On December 4, 2019 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that Kenneth A. Berlin, President and Chief Executive Officer will present at the upcoming LD Micro Main Event Investor Conference being held from December 10-12, 2019 at the Luxe Sunset Boulevard Hotel in Los Angeles, California (Press release, Advaxis, DEC 4, 2019, View Source [SID1234551913]).

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Presentation Information:

Date: Tuesday, December 10, 2019

Time: 9:20 AM PT / 12:20 PM ET

Location: Luxe Sunset Boulevard Hotel (Los Angeles, CA)

Webcast: View Source

On December 4, 2019 AIM ImmunoTech (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers and immune-deficiency diseases — such as severe chronic fatigue syndrome (CFS) — reported its stockholders with an update on the first three quarters of 2019 and detailed expected upcoming milestones in clinical studies using its drug Ampligen (Press release, AIM ImmunoTech, DEC 4, 2019, View Source [SID1234551912]). For more detailed information on the most recent quarter, please see the company’s 10-Q filed on 11/14/19. The below letter is also available on the company’s website.

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To our valued stockholders,

This has been a transformational year for AIM ImmunoTech. Our flagship drug, Ampligen, is now being studied in six immuno-oncology clinical trials. We are focusing on highly lethal malignancies where there are unmet medical needs. These trials are underway at highly respected National Cancer Institute (NCI)-Designated Cancer Centers. Several more clinical trials are slated for 2020. Our principal obligation is to supply Ampligen, while the substantial costs in all of these clinical trials are funded by third-party grants from government or industry. We believe this significant third-party support validates the potential of Ampligen for use in combinational "synergy" therapies to fight cancer.

Most notably, two grants by the U.S. Department of Defense (DOD) were issued for Ampligen immuno-oncology research. These DOD "Breakthrough Awards" total approximately $15 million to Roswell Park Comprehensive Cancer Center and Moffitt Cancer Center to study Ampligen in combination with other immunotherapies — including pembrolizumab (KEYTRUDA) and Intron A — in the treatment of brain metastatic breast cancer. We expect both these DOD-funded trials to commence in 2020.

At the same time, we’re nearing completion of manufacturing in a plan to ensure sufficient supplies of Ampligen for future clinical trials and the Argentina commercial launch. Once manufacturing is completed, we anticipate a corresponding reduction in our expenses, which should ensure adequate resources as we await data from the ongoing clinical trials and begin preparations for upcoming trials.

Looking ahead, we anticipate several important clinical trial milestones in 2020, some of which we believe will have breakthrough potential:

●Publication of data from a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer at University of Pittsburgh Medical Center. The Phase 1 portion of the study showed the intraperitoneal safety profile of Ampligen with positive survival data. View Source

●Interim data from a follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab, plus Ampligen at University of Pittsburgh Medical Center. Enrollment has commenced and several patients have begun treatment, with up to 45 patients to be enrolled. View Source

●Interim data from a Phase 2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab, at Roswell Park Comprehensive Cancer Center. A number of the planned 6 patients are in treatment. This is an important study because prevalence of this lethal malignancy is approximately 350,000 in the U.S. alone, and a previous clinical study determined that pembrolizumab as a monotherapy was successful on only 5% of patients who had previously undergone chemotherapy. View Source

●Interim data in a Phase 2a study of Ampligen as a component of a chemokine modulatory regimen (celecoxib) on Stage 4 colorectal cancer metastatic to liver at Roswell Park Comprehensive Cancer Center. A number of the 12 planned patients are in treatment. View Source

●First enrollment and the subsequent commencement of treatment of patients in a Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy (Roswell Park Comprehensive Cancer Center, Dr. G. Chatta, PI). IRB and FDA approval to proceed has been received. View Source

●First enrollment and subsequent commencement of treatment in a Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer, which has received FDA authorization. The objective of this study is to evaluate the safety and tolerability of a combination of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy in the early stages of this lethal malignancy.

Once we receive adequate data from the above clinical trials, our plan is to seek Breakthrough / Fast Track designations in certain oncology indications from the FDA. If received, this would make Ampligen eligible for many distinct benefits, including Accelerated Approval, Priority Review and Rolling Review. Such designation would be invaluable, as we continue to work to bring Ampligen to market—especially in these lethal malignancies where a current unmet medical need exists. At the same time, we remain focused on aggressively expanding our patent estate.

Overall, we have had an extremely productive year at AIM and we are focused on achieving these important milestones in order to ensure the future success of Ampligen. In addition to significant non-dilutive, third-party funding support paying for the major expenses in all the ongoing immuno-oncology clinical studies, we successfully raised $10 million over the past several months. This significantly enhances our balance sheet and provides us a substantial runway to support our ongoing activities as we await results in multiple ongoing immuno-oncology clinical trials.

I would like to thank our stockholders for their continued support. We are engaged in very important research which, if successful, has the potential to save tens of thousands of lives, as well as create long-term value for you, our stockholders. The risks are high, but the potential rewards are great. I look forward to keeping you apprised of developments as they unfold.

On December 4, 2019 ImCheck Therapeutics, a biotech company developing a first-in-class antibody to activate gamma delta (gd) T cells in a range of cancer indications and a portfolio of novel immunotherapies for the treatment of cancer and autoimmune diseases, reported the closing of a $53 million (€48 million) Series B financing round (Press release, ImCheck Therapeutics, DEC 4, 2019, View Source [SID1234551908]). The round was co-led by Pfizer Ventures, the venture capital arm of Pfizer Inc. (NYSE: PFE), and Bpifrance through its InnoBio 2* and Large Venture funds and joined by new investors Wellington Partners, Agent Capital and Alexandria Venture Investments. Life Sciences Partners (LSP), Gimv, Idinvest Partners, Kurma Partners and Boehringer Ingelheim Venture Fund that contributed to the 2017 €20 Million Series A round also participated for a significant portion of this raise. The proceeds of the Series B will be used to fund the initial clinical trial for ImCheck’s first-in-class monoclonal antibody ICT01, to further expand the company’s broad pipeline of immunomodulators targeting the butyrophilins super-family and to bring additional immuno-oncology antibody programs into the clinic.

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"ImCheck’s first clinical trial starting next year with ICT01 is based on comprehensive translational research supporting its potential to activate gd T cells to kill malignant cells. The Series B funding, bringing the total capital raised in 2.5 years to nearly $80 million, allows us to accelerate the development of our unique immuno-oncology pipeline, further investigate the potential of our antibodies in autoimmune disease, and establish clinical operations and corporate development activities in the US," said Pierre d’Epenoux, Chief Executive Officer at ImCheck Therapeutics.

ImCheck’s Board of Directors will transition to include Michael Baran from Pfizer Ventures, Thibaut Roulon from Bpifrance, Regina Hodits from Wellington, Rémi Droller from Kurma, Vincent Brichard from LSP, Bram Vanparys from Gimv, Debasish Roychowdhury as independent Chairman and Pierre d’Epenoux, CEO of ImCheck.

"We believe that furthering the understanding of gd T cell activation could provide the basis for an area of research that could have tremendous potential for treating patients with certain cancers and autoimmune diseases, and we are pleased to be co-leaders in this financing round," commented Michael Baran, PhD, MBA, Principal, Pfizer Ventures and Executive Director, External Science & Innovation, Pfizer.

"ImCheck has produced a pipeline of first-in-class immuno-modulatory antibodies targeting gd T cells and built a world-class drug development organization with a significant potential to expand the current immune-modulatory arsenal against cancer," added Thibaut Roulon, PhD, Investment Director at Bpifrance.

"We are very pleased to add these top tier institutional and strategic investors from both the US and EU in the closing of our Series B financing," commented Debasish Roychowdhury, MD, Chairman of ImCheck Board of Directors. "We believe this investment represents a strong validation of our pipeline and its potential both in cancer and autoimmune diseases."

Legal counsel for the Series B transaction provided by Dentons Europe and Dechert LLP. Investor relations support provided by Trophic Communications. French media and communications support provided by ATCG.

On December 4, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations (Press release, Hoffmann-La Roche, DEC 4, 2019, View Source [SID1234551906]).

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"We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Today’s approval offers another opportunity to help prolong the lives of people with this type of the disease."

This approval is based on results from the Phase III IMpower130 study, which showed Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival [OS]=18.6 versus 13.9 months; hazard ratio [HR]=0.80; 95% CI: 0.64–0.99; p=0.0384) in the intention-to-treat wild-type (ITT-WT) population.1 The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) compared with chemotherapy alone (median PFS=7.2 versus 6.5 months; HR=0.75; 95% CI: 0.63–0.91; p=0.0024) in the ITT-WT population.1

Safety for the Tecentriq plus chemotherapy combination appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving Tecentriq plus chemotherapy compared with 60.3% of people receiving chemotherapy alone.

In lung cancer, Tecentriq is also approved in the US in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations. Additionally, Tecentriq is approved by the FDA to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for NSCLC harbouring these aberrations prior to receiving Tecentriq. Tecentriq is also approved in the US in combination with carboplatin and etoposide (chemotherapy) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

Roche has an extensive development programme for Tecentriq, including nine Phase III studies underway across different types of lung cancer, and multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpower130 study
IMpower130 is a Phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq in combination with nab-paclitaxel and carboplatin versus chemotherapy (nab-paclitaxel and carboplatin) alone for chemotherapy-naïve patients with stage IV non-squamous NSCLC. The study enrolled 724 people, of whom 681 were in the ITT-WT population and were randomised (2:1) to receive:

Tecentriq plus nab-paclitaxel and carboplatin (Arm A), or
Nab-paclitaxel and carboplatin (Arm B, control arm)
During the treatment-induction phase, people in Arm A received Tecentriq and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurred first. People in Arm A received Tecentriq during the maintenance treatment phase until loss of clinical benefit was observed.

During the treatment-induction phase, people in Arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurred first. People in Arm B received best supportive care during the maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. People who were consented prior to a protocol revision were given the option to crossover to receive Tecentriq as monotherapy until further disease progression.

The co-primary endpoints were:

PFS, as determined by the investigator using RECIST v1.1 in people without EGFR or ALK mutations (the ITT-WT population)
OS in the ITT-WT population
About NSCLC
Lung cancer is the leading cause of cancer death globally.2 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.3 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.3

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link: View Source

On December 3, 2019 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, and Hanmi Pharmaceutical Co., LTD reported a license and collaboration agreement for FLX475 in Asia (Press release, RAPT Therapeutics, DEC 3, 2019, View Source [SID1234570684]). FLX475 is an oral, small molecule CCR4 antagonist in development for the treatment of multiple cancers.

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"We are actively building our immuno-oncology portfolio, and see FLX475 as a potential keystone in our effort to deliver new safe and effective cancer therapeutics to patients who need them," said Hanmi CEO Se-Chang Kwon, Ph.D. "This compound complements our current product portfolio and has the potential to address a large and growing population of patients suffering from cancers that are prevalent in Asian countries. We look forward to partnering with RAPT to advance FLX475 through the clinic efficiently."

Under the terms of the agreement, RAPT will receive $10 million in an upfront payment and near-term milestone payment. Additionally, RAPT will receive up to $48 million in success-based development milestones and up to $60 million in potential sales milestones, as well as double-digit royalties on any future sales of FLX475 in the specified territories. In return, Hanmi will receive an exclusive license to develop, in parallel with RAPT, and commercialize FLX475 for the treatment of cancer in South Korea and China, including Taiwan and Hong Kong. In addition to leveraging its clinical trial infrastructure in Korea and China to augment RAPT’s ongoing Phase 1/2 clinical study of FLX475, Hanmi will also conduct a Phase 2 clinical trial in Korea and China to evaluate FLX475 in patients with gastric cancer.

"FLX475 targets "charged" tumors including virally-associated cancers, gastric cancer, non-small cell lung cancer, triple negative breast cancer and head and neck cancers, which are predicted to have high levels of CCR4 ligands, regulatory T cells and CD8+ effector T cells," said Yung-Jue Bang, M.D., Ph.D., professor of Medical Oncology at Seoul National University Hospital. "I believe FLX475 has the potential to offer patients a new therapeutic option that is desperately needed, particularly in Korea, which has the highest rate of gastric cancer in the world."

"This collaboration with Hanmi can provide us an entry point into the Asian market, allowing us to potentially expand our geographic footprint in a region with high prevalence of patients with "charged" tumors who we believe are most likely to respond to FLX475," said Brian Wong, M.D., Ph.D., president and CEO of RAPT Therapeutics. "Hanmi, with its fully integrated R&D infrastructure and nimble execution efficiency, has accumulated clinical development experiences and an extensive network of key opinion leaders. We believe Hanmi is a perfect partner for the development of FLX475."

FLX475 is a small molecule CCR4 antagonist designed to block the migration of regulatory T cells (Treg) specifically into tumors, but not healthy tissues. Treg represent a dominant pathway for downregulating the immune response, and may limit the effectiveness of currently available therapies such as checkpoint inhibitors. RAPT is developing FLX475 for the treatment of a broad range of "charged" tumors, which represent cancer types the company believes are most likely to respond to FLX475, where a large quantity of Treg cells are likely to be the cause of immune suppression within the tumor. FLX475 blocks the migration of Treg to the tumor, which may restore naturally occurring antitumor immunity and synergizing with a variety of both conventional and immune-based therapies, such as radiation, chemotherapy, checkpoint inhibitors, immune stimulators and adoptive T cell therapy.

RAPT is currently enrolling patients in a Phase 1/2 study of FLX475 as a monotherapy, and in combination with pembrolizumab, in patients with "charged" tumors and expect results from the Phase 2 portion of the trial in the first half of 2020.