On November 1, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage biotech company with a differentiated, small-molecule approach to treating inflammatory conditions and diseases by selectively targeting the resident microbiome to restore gut-immune homeostasis, reported financial results for the third quarter ended September 30, 2021 (Press release, Kaleido Biosciences, NOV 1, 2021, View Source [SID1234594021]).

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"This has been a productive quarter for Kaleido, highlighted by the reporting of positive data from our first-in-human study in mild-to-moderate ulcerative colitis paving a clear path forward to advance KB295 into a Phase 2 clinical trial under an IND next year," said Dan Menichella, President and Chief Executive Officer of Kaleido. "Additionally, we are continuing to work closely with our partners at the COPD Foundation and remain on track to initiate a Phase 2 trial of KB109 in COPD in the first half of 2022. We are excited to initiate clinical trials in these two indications next year and look forward to demonstrating the immunomodulatory effect of our unique, microbiome metabolic therapies."

Recent Program and Corporate Highlights

In October, Kaleido announced the primary objective of safety and tolerability in the non IND/CTA K030 study evaluating KB295 in mild-to-moderate ulcerative colitis (UC) was achieved. Findings from the study revealed KB295 was well tolerated across subjects, including those taking 5-ASA medications and/or biologics, and no product-emergent serious adverse events were reported. In addition, subjects receiving KB295 experienced a reduction in three biomarkers known to be associated with UC disease activity, fecal calprotectin (FCP), fecal lactoferrin, and FimH. These results, together with pre-clinical data from ex vivo studies, support the Company’s plans to initiate a phase 2 trial, under an Investigational New Drug (IND) application and Clinical Trial Application (CTA), of KB295 in mild-to-moderate UC in the first half of 2022.
The Company remains on track to initiate a Phase 2 clinical trial of KB109 in patients with chronic obstructive pulmonary disease (COPD) in the first half of 2022, in collaboration with the COPD Foundation.
Third Quarter Financial Results

Kaleido reported a net loss of $23.1 million, or $0.54 per common share, for the third quarter of 2021 compared to $23.1 million, or $0.65 per common share, for the same period in 2020. The third quarter net loss includes non-cash stock-based compensation expenses of $2.0 million, as compared to $4.4 million for the same period in 2020.

Research and development (R&D) expenses were $17.4 million and $15.7 million for the three months ended September 30, 2021 and 2020, respectively. The increase was primarily due to an increase in production of material for use in our clinical studies.

General and administrative (G&A) expenses were $5.1 million and $7.2 million for the three months ended September 30, 2021 and 2020, respectively. The decrease was primarily due to the modification of the vesting provision of stock options and restricted stock units related to the resignation of our former CEO in July 2020.

As of September 30, 2021, the Company reported cash and cash equivalents of $55.7 million and has cash runway into the second quarter of 2022.

About Microbiome Metabolic Therapies (MMT)

Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates into clinical studies in healthy subjects and patients. These human clinical studies may be conducted under regulations supporting research with food, evaluating safety and tolerability and impact on the microbiome. For MMT candidates that are developed as therapeutics, the Company currently conducts and will conduct clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., often in Phase 2 or later development.

On November 1, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that a conference call will be held on Thursday, November 4, 2021 at 8:30 AM ET to discuss results for the third quarter 2021 and provide a business outlook for the remainder of the year. Michael S. Weiss, Chairman and Chief Executive Officer, will host the call (Press release, TG Therapeutics, NOV 1, 2021, https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-host-conference-call-third-quarter-2021 [SID1234594020]).

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In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

On November 1, 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 accepted for review the Biologics License Application ("BLA") for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma ("NPC") and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy (Press release, Coherus Biosciences, NOV 1, 2021, View Source [SID1234594019]). The FDA has granted Priority Review Designation for the toripalimab BLA and set a Prescription Drug User Fee Act ("PDUFA") action date for April 2022. The FDA is not currently planning to hold an advisory committee meeting to discuss the application.

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"Nasopharyngeal carcinoma is an aggressive tumor that currently has no FDA-approved immuno-oncology treatment options, and we believe that toripalimab in combination with chemotherapy, if approved, will establish a new standard of care for first line treatment of advanced NPC," said Denny Lanfear, CEO of Coherus. "Toripalimab is the PD-1 cornerstone of our immuno-oncology strategy, and we are pleased that the FDA has accepted the BLA for review. Including the toripalimab application, Coherus now has three product candidate BLAs under review by the FDA, and our team is making rapid progress toward our goal to diversify and expand our commercial product portfolio."

"We are excited by the continued progress of toripalimab toward a first marketing authorization outside of China," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "With the earlier approval in China, toripalimab became the world’s first immune checkpoint inhibitor for the treatment of nasopharyngeal carcinoma, bringing a novel therapy to a disease that has long lacked new drug development. We will cooperate closely with our partner, Coherus, to leverage the FDA’s Priority Review designation to accelerate the completion of the BLA review and believe toripalimab, if approved, will bring an important new treatment option for NPC patients in the United States."

The toripalimab BLA is supported by the results from clinical studies "POLARIS-02" and "JUPITER-02". The POLARIS-02 study is a multi-center, open-label, pivotal Phase II clinical study, the results of which were published online in January 2021 in the Journal of Clinical Oncology. The JUPITER-02 study is a randomized, double blind, placebo-controlled, international multi-center Phase 3 clinical trial, the results of which were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in a Plenary Session presentation (#LBA2) and were published as the cover article of the September 2021 issue of Nature Medicine.

In August 2021, the FDA granted Breakthrough Therapy Designation ("BTD") for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the 1st line treatment of recurrent, locally advanced or primary metastatic non-keratinizing nasopharyngeal carcinoma ("NPC") and in September 2020 granted BTD for toripalimab monotherapy for patients with recurrent or metastatic non-keratinizing NPC with disease progression on or after platinum-containing chemotherapy. The toripalimab BLA has been granted priority review with a six-month target action date, as compared to a 10-month standard review timeline. Priority review designation directs FDA resources to the evaluation of applications for drugs that, if approved, would represent significant improvements in the treatment of serious conditions.

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 for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC and 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. Earlier, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and also for toripalimab monotherapy in the second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for 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.

About Nasopharyngeal Carcinoma
Nasopharyngeal carcinoma ("NPC") is a type of aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. NPC is rare in the United States with annual incidence of fewer than 1 per 100,000. The five-year survival rate for all patients diagnosed with NPC is approximately 60%; however, those who are diagnosed with advanced disease have a five-year survival rate of approximately 25%. Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. Patients with advanced or recurrent disease are treated with combination chemotherapy. There are currently no FDA-approved immuno-oncology agents for NPC.

On November 1, 2021 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported that it will report third quarter 2021 financial results on Monday, November 8, 2021 (Press release, AVEO, NOV 1, 2021, View Source [SID1234594017]). AVEO’s management team will host a conference call and audio webcast at 4:30 p.m. ET on Monday, November 8, 2021, to discuss the financial results and provide a business update.

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The call can be accessed by dialing (844) 882-7841 (U.S. and Canada) or (574) 990-9828 (international). The passcode for the conference call is 1647457. To access the live webcast, or the subsequent archived recording, please visit the Calendar of Events sub-section within the Investors section of the AVEO website at www.aveooncology.com.

On November 1, 2021 Incyte (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for parsaclisib, an investigational novel potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) (Press release, Incyte, NOV 1, 2021, View Source [SID1234594016]).

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The submission is based on data from several Phase 2 studies (CITADEL-203, -204 and -205) evaluating parsaclisib as a treatment for relapsed or refractory non-Hodgkin lymphomas (NHLs) (FL, MZL and MCL). Parsaclisib was generally well-tolerated in all studies with a manageable safety profile.

"Non-Hodgkin lymphomas are some of the most common cancers in the United States, and the FDA’s acceptance of this NDA represents an important milestone for Incyte and for NHL patients who have not responded to or who have progressed on initial therapies," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "We look forward to working with the FDA to bring this innovative therapy to patients who may benefit."

Parsaclisib has been granted Priority Review by the FDA for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with MCL who have received at least one prior therapy. The FDA grants Priority Review to medicines that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. This designation shortens the review period by four months as compared to Standard Review so the Prescription Drug User Fee Act (PDUFA) target action date for these indications is April 30, 2022. The NDA for use of parsaclisib in adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies will have a Standard Review and a PDUFA target action date of August 30, 2022.

Confirmatory phase 3 studies are in preparation for parsaclisib in patients with MCL (CITADEL-310) and relapsed or refractory FL and MZL (CITADEL-302).

About Follicular, Marginal Zone and Mantle Cell Lymphomas

Non-Hodgkin lymphoma (NHL) is a type of cancer that starts in the lymphocytes, a type of white blood cell. Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) are forms of B-Cell NHLs. FL and MZL are indolent or slow growing lymphomas; MCL is an aggressive or rapidly developing form. There is an unmet medical need for treatment options for patients who are relapsed or refractory to initial therapies.

About CITADEL

The CITADEL (Clinical Investigation of TArgeted PI3K-DELta Inhibition in Lymphomas) clinical trial program is evaluating parsaclisib in several ongoing studies as a treatment for adult patients with lymphomas, including:

CITADEL-203 (NCT03126019) is evaluating patients with relapsed or refractory follicular lymphoma (FL) Grade 1, 2 or 3a who received at least two prior systemic therapies, had an Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2, and were ineligible for hematopoietic stem cell transplantation (HSCT).
CITADEL-204 (NCT03144674) is evaluating patients with relapsed or refractory marginal zone lymphoma (MZL) who received at least one prior systemic therapy and were Bruton’s tyrosine kinase (BTK) inhibitor treatment naive. Patients with prior ibrutinib treatment were initially allowed to enroll; however, the cohort was terminated due to slow enrollment. Eligible patients had radiologically measurable lymphadenopathy or extranodal lymphoid malignancy (or histologically confirmed bone marrow infiltration in cases of splenic MZL), and an ECOG PS ≤2.
CITADEL-205 (NCT03235544) is evaluating patients with relapsed or refractory mantle cell lymphoma (MCL), who received one to three prior systemic therapies and were either naive to or were previously treated with a BTK inhibitor. Eligible patients had an ECOG PS ≤2, and radiologically measurable lymphadenopathy or extranodal lymphoid malignancy.
Patients eligible for each trial were allocated to receive parsaclisib 20 mg once daily for eight weeks followed by either 20 mg once weekly (weekly-dosing group [WG]) or 2.5 mg once daily (daily-dosing group [DG]). Subsequently, daily dosing was selected as the preferred regimen and the WG patients were allowed to switch to DG. Prophylaxis for Pneumocystis jirovecii pneumonia (PJP) was required.

About Parsaclisib

Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). It is currently under evaluation as a monotherapy in several ongoing Phase 2 trials as a treatment for non-Hodgkin lymphomas (follicular, marginal zone and mantle cell); and autoimmune hemolytic anemia. Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are underway; and there are plans to initiate trials to evaluate parsaclisib in combination with tafasitamab, including a pivotal trial in B-cell malignancies.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib. Under the terms of the agreement, Innovent has received the rights to develop and commercialize parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.