On November 15, 2021 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or (TIL), therapies for the treatment of patients with cancer, reported its third quarter 2021 financial results and provided a corporate update (Press release, Instil Bio, NOV 15, 2021, View Source [SID1234595617]).

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"We have achieved key milestones in our continued development of ITIL-168 with clearance of our IND for the DELTA-1 study, Fast Track Designation approval and initiation of enrollment in DELTA-1," said Bronson Crouch, Chief Executive Officer of Instil. "Our progress in establishing a platform for cell therapy continues with the expansion of our UK clinical manufacturing capabilities which are on track to reach an annual capacity of over 200 lots by year end 2021 as well as with US clinical manufacturing coming online next year. With this added capacity, we expect to initiate additional trials in the months ahead as we progress both ITIL-168 and ITIL-306, our first genetically-engineered CoStAR-TIL."

Third Quarter 2021 Highlights and Recent Corporate Updates:

Clinical Development:

Received IND Clearance from the FDA to Initiate DELTA-1, a Phase 2 Clinical Trial for Patients with Advanced Melanoma: On September 13, 2021, Instil reported clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to initiate DELTA-1, a global Phase 2 clinical trial of ITIL-168 with registrational intent in patients with advanced melanoma. The DELTA-1 trial was expanded during the IND review process in consultation with FDA to include additional populations of patients with advanced melanoma, including patients who discontinued PD-1 inhibitor therapy due to intolerable toxicity and patients who had an unsatisfactory response to prior PD-1 inhibitor.

Initiated enrollment in DELTA-1: Instil reported that patients have been enrolled and recruitment is ongoing into the pivotal study. Enrollment for Cohort 1 is expected to be completed within 12 months, with Cohorts 2 and 3 finishing enrollment thereafter. Instil expects top-line data and BLA filing submission in 2023 and a European Medicines Agency (EMA) marketing authorization application (MAA) filing in 2024.

ITIL-168 in Advanced Melanoma Granted FDA Fast Track Designation: Instil was recently granted Fast Track Designation from the U.S. FDA for ITIL-168 in advanced melanoma. Fast Track designation confers certain benefits on the development process, including more frequent communications with the FDA and potential eligibility for accelerated approval and priority review.

Readiness to Initiate DELTA-2 in H1 2022: Preparations are on track to initiate enrollment in DELTA-2, a Phase 1 study of ITIL-168 in non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), cervical cancer, and cutaneous squamous cell carcinoma (CSCC). Enrollment in DELTA-2 is planned to initiate in H1 2022.

Presented Clinical Data in Advanced Cutaneous Melanoma at ESMO (Free ESMO Whitepaper): Instil presented a subset analysis of treatment outcomes with TILs in 12 patients with checkpoint inhibitor-refractory advanced cutaneous melanoma, demonstrating a 58% objective response rates and median overall survival of 21.3 months; all patients in the subset analysis had experienced disease progression following treatment with a PD-1 inhibitor and CTLA-4 inhibition with ipilimumab.
Manufacturing and Technical Operations:

Clinical Manufacturing Readiness: U.K. manufacturing capacity remains on track for regulatory approval of the additional IMPACT manufacturing suite in Q4 2021, which will approximately triple the current U.K. manufacturing capacity. U.S. clinical manufacturing in Tarzana, CA remains on track for launch of clinical manufacturing in H1 2022, with qualification ongoing.
Research:

Appointed Mark Dudley, Ph.D. as Head of Research: Instil has appointed Mark Dudley, Ph.D. as Head of Research. Prior to Instil, Dr. Dudley led early development of T cell therapies at Adaptimmune Therapeutics plc, and before that was on the technical R&D leadership team at Novartis. Before Novartis, Dr. Dudley spent nearly two decades at the Surgery Branch of the National Cancer Institute, where he contributed to a diverse portfolio of experimental T cell therapies, including TIL, TCR-T, and CAR-T products. Dr. Dudley is a recognized pioneer in adoptive cell therapy, having published seminal studies in TIL therapy for refractory melanoma patients, and the first studies of CD19 CAR-T in humans, IL-2 and IL-12 genetically engineered T cells in clinical trials, and TCR-T cells in clinical trials.

Successful Pre-IND Meeting with FDA on First-in-Human Study of ITIL-306: Instil Bio recently completed a pre-IND meeting with the FDA for the proposed first-in-human Phase 1 study of ITIL-306, a TIL product genetically engineered to express a Costimulatory Antigen Receptor (CoStAR) molecule, to gain alignment on nonclinical, manufacturing, and clinical aspects of the program. The company expects initiate a Phase 1 study of ITIL-306 in multiple cancer indications in H1 2022.

Presented Pre-clinical Data on the CoStAR Platform at SITC (Free SITC Whitepaper): Instil presented posters highlighting pre-clinical data from the CoStAR platform which demonstrated that CoStAR expression by T cells led to marked enhancement of effector function and proliferation of T cells and TILs. The novel design of CoStAR, which includes two intracellular costimulatory domains derived from CD28 and CD40, showed significantly improved activity compared to a CoStAR that contained only a CD28 domain, demonstrating the superiority of CD40-containing CoStAR molecules and important synergies of CD40 and CD28 signaling. Further details can be found in the poster publications available here.
Third Quarter 2021 Financial and Operating Results:

As of September 30, 2021, we had $20.4 million in cash and cash equivalents and $495.0 million in marketable securities, compared to $241.7 million in cash and cash equivalents and no investments in marketable securities as of December 31, 2020. The Company expects that its cash, cash equivalents and marketable securities as of September 30, 2021 will enable it to fund its operating plan into 2023.

Research and development expenses were $29.1 million and $64.7 million for the three and nine months ended September 30, 2021, compared to $4.9 million and $9.2 million for the three and nine months ended September 30, 2020.

General and administrative expenses were $14.0 million and $37.1 million for the three and nine months ended September 30, 2021, compared to $2.9 million and $7.2 million for the three and nine months ended September 30, 2020.

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 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to participate in a fireside chat at the Piper Sandler 33rd Annual Virtual Healthcare Conference taking place November 30, 2021 to December 2, 2021 (Press release, Cytokinetics, NOV 15, 2021, View Source [SID1234595707]).

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The pre-recorded fireside chat will be available for on-demand viewing beginning November 22, 2021 at 10:00 AM ET. Interested parties may access it by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. A replay of the fireside chat will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days.

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.