and distribution in China. We are impressed by the management team of Chongqing Jingdong Pharmaceutical and are confident that this partnership will create strong synergies and a platform for growth for both companies in China. Chongqing Jingdong Pharmaceutical’s experience and execution in the Chinese market will be critical to bringing our product to market in the country."

Athenex has a license agreement with Almirall, S.A. on the rights to KX2-391 ointment in the following territories: USA, European Union, Russia and Turkey. Details of this arrangement were disclosed in December 2017.