On May 19, 2022 Physicians and scientists at the University of Minnesota reported that have opened a new solid tumor cancer clinical trial and have treated their first patient with HCW9218, an injectable, bifunctional immunotherapeutic, developed by HCW Biologics Inc (NASDAQ: HCWB) (Press release, HCW Biologics, MAY 19, 2022, View Source [SID1234614907]). This Phase I, first-in-human clinical trial is enrolling patients that have advanced solid tumors with progressive disease after prior chemotherapies.

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The trial is led by University of Minnesota oncologist Melissa Geller, MD, MS, Professor, and Division Director, Gynecologic Oncology, Department of Obstetrics, Gynecology and Women’s Health (OBGYN) in the Medical School and the Masonic Cancer Center’s Associate Director for Clinical Research, with collaboration from Jeffrey Miller, MD, Professor of Medicine in the Medical School’s Division of Hematology, Oncology and Transplantation and Deputy Director of the Masonic Cancer Center, and Manish Patel, DO, Associate Professor of Medicine, Division of Hematology, Oncology and Transplantation and Director of the Developmental Therapeutics Clinic.

"Our team is very excited to bring this clinical trial to patients who have recurrent cancer," noted Dr. Geller. "With the ease of a subcutaneous injection, this innovative compound can stimulate the immune system while at the same time inhibiting proteins that cause immunosuppression. This unique combination will provide patients with cancer a novel immune-based therapy when previous treatments have failed."

The treatment, HCW9218 has an IL-15 component that activates the immune system (NK cells and T cells) and a second component that neutralizes TGF-beta, a common protein induced by tumors to suppress the immune system. As a result, this bifunctional fusion protein complex is designed to drive anti-tumor immune activity to attack cancer cells while simultaneously blocking unwanted immunosuppressive activities.

On May 19, 2022 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported that John Butler, Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright Global Investment Conference, which will take place as a hybrid event May 23–26, 2022 (Press release, Akebia, MAY 19, 2022, View Source/news-releases/news-release-details/akebia-therapeutics-present-hc-wainwright-global-investment" target="_blank" title="View Source/news-releases/news-release-details/akebia-therapeutics-present-hc-wainwright-global-investment" rel="nofollow">View Source [SID1234614874]).

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An audio replay of the fireside chat will be available through the Investors section of Akebia’s website at View Source starting on May 24th and for approximately 90 days following the conference.

On May 19, 2022 Tallac Therapeutics, Inc., a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer, reported the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) Application to study TAC-001 in a Phase 1/2 clinical trial for patients with advanced or metastatic solid tumors (Press release, Tallac Therapeutics, MAY 19, 2022, View Source [SID1234614890]). TAC-001 is the company’s lead clinical candidate from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform.

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"We are delighted that our IND for TAC-001 was cleared by FDA," said Dr. Hong I. Wan, president, CEO and co-founder of Tallac Therapeutics. "TAC-001 is a novel antibody-oligonucleotide conjugate designed to deliver systemic TLR9 agonism with targeted immune activation of B cells, which plays a key role in cancer immunity. In preclinical studies, systemically administered TAC-001 is active as a single agent across a number of syngeneic tumor models including ones with immune suppression and resistance, leading to complete tumor eradication and immune memory. We believe this is a major advancement over the clinically validated intratumorally administered TLR9 agonists and we look forward to advancing TAC-001 into clinical development for cancer patients."

Toll-like receptor 9 (TLR9) agonists are a class of immunotherapy that generate both innate and adaptive immune response which may produce more robust and durable anti-cancer immunity to help overcome resistance to standard-of-care oncology treatments. TLR9 agonists have demonstrated clinical activity in melanoma patients when administered intratumorally. B cells express TLR9 and play pivotal roles in the immune system, and represent a major component of the tumor microenvironment, where they are predominantly associated with tertiary lymphoid structure (TLS). The presence of B cells and TLS is a positive prognostic factor and predicts treatment response to checkpoint inhibitors in multiple solid tumor types.

Tallac Therapeutic’s TRAAC platform is designed to deliver a potent and differentiated TLR9 agonist (T-CpG) for targeted immune activation via systemic administration. TAC-001 is comprised of T-CpG conjugated to an antibody against CD22, a receptor restricted to B cells, including tumor-infiltrating B cells. Preclinical studies demonstrate that the innate and adaptive immune responses triggered by TAC-001 leads to robust, curative, and durable single agent anti-tumor activity in checkpoint inhibitor resistant and refractory tumor models. Increased B cell infiltration, T cell effector functions and modulation of suppressive myeloid cells within the tumor microenvironment was observed following systemic TAC-001 administration. These results support the development of TAC-001 for a broad range of solid tumor malignancies, particularly in the tumor types with B cell/TLS involvement.

About TAC-001

TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) comprised of a potent Toll-like Receptor 9 agonist (T-CpG) conjugated to an antibody against CD22, a receptor restricted to B cells, including tumor-infiltrating B cells. TAC-001 is designed to systemically deliver T-CpG to B cells by binding to CD22, leading to internalization of TAC-001, TLR9 signaling, B cell activation and a cascade of immune reactions. Preclinical studies demonstrate that the innate and adaptive immune responses triggered by TAC-001 leads to potent anti-tumor activity. TAC-001 is being developed for the potential treatment of solid tumors.

On May 19, 2022 ChromaDex Corp. (NASDAQ:CDXC) ("the Company") a global bioscience company dedicated to healthy aging, reported it has entered into an agreement (the "JV Agreement") to establish a joint venture through its wholly owned subsidiary ChromaDex Asia Limited (the "JV" or "ChromaDex Asia") (Press release, ChromaDex, MAY 19, 2022, View Source [SID1234614859]). Upon establishment of the JV, membership of ChromaDex Asia will collectively consist of the Company; Crystal Lake Developments Limited; Pioneer Idea Holdings Limited; and Hong Kong Taikuk (China) Group Limited. ChromaDex Asia is expected to assume the distribution agreement noted in a previous announced press release with Sinopharm Xingsha ("Sinopharm") as it relates to the commercialization of Tru Niagen in mainland China and its territories, excluding Hong Kong, Macau and Taiwan (the "Territory"). The JV’s entry into a distribution agreement will be contingent upon Sinopharm successfully attaining health food product registration for Tru Niagen with the People’s Republic of China’s State Administration for Market Regulation ("SAMR"). SAMR is the regulatory body responsible for health food registration. Health food registration is a key regulatory step required to be able to broadly market and distribute Tru Niagen products in China. Formation of the joint venture is subject to customary closing conditions.

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"The establishment of this joint venture marks an expansion milestone in ChromaDex’s China strategy and sets the necessary foundation to advance sales of Tru Niagen in this key market," said Rob Fried, CEO of ChromaDex. "We are honored to extend our professional relationship with existing strategic partners, as well as our new partner in this venture, Taikuk."

For detailed transaction terms, see 8-K (filed on May 19, 2022).

On May 19, 2022 Mevion Medical Systems reported that it has been selected to install a MEVION S250i Proton Therapy System with HYPERSCAN Pencil Beam Scanning (PBS) in a comprehensive hospital in Southern China (Press release, Mevion Medical Systems, MAY 19, 2022, View Source [SID1234614875]).

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Proton therapy is a superior form of radiation therapy that can reduce the amount of unnecessary radiation exposure to surrounding healthy tissue and sensitive organs at risk. HYPERSCAN PBS improves on these benefits by using Mevion’s unique Adaptive Aperture pMLC to enable faster and sharper delivery of therapeutic radiation to tumors while sparing healthy tissue.

The MEVION S250i Proton Therapy System’s leading-edge clinical capabilities, combined with its compact, affordable design, and industry-leading ramp-up time, have changed the landscape of proton therapy. Mevion received US FDA 510(k) clearance for the system in 2017 and is actively seeking regulatory approval from the National Medical Products Administration (NMPA) in China.

"We are proud to be selected to equip a new proton center in Southern China," said Tina Yu, Ph.D., CEO and President of Mevion Medical Systems. "It confirms Mevion’s leading position as a trusted compact proton therapy provider and marks another milestone of our growth in China."

According to Global Cancer Observatory, there were over 4.5 million cancer cases in China in 2020. However, only 3 proton centers are currently in clinical operation in Mainland China, leaving a substantial number of patients without access to this advanced cancer-fighting technology. As the innovator of the single-room system, Mevion’s approach allows for an expedited project timeline, efficient center operation, and financial success, all of which will benefit the underserved China market.