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ChromaDex to Participate in a Fireside Chat at the Lytham Partners Fall 2024 Investor Conference

On September 26, 2024 ChromaDex Corp. (NASDAQ:CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) with a focus on healthy-aging research, reported that Rob Fried, CEO of ChromaDex and Founder of Tru Niagen, will participate in a fireside chat moderated by Sean McGowan, Senior Analyst at Roth Capital Partners, at the Lytham Partners Fall 2024 Investor Conference (Press release, ChromaDex, SEP 26, 2024, View Source [SID1234646874]). Wesley Yu, Vice President of Finance at ChromaDex, and Mr. Fried will also host virtual one-on-one meetings with investors.

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Company Webcast

The webcasted fireside chat will take place at 1:15 PM ET on Tuesday, October 1, 2024. The webcast can be accessed at View Source or on the Company’s website at chromadex.com. The webcast will also be available for replay following the event.

1×1 Meetings

Mr. Fried and Mr. Yu will participate in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners at 1×[email protected] or register for the event at View Sourceinvreg" target="_blank" title="View Sourceinvreg" rel="nofollow">View Source .

Further information on the conference is available at View Source .

For additional information on ChromaDex, visit www.chromadex.com.

OncoC4 and AcroImmune Announce Merger

On September 25, 2024 OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer, and AcroImmune, a biopharmaceutical company developing immunotherapy drugs for malignant tumor and inflammatory disease, reported that the companies, which are under common control, have entered into a definitive merger agreement to combine in an all-stock transaction (the Merger) (Press release, OncoC4, SEP 25, 2024, View Source [SID1234655989]). Under the terms of the agreements, OncoC4 will acquire 100% of the outstanding equity interests of AcroImmune. Upon completion of the Merger, the combined company is expected to operate under the name OncoC4, Inc., will be headquartered in Rockville, Maryland, and led by Yang Liu, PhD, Co-Founder, Chief Executive Officer (CEO). Both OncoC4 and AcroImmune were co-founded by Drs. Yang Liu and Pan Zheng and have a similar shareholder base.

"This Merger seamlessly bolsters OncoC4’s wholly owned immunotherapy pipeline and adds investigational new drug (IND)-ready PD-1/VEGF bispecific antibody AI-081 with best-in-class potential and clinical stage assets with near-term catalysts including next-generation siglec agonist AI-071," said Yang Liu, PhD, Co-Founder, CEO and Chief Scientific Officer (CSO) of OncoC4. "Additionally, the Merger will also expand OncoC4’s geographical footprint and establish in-house clinical manufacturing capabilities including R&D, clinical, and manufacturing sites in China."

Dr. Liu continued, "Collectively, these synergies further strengthen the potential of OncoC4 to deliver differentiated and novel immunotherapies spanning multiple modalities for difficult to treat solid tumors and hematological malignancies. We look forward to continued advancement across our innovative pipeline with several upcoming early and late-stage clinical milestones over the next 12 months."

Dr. Pan Zheng, MD, PhD, OncoC4’s Chief Medical Officer (CMO) and cofounder of OncoC4 and AcroImmune added, "A bispecific targeting PD-1 and VEGF holds potential to broaden the horizon of checkpoint therapy across cancers. AI-081 consists of fully owned and high affinity binding motifs to PD-1 and VEGF that are designed to be best in-class among an emerging class of potentially transformative cancer therapies. We are very excited to file an IND application for AI-081 in the fourth quarter of the year."

OncoC4’s Pipeline Programs and Expected Upcoming Milestones
Newly Added Wholly Owned Programs

AI-081 – A potentially best-in-class bispecific antibody against PD-1 and VEGF that has demonstrated high potency and in vivo anti-tumor activity in preclinical models
IND filing expected in Q4 2024
AI-071 – A Phase 2 ready, next-generation siglec agonist that is designed for broad siglec coverage with potential application across immunotherapy treated indications. Siglec is a novel innate immune checkpoint discovered by OncoC4 founders with broad application for cancer and excessive inflammation.
Initiation of Phase 2 trial for acute respiratory failure expected in Q4 2024
Initiation of Phase 2 trial for immune related adverse events expected in Q1 2025

Legacy OncoC4 Wholly Owned Progams

CD24 Siglec Program – Novel innate immune checkpoint discovered by OncoC4 founders with broad application for the treatment of cancer and excessive inflammation.

ONC-841 – First-in-class anti-Siglec 10 mAb designed for broader impact across innate and adaptive immunity in tumor microenvironment
Initiated Phase 1 trial in solid tumors in Q3 2024
Cancer Specific CD24 Platform Program – CD24 is a potent ‘don’t eat me’ signal used by tumors to evade innate immune destruction and an oncogene overexpressed in 70% of all human cancers. OncoC4’s cancer-specific mAb targets a neo-CD24 epitope with application across multiple therapeutic modalities.

ONC-782 – CAR-T cell therapy for solid and hematological malignancies
Initiation of Phase 1 Investigator Initiated Trial in China expected in 2H 2024
ONC-783 – Bispecific mAb for hematological malignancies
IND enabling studies initiated in Q2 2024
ONC-784 – ADC for solid tumors
IND enabling studies to be initiated in Q1 2025
Partnered Programs

Gotistobart (BNT316/ONC392) is a next-generation anti-CTLA-4 antibody candidate in joint late-stage clinical development with BioNTech as a monotherapy and in combination in multiple ongoing solid tumor indications. Designed for improved toxicity and ability to overcome immune suppression in the tumor microenvironment by depleting regulatory T cells to turn immunologically cold tumors hot.

Allarta to present at the Alliance for Regenerative Medicine’s 2024 Cell & Gene Meeting on the Mesa

On September 25, 2024 Allarta reported that its CEO Dr. Harald Stover will be presenting at the 2024 Cell and Gene Meeting on the Mesa (Press release, Allarta Life Science, SEP 25, 2024, View Source [SID1234647013]). He will be discussing Allarta’s hydrogel encapsulation to protect transplanted cells and highlighting Allarta’s work to enable a curative therapy for T1D as well as our transformative Cryogels to aid transport and storage.

Presentation: October 7, 2024 @ 2:30pm MST
Location: Arizona Biltmore, Ballroom G

ExThera Announces Completion of Phase I OSCAR I Trial

On September 25, 2024 ExThera Medical reported the completion of the Phase I OSCAR I STUDY (ONCObind CTC Removal Study NCT) at OU Health Stephenson Cancer Center, the clinical partner of the University of Oklahoma (Press release, ExThera Medical, SEP 25, 2024, View Source [SID1234646870]). The OSCAR study is a Prospective Single-Arm Feasibility Trial to evaluate the initial safety and signals of efficacy by determining the ability of the ONCObind Procedure Hemoperfusion Filter to remove Circulating Tumor Cells (CTCs) from the blood of patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC).

A total of five patients with PDAC have completed the ONCObind Procedure with no safety concerns or signals that have been observed. Data has subsequently been submitted to the FDA for review and approval, in order to proceed to the second phase of the feasibility trial (OSCAR II), with a proposal for expanding the patient population to include Metastatic Colorectal Cancer (MCRC), in addition to metastatic PDAC.

"We are happy to report that the ONCObind Procedure was well tolerated by all patients," said ExThera Medical Chairman and President Bob Ward, Ph.D., NAE. "We were also pleased by the rapid reduction in patients’ sedimentation rates and their noticeable improvement in appetite."

Sanja Ilic, M.D., M.S., RAC and the chief regulatory officer for ExThera, added, "We have a great partnership with the team at Stephenson Cancer Center and look forward to partnering with them on future pancreatic cancer studies, with the potential to expand into colorectal cancer."

The ONCObind Procedure Hemoperfusion Filter is the product brand name for the Onco-Seraph platform technology, an extracorporeal blood filtration procedure designed to target and filter out CTCs from the bloodstream of patients. CTCs are shed from primary tumors and contribute to metastasis, which is responsible for most cancer-related deaths. The ONCObind Procedure uses a blood filter based on ExThera’s Seraph 100 Microbind Affinity Blood Filter technology, which has shown significant success in reducing CTCs in a recent in vitro study. Both the ONCObind Procedure Hemoperfusion Filter and the Seraph 100 Microbind Affinity Blood Filter are investigational medical devices in the United States and are not approved by the U.S. Food and Drug Administration for sale or distribution.

MesoPher Cell Therapy Increases 2-Year RFS Rate in Resected Pancreatic Cancer by 50%; Amphera Announces Publication of Phase II Results in Journal of Clinical Oncology and Orphan Designation Granted by FDA & EMA

On September 25, 2024 Amphera B.V., a late-stage biotechnology company developing MesoPher cell therapy to treat cancer, reported publication of the results of a phase II trial in resected pancreatic cancer (REACTIVE) in the Journal of Clinical Oncology (JCO) (Press release, Amphera, SEP 25, 2024, View Source [SID1234646869]).

Highlights from the REACTIVE trial in resected pancreatic cancer:

The phase II trial, including 38 patients with resected pancreatic cancer who had completed standard-of-care chemotherapy, met the primary endpoint demonstrating a clinically significant increase in 2-year recurrence-free survival of 64% compared to an expected 40%. This was accompanied with only low grade side effects.
The 2-year overall survival rate was 83%. Translational immune-profiling supports an induction of an effective immune-activation against the tumor.
Patients in the REACTIVE trial received 3 bi-weekly injections of Amphera’s MesoPher dendritic cell therapy and booster injections at 4 and 7 months.
Prof Casper van Eijck, pancreatic cancer surgeon, Erasmus MC in Rotterdam and Principal Investigator of the REACTIVE trial said: "These results are promising as recurrence rates are high and long-term survival is rare in this patient group. We are now preparing a randomized phase II/III trial to replicate this efficacy signal. I am happy to announce that the DPCG, the Dutch Pancreatic Cancer Group, one of the world’s leading research groups in this field, has committed to participate in this trial."

Ilona Enninga, COO of Amphera added "We have created a promising cell therapy bridgehead. MesoPher is derisked as to safety and manufacturing. This trial shows that MesoPher induces a clinically meaningful immune response, causing an increase in patient survival. EMA has granted MesoPher Orphan Designation for pancreatic cancer, based on potential significant benefit. We are very happy to announce today that the FDA has granted MesoPher Orphan Designation for pancreatic cancer as well."

Rob Meijer, CEO of Amphera said "The potential of MesoPher cell therapy is increasingly recognized in the scientific and regulatory community. The JCO publication will certainly help us to realize the necessary funding and partners for our next step: a randomized trial in resected pancreatic cancer."