On June 1, 2022 Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada) for a planned Phase 1a/1b dose escalation and expansion trial to evaluate AB248, Asher Bio’s novel investigational CD8-targeted interleukin 2 (IL-2), as a monotherapy and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with locally advanced or metastatic solid tumors, including melanoma, renal cell carcinoma (RCC), non-small cell lung carcinoma (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN) (Press release, Asher Biotherapeutics, JUN 1, 2022, View Source [SID1234615378]). Under the terms of the agreement, Asher Bio is responsible for conducting the Phase 1a/1b trial, which it expects to initiate in the second half of 2022.

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Mechanistically, IL-2 signaling is complementary to PD-1 checkpoint blockade: checkpoint inhibitors release the brakes on T cells, allowing them to kill cancer cells, while IL-2 pushes on the gas pedal driving an increase in the number and activity of T cells. In the clinic, there have been studies conducted on high dose IL-2 as a monotherapy to treat PD-1 failures and on high dose IL-2 in combination with PD-1 checkpoint inhibitors in earlier lines of therapy that both demonstrated encouraging activity. However, despite high dose IL-2 efficacy in these settings, severe toxicities significantly hamper use of IL-2 in practice.

Asher Bio previously reported preclinical data from studies of a murine surrogate of AB248, which achieved significant anti-tumor activity as monotherapy and in combination with anti-PD1, without toxicity associated body weight loss. In comparison, treatment with a "not α" IL-2 achieved lower anti-tumor activity and was accompanied by body weight loss.

"We are looking forward to initiating this trial in collaboration with Merck to evaluate AB248 in combination with KEYTRUDA in a range of cancers," said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. "Treatment with PD-1 checkpoint blockade monotherapy or in combination with chemotherapy or another immunotherapy has become a recommended first line treatment in multiple indications. Yet for patients who failed to achieve a response or who relapse, treatment options are limited. In addition, there is a subset of first line patients where there is an opportunity to enhance the current standard of care. We believe that by precisely focusing the effect of IL-2 to the primary immune cell subset that drives anti-tumor efficacy, AB248 may have the potential to deliver a highly differentiated product profile that could become a backbone of immuno-oncology across a range of solid tumors."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.

About AB248
AB248 is a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to a humanized IgG1 anti-CD8β antibody. It was specifically engineered to selectively and potently expand CD8+ T-cells, while avoiding natural killer (NK) cells, which can act as a pharmacological sink and contribute to toxicity, and regulatory T (Treg) cells, which are immunosuppressive. In some preclinical studies, AB248 exhibits an approximately 1,000-fold preference for the activation of CD8+ T cells over NK cells and Tregs. In other nonclinical studies, AB248 has demonstrated potent anti-tumor activity both alone and in combination with PD-1 checkpoint blockade in a wide variety of murine tumor models.

On June 1, 2022 Arrakis Therapeutics, a biopharmaceutical company pioneering the discovery of a new class of small molecule medicines that directly target RNA, reported that Michael Gilman, Ph.D., Chief Executive Officer, will present a corporate overview at the Jefferies Healthcare Conference on Thursday, June 9, 2022 at 3:30 p.m. ET in New York (Press release, Arrakis Therapeutics, JUN 1, 2022, View Source [SID1234615377]).

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On June 1, 2022 AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, reported it will present at the Jefferies 2022 Global Healthcare Conference in New York on Friday, June 10 at 9:00 AM (Press release, AnHeart Therapeutics, JUN 1, 2022, View Source [SID1234615376]). Presenting for the company will be Lihua Zheng, J.D. Ph.D., Chief Business Officer and Co-Founder, AnHeart Therapeutics.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live audio webcast of the presentation will be available on the News section of the Company’s website at www.anhearttherapeutics.com/news. A replay of the presentation will be posted in the "News" section of the AnHeart website after the event.

In addition, AnHeart Therapeutics will also be participating at the following events:

Endpoints News – ASCO (Free ASCO Whitepaper) 2022 Virtual Webinar

Panel: Next-generation ROS1 inhibitors for lung cancer – what’s next?

Time/Date: 1:00 – 1:45 PM ET, Tuesday, June 7

Location: Virtual, register here.

Panelists will include key opinion leaders Dr. David Ross Camidge, University of Colorado; Dr. Caicun Zhou, Shanghai Pulmonary Hospital; Dr. Misako Nagasaka, University of California Irvine; and Dr. Wei Li, Shanghai Pulmonary Hospital.

BIO 2022 International Conference

Panel: Next Gen Oncology Therapeutics: Changing the Cancer Landscape

Date/Time: 11:00 AM -12:00 PM PT, Tuesday, June 14

Location: Upper Level, Session Room 11A, San Diego Convention Center

Lihua Zheng, CBO and co-Founder of AnHeart, will represent the company in the panel discussion.

Contact [email protected] to meet our team on-site at ASCO (Free ASCO Whitepaper) and BIO.

On June 1, 2022 Teon Therapeutics (Teon), a clinical-stage biopharmaceutical company targeting metabolic signaling pathways and pioneering the development of G-Protein Coupled Receptor (GPCR) immuno-oncology therapies in difficult-to-treat cancers, reported the acceptance by the U.S. Food and Drug Administration (FDA) of Teon’s Investigational New Drug (IND) application for the study of TT-816 (Press release, Teon Therapeutics, JUN 1, 2022, View Source [SID1234615375]). TT-816 is a novel, oral cannabinoid CB2 receptor antagonist acting as an immune checkpoint inhibitor for the treatment of a broad range of solid tumors. The IND enables Teon to initiate its planned Phase 1/2 clinical trial designed to assess the dosing, tolerability and safety of TT-816 in patients with advanced cancers as a monotherapy and in combination with existing standard of care anti-PD-1 checkpoint inhibitors.

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"The FDA’s acceptance of the IND for TT-816 is an important validation of our approach to targeting a novel immune checkpoint pathway and marks a significant milestone for Teon," said Serge Messerlian, Chief Executive Officer of Teon. "As a highly-selective orally-administered checkpoint inhibitor, we believe that TT-816 has the promise to change the treatment landscape in many difficult-to-treat cancers, including lung, renal, and ovarian, and we are very pleased to begin evaluating its potential in the clinic."

The cannabinoid CB2 receptor belongs to the G protein-coupled receptor family. The cannabinoid CB2 receptor, selectively targeted by TT-816, is a peripheral receptor found predominantly in the immune system and regulates inflammation and the immune response. Elevated CB2 receptor expression is associated with worse overall survival[1-5] and aggressiveness of cancer.[6,7] Research has shown that CB2 receptor activation does not have any psychoactive properties unlike CB1 receptors which are located primarily in the brain.8

Preclinical results indicate that TT-816 enhances both the effect of NK cell tumor killing and T cell activation in vitro and increases both tumor infiltrating T cells and NK cells in vivo. TT-816 dose-dependently inhibits tumor growth in animal models, has an additive effect with anti-PD-1 in the ‘hot’ tumor model and acts synergistically with anti-PD-1 in the ‘cold’ tumor model where the anti-PD-1 alone had no effect.

"TT-816 is a novel immune checkpoint inhibitor that has demonstrated that it may have the potential to enhance both innate and adaptive immunity, synergize antitumor effects with current immune checkpoint inhibitor therapies​ and directly promote immune cell penetration into solid tumors," said Lina Yao, MD, PhD, Chief Scientific Officer of Teon. "TT-816 adds to Teon’s strong portfolio of highly-selective small molecules furthering the Company’s aim to advance first- or best-in-class cancer immunotherapies to patients."

Initiation of the Phase 1/2 TT-816 clinical trial is on track for third quarter 2022.

About TT-816
TT-816 is a first-in-class, oral cannabinoid CB2 receptor antagonist acting as an immune checkpoint inhibitor and is highly selective for the CB2 receptor versus the CB1 receptor. By inhibiting the actions of the CB2 receptors found in many difficult-to-treat cancers, including lung, renal, and ovarian, TT-816 has the potential to enhance immune response to treat solid tumors.

Targeting GPCR for Oncology – Tomorrow’s Treatments
With more than 700 approved drugs currently directed at them, GPCRs are the most commonly utilized target in today’s treatment paradigm, however, their potential in oncology and moreover, immuno-oncology, has yet to be leveraged. GPCRs control a broad range of cellular processes vital to the formation and progression of tumors. Small molecules are the most prevalent modulators of GPCR-targeted therapies. Insights into the roles of GPCRs in the tumor microenvironment and how they modulate both tumor-generating signal transduction pathways as well as interactions with immune system defense mechanisms may allow the pursuit of more novel GPCR-directed therapies.

On June 1, 2022 Flatiron HealthⓇ reported the appointment of Javier Jimenez, MD, MPH, as Chief Medical Officer, effective June 1, 2022 (Press release, Flatiron Health, JUN 1, 2022, View Source [SID1234615374]). In his new role, Dr. Jimenez will drive our vision for integrated evidence, harnessing new approaches to oncology evidence generation through Flatiron’s engaged care network and fit-for-purpose scientific methods and tools. His clinical expertise and proven leadership, as well as his extensive experience with real-world evidence, will continue to advance our scientific efforts and a future where we accelerate R&D and realize a more equitable and sustainable cancer care ecosystem. Dr. Jimenez succeeds Dr. Michael Vasconcelles, who will remain at Flatiron as a senior advisor through August 1, 2022.

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"Our commitment to reimagining the infrastructure of cancer care is unwavering. Mike has been instrumental in elevating and deepening the expertise and focus of our scientific, clinical, and regulatory efforts, establishing the foundational building blocks for our path forward. I would like to thank him for his significant contributions to Flatiron, and for doing so with dedication and passion," said Carolyn Starrett, Flatiron CEO. "I’m pleased to welcome Javier as our new Chief Medical Officer, joining our executive team. Javier is a visionary and one of the most deeply experienced healthcare leaders in the field of real-world evidence and novel study design. Flatiron is approaching our ten-year anniversary as a company, and we are more passionate than ever to lay the groundwork for a world where cancer research and care are integrated and accelerated globally. Javier has been pursuing a similar vision as a Flatiron customer since our inception."

Prior to Flatiron, Dr. Jimenez served as Executive Vice President, Real World Evidence and Late Phase at Syneos Health, with expertise spanning Clinical Development, Medical Affairs, Market Access and Product Commercialization. During his time at Syneos Health, Dr. Jimenez grew the RWE function, integrating RWE solutions experts, data and analytics, innovation and RWE clinical operations, while driving the RWD and analytics and technology company strategy. Dr. Jimenez started his journey in the pharmaceutical industry over twenty years ago, first spending sixteen years leading Medical Evidence, Observational Research, Epidemiology, Regulatory, and HTA teams across the US and Europe at AstraZeneca, while building Phase IIIb/IV design and delivery capabilities as well. Dr. Jimenez’s vast experience in Oncology includes leading AstraZeneca’s collaboration with ASCO (Free ASCO Whitepaper)’s CancerLinQ. Following his time at AstraZeneca, Dr. Jimenez spent four years building the RWE, Advance Analytics and Clinical Outcomes functions at Sanofi to support all Sanofi Global Business units, as well as developing technology, tools and capabilities to leverage RWD and generate insights. As an MD and Epidemiologist by training, Dr. Jimenez is a passionate champion and key opinion leader in the use of real-world data to transform regulatory decision making and in the design of novel clinical trials. Dr. Jimenez’s recent research contributions span hypoglycemia predictive modeling in patients with Type 2 diabetes and cardiovascular risk prevention, management in clinical practice settings and use of RWD to identify novel indications for products in development and build research-grade RWD.

"I am incredibly honored to join Flatiron, a global leader and pioneer in real-world evidence in oncology," said Dr. Jimenez. "Flatiron is at a transformative point in its trajectory, working to create a more modern, connected oncology ecosystem – and I am inspired to be a part of an organization that is committed to improving lives by learning from the experience of every cancer patient."