On July 7, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard-to-treat cancers, reported it has entered into a manufacturing agreement with Catalent Pharma Solutions LLC ("Catalent"), which will include cGMP manufacturing for the Company’s recombinant protein, Human DNase I (Press release, Xenetic Biosciences, JUL 7, 2022, View Source [SID1234616530]).

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Catalent is the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities.

"We are pleased to be working with a preeminent contract development and manufacturing organization such as Catalent, and to have the opportunity to leverage their broad expertise and successful track record with early-stage development through commercial manufacturing. We are excited to take this step forward on the path to the clinic and look forward to investigating systemic DNase as an adjunctive therapy for locally advanced or metastatic cancers," commented, Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

"This agreement is an important step towards long-term collaboration betweenCatalent and Xenetic," added Vikalp Mohan, Global Vice President, Head of Drug Substance at Catalent Biologics. "We look forward to leveraging Catalent’s proven biomanufacturing expertise at our site in Madison, Wisconsin to support the advancement of Xenetic’s DNase clinical development program and accelerating their path to first-in-human studies."

Xenetic’s interventional DNase based oncology platform is aimed at improving outcomes of existing treatments, including immunotherapies. The Company exclusively licensed intellectual property for uses of DNases in cancer include systemic co-administration of DNases along with standard therapies, including chemotherapy, radiation and checkpoint inhibitors, or along with conventional chimeric antigen receptor (CAR) T therapies.

The DNase platform is designed to target neutrophil extracellular traps ("NETs"), which are weblike structures composed of extracellular chromatin coated with histones and other proteins. NETs are expelled by activated neutrophils, in response to microbial or pro-inflammatory challenges. However, excessive production or reduced clearance of NETs can lead to aggravated inflammatory and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of cancer growth and metastasis.

The Company is working toward its planned first-in-human study to evaluate DNase combined with immune checkpoint inhibitors or chemotherapy.

On July 7, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the Company has added a second, once-a-week dose cohort in its ongoing global Phase 1 clinical trial in both the United States and China with the highly selective CDK9 inhibitor GFH009 for patients suffering from advanced relapsed or refractory lymphoma and acute myeloid leukemia (AML) (Press release, Sellas Life Sciences, JUL 7, 2022, View Source [SID1234616529]).

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SELLAS previously reported that AML patients treated twice-a-week at the 22.5mg dose level experienced no dose-limiting toxicities, including no Grade 3/4 neutropenia (an abnormally low count of neutrophils, a type of white blood cell). The patients in the AML arm of the clinical trial have entered the last twice-a-week 30mg planned dose level. Additionally, enrollment for lymphoma patients at the twice-a-week 15mg dose level cohort has been completed and safety assessments are underway. The twice-a-week dose regimens for both groups will proceed as planned and are on target for completion this year.

Given that both AML and lymphoma patients tolerated all dose levels studied to date with the twice-a-week administration as well as the efficacy signals seen with both AML and lymphoma patients, SELLAS has amended its protocol to introduce an additional single-dose cohort to study GFH009 once-a-week administration starting at the higher dose level of 30 mg.

The new, weekly single-dose cohort regimen is as follows:

Dose levels are 30mg, 45mg and 60mg once per week.
The amended protocol allows SELLAS to further escalate the doses if each level is determined safe for patients.
The new cohort is expected to take approximately one month to enroll patients and another 21 days to complete the safety assessment for each dose level.
"As we continue to evaluate GFH009 with its unique mechanism of action, increasing the dose administered and extending the administration of the dose will allow us to expand our knowledge of the drug’s safety and efficacy profile, including potentially seeing whether there are further increases in efficacy beyond the already observed efficacy for these patients," said Dragan Cicic, MD, Senior Vice President, Clinical Development, SELLAS. "With this additional valuable data on the new dose levels and regimen, SELLAS will be one step closer to discovering the optimal dosage for patients in preparation for the Phase 2 study."

On July 7, 2022 Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) (Theratechnologies), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it will report financial results for its second quarter of fiscal 2022 ended May 31 on Thursday, July 14, 2022 (Press release, Theratechnologies, JUL 7, 2022, View Source [SID1234616524]).

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The conference call will be held on July 14, 2022 at 8:30 a.m. (ET) to discuss the results and recent business updates. The call will be hosted by Paul Lévesque, President and Chief Executive Officer. Joining Mr. Lévesque on the call will be other members of the management team, including Chief Financial Officer Philippe Dubuc and Chief Medical Officer Christian Marsolais, who will be available to answer questions from participants following prepared remarks.

Participants are encouraged to join the call ten minutes in advance to secure access.

The live conference call will be accessible via webcast at: View Source

O July 7, 2022 Exelixis, Inc. (Nasdaq: EXEL) and Ryvu Therapeutics S.A. ("Ryvu") (Warsaw Stock Exchange: RVU) reported that the companies have entered into an exclusive license agreement focused on the development of novel targeted therapies utilizing Ryvu’s STING (STimulator of INterferon Genes) technology (Press release, Exelixis, JUL 7, 2022, View Source [SID1234616518]). The agreement expands Exelixis’ portfolio of biotherapeutics by combining Ryvu’s proprietary small molecule STING agonists and STING biology know-how with Exelixis’ network of expertise and resources in antibody engineering, antibody-drug conjugate (ADC) technologies, and proven history of developing and commercializing oncology therapeutics.

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"Ryvu has leveraged its in-depth structural protein knowledge to rationally design small molecules that are structurally distinct from known STING agonists and outperform most other potentially competitive compounds in in vitro immune cell assays"

Under the terms of the agreement, Exelixis will pay Ryvu an upfront fee of $3 million in exchange for certain rights to Ryvu’s STING agonist small molecules, which Exelixis will seek to incorporate into targeted therapies such as ADCs. Exelixis will lead all research activities and, upon selection of each development candidate, will be responsible for all development and commercialization activities. Ryvu will provide expert guidance and know-how during the early research phase of the partnership, and will be eligible to receive development, regulatory and commercialization milestone payments, as well as tiered royalties on the annual net sales of any products that are successfully commercialized under the collaboration. Ryvu will also retain all development and commercial rights to develop its STING agonist portfolio as standalone small molecules.

"Gaining access to novel targets and technologies is an essential component of our strategy to expand our biotherapeutics pipeline, and this relationship allows Exelixis to capitalize on Ryvu’s STING-related assets and expertise," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer, Exelixis. "Ryvu’s portfolio of STING agonists comprises compounds with diverse drug-like attributes that have been extensively characterized. This includes small molecule agonists with demonstrated activity against all STING variants that are suitable for incorporation into ADCs. We believe that these properties will support the development of novel, STING-targeted therapies with the potential to provide benefit to more patients across diverse cancer indications, which is a critical priority for everyone at Exelixis."

The STING pathway can be activated in immune cells in the tumor microenvironment and in tumor cells, and induces innate and adaptive immunity via activation of antigen presenting cells (APCs), cytotoxic T cells and natural killer (NK) cells. Targeted delivery of Ryvu’s STING agonist payloads could provide a differentiated and novel mechanism of action for killing cancer cells. Ryvu’s STING agonists have been rationally designed for differentiation from competitor compounds and have demonstrated STING-dependent, durable anti-tumor activity and cytokine release in preclinical models.

"Ryvu has leveraged its in-depth structural protein knowledge to rationally design small molecules that are structurally distinct from known STING agonists and outperform most other potentially competitive compounds in in vitro immune cell assays," said Krzysztof Brzózka, Ph.D., Chief Scientific Officer, Ryvu. "Exelixis’ expertise in the development of targeted cancer therapies and its growing network of biologics resources and assets make it the partner of choice for realizing the potential of our STING technology as the foundation for novel cancer therapies and provides another strong validation for our immune-oncology acumen and Ryvu discovery platform. We are excited to partner with a leading oncology company that shares our passion for innovation, strives toward achieving a meaningful impact on patient care, and advances the boundaries of oncology therapeutics development."

On July 7, 2022 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the company has received Investigational New Drug (IND) approval of clinical trial from the NMPA (National Medical Products Administration) for its novel targeted protein degrader ICP-490 for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL) (Press release, InnoCare Pharma, JUL 7, 2022, View Source [SID1234616517]).

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ICP-490 is developed from InnoCare’s molecular glue platform. By specifically binding to CRL4-CRBN-E3 ligase complex, ICP-490 induces ubiquitination and degradation of transcription factors including Ikaros and Aiolos, thereby downregulating the expression of IRF4, an oncogenic transcription factor that drives multiple myeloma to exert direct anti-myeloma effects. It also has immunomodulatory effects by enhancing the function of effector T cells, resulting from Ikaros and Aiolos degradation and the degradation-mediated releasing of interleukin IL-2.

Multiple myeloma (MM) is a malignant tumor with clonal abnormal proliferation of plasma cells, which is characterized by abnormal proliferation of bone marrow plasma cells and most of them with overproduction of monoclonal immunoglobulin (M protein). MM is often accompanied by multiple osteolytic lesions, hypercalcemia, anemia, kidney injury, etc. MM accounts for about one percent of tumor diseases and 10 percent of blood tumors1.

Non-Hodgkin’s lymphoma (NHL) is the most common hematological malignancy in the world, accounting for nearly three percent of cancer diagnosis and death2. NHL ranks among the top 10 common malignant tumors in China. Its common types include diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Dr. Jasmine Cui, the co-founder, Chairwoman and CEO of InnoCare said, "InnoCare has built a strong pipeline in the field of blood tumor. With the approval of ICP-490 for clinical trials, InnoCare will further strengthen its blood tumor pipeline and aim to provide better treatment options for those patients in China and around the world."