On November 21, 2022 Chimeric Therapeutics (ASX: CHM, "Chimeric"), a clinical-stage cell therapy company and an Australian leader in cell therapy, reported that it has entered into an exclusive license agreement with Case Western Reserve University (CWRU) for the CORE-NK platform, invented by Dr David Wald (Press release, Chimeric Therapeutics, NOV 21, 2022, View Source [SID1234624264]).

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The CORE-NK platform uses a novel, proprietary genetically-modified feeder cell line to activate and expand universal off-the-shelf allogeneic NK cell products derived from healthy donors. The expanded CORE-NK cells exhibit enhanced cytotoxicity, metabolism, and expression of activating receptors compared to fresh, activated NK cells.

Under the agreement, Chimeric gains exclusive global rights to the CORE-NK platform for oncology, where Chimeric and CWRU are currently advancing multiple product candidates in Dr Wald’s laboratory under the recently announced Sponsored Research Agreement. Chimeric also receives exclusive global rights to the CORE-NK platform for immune disorders and viral infectious diseases.

"We are excited to continue building on our collaboration with CWRU with the definitive license agreement for the CORE-NK platform," said Jennifer Chow, CEO and Managing Director of Chimeric. "This transaction builds significant value for Chimeric, first by bringing a highly promising and clinically de-risked asset with CHM 0201 fully into our portfolio, and second by establishing the foundation for a suite of next-generation genetically modified NK cell products."

Chimeric’s NK cell therapy portfolio foundational asset, CHM 0201 was studied in a phase 1 clinical trial at University Hospitals Seidman Cancer Center in Ohio. Clinical results published earlier this year in the journal Transplantation and Cellular Therapy demonstrated safety with no GvHD (Graft versus host disease), NK cell persistence for at least 28 days, and encouraging For personal use only early activity signals, particularly in blood cancers where all patients achieved disease control and one patient achieved a complete response that was sustained for over 15 months at time of study publication.

Chimeric’s exclusive global license from CWRU covers patent rights, knowhow, and biological materials for the NKF feeder cell line and CORE-NK manufacturing process in the fields of use, including access to regulatory documents for the first-in-human Phase 1 trial of CHM 0201. Upfront fees associated with the license agreement will be funded entirely from existing cash reserves. The agreement also includes industry standard development milestones, patent costs, maintenance fees, and royalties on commercial net sales.

Dr Wald is an Associate Professor, Department of Pathology, School of Medicine, CWRU, a member of the Immune Oncology Program, Case Comprehensive Cancer Center, and the Associate Director for Basic Research, University Hospitals, Wesley Center for Immunotherapy.

Chimeric previously announced its exclusive option agreement with CWRU in November 2021 and exercise of the exclusive option in May 2022.

On November 21, 2022 Cambrex, a leading global contract development and manufacturing organization (CDMO) providing drug substance, drug product, and analytical services across the entire drug lifecycle, reported that it has entered into a definitive agreement to acquire Snapdragon Chemistry, a leading US-based provider of chemical process development services to a broad range of emerging and established biopharma customers (Press release, Cambrex, NOV 21, 2022, View Source [SID1234624263]).

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Snapdragon specializes in active pharmaceutical ingredient (API) batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges. The team of scientists and engineers apply deep process understanding afforded by data-rich experimentation to design and rapidly execute efficient GMP and non-GMP manufacturing processes. With R&D and manufacturing headquartered in Waltham, Massachusetts, Snapdragon’s 74 employees come with strong ties to the local scientific community, with 31 PhD scientists on staff.

"The acquisition of Snapdragon will accelerate our growth in the area of continuous flow process development and manufacturing, complementing our recent organic investments in our High Point, North Carolina facility," said Tom Loewald, CEO of Cambrex. "With R&D and manufacturing capabilities in the heart of Boston’s biopharma hub, Snapdragon will continue to focus on solving their customers’ most difficult process development challenges."

"We are excited to be joining Cambrex, a company with over 40 years of drug substance development and manufacturing expertise," said Matt Bio, CEO of Snapdragon. "Partnering our best-in-class process development capabilities with Cambrex’s larger scale manufacturing facilities in North America and Europe is a natural fit, both for our employees and our customers."

Snapdragon recently opened its second facility, a new 51,000-square-foot facility to manufacture experimental pharmaceutical products for human clinical trials. The new facility expanded the company’s capacity for supplying clinical intermediates and drug substances.

The transaction is expected to close following the completion of customary regulatory approvals. This will be Cambrex’s second acquisition within a year along with Q1 Scientific, consistent with its strategy to expand its portfolio of specialized solutions for pharmaceutical development and manufacturing.

On November 21, 2022 Starpharma (ASX: SPL, OTCQX: SPHRY) reported that VIRALEZE nasal spray has now launched online in Hong Kong and Macau, with launch in leading pharmacies to occur this week (Press release, Starpharma, NOV 21, 2022, View Source;mc_cid=d97ae29cc2&mc_eid=bf52dd3418 [SID1234624261]). This announcement follows the recently signed distribution agreement with Hengan Pharmacare Company Limited, a subsidiary of Hengan Group (HKSE:1044.HK) (see company announcement dated 21 October 2022).

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For the Hong Kong and Macau markets, VIRALEZE will carry Hengan’s local brand which is also used for their COVID-19 related products, such as face masks and rapid antigen tests. The product will be supported with extensive traditional and digital marketing activities by Hengan Group.

Hengan Pharmacare Company Limited Managing Director Ms. Wong Pui Wai, Nancy commented, "We are excited to launch VIRALEZE in Hong Kong and Macau, bringing this innovative product to consumers."

Dr Jackie Fairley, Starpharma CEO, said "We are delighted to see our new partner, Hengan Group, launch VIRALEZE in Hong Kong and Macau so quickly and through leading pharmacies and online channels."

On November 21, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the approval of its Investigational New Drug (IND) application by the United States Food and Drug Administration (US FDA) to evaluate its SAR-Bombesin product for identification and treatment of metastatic castrate-resistant prostate cancer (mCRPC) (Press release, Clarity Pharmaceuticals, NOV 21, 2022, View Source [SID1234624260]).

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Clarity’s Executive Chairman, Dr Alan Taylor, commented, "This trial with SAR-Bombesin marks our third therapy program, and sixth program overall, in the Targeted Copper Theranostic pipeline that is progressing through clinical trials in the US. Receiving clearance from the FDA is yet another significant milestone for the Company as it continues to showcase the capabilities of Clarity’s small but high performing team in developing next-generation theranostics from the benchtop, through preclinical studies and into clinical trials in the largest pharmaceutical market in the world. This is Clarity’s fifth IND, highlighting our strategy of developing radiopharmaceuticals for the very large US market."

This IND gives Clarity clearance to proceed with a US-based Phase I/IIa 64Cu/67Cu SAR-Bombesin theranostic trial for identification and treatment of mCRPC that is expressing the Gastrin-Releasing Peptide receptor (GRPr).

COMBAT (Copper-67 SAR Bombesin in metastatic castrate resistant prostate cancer) is a dose escalation study with a cohort expansion. The aim for the study is to determine the safety and efficacy of 67Cu-SAR-Bombesin in participants with GRPr-expressing mCRPC in patients who are ineligible for therapy with 177Lu-PSMA-617.

Approximately 25% of mCRPC patients have low or no uptake of a PSMA-targeting tracer.1 These patients are therefore unlikely to show uptake of PSMA-targeted products, such as 68Ga-PSMA-11 for imaging or 177Lu-PSMA-617 for therapy, and currently have few radiopharmaceutical treatment options available to them. Given prostate cancer is one of the largest indications in oncology, there is a significant unmet medical need in this segment. The SAR-Bombesin product targets the GRP receptor found on prostate and many other cancers. As such, the SAR-Bombesin could offer valuable imaging and therapeutic options for not only PSMA negative patients, but also the large number of patients that have the target receptor on their cancers.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We look forward to further progressing the development of SAR-Bombesin as a theranostic under this trial, as well as a stand-alone diagnostic agent under the SABRE and BOP clinical trials that are currently progressing in the US and Australia respectively. The diagnostic SAR-Bombesin product has already shown utility in improving the management of disease for PSMA-negative prostate cancer patients and, given the mounting clinical and preclinical data to date, we believe that it has potential to provide this large patient population with more accurate and precise detection and treatment of disease. SAR-Bombesin is a pan-cancer product, and the open IND offers exciting opportunities for exploring new theranostic indications with this versatile product as Clarity pursues our ultimate goal of improving treatment outcomes for children and adults with cancer."

Clarity’s Prostate Cancer clinical trial program overview

About SAR-Bombesin
SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in approximately 75-100% of prostate cancers, including prostate cancers that don’t express PSMA (PSMA-negative)2-6. The product utilises Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide7. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease8.

On November 20, 2022 Elpiscience Biopharmaceuticals, Inc. ("Elpiscience"), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, reported positive studies for its innovative immunotherapeutic molecules at the SITC (Free SITC Whitepaper) 2022 Annual Meeting, including anti-SIRPα monoclonal antibody ES004, PD-L1/SIRPα bispecific antibody ES019, anti-LILRB2 monoclonal antibody ES009, anti-SIGLEC15 antibody ES012, and anti-LAG3 monoclonal antibody ES005 (Press release, Elpiscience, NOV 20, 2022, View Source [SID1234624262]).

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Study highlights:

1. Title: Treatment of anti-SIRPα in combination with anti-TAA exerts superior anti-tumor activity
Abstract No.: 793

SIRPα is an inhibitory receptor expressed mainly on myeloid cells and dendritic cells. Ligation of CD47 to SIRPα delivers a "don’t eat me" signal to suppress macrophage phagocytosis. Tumor cells frequently overexpress CD47 to evade macrophage-mediated destruction. Anti-SIRPα mAb ES004 potently potentiates antibody dependent cellular phagocytosis (ADCP) activity of antibodies against tumor associated antigens (TAAs) in vitro and in vivo.

Highlights:

ES004 recognizes pan-allele human SIRPα with high affinity
ES004 binds to a unique epitope on the CD47 binding domain of SIRPα
ES004 potently blocks CD47-SIRPα interaction and CD47 induced SIRPα signaling
ES004 effectively potentiates pan-allelic macrophage phagocytosis of tumor cells
ES004 has no negative impact on T cell activation
ES004 enhances anti-tumor activity in combination with anti-Claudin18.2 in MC38/hCLDN18.2 syngenetic tumor model
ES004 has demonstrated favorable PK, full target occupancy and excellent safety profile in cynomolgus monkeys.
2. Title: Dual targeting of innate and adaptive immune checkpoints with a PD-L1/SIRPα bispecific macrophage engager to promote anti-tumor activity
Abstract No.: 1211

The anti-PDL1/SIRPα bispecific antibody ES019, designed for tumor cell and immune cell dual targeting, is capable of reactivating macrophages and T cells to kill cancer cells with the potential to overcome the limitations of traditional anti-PD1 therapies and has demonstrated significantly enhanced tumor therapeutic efficacy and specificity versus combo or monotherapies.

Highlights:

ES019 phagocytosis activity is corrected with PD-L1 level on tumor cells
ES019 leads to better phagocytosis capability of tumor cells by M2-like than M1-like macrophage
ES019 activates T cells without induction of phagocytosis of T cells
ES019 shows favorable PK in mouse model
ES019 demonstrates single agent anti-tumor efficacy in animal model
3. Title: ES009, a LILRB2-specific blocking antibody, reprograms myeloid cells into pro-inflammation phenotype and potentiates T cell activation
Abstract No.: 1062

LILRB2 is predominantly expressed in myeloid lineage cells. Human LILRB2 broadly binds to multiple ligands and contributes to immune suppression in the tumor microenvironment (TME). Anti-LILRB2 mAb ES009 has demonstrated superior effects in converting immunosuppressive myeloid cells into pro-inflammation phenotypes in in vitro and ex vivo models.

Highlights:

ES009 specifically binds human LILRB2 with high affinity
ES009 binds to a unique epitope on D1 domain of LILRB2
ES009 potently blocks LILRB2 binding to multiple ligands
ES009 promotes monocytes and monocytes derived DCs into a pro-inflammatory status
ES009 effectively reprograms human monocyte derived M2 macrophages into pro-inflammation M1 phenotypes
ES009 effectively relives T cells from M2 macrophages mediated suppression
ES009 converts primary macrophages in malignant ascites in ovarian cancer patients into a pro-inflammatory status
4. Title: SIGLEC15 induces monocyte apoptosis and an SIGLEC15 antibody ES012 reverses myeloid cells driven immunosuppression
Abstract No.: 1401

SIGLEC15 is a glycan-recognition proteins belonging to the SIGLEC family and is highly expressed on TAM and many tumor cells. It’s reported that SIGLEC15 inhibits T cell activity via its binding to an unknown receptor on T cells. Elpiscience has identified a novel function of SIGLEC15 that SIGLEC15 can induce monocyte apoptosis and its inhibitory effect on T cell function is indirect. Based on this newly discovered SIGLEC15 biology, we have developed a potent, functional anti-SIGLEC15 mAb ES012 that has great potential to reverse immune suppression in TME to promote anti-tumor immunity.

Highlight:

SIGLEC15 induces monocyte apoptosis, which is dependent on sialic acid binding and mediated via caspase-3
SIGLEC15 inhibits T cell function via myeloid cells but not by directly binding to T cells
ES012 is a high affinity anti-SIGLEC15 monoclonal antibody.
ES012 can rescue monocyte apoptosis and inhibit T cells by SIGLEC15.
ES012 showed superior anti-tumor efficacy and better PK profile than benchmark antibody in preclinical model
5. Title: ES005, a high affinity anti-LAG3 monoclonal antibody, inhibits the interactions between LAG3 and multiple ligands and enhances anti-tumor activity of T cells in preclinical models
Abstract No.: 426

LAG3 plays an important role in regulating immune homeostasis with multiple biological activities related to T cell functions. Anti-LAG3 mAb ES005 has demonstrated significant tumor growth inhibition in in vivo mouse tumor models, and showed excellent PK and safety profile in NHPs, indicating great potential to be used as next-generation immune checkpoint inhibitor in cancer treatment.

Highlights:

ES005 is a high affinity and cynomolgus reactive anti-LAG3 mAb
ES005 binds to a unique epitope on LAG3 D1 domain
ES005 potently blocks LAG3 binding to multiple ligands including FGL-1
ES005 effectively upregulates NFAT reporter gene transcription via blocking LAG3/MHC-II interaction
ES005 effectively reverses LAG3 driven inhibition of T cell activation
ES005 monotherapy potently inhibits tumor growth in EMT6 syngeneic tumor model
ES005 was well tolerated in cynomolgus monkeys with favorable PK Profile