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.

On May 19, 2022 Dxcover Limited, a clinical stage diagnostics company developing its spectroscopic biopsy technology for early detection of multiple cancers, reported that it will be presenting new data at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 3-7 (Press release, Dxcover, MAY 19, 2022, View Source [SID1234614891]).

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Dxcover has pioneered the early detection and identification of cancer by employing infrared spectroscopy of circulating non-genetic biomarkers. The company has completed two groundbreaking studies on earlier diagnosis of brain cancer and is currently developing its platform for the detection of commonly occurring cancers.

"While we know that earlier detection of cancer, when the patient’s tumor is small, results in significantly higher survival rates compared to late-stage diagnosis, the liquid biopsy tests currently used have limited ability to detect and identify early cancers and there are no effective first-line screening options for the early detection of many solid tumors," said Dr. Matthew J. Baker, Chief Technology Officer and co-founder of Dxcover. "Dxcover was founded precisely to solve the problem of shortening the time to cancer diagnosis and enable people to live better, longer lives and we look forward to sharing the results of our multicancer early detection study at ASCO (Free ASCO Whitepaper)."

In addition, Dxcover will also be releasing data for publication only during ASCO (Free ASCO Whitepaper) from its proof-of-concept study which investigates the use of the Dxcover cancer liquid biopsy as a novel approach for pancreatic cancer and detection of multiple cancers.

Details of the sessions are as follows:

Title: Multicancer early detection with a spectroscopic liquid biopsy platform.
Session Title/Track: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Type: Poster Discussion Session

Title: Machine learning based detection of pancreatic tumors using the Dxcover cancer platform.
Session Title/Track: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Type: Publication Only

On May 19, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Almirall S.A. (ALM), a global biopharmaceutical company focused on skin health, reported a multi-target alliance in Medical Dermatology (Press release, Evotec, MAY 19 , 2022, View Source [SID1234614843]). The companies aim to discover and develop novel therapeutics for severe skin diseases, including immune-mediated inflammatory conditions such as atopic dermatitis and non-melanoma skin cancer such as basal cell carcinoma.

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The alliance will leverage Evotec’s fully integrated multimodality platform and combine it with Almirall’s leading expertise in Medical Dermatology. Both partners will contribute drug targets in the research process. Leveraging the Company’s end-to-end integrated, AI/ML-driven EVOiR&D platform, Evotec will be responsible for drug discovery and pre-clinical development. Almirall will lead the clinical development and marketing.

Under the agreement, Evotec receives an undisclosed upfront payment, research payments, as well as success-based milestones of potentially up to € 230 m per programme and royalties on net sales in the high single-digit percentage range.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "We are very happy to enter this collaboration with Almirall, one of the leaders in the field of Medical Dermatology. The collaboration has the potential to deliver superior first-in-class therapeutic options for many patients suffering from severe skin diseases such as atopic dermatitis or basal cell carcinoma. We are looking forward to leveraging the complementary expertise of Evotec and Almirall in order to develop promising new drug candidates."

Dr Karl Ziegelbauer, Chief Scientific Officer of Almirall, stated: "We are very excited about the strategic alliance with Evotec and believe that combining Almirall’s experience and know-how in Medical Dermatology with Evotec’s integrated drug discovery and preclinical development small molecule platform will enable us to deliver novel solutions for patients suffering from auto-immune skin diseases or common forms of skin cancer."