On January 18, 2022 TC BioPharm reported that Executive Chairman and Founder, Dr. Michael Leek will be participating in Advanced Therapies Week in Miami, Florida January 25-28 (Press release, TC Biopharm, JAN 18, 2022, View Source [SID1234605603]).

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Michael will participate in a session titled, Treating Cancer and Covid – Use of Banked Allogeneic Gamma-Delta T Cells in Oncology and Severe Viral Infection. The presentation will take place on Friday January 28th at 9:50 am ET at the Miami Beach Convention Centre. For more information or to register for the event, please visit; View Source

Dr. Michael Leek has 30 years’ experience in regenerative medicine, during which he progressed 10 different cell-based products from the laboratory into clinic. In 2017, Michael received the ‘Scottish Life-Sciences Entrepreneurial Business Leadership’ award for 2016-2017. Michael is also a Fellow of the Royal Society of Medicine and Honorary Lecturer at the University of Aberdeen, School of Medical Sciences.

Advanced Therapies Week is a large and immersive expo for companies in the cell and gene therapy sector. It has a focus on knowledge sharing, relationship building and deal making to advance a major pillar of medicine.

On January 18, 2022 – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, and PersonGen BioTherapeutics, a Chinese biotech company at clinical trial stage, which is developing breakthrough and innovative CAR-T cell therapies for solid tumors and hematologic tumors, reported a strategic collaboration to evaluate the feasibility and efficacy of combination therapy associating PersonGen’s TAA06 CAR-T cell injection with intravenous (IV) administration of an armed oncolytic virus, from Transgene’s Invir (Press release, Transgene, 18 18, 2022, View Source [SID1234605602]). IO platform, in solid tumors including pancreatic cancer and brain glioma. The collaboration aims to demonstrate the combination’s likely synergistic mechanisms to potentiate CAR-T cell therapy.

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Under the terms of the collaboration agreement, Transgene will develop multiple new OV
candidates, using its patented oncolytic virus backbone VVcopTK-RR- and its Invir.IO technology
platform, specifically for IV administration in combination with PersonGen’s TAA06 CAR-T
injection. PersonGen will evaluate the efficacy of the combination to eliminate solid tumors in
preclinical models.

While CAR-T cell drugs have achieved great success in the treatment of hematological tumor
therapies, there are many clinical challenges with the use of these novel therapies to treat solid
tumors. One of the most critical obstacles is that the solid tumor microenvironment not only
obstructs the homing of CAR-T cells, but also inhibits CAR-T cells’ function. In addition, the high
heterogeneity of solid tumors also facilitates immune escape from CAR-T cell therapy.
TAA06, has been independently developed by PersonGen, which has filed an investigational new
drug (IND) application for this novel CAR-T therapy in China and will initiate the IND in the US later
this year. Preclinical studies with TAA06, including pharmacodynamic data have shown superior
in vivo and in vitro therapeutic efficacy in solid tumors.

Patented VVcopTK-RR- oncolytic viruses developed with Transgene’s Invir.IO platform are able to:
• selectively replicate in cancer cells leading to tumor lysis; effectively release antitumor payloads into the tumor;
• stimulate an immune response locally in the tumor, thus optimizing the safety profile
of the virus with the added potential to transform a "cold" tumor into a "hot" tumor.
Clinical and preclinical data has demonstrated that after IV administration, VVcopTK-RR- oncolytic
viruses selectively replicate and persist in tumor cells leading to the local expression of its
functional payload*
.
Based on these highly supportive data, Transgene and PersonGen believe that combining
Transgene’s OV and PersonGen’s CAR-T therapies could overcome the challenges of solid tumor
heterogeneity by improving the tumor microenvironment.

On January 18, 2022 Cardiff Oncology reported new data from its lead clinical program evaluating onvansertib in combination with standard-of-care (SOC) FOLFIRI/bevacizumab for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC) (Press release, Cardiff Oncology, JAN 18, 2022, View Source [SID1234605601]). A subset of these data will be featured in a poster presented by Dr. Heinz-Josef Lenz, principal investigator, USC Norris Comprehensive Cancer Center, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCOGI) on Saturday, January 22, 2022.

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"As we have increased the number of patients evaluated and the duration of follow-up, our Phase 1b/2 trial has consistently generated data suggesting that onvansertib provides meaningful clinical benefits when added to SOC," said Katherine L. Ruffner, M.D., chief medical officer of Cardiff Oncology. "The objective response rate and median progression free survival observed substantially exceed what would be expected with SOC alone, and five patients receiving onvansertib have been able to pursue potentially curative metastasis-directed treatments. We also observed a confirmed complete response, which is exciting given the difficult-to-treat nature of second line mCRC patients."

The most current data for the trial are shown below and include patient follow up collected after the cutoff dates for both the ASCO (Free ASCO Whitepaper)-GI abstract and poster (one additional PR was recorded after December 3):

Efficacy data in evaluable patients (represents an update from ASCO (Free ASCO Whitepaper)-GI abstract/poster):

Among patients treated per protocol at the recommended Phase 2 dose (RP2D; 15 mg/m2) in combination with FOLFIRI-bev:
12 of 35 (34%) achieved an initial complete response (CR) or partial response (PR)
10 of 35 (29%) achieved a confirmed CR or PR (awaiting confirmatory scan for 1 patient)
33 of 35 (94%) had a best response of disease control (CR + PR + SD)
Objective response rates of 5-13% observed in historical control trials in similar patient populations treated with various different drug combinations, including the standard of care chemotherapy of FOLFIRI with bevacizumab1-4
Patients evaluable for response treated at all dose levels (12 mg/m2, 15 mg/m2, 18 mg/m2)
17 of 48 (35%) achieved an initial CR or PR
13 of 48 (27%) have achieved a confirmed CR or PR (awaiting confirmatory scan for 1 patient)
44 of 48 (92%) had a best response of disease control (CR + PR + SD)
Status of 4 unconfirmed PRs:
1 patient discontinued from the trial prior to confirmatory scan due to an adverse event that was unrelated to treatment (hepatitis B)
1 patient went from PR to SD at the confirmatory scan and patient subsequently discontinued from the trial to pursue potentially curative metastasis-directed therapy
1 patient went from PR to SD at the confirmatory scan (patient remains on treatment)
1 patient has yet to have their confirmatory scan
5 of 48 (10%) evaluable patients discontinued therapy to pursue potentially curative metastasis-directed therapy (surgery or microwave ablation), including 2 patients with SD
Median progression free survival (mPFS; no update from ASCO (Free ASCO Whitepaper)-GI poster)

mPFS has not yet been reached in patients treated per protocol at the RP2D
mPFS across all response-evaluable patients (n = 48) is 9.4 months (95% confidence interval: 7.1 – not yet reached)
mPFS of ~4.5-5.7 months has been reported in trials used as historical controls1-4
Biomarker data across all patients (no update from ASCO (Free ASCO Whitepaper)-GI poster):

Responses (CRs or PRs) were observed across seven different KRAS mutation variants, including the 3 most commonly observed in colorectal cancer (G12D, G12V, G13D)
Patients achieving a best response of a CR or PR showed the greatest decreases in plasma KRAS mutant allelic frequency (MAF) measured by droplet digital PCR (ddPCR) after 1 cycle (28 days) of therapy
Safety data across all patients (no update from ASCO (Free ASCO Whitepaper)-GI poster):

The combination of onvansertib and FOLFIRI/bevacizumab was shown to be well-tolerated with only 11% (84/788) of reported treatment-emergent adverse events (TEAEs) being G3/G4
The most commonly reported adverse event was neutropenia/neutrophil count decreased
Most reported TEAEs were manageable and reversible with supportive care
Baseline characteristics of patients at all dose levels (no update from ASCO (Free ASCO Whitepaper)-GI poster):

The patients’ median age was 61 years (range 35-83), and 56% were male
67% patients had previously received bevacizumab
16 of 48 (33%) evaluable patients remain on trial at the data cutoff date
Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology, commented, "These impressive results show radiographic responses across multiple KRAS mutation variants when onvansertib is combined with the standard of care regimen of FOLFIRI-bev and demonstrate a substantial increase in disease response relative to historical controls. We believe the data presented today further validate the potential of onvansertib to provide a meaningful improvement in the treatment outcome of a large patient population that has limited available treatment options. Looking forward, and with our strong cash position, we have the ability to explore the full potential of onvansertib."

Webcast and Conference Call

The newly announced data are being discussed today at 5:00 PM ET as part of a webcast and conference call with members of the Cardiff Oncology management team. To access the webcast, click here. To participate by phone, please dial 1-877-407-9208 (domestic) or 1-201-493-6784 (international) and refer to conference ID 13725845. Following the live event, an archived webcast will be available on the "Events" section of the Cardiff Oncology website.

About the Phase 1b/2 Trial of Onvansertib in the Second-Line Treatment of KRAS-mutated mCRC

This is a multi-center, single-arm, Phase 1b/2 trial of onvansertib in combination with standard-of-care FOLFIRI and Avastin (bevacizumab) to evaluate the safety and preliminary efficacy of the combination regimen in the second-line treatment of patients with KRAS-mutated mCRC. The trial, A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second–Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation, is enrolling patients with histologically confirmed metastatic and unresectable colorectal carcinoma harboring a KRAS mutation. Patients must also have experienced disease progression or treatment intolerance to first-line treatment with fluoropyrimidine and oxaliplatin (FOLFOX or CapeOx) with or without bevacizumab to be eligible. The trial is being conducted at the following cancer centers across the U.S.: USC Norris Comprehensive Cancer Center, The Mayo Clinic (Arizona, Rochester, and Jacksonville), Kansas University Medical Center (KUMC), CARTI Cancer Center and Inova Schar Cancer Institute. For more information on the trial, please visit NCT03829410.

References

Giessen et al., Acta Oncologica 2015, 54: 187-193
Cremolini et al., Lancet Oncol 2020, 21: 497–507
Antoniotti et al., Correspondence Lancet Oncol June 2020
Bennouna et al., Lancet Oncol 2013; 14: 29–37

On January 18, 2022 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported that Scott Carmer, Chief Executive Officer, will participate in the LLS TAP panel discussion entitled "Expanding the Possible with Next Generation Cell Therapies" on Friday, January 21, 2022 at 12:00 p.m. Eastern Time (Press release, NexImmune, 18 18, 2022, View Source [SID1234605598]).

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The webcast will be accessible on the Investor Relations page of NexImmune’s website at Events and Presentations | NexImmune, Inc. Participants may also register at LLS TAP: Expanding the Possible with Next-Generation Cell Therapies.

LLS and NexImmune have a long history of working together. In October 2017, NexImmune benefitted from an initial TAP investment and in 2021 received a second investment as part of the Company’s initial public offering to support NexImmune’s ongoing Phase 1/2 studies in AML/MDS and multiple myeloma.

"We are excited with our continued support of NexImmune and their participation in this panel. The LLS track record in accelerating lifesaving blood cancer treatments is unparalleled," said Lee Greenberger, Ph.D., LLS Chief Scientific Officer. "The continuity of our funding from preclinical through clinical research demonstrates our commitment to supporting innovative therapies as they move from the laboratory into practice."

On January 18, 2022 Exact Sciences reported performance data for a second-generation Cologuard (multi-target stool DNA) test showing overall sensitivity of 95.2% for colorectal cancer (CRC) at specificity of 92.4% for negative samples confirmed by colonoscopy (Press release, Exact Sciences, JAN 18, 2022, View Source [SID1234605599]). Subgroup analyses showed 83.3% sensitivity for high-grade dysplasia, the most dangerous precancerous lesions, and 57.2% for all advanced precancerous lesions. These data will be presented January 22 at ASCO (Free ASCO Whitepaper) GI in a poster titled, "Second-generation Multi-target Stool DNA Panel Reliably Detects Colorectal Cancer and Advanced Precancerous Lesions."

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Cologuard is the first and only FDA-approved, non-invasive stool DNA test used to screen average-risk people for CRC. Exact Sciences is developing a second-generation Cologuard to improve the specificity and precancer sensitivity of the test, decreasing the false positive rate and increasing the detection rate of precancerous lesions. The study shows the potential of a highly discriminate panel of methylated DNA markers and fecal hemoglobin to accomplish both in a real-world setting. If approved, the second-generation Cologuard test could help increase screening rates while sending fewer people to follow-up colonoscopies unnecessarily and identifying more advanced precancers before they progress to cancer, helping prevent the disease.

"The Exact Sciences team is constantly innovating to help make earlier cancer detection a routine part of medical care," said Kevin Conroy, chairman and CEO. "These data demonstrate our commitment to patients and the power of our research and development teams, scientific platform, and expertise in colorectal cancer screening."

The study was carefully designed to simulate a true screening population and better predict real-world, prospective performance of the marker panel. It included non-advanced precancers, samples collected prospectively across all precancer types and sizes, and colorectal cancer samples weighted heavily towards early stages. The study consisted of 777 stool samples collected in the United States and Canada across 134 sites, including 112 cancers – 78% in stages I and II, 98 prospectively collected advanced precancerous lesions, 176 non-advanced precancerous lesions, and 391 negative controls.

"Exact Sciences and Mayo Clinic scientists worked together to discover these new methylation markers, which demonstrate improved performance over first-generation Cologuard markers," said Paul Limburg, MD, MPH, AGAF, Chief Medical Officer for Screening at Exact Sciences. "In particular, the observed increased specificity suggests that false positive screening results can be reduced, which has important implications for clinical practice and decision-making."

Colorectal cancer is the second deadliest cancer impacting both men and women in the United States. It’s also treatable if caught in early stages.1 Despite the benefits of CRC screening, approximately 45 million average-risk people in the United States remain unscreened.2 A multi-center pivotal trial evaluating second-generation Cologuard markers is ongoing, and results are expected late 2022 or early 2023. Exact Sciences plans to use results of the ongoing trial to support an FDA submission and approval and make the enhanced Cologuard test available broadly.

Conference call and webcast details

Exact Sciences management and Mayo Clinic will host a conference call and webcast on Wednesday, Jan. 19, 2022, at 11 a.m. ET to discuss results of the second-generation Cologuard study. The webcast will be available at www.exactsciences.com. Domestic callers should dial (833) 952-1519 and international callers should dial +1 236-714-2125. The access code for both domestic and international callers is 3972189.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or +1-416-621-4642 internationally. The access code for the replay of the call is 3972189. The webcast, conference call, and replay are open to all interested parties.

Additional data presented at 2022 ASCO (Free ASCO Whitepaper) GI Cancers Symposium

Four additional Exact Sciences abstracts were accepted and will be shared at ASCO (Free ASCO Whitepaper) GI. Details for each are included below and all abstracts can be found on the conference website.

Cologuard abstracts

Title: Patterns of Colorectal Cancer (CRC) Screening Rates Among the Average Risk US Population
Authors: Fisher, D., et al.
Date/Time: Jan. 22, 2022, 9:30 a.m. ET

Title: Preferences for Colorectal Cancer Screening of Physicians and Individuals at Average Risk in the United States: A Discrete Choice Experiment
Authors: Heidenreich, et al.
Date/Time: Jan. 22, 2022, 9:30 a.m. ET

Oncoguard Liver abstracts

Title: A Prospective Trial to Evaluate the Performance of the Multi-Target Hepatocellular Carcinoma Blood Test (mt-HBT) for Screening At-Risk Patients: The ALTUS Study
Authors: John, B., et al.
Date/Time: Jan. 21, 2022, 3:05 p.m. ET

Title: Multi-Target Blood Test Can Improve the Performance of Hepatocellular Carcinoma Surveillance Programs: A Modeling-Based Virtual Trial
Authors: Chhatwal, J., et al.
Date/Time: Jan. 21, 2022, 3:05 p.m. ET

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