On January 29, 2024 Oricell Therapeutics (Oricell), a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for OriCAR-017 for patients with relapsed/refractory multiple myeloma (R/R MM) (Press release, OriCell Therapeutics, JAN 29, 2024, View Source [SID1234639692]). OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D. The therapy leverages Oricell’s proprietary platforms including OriAb antibodies, OriCAR construct and unique CMC know-how to achieve optimal binding and superior persistence and anti-tumor efficacy out of rejuvenated CAR-T cells. The IND enables Oricell to initiate the clinical development for OriCAR-017 in the US immediately.

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The FDA IND approval for OriCAR-017 follows its NMPA IND approval in 2023 and the publication of clinical results from an Investigator Initiated Trial (POLARIS study) at the 2022 ASCO (Free ASCO Whitepaper), 2022 EHA (Free EHA Whitepaper) and The Lancet Haematology. The data showed that all ten patients with R/R MM responded to the therapy per IMWG criteria, achieving a 100% overall response rate (ORR), 80% stringent complete response. 100% minimal residual disease (MRD) negative rate was detected at day 28 and further confirmed at month 3. The therapy was well-tolerated, with no Immune effector cell-associated neurotoxicity syndrome (ICANS), no cerebellar disorder, no delayed infections, and only Grade 1/Grade 2 CRS that resolved rapidly. Of the ten R/R MM patients, 40% had extramedullary disease (EMD), 50% received prior BCMA CAR-T treatment(s), 70% had high-risk cytogenetics, and 70% with ECOG 2, 80% at ISS stage II & III.

"The evidenced superior safety, efficacy and durability profile of OriCAR-017 is truly exciting and will significantly benefit multiple myeloma patients on a global scale. Ten years’ R&D cumulates not only OriCAR-017 but also the robust and integrated technology platforms that generate one-of-its-kind CAR-T products for liquid and solid tumors," said Peter He, Co-founder and Chief Scientific Officer of Oricell.

"Exceptional teamwork is what Oricell relies upon. The fact that we were able to complete technical transfer from China to the U.S. in five months speaks for the standard of our teamwork." Helen Yang, Co-founder and Chief Executive Officer of Oricell further stated that, "With a great team and support from our stakeholders, we are confident in our ability to delivering best-in-class cell therapies to patients, providing them new hope and possibilities."

On January 29, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, reported its participation in the 2024 NeauxCancer Conference organized by the Cancer Advocacy Group of Louisiana (CAGLA), being held February 29 – March 2, 2024 in New Orleans (Press release, Anixa Biosciences, JAN 29, 2024, View Source [SID1234639691]). Anixa Chairman and CEO Dr. Amit Kumar will present and meet one-on-one with investors throughout the day on Friday, March 1st.

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Dr. Kumar’s remarks will feature Anixa’s use of the body’s immune system to take multiple approaches in fighting cancer. The Company’s vaccines focus on immunizing against "retired" proteins found to be expressed in certain forms of cancer, a mechanism that has never before been utilized for cancer vaccine development.

Attendees at the conference will include oncologists and other clinicians interested in learning and discussing the latest practices for treating and taking care of cancer patients. The investment track will enable the medical professionals attending the conference, as well as regional investment professionals, to learn about emerging technologies for cancer treatment and prevention.

Registration and attendance at the conference for investors is complimentary. Investors can register via the link below.

Investment Track Details:

Anixa presentation:

Friday, March 1, 2024, at 11:30 AM CST

Conference registration:

Available on the conference website

1×1 meetings:

Open to investors upon conference registration

Chadwick Landry, President and Executive Director of CAGLA stated, "We are pleased to be adding an investment track to our annual conference. We are also pleased that Anixa will be presenting at this inaugural year of the investment track. We plan to make the investment track a regular event at this well-attended conference to enable regional investors and medical professionals to gain firsthand exposure to some of the most exciting emerging companies developing technologies to address cancer."

The 2024 NeauxCancer Conference has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Ochsner Clinic Foundation and CAGLA. The Ochsner Clinic Foundation is accredited by the ACCME to provide continuing medical education for physicians.

On January 29, 2024 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the U.S. Patent and Trademark Office has granted the registration of trademarks for its proprietary technology platforms PACbody (Reg. No. 7,080,972), SPECpair (Reg. No. 7,279,821) and ATACCbody (Reg. No. 7,075,638) (Press release, Phanes Therapeutics, JAN 29, 2024, View Source [SID1234639690]). The three proprietary platforms were developed for bispecific antibodies with native IgG-like structure.

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PACbody is a proprietary approach for constructing bispecific antibodies with native IgG-like structure, which have been shown to have increased stability and high expression levels. The PACbody technology does not involve any protein fusion approach.

SPECpair enables the use of the conventional monoclonal antibody (mAb) manufacturing process in the production of native IgG-like bispecific antibodies with lower CMC and clinical risks.

ATACCbody is a technology for targeting solid tumors using immuno-oncology molecules with modulated anti-CD3 activities designed to minimize the risk of cytokine release syndrome.

Both PACbody and SPECpair were employed in the design of PT886, a first-in-class bispecific antibody targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) by the FDA for the treatment of pancreatic cancer in 2022 and is currently in phase 1 clinical trial.

"Phanes is very pleased about the granted registrations of trademarks for our technology platforms," said Dr. Ming Wang, Founder and CEO of Phanes. "We will continue to leverage these technologies in the discovery of innovative therapies for patients."

On January 29, 2024 Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases, reported the results of the Phase III clinical trial and real-world study for APL-1706, a drug designed for the diagnosis and management of bladder cancer (Press release, Asieris Pharmaceuticals, JAN 29, 2024, View Source [SID1234639689]). This significant announcement was made at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO-GU), featuring a poster presentation (Abstract No. 593).

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The study incorporated 158 patients in a randomized controlled trial (RCT) and 19 patients in a real-world study (RWS). Notably, the use of Blue Light Cystoscopy (BLC) in conjunction with APL-1706 significantly improved the detection of bladder cancer lesions compared to traditional white light cystoscopy (WLC). In the RCT, 43.3% of patients (42 out of 97) diagnosed with Ta, T1, or CIS and 33.3% in the RWS (4 out of 12 patients) had at least one lesion detected by BLC that was not identified by WLC (p<0.0001). Additionally, in the RCT, 9.6% (11 out of 114) and in the RWS, 7.1% (1 out of 14) of CIS patients had additional lesions detected under BLC that were not found using WLC.

The detection rates for PUNLMP, CIS, Ta, T1, and T2 ~ T4 tumors in the RCT were notably high with BLC, reaching 94.7%, 100%, 98.2%, and 100% respectively, compared to the WLC detection rates of 42.1%, 76.1%, 91.2%, and 100%. Similarly, in the RWS, BLC detection rates for these tumor stages were 100%, compared to WLC rates of 50%, 81%, and 100%. These findings confirm that APL-1706 combined with BLC offers superior detection of bladder cancer in the Chinese population, especially in CIS patients, while maintaining good tolerability.

Following these encouraging results, the New Drug Application (NDA) for APL-1706 was accepted by the National Medical Products Administration (NMPA) in November 2023.

On January 29, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) reported an amendment to their collaboration agreement and a separate equity investment by Gilead of $320 million in Arcus common stock at $21.00 per share (Press release, Gilead Sciences, JAN 29, 2024, View Source [SID1234639688]). The equity investment and collaboration amendment enable accelerated growth of the companies’ joint development programs that span multiple indications. Additionally, Johanna Mercier, Chief Commercial Officer at Gilead Sciences, will join the Arcus Board, bringing Gilead’s total director designees to three. The amendment also includes governance enhancements enabling streamlined decision-making and reflecting the continued growth of the collaboration.

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"This amendment allows Gilead to accelerate the domvanalimab program and enables Arcus to focus on progressing multiple pipeline assets, including both Gilead-optioned and non-optioned programs," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "We look forward to strengthening our collaboration as we explore the collective power of our cross-portfolio combinations to help transform how cancer is treated."

Gilead and Arcus have reprioritized the joint domvanalimab development program to focus on advancing and potentially accelerating the Phase 3 studies STAR-121 (lung cancer) and STAR-221 (gastrointestinal cancer), which are both expected to be fully enrolled by year-end. This prioritization focuses on domvanalimab-containing regimen research in areas where it may have significant impact in combination with chemotherapy and in settings with high unmet need through all-comer study designs. The companies also plan to initiate STAR-131, a new registrational Phase 3 lung cancer study that includes the domvanalimab plus zimberelimab regimen. This prioritization reflects the companies’ continued conviction in the TIGIT pathway and the Fc-silent design of domvanalimab, which has the potential for differentiation in both efficacy and safety.

"Since the inception of our partnership with Gilead in 2020, the companies have moved increasingly closer in all aspects of our research and development efforts," said Terry Rosen, PhD, Chief Executive Officer, Arcus. "This investment and prioritization enable both companies to leverage their respective strengths and focus on efficiently advancing novel combinations that have the potential to change the landscape of cancer treatment. The additional investment by Gilead, which extends our cash runway into 2027, will enable us to fund our Phase 3 studies of quemliclustat in pancreatic cancer and AB521 in kidney cancer, as well as to begin preparation for our first potential product approvals."

Additional changes during this prioritization will include discontinuing further enrollment in the Phase 3 ARC-10 study evaluating domvanalimab plus zimberelimab compared to pembrolizumab monotherapy in first-line locally advanced or metastatic, PD-L1-high NSCLC. The discontinuation of the ARC-10 study is based on strategic prioritization to advance and potentially accelerate the Phase 3 studies STAR-121 and STAR-221, which have the potential to address a higher unmet need for patients with lung and gastrointestinal cancers.

Gilead and Arcus are grateful to the patients and investigators who have made the choice to participate in ARC-10, which will continue to generate data and insights that will be shared at future scientific conferences. Patients currently enrolled in ARC-10, or who consented prior to January 29, 2024, and choose to enroll in the study, may continue their treatment and be monitored according to the study protocol. No changes to the safety and efficacy profile of domvanalimab and zimberelimab have been observed.

Also, under the terms of the amended collaboration agreement, the planned Phase 3 first-line study in pancreatic cancer evaluating the investigational small molecule CD73 inhibitor quemliclustat will become an Arcus independent study.

Domvanalimab, zimberelimab and quemliclustat are investigational molecules. Neither Gilead nor Arcus has received approval from any regulatory authority for any use of these molecules, and their safety and efficacy for the treatment of lung, gastrointestinal and pancreatic cancers have not been established.

About Domvanalimab

Domvanalimab is the first Fc-silent investigational monoclonal antibody in pivotal trials which was designed to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a protein on immune cells that acts as a brake on the immune response. Cancer cells can exploit TIGIT to avoid detection by the immune system. By binding to TIGIT, domvanalimab is designed to free up immune activating pathways and activate immune cells to attack and kill cancer cells. Domvanalimab has demonstrated complete target coverage on all TIGIT-expressing immune cells in the blood of patients.

Domvanalimab is being evaluated in three registrational Phase 3 studies across lung and gastrointestinal cancers, including: (1) STAR-121, evaluating domvanalimab plus zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy in first-line all-comer NSCLC regardless of PD-L1 expression levels; (2) STAR-221, evaluating domvanalimab plus zimberelimab and chemotherapy versus nivolumab plus chemotherapy in first-line locally advanced, unresectable or metastatic gastric, esophageal and gastro-esophageal junction adenocarcinomas; and (3) PACIFIC-8, being operationalized by AstraZeneca, evaluating domvanalimab plus durvalumab in unresectable Stage 3 NSCLC.

About Zimberelimab

Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. As a differentiated next-generation, fully human antibody, zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types.

Guangzhou Gloria Biosciences Co. Ltd., who holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab as the first and only anti-PD-1 antibody to treat recurrent or metastatic cervical cancer (September 2023). Additionally, in China, zimberelimab is approved to treat relapsed or refractory classical Hodgkin’s lymphoma (August 2021). Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead.