On March 11, 2020 Cofactor Genomics reported that Tumor-infiltrating lymphocytes (TILs) are lymphocytes that directly infiltrate the tumor microenvironment (TME) opposing or surrounding tumor cells and in some cases subsets of cancer-reactive T-cells with killing activity clonally expand and mount an anti-tumor response (Press release, Cofactor Genomics, MAR 11, 2020, View Source [SID1234555565]). The degree of TIL infiltration is measured by both the extent and density of the TIL infiltrate using standardized systems that have been defined for objective grading of the degree of infiltration.¹ Accurate TIL measurement is critical as the extent of infiltration has been associated with favorable outcomes for a variety of tumors.2,3,4 Furthermore, the revolutionary emergence of immune checkpoint inhibition to treat cancers is limited to tumors that exhibit endogenous populations of TILs at sufficient frequencies that can be sufficiently reinvigorated to recognize tumor antigens and mediate tumor killing. For tumors where the extant population of TILs is absent or fails to function, other immune modulating therapies such as adoptive T-cell transfer, engineered T-cell therapies or cancer vaccines can be used to augment the native TIL population in the anti-tumor response. Accordingly, measurement of tumor-infiltrating lymphocytes infiltration is key to informing the most effective therapeutic options and patient outcomes.

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In combination with tumor-infiltrating lymphocytes, PD-1/PD-L1 expression is also a common parameter for evaluating the tumor microenvironment (TME).5 Though the importance of PD-1/PD-L1 expression has been demonstrated in some cases (e.g., registration of pembrolizumab for non-small cell lung cancer patients with PDL1 expression in >50% of analyzed tumor cells6), its well-established variability, both temporally and spatially, limits its applicability as a predictor of response. Indeed, it is likely that PD-1/PD-L1 expression is just one of many multivariates in the TME that mediate response and it has been suggested that more relevant correlates might include the overall mutational burden of the tumor (TMB) in addition to the clonal diversity of the tumor-infiltrating lymphocytes population and to the expression of PD-1/PD-L1 on the infiltrating lymphocytes themselves.7,8 Moreover, other important attributes of the TME, such as the presence of tumor-associated macrophages (TAMs) or myeloid-derived suppressor cells (MDSCs), are currently underestimated and not included in most of the currently used classifications of immune infiltrates.9

Immune checkpoint inhibitors and T-cell-based therapies, both adoptive and engineered, have unlocked new avenues to treat cancer. Due to their novel mechanism of action, these therapies are not associated with the traditional adverse events seen with cytotoxic chemotherapy.10,11 However, inhibition of checkpoint receptors/ligands and introduction of engineered T-cells (e.g., CAR-T) can lead to excessive immune system activation with the upregulation of T-cell proinflammatory responses, cytokine release syndrome, and immune effector cell-associated neurotoxicity syndrome.10,11 This activation of the immune system can result in immune-related adverse events and the precise exact mechanism of these has not been fully elucidated, but it is hypothesized that T-cell activity, autoantibodies, and proinflammatory cytokines likely contribute to their onset. Dermatologic, gastrointestinal, endocrine, and pulmonary-related immune-related adverse events are the most common, but they can manifest in any organ system.

Accurate assessment of immune cell infiltration in the tumor microenvironment, the subtypes of immune cells present, the expression levels of immune escape genes and the overall neoantigen load of the tumor (as estimated by TMB) are emerging as predictive variables that in combination might serve to better inform immunotherapy treatment decisions. It is likely that additional variates will emerge and when combined, enable the development of multidimensional biomarker with significantly enhanced predictive accuracy for treatment type, likelihood of response and potential for adverse events.

Cofactor has built an immune-profiling solution with ImmunoPrism, that allows many of these immune features to be measured, in parallel, from two sections of FFPE. Importantly, as described above, it’s unlikely that one single measurement provides sufficient context for understanding disease and therapy response, which is what drives us to use machine-learning to build multidimensional biomarkers.

On March 11, 2020 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the full-year ended December 31, 2019 (Press release, Checkpoint Therapeutics, MAR 11, 2020, View Source [SID1234555507]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "Checkpoint achieved significant progress in 2019. Notably, we continued to advance the development of our lead antibody product candidate, cosibelimab, which is in an ongoing, multicenter, registration-enabling Phase 1 clinical trial intended to support a potential Biologics License Application ("BLA") submission for the initial indication of metastatic cutaneous squamous cell carcinoma ("CSCC"). Importantly, earlier this year, we announced confirmation by the FDA of the registration submission pathway in CSCC based on the ongoing clinical trial, which we are pleased to report is now over one-third enrolled. We also successfully closed on gross proceeds of approximately $20 million in a November financing to extend our cash runway to support these efforts." Mr. Oliviero continued, "We believe cosibelimab, upon approval, has the potential to be a market disrupting product through both its differentiated two-fold mechanism of action and our plan to enter the market at a price point substantially lower than the class of PD-1 and PD-L1 agents available today that generate over $25 billion in annual sales."

2019 and Recent Corporate Highlights:

In March 2019, Checkpoint announced two new patent issuances by the U.S. Patent and Trademark Office and the European Patent Office for CK-101, our third-generation epidermal growth factor receptor ("EGFR") inhibitor in Phase 1 development as a treatment for patients with EGFR mutation-positive non-small cell lung cancer ("NSCLC"). The patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extensions.
In June 2019, Checkpoint was added to the Russell 2000 Index.
In September 2019, positive interim results for cosibelimab were presented at the European Society for Medical Oncology ("ESMO") Congress 2019 in Barcelona, Spain. The poster presentation provided updated interim efficacy and safety results from the ongoing multicenter Phase 1 clinical trial of cosibelimab, including expansion cohorts in CSCC and NSCLC. A 50% objective response rate was observed in CSCC and a 40% objective response rate was observed in NSCLC. Cosibelimab appeared to be safe and well-tolerated with a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies.
In November 2019, pharmacokinetic and target occupancy modeling data for cosibelimab were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting. The poster, titled "Semi-mechanistic PK and target-occupancy modeling to support dose justification for anti-PD-L1 clinical candidate CK-301 (TG-1501) in oncology patients," compared pharmacokinetic and tumor target occupancy data at steady state under various dosing regimens of cosibelimab to those of three marketed anti-PD-L1 monoclonal antibodies: atezolizumab, durvalumab and avelumab. The results demonstrated that cosibelimab dosed at 800 mg and 1,200 mg once every two weeks or every three weeks is expected to achieve over 99% PD-L1 target occupancy throughout the dosing interval, which is comparable to atezolizumab and durvalumab and higher than avelumab at approved doses.
Also in November 2019, Checkpoint closed on gross proceeds of approximately $19.6 million in an underwritten public offering of its common stock before deducting underwriting discounts and commissions and other offering-related expenses.
In January 2020, Checkpoint announced confirmation of the registration path for cosibelimab in metastatic CSCC. U.S. Food and Drug Administration feedback supports the plan to submit a BLA based on data from the ongoing Phase 1 trial. Approximately one-third of enrollment is complete as of year-end in the cohort of patients with metastatic CSCC.
Financial Results:

Cash Position: As of December 31, 2019, Checkpoint’s cash and cash equivalents totaled $26.1 million, compared to $22.0 million at December 31, 2018, an increase of $4.1 million.
R&D Expenses: Research and development expenses for the year ended December 31, 2019, were $19.3 million, compared to $33.7 million for the year ended December 31, 2018, a decrease of $14.4 million. Research and development expenses for the year ended December 31, 2019, included $3.2 million of non-cash stock expenses, compared to $1.8 million in stock compensation expense for the year ended December 31, 2018.
G&A Expenses: General and administrative expenses for the year ended December 31, 2019, were $7.2 million, compared to $6.6 million for the year ended December 31, 2018, an increase of $0.6 million. General and administrative expenses for the year ended December 31, 2019, included $3.2 million of non-cash stock expenses, compared to $2.7 million in stock compensation expense for the year ended December 31, 2018.
Net Loss: Net loss attributable to common stockholders for the year ended December 31, 2019, was $24.7 million, or $0.70 per share, compared to a net loss of $36.4 million, or $1.27 per share, for the year ended December 31, 2018.

On March 11, 2020 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, reported the pricing of an underwritten public offering of 7,500,000 shares of its common stock, at a price to the public of $0.60 per share (Press release, Apricus Biosciences, MAR 11, 2020, View Source [SID1234555499]). In addition, the Company granted the underwriters a 45-day option to purchase up to 1,125,000 additional shares of its common stock to cover over-allotments, if any. All of the shares of common stock in the offering are being sold by Seelos.

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Benchmark Company is acting as sole book-running manager for the offering.

Seelos anticipates the aggregate net proceeds from the offering will be approximately $3.9 million, after deducting the underwriting discounts and commissions and estimated offering expenses payable by Seelos, but excluding any exercise of the underwriters’ option to purchase additional shares of common stock. Seelos intends to use the net proceeds from the offering for general corporate purposes and to advance the development of its product candidates. This offering is expected to close on or about March 16, 2020, subject to the satisfaction of customary closing conditions.

The securities described above were offered by Seelos pursuant to a shelf registration statement on Form S-3 (File No. 333-221285) previously filed with the Securities and Exchange Commission (the "SEC") on November 2, 2017, amended on December 1, 2017 and declared effective by the SEC on December 7, 2017. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting The Benchmark Company, LLC, Attn: Prospectus Department, 150 E. 58th Street, 17th floor, New York, NY 10155, by calling (212) 312-6700 or by e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On March 11, 2020 Fight Colorectal Cancer (Fight CRC) reported the launch of the Catalyst State-by-State Advocacy Program, with the help of an unrestricted grant from Exact Sciences (Press release, Fight CRC, MAR 11, 2020, https://www.prnewswire.com/news-releases/fight-colorectal-cancer-receives-grant-from-exact-sciences-to-launch-program-aimed-at-reducing-patient-barriers-to-colorectal-cancer-screening-301021163.html [SID1234555441]). The new initiative will provide funding and expertise to help advance legislation and policies geared toward increasing participation with colorectal cancer screening.

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Colorectal cancer is the second-leading cause of cancer death in the U.S. in men and women combined1 even though it can be effectively prevented or detected early and treated through screening. One in three adults ages 50 to 75 are not screened as recommended according to American Cancer Society (ACS) guidelines.2 Colorectal cancer is also on the rise in younger adults,3 prompting ACS to lower the recommended screening age to 45. ACS also stressed the importance of getting screened and following all positive noninvasive screening tests with a colonoscopy.4 Cost is a well-known barrier to screening and often patients don’t complete a follow-up colonoscopy because they fear a bill. According to a large study in one health system, patients who do not follow up on an abnormal test result are seven times more likely to die from colorectal cancer than those who complete the entire screening process.5

In the program’s first year, Fight CRC will award four states Catalyst grant funding and provide technical assistance to support two primary objectives:

Ensure that insurance coverage is in place for colorectal cancer screening starting at age 45, consistent with ACS guidelines.
Remove cost barriers for patients who need a follow-up colonoscopy, following a positive first-line screening test.
"Fight CRC is thrilled to launch the Catalyst State-by-State Advocacy Program and begin working at the state level to implement policy that will increase access to colorectal cancer screening. We are grateful for Exact Sciences’ commitment to supporting advocacy efforts to ensure people have timely access to screening, regardless of the test they choose," said Anjee Davis, President of Fight CRC. "It will allow us to empower a community of advocates across the country to impact meaningful policy change and ultimately bring us one step closer to a world without colorectal cancer."

Catalyst grants will help local leaders and advocates build the infrastructure and expertise needed to address these issues through policy change. Applications will be accepted from non-profit organizations (501(c)(3), 501(c)(4)), universities, and state and local coalitions. The program will be guided by an independent advisory council comprised of representatives including the American Cancer Society Cancer Action Network (ACS CAN) and the Prevent Cancer Foundation. The council reviews grant applications, selects recipients, and provides grant recipients with subject matter expertise. Fight CRC will award smaller Spark grants to additional organizations in other states to conduct action planning and help lay the foundation for success in future years. Fight CRC will announce the first Catalyst grant recipients in the coming weeks.

"Policy change is most effective when it’s driven by sound science. We are grateful that our partners at Exact Sciences and Fight CRC are teaming up to push for public policy changes at the state level that will increase screening rates for colorectal cancer," said Lisa Lacasse, president of ACS CAN. "We look forward to working collectively to ensure more and more Americans have access to covered colorectal cancer screening, free of any potential cost-sharing barriers, creating the opportunity to save more lives from colorectal cancer."

"Colorectal cancer is the second-leading cause of cancer death in the U.S. and the rising number of cases among those under the age of 45 is alarming," said Carolyn Aldigé, Founder and CEO, Prevent Cancer Foundation. "Because regular screenings are critical to reducing the risk of developing or dying from the disease, these Catalyst grants will go a long way toward helping states implement policy to increase access to colorectal cancer screening in accordance with appropriate screening guidelines. This is one cancer that can be stopped before it starts."

"Colorectal cancer is a pressing public health problem, despite it being one of the most preventable cancers. The Catalyst program taps into the best of all of us to get more people screened," said Kevin Conroy, chairman and CEO of Exact Sciences. "We are proud to stand shoulder to shoulder with Fight CRC to empower the grant recipients with the resources they need to remove barriers to screening."

Representatives from the inaugural grant recipients will participate in a training session as part of Fight CRC’s annual Call-on Congress, March 15-16. Grantees will share their goals and challenges and begin developing an action plan to achieve policy change in their state.

On March 11, 2020 Concord Medical Services Holdings Limited ("Concord Medical" or the "Company") (NYSE: CCM), a healthcare provider specializing in cancer care, research, education and prevention by operating a network of medically advanced comprehensive cancer hospitals and standalone radiotherapy and diagnostic imaging centers in China, reported that CITIC Industrial Investment Group Limited, a renowned investment institution, will make an investment in Concord Medical’s subsidiary, Meizhong Jiahe Hospital Management Group Co., Ltd. ("Meizhong Jiahe"), subject to the satisfaction of closing conditions pursuant to an agreement entered into between the parties (Press release, Concord Medical Services Holdings, MAR 11, 2020, View Source [SID1234555440]). The total investment will be approximately RMB700 million.

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As the most important operating platform of Concord Medical in China, Meizhong Jiahe is focusing on the development and management of comprehensive cancer hospitals and the standalone radiotherapy and diagnostic imaging center network in China. Meizhong Jiahe is committed to provide its patients with high-quality patient-centered multidisciplinary cancer care services. In addition, Meizhong Jiahe provides the cutting-edge Proton therapy treatment option in the Company’s Beijing, Shanghai and Guangzhou cancer hospitals. Meizhong Jiahe is dedicated to become a premier cancer medical services provider for the patients in China by helping to eradicate the cancer diseases by offering international recognized clinical research, multidisciplinary treatment care approach and advanced hospital management systems.

Dr. Jianyu Yang, Chairman and Chief Executive Officer of Concord Medical, commented, "We are excited and honored to have such a strong partner to make a significant investment in Meizhong Jiahe, which can support the opening of our Guangzhou Cancer Hospital this year and the operation of our other medical institutions. We are very confident that Meizhong Jiahe will continue to take this opportunity to invest in the healthcare industry in China and to introduce more state-of-the art medical technologies to our hospitals. We also believe that Meizhong Jiahe will offer the high-quality clinical outcomes and the world-class cancer care services to our patients."