On November 15, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that members of the senior management team will participate in a fireside chat at the Piper Sandler 33rd Annual Virtual Healthcare Conference, taking place on Monday, November 29 – Thursday, December 2, 2021 (Press release, Leap Therapeutics, NOV 15, 2021, View Source [SID1234595631]).

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A replay of the pre-recorded fireside chat can be accessed on Monday, November 22, 2021 at 10:00 a.m. eastern time on the Investors page of the company’s website at View Source, where a replay of the event will also be available for a limited time.

On November 15, 2021 Athos Therapeutics, Inc., a late preclinical stage biotechnology company pioneering the development of first-in-class precision therapeutics for patients with autoimmune diseases and cancer, reported the completion of an oversubscribed $15MM Series A financing (Press release, Athos Therapeutics, NOV 15, 2021, View Source [SID1234595647]).

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The funding will be used to advance the company’s pre-clinical and clinical programs, including the initiation of a first in human phase I clinical trial of ATH-63 in 2022. Athos is developing ATH-63 for Inflammatory Bowel Disease, Lupus, other autoimmune disorders, and select cancer indications. Funding will also be used to develop additional novel targets for autoimmune diseases and two first-in-class small molecule inhibitors for solid cancers and AML. Additionally, Athos will further advance its proprietary artificial intelligence drug discovery platform, and substantially expand its patient biomaterial omics database through collaborations with large academic medical centers all over the world, including the Cleveland Clinic Foundation.

Athos Therapeutics completes an oversubscribed $15MM Series A financing

"I am delighted at the progress Athos has made since our Seed round of $4.25MM in March of 2020. Those seed funds enabled us to hire a stellar team, develop a powerful drug discovery engine, perform multi-omics analysis of annotated patient samples from key IBD centers around the world, file 8 patents, and create a medicinal chemistry platform that produced 100’s of highly selective and safe compounds with excellent pharmacologic profiles. The addition of more than $15MM in new funding will allow us to complete a Phase 1 human clinical trial with ATH-63 and progress our autoimmune and novel cancer programs towards the clinic," said Dimitrios Iliopoulos, PhD, MBA, President & Chief Executive Officer of Athos. "Furthermore, we are excited about the development of a new small molecule inhibitor that addresses the unmet needs of a subpopulation of AML patients," he added.

ATH-63 is a small molecule, first-in-class, approach to the massive unmet medical need of IBD. Medications currently prescribed for IBD are associated with limited efficacy, serious side effects, and were not developed for any specific IBD patient subtype. The development of ATH-63 was the result a meticulous systems biology approach where Athos was able to characterize IBD subtypes at the molecular level, using a proprietary biologic and network computational analysis of multi-omics data from highly annotated IBD patient samples.

"The field of IBD is in dire need of more precise, long-lasting, and far safer therapeutic options for millions of patients that suffer from the disease. In response to this need, we developed a highly targeted, precision medicine drug development platform to specifically identify compounds, like ATH-63, that we think will be game-changers for patients," said Allan J. Pantuck, MD, MS, Chairman and Chief Medical Officer of Athos. "Our entire team and Board want to extend our sincere thanks to our original seed funders, the many seed holders who also participated in the Series A, and our new Series A investors. We are honored to have all of you on Team Athos," he added.

On November 15, 2021 Carsgen Therapeutics reported that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to CT041, an autologous CAR T-cell product candidate against the claudin18.2 protein (CLDN18.2) for the treatment of gastric/gastroesophageal junction cancer (GC/GEJ) (Press release, Carsgen Therapeutics, NOV 15, 2021, View Source [SID1234618646]).

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As of this announcement, CT041 is the only CLDN18.2-targeted CAR T-cell product candidate globally that is being studied in clinical trials with IND approvals from both the FDA and the NMPA. Also, CT041 is the first solid tumor CAR T-cell product to be granted PRIME eligibility. CARsgen is currently the only company with two CAR T-cell products active in the PRIME scheme.

"Access to PRIME support and enhanced interaction with EMA is an important milestone in accelerating the development and commercialization of CT041 CAR T cells," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen. "We believe that CT041 has the potential to become a backbone therapy for gastric/gastroesophageal junction cancer and pancreatic cancer in the future. With the mission of ‘making cancer curable,’ we will continue our efforts to develop more innovative technologies and products for cancer patients worldwide."

About CT041

CT041 is an autologous CAR T-cell product candidate against the protein CLDN18.2 that has the potential to be the first in its class globally. CT041 targets the treatment of CLDN18.2-positive solid tumors with a primary focus on GC/GEJ and pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials.

In addition to the investigator-initiated trials in China, CARsgen has initiated a Phase Ib/II clinical trial for advanced GC/GEJ and PC in China and a Phase 1b clinical trial for advanced gastric or pancreatic adenocarcinoma in the United States. CT041 received Orphan Drug designation for the treatment of GC/GEJ from the U.S. FDA in 2020 and Orphan Medicinal Product designation for the treatment of gastric cancer from the EMA in 2021. CARsgen has applied to the NMPA for the required regulatory approval for initiating the pivotal Phase II clinical trial in China. CARsgen also intends to conduct a pivotal Phase 2 clinical trial in North America in 2022.

About PRIME

PRIME is a scheme operated by the EMA to support the development of medicines that target an unmet medical need. Through PRIME, EMA offers early and proactive support to medicine developers to optimize the generation of robust data and enable accelerated assessment of medicine applications.

The PRIME scheme helps patients to benefit as early as possible from treatments that may significantly improve their quality of life. To be accepted for PRIME, a medicine must show its potential to offer a major therapeutic advantage over existing treatments, or to benefit patients without treatment options.

On November 15, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) reported that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation (ODD) for toripalimab for the treatment of esophageal cancer. Orphan drug designation is granted to drugs and biologics intended to treat rare diseases with a patient population less than 200,000 in the U.S (Press release, Coherus Biosciences, NOV 15, 2021, View Source [SID1234595586]). The designation provides incentives to advance development and commercialization of rare disease drugs.

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Esophageal cancer ("EC") is a malignant tumor originating in the inner lining of the esophagus. Esophageal squamous cell carcinoma ("ESCC") and adenocarcinoma are the two main subtypes of esophageal cancer. EC is rare in the United States, with approximately 19,000 newly diagnosed cases and 15,000 deaths annually, according to estimates from the American Cancer Society. The prognosis of patients with advanced EC is poor, with five-year survival rates of less than 20%.

"Esophageal squamous cell carcinoma is an aggressive cancer, and patients need new and better treatment options. We plan to work closely with our partner, Junshi Biosciences, to submit a BLA supplement for toripalimab for this indication in 2022," said Denny Lanfear, CEO of Coherus.

In September, Coherus and Junshi Biosciences announced results of the Phase 3 clinical trial, JUPITER-06, a randomized, double blind, placebo-controlled study evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic ESCC. The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival (PFS) and overall survival (OS) for patients treated with the toripalimab and chemotherapy combination, compared to chemotherapy alone. In 2022, Coherus and Junshi Biosciences are planning to submit a biologics license application ("BLA") supplement to the FDA for toripalimab in combination with platinum-based chemotherapy for the first-line treatment of advanced or metastatic ESCC. A BLA for toripalimab for advanced recurrent or metastatic nasopharyngeal carcinoma is currently under priority review by the FDA with a target action date of April 2022.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma ("NPC") after failure of at least two lines of prior systemic therapy. In April, the NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs, one for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC, and the other for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma, were accepted by the NMPA for review in February and July 2021, respectively.

In the United States, the FDA has granted priority review for the toripalimab BLA for the treatment of recurrent or metastatic NPC, an aggressive head and neck tumor which currently has no FDA-approved immuno-oncology treatment options. Earlier, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for esophageal cancer, NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.

On November 15, 2021 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended September 30, 2021 and provided a corporate update (Press release, Athersys, NOV 15, 2021, View Source [SID1234595602]).

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"The third quarter brought several important milestones in the development and potential commercialization of MultiStem cell therapy," stated Mr. William (B.J.) Lehmann, Jr., Interim Chief Executive Officer of Athersys. "First, our partner Healios announced positive topline data from its ONE-BRIDGE acute respiratory distress syndrome (ARDS) study, giving us further confidence in the potential of our cell therapy for the treatment of ARDS and critical care more generally. Second, enrollment has been completed for the Japan TREASURE study of MultiStem treatment for ischemic stroke patients, starting the countdown to the release of pivotal study data in this area. And third, we realigned our collaboration with Healios to put us in the best position to prepare together for commercialization in Japan.

"Additionally, we demonstrated steady progress in our MASTERS-2 study as well as in the steps necessary to establish commercial manufacturing capability," added Mr. Lehmann. "We look forward to important data readouts ahead of us, our partner’s progress in Japan in the application process for marketing approval, and further development of our commercial capabilities."

Highlights of the third quarter of 2021 and recent events include:

Positive topline results from the ONE-BRIDGE study announced by HEALIOS K.K. (Healios). The ONE-BRIDGE study evaluated the Company’s proprietary cell therapy, MultiStem (HLCM051; invimestrocel), for the treatment of pneumonia-induced and COVID-induced acute respiratory distress syndrome (ARDS) in Japan. Data from the study are consistent with the Company’s MUST-ARDS study results, and analyses of the pooled data of both studies reflect positive benefit trends;
Completion of TREASURE study enrollment announced by Healios. The TREASURE study is evaluating MultiStem for the treatment of ischemic stroke patients in Japan. Based on the advice from the Pharmaceuticals and Medical Devices Agency (PMDA), in order to avoid any potential bias to the 365-day data (and related secondary endpoints) that could result from unblinding and disclosure of 90-day data (primary endpoint) the decision was made that the 90-day unblinding, data analysis and release would take place after the 365-day data is locked. This will follow the last patient’s one-year follow up visit which Healios expects to occur in March of 2022;
Improved our collaboration with Healios and optimized the structure of the relationship to help drive commercial success for MultiStem therapy in Japan;
Steadily progressed our MASTERS-2 study, including the initiation of new sites, including our first sites outside of the U.S.;
Published additional important research findings covering Multipotent Adult Progenitor Cells (MAPC) and Treg biology and MAPC mechanisms of action, with references available on the Company’s website;
Achieved a "Prime" corporate rating from Institutional Shareholder Services Environmental, Social and Governance (ISS ESG) for fulfilling the requirements regarding sustainability performance in the Pharmaceuticals & Biotechnology sector;
Recognized net loss of $16.2 million, or $0.07 net loss per share, for the quarter ended September 30, 2021; and
Ended the third quarter with $49.7 million of cash and cash equivalents.
Third Quarter Results

Revenues increased to $4.8 million for the three months ended September 30, 2021 compared to $0.1 million for the three months ended September 30, 2020. Our collaboration revenues currently fluctuate from period to period based on the delivery of goods and services under our arrangement with Healios.

Research and development expenses decreased to $17.2 million for the three months ended September 30, 2021 from $18.5 million for the comparable period in 2020. The $1.3 million decrease is associated with decreases in clinical trial and manufacturing process development costs of $2.0 million and internal research supplies of $0.6 million. These decreases were partially offset by increases in personnel costs of $0.5 million, facilities costs of $0.4 million and outside service costs of $0.4 million. Our clinical development, clinical manufacturing and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials and manufacturing process development projects.

General and administrative expenses decreased to $3.6 million for the three months ended September 30, 2021 from $3.7 million for the comparable period in 2020.

Net loss for the third quarter of 2021 was $16.2 million compared to a net loss of $22.5 million in the third quarter of 2020. The difference primarily results from the above variances.

During the nine months ended September 30, 2021, net cash used in operating activities was $56.9 million compared to $44.5 million in the nine months ended September 30, 2020. At September 30, 2021, we had $49.7 million in cash and cash equivalents, compared to $51.5 million at December 31, 2020.

Conference Call

We encourage shareholders to listen using the webcast link above. If you would like to dial in using the phone to ask a question, please register for the conference call ahead of time using the call registration link above. Once registered, you will receive the toll-free number, a direct entry passcode and a registrant ID.

A replay of the event will be available on the webcast link at www.athersys.com under the investors’ section approximately two hours after the call has ended. Shareholders may also call in for on-demand listening approximately three hours after the completion of the call until 11:59 PM EST on November 22, 2021, by dialing (800) 585-8367 or (416) 621-4642 and entering the conference code 6652068.