On November 1, 2021 Provectus (OTCQB: PVCT) reported that updated response, safety, and immune correlative data from the Company’s ongoing Phase 1b clinical trial of cancer immunotherapy PV-10 (rose bengal disodium), in combination with Keytruda (pembrolizumab), for the treatment of advanced cutaneous melanoma in patients refractory to immune checkpoint blockade (CB) (NCT02557321: first expansion cohort) will be presented at the SMR 2021 Virtual Congress (the Society for Melanoma Research annual meeting), which is being held online from October 28th to 31st (Press release, Provectus Biopharmaceuticals, NOV 1, 2021, View Source [SID1234594034]).

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Highlights of the SMR 2021 presentation:

Baseline characteristics
22 patients; 19 evaluable for efficacy
68% male; median age of 72 years (range 28-90); 50% Stage IV M1b-d
CB-refractory status: 9% CTLA-4, 32% PD-1, 59% CTLA-4+PD-1
Safety (22 patients)
Principally grades 1-2 injection-site reactions for PV-10
Principally grades 1-3 immune-mediated reactions for Keytruda
Best overall response (BOR) by RECIST 1.1 (19 patients)
5% complete response (CR), 26% objective response rate (ORR), 53% disease control rate (DCR)
Prior PD-1 (6 patients): 50% ORR, 67% DCR
Prior CTLA-4+PD-1 (12 patients): 8% CR, 17% ORR, 50% DCR
Durability of response
4.9 months median progression-free survival (mPFS)
Survival
34.1 months median overall survival (mOS)
Immune correlative assessment (6 patients)
Increases in damage-associated molecular pattern (DAMP) high mobility group box protein 1 (HMGB1) were consistent with the HMGB1 pattern of PV-10-treated CB-naïve melanoma patients
IFNγ expression of peripheral T cells demonstrates the induction of tumor-specific reactivity to HLA-matched cell lines, equivalent to that in CB-naïve melanoma patients
Immune correlative data substantiate the same PV-10 immune-mediated mechanism of action in CB-naïve monotherapy and CB-naïve and -refractory combination therapy melanoma patients
Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "Our melanoma drug development program has consistently and reproducibly shown PV-10’s unique innate and adaptive immune signaling mechanisms in single-agent and checkpoint blockade combination therapy clinical trials. To date, more than 50 patients have been treated with PV-10-Keytruda combination therapy for different melanoma indications. Current data notably demonstrate that cancer immunotherapy PV-10 can restore checkpoint blockade activity in patients who are refractory to this immunotherapy drug class."

Prior study data is also available on Provectus’ website:

Melanoma Bridge 2020, December 3-5: 14 evaluable patients, 7% CR, 29% ORR, 57% DCR,
European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, September 19-21: 11 evaluable patients, 9% CR, 36% ORR, 54% DCR, and
SMR 2019 Congress, November 20-24: 8 evaluable patients, 25% ORR, 50% DCR, 4.9 months estimated mPFS, mOS not reached.
About PV-10

Intralesional (IL) administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death within hours of tumor injection, and induce tumor-specific reactivity in circulating T cells within days. This PV-10-induced functional T cell response may be enhanced and boosted in combination with immune checkpoint blockade (CB). In CB-refractory advanced cutaneous melanoma, PV-10 may restore disease-specific T cell function. IL PV-10 has been administered to over 450 patients with cancers of the skin and of the liver. It is administered under visual, tactile, or ultrasound guidance to superficial malignancies, and under CT or ultrasound guidance to visceral hepatic tumors. IL PV-10 is also undergoing preclinical study for pediatric solid tumor cancers (including neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma).

Systemic administration of PV-10 is undergoing preclinical study as prophylactic and therapeutic treatments for high-risk and refractory adult solid tumor cancers, and as a treatment for relapsed and refractory blood cancers.

Different formulations and routes of administration of PV-10 and rose bengal disodium are also undergoing clinical and/or preclinical study in virology, microbiology, ophthalmology, dermatology, and animal health.

On November 1, 2021 Akeso, Inc. (the Company, 9926.HK) announces that AK112 (PD-1/VEGF bi-specific antibody), the novel immuno-oncology drug independently developed by the Company, reported that obtained approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the People’s Republic of China to initiate a phase II clinical trial for monotherapy or combined chemotherapy neoadjuvant/adjuvant therapy of resectable non-small cell lung cancer (NSCLC) (Press release, Akeso Biopharma, NOV 1, 2021, View Source [SID1234594050]).

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This is an open and multi-center phase II randomized clinical trial aiming to evaluate whether pre-operative AK112 monotherapy or combined chemotherapy neoadjuvant/adjuvant therapy can improve the surgical pathological remission rate for patients with resectable NSCLC.

Lung cancer is one of the cancers with the highest morbidity and mortality in the world, of which about 85% are NSCLC, and about 30% of patients belong to resectable early and midstage NSCLC when they are first diagnosed. Certain clinical trials have shown that neoadjuvant immunotherapy can play an important role in the comprehensive treatment of early stage NSCLC, with controllable adverse reactions and less surgery delay.

Currently, the consensus on NSCLC neoadjuvant immunotherapy is: patients with resectable phase IB-IIIA NSCLC may consider neoadjuvant immunotherapy combined with platinumcontaining dual-agent chemotherapy or neoadjuvant immune monotherapy before surgery. The efficacy of immunotherapy combined with chemotherapy is better than chemotherapy with controllable safety, but the improvement of pathological remission rate is limited.

Immune checkpoint inhibitors plus anti-angiogenic drugs have been synergistically observed in multiple tumor types, PD-1/VEGF bi-specific antibody combined with chemotherapy is therefore expected to obtain better clinical benefits.

AK112 has shown good safety and tolerability in early clinical trials on various types of lung cancers including NSCLC and small cell lung cancer (SCLC), and has also shown excellent anti-tumor effects.

AK112 is the world’s leading drug which entered phase III clinical trial among the same type of drugs. AK112 is another first-in-class bi-specific antibody drug developed by the Company to enter advanced clinical stage after the first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and development code: AK104) entered the review stage.

In addition, the registrational phase III clinical trial of AK112 for the treatment of NSCLC after treatment failure by epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI) has been initiated; the phase III clinical trial of AK112 for the first-line treatment of driver-gene negative PD-L1 positive NSCLC and the phase III clinical trial of AK112 for the first-line treatment of extensive stage SCLC are about to be initiated.

INFORMATION ABOUT AK112 (PD-1/VEGF BI-SPECIFIC ANTIBODY)

AK112 is a first-in-class and the first to enter clinical trial PD-1/VEGF bi-specific antibody independently developed by the Company. Engineered with our unique Tetrabody technology, AK112 blocks PD-1 binding to PD-L1 and PD-L2, and blocks VEGF binding to VEGF receptors. PD-1 antibody in combination with VEGF blocking agents have shown robust efficacy in various tumor types (including renal cell carcinoma, non-small cell lung cancer and hepatocellular carcinoma). In the view of the co-expression of VEGF and PD-1 in the tumor micro environment, AK112, as a single agent to block these two targets, may block these two pathways more effectively and enhance the anti-tumor activity, as compared to combination therapy.

On November 1, 2021 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported that the company will provide an update on its ACTengine IMA203 trial in a late-breaking oral presentation as well as an update on Immatics’ next-generation CD8ab TCR-T approach at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) (Press release, Immatics, NOV 1, 2021, View Source [SID1234594068]). The conference will take place, both in person and virtually, from November 10 – 14, 2021.

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Today, SITC (Free SITC Whitepaper) announced presentation titles and timings as follows:

IMA203 Phase 1a Clinical Data Update:

Presentation Title: Safety and anti-tumor activity of TCR-engineered autologous, PRAME-directed T cells across multiple advanced solid cancers at low doses – clinical update on the ACTengine IMA203 trial
Speaker: Martin Wermke, MD, Coordinating Investigator of Immatics ACTengine trials in Germany and Head of the Early Clinical Trial Unit of the National Center for Tumor Diseases Dresden (NCT/UCC) at the University Hospital Carl Gustav Carus in Dresden, Germany
Abstract Number: 959
Category: Late-breaking oral abstract presentation
Date & Time: Saturday, November 13, 2021; 12:00 – 12:15 pm EDT

Next-generation CD8ab TCR-T approach – Preclinical Data Update:

Presentation Title: Improved anti-tumor activity of next-generation TCR-engineered T cells through CD8 co-expression
Speaker: Mamta Kalra, PhD, Director CMC (Process Development) at Immatics
Abstract Number: 163
Category: Poster abstract presentation
Date & Time: Friday, November 12, 2021; Poster Hall Hours: 7 am–8:30 pm EDT

All posters presented at the poster hall will be made available as virtual ePosters throughout the SITC (Free SITC Whitepaper) 36th Annual Meeting.

About ACTengine IMA200 programs
Each of the product candidates of the IMA200 programs is based on Immatics’ proprietary ACTengine approach in which the patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor, an approach also known as TCR-T. ACTengine programs IMA201, IMA202 and IMA203 are currently in clinical development for the treatment of solid tumor indications, both in the US and in Germany. IMA204 is currently in pre-clinical development. All ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth. The ACTengine IMA200 Programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).

On November 1, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that its proprietary A.I. platform RADR has exceeded 10.4 billion datapoints(Press release, Lantern Pharma, NOV 1, 2021, View Source [SID1234594650]). RADR is Lantern’s proprietary integrated A.I. platform for large-scale biomarker and drug-tumor interaction data analytics that leverages machine-learning. RADR is used to provide mechanistic insights about drug-tumor interactions, predict the potential response of cancer types and subtypes to existing drugs and drug candidates, and uncover patient groups that may respond to potential therapies being developed by Lantern and its collaborators.

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RADR is also being used to: (1) help define and develop combination strategies involving drugs in development by Lantern and existing drugs that are approved for a range of oncology indications; (2) guide the prioritization of potential indications for development; and (3) identify potential new drug candidates to in-license and develop.

The increase to 10.4 billion datapoints was also accompanied by other significant improvements in the functionality, feature set and further automation of RADR, which are intended to help scale the A.I. platform’s drug development capabilities. The significant increase in the number of drug-tumor interaction data sets and cancers sub-types covered by RADR includes new data from collaborations in glioblastoma multiforme (GBM) and pancreatic cancer and data from transcriptome, genome and methylome data-sets in blood, bladder and other rare cancers being considered for future development or have limited therapeutic options.

Panna Sharma, CEO and President of Lantern Pharma, stated, "Our team has been well ahead of schedule in the growth of our platform, and RADR has now surpassed 10.4 billion data points covering more cancer sub-types, which further advances our goal of building the most complete and powerful A.I. platform for precision oncology drug development. Additionally, the new data will drive insights and potential drug-candidate innovations faster and into areas of cancer that have remained untouched or intractable."

Corresponding with this growth in datapoints, the Company has also focused resources and technology development on the growth and improvements to the library of algorithms designed specifically to help solve challenging data and correlation problems for cancer drug development. By using an ensemble-based approach in applying the library of algorithms to statistical, correlative and inferential problems related to drug-tumor interaction, RADR can rapidly analyze large amounts of complex data and predict with high accuracy how both tumors and patients will respond to drugs and drug candidates. RADR’s ability to rapidly sift through large amounts of curated and complex datasets is key in predicting the probability of a tumor or a patient group in responding to a cancer treatment. Additionally, the RADR platform evolves as new datasets are added, which improves and sharpens the insights generated from the algorithms. Lantern plans on continuing further RADR expansion by incorporating and curating additional datasets from proprietary studies and public data sources and further automating the evolution of its library of algorithms. Additionally, the Company will be augmenting the 10.4 billion datapoints with additional data from immuno-oncology related studies and clinical trials, including antigen, immune-response and protein data that it believes will enable a potentially more robust and more powerful multiomic analysis. "In the next phase of growth for RADR our belief is that we can deepen our capabilities in novel ADC development and also predict combination therapy approaches using our drug candidates and existing approved immuno-oncology therapies," stated Mr. Sharma.

"Previously, the task of identifying new cancer therapies has been costly, risky, and inefficient. Specifically, studying how existing compounds and therapeutic combinations can affect different cancer subtypes often took years, whereas our platform can reduce many key aspects of this process to months. As a result, we believe our platform changes the industry paradigm in a meaningful way. We have witnessed first-hand the growing industry interest in solutions that innovate the development of precision therapeutics and combination therapies, which we believe will pave the road to new partnerships. Accordingly, we believe our growing A.I. platform will be pivotal in uncovering potential new therapeutic opportunities and developing insights into the creation of combination-therapy programs, both internally and through third-party party collaborations to drive long-term shareholder value."

RADR’s highly scalable machine-learning methods are designed to guide drug development and yield new biological insights, while also having the potential to increase response rates and improve outcomes in clinical trials. The robustness and growing number of datasets powering RADR is anticipated to continue to improve machine-learning results, accelerate automation of other features and aid oncology drug development for Lantern and its partners with an ultimate focus on benefitting cancer patients.

On November 1, 2021 xFOREST Therapeutics Co., Ltd. (Headquarter: Kamigyoku, Kyoto, Japan, President and CEO: Shunichi Kashida, "xFOREST"), Axcelead Drug Discovery Partners Inc. (Headquarter: Fujisawa, Kanagawa, President: Yoshinori Ikeura, "Axcelead DDP"), and Kyowa Kirin Co., Ltd. (Headquarter: Chiyoda-ku, Tokyo, TSE:4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin") reported that the three companies have entered into a joint research agreement to discover multiple drugs that target RNA structures (Press release, Kyowa Hakko Kirin, NOV 1, 2021, View Source [SID1234593975]).

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Axcelead DDP and Kyowa Kirin originally started collaboration on the development of innovative small-molecule drugs based on a novel drug discovery technology platform in October 2020. Under the terms of the agreement among three companies announced here, xFOREST participates in the research being conducted by Axcelead DDP and Kyowa Kirin on the drug discovery targeting RNA structures.

xFOREST will provide its proprietary FOREST technologies, a suite of large-scale parallel analysis platforms, to promote systematic small-molecule drug discovery research targeting RNA structures. xFOREST obtains rights to receive milestone payments and royalties on sales from Kyowa Kirin according to the progress and success of its R&D. Kyowa Kirin has exclusive rights to develop and commercialize RNA-targeted small-molecules discovered from the collaboration.

Shunichi Kashida, Ph.D., President and CEO of xFOREST commented, "xFOREST Therapeutics has been promoting the development of its proprietary FOREST technologies, aiming to realize highly effective systematic RNA-targeted drug discovery. We appreciate that we will initiate the brandnew challenge to research for discovering the RNA-targeted drug with Kyowa Kirin and Axcelead DDP and we will push forward this research collaboration to deliver new drugs to patients as soon as possible."

Yoshinori Ikeura, Ph.D., President of Axcelead DDP commented, "Since Axcelead DDP and Kyowa Kirin started collaboration in 2020, we have been striving to develop fundamental technologies that will open up a new era of small-molecule drugs together. We feel the excitement at xFOREST’s participation in our collaboration, which is sure to help us construct a novel unparalleled platform for RNA-targeted small-molecule drug discovery. We are delighted that we utilize our expertise and technologies accumulated in the pharmaceutical industry for the development of novel technology."

Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin commented, "We are very delighted to initiate a collaboration with xFOREST and Axcelead DDP. We highly expect that xFOREST’s unique platform could further accelerate our efforts by integrating it with the Axcelead DDP’s extensive technology and experience of small-molecule drug discovery and our innovative drug discovery technology. We will work closely with both companies to research and develop novel drugs to answer unmet medical needs."