August 2020 – Page 169 – 1stOncology™: Cancer Intelligence Service

10-Q – Quarterly report [Sections 13 or 15(d)]

Merck & Co has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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10-Q – Quarterly report [Sections 13 or 15(d)]

Regeneron has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

INmune Bio, Inc. Announces Second Quarter 2020 Results and Provides Business Update

On August 5, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company developing treatments that harness the patient’s innate immune system to fight disease reported its financial results for the second quarter ended June 30, 2020 and is providing a business update (Press release, INmune Bio, AUG 5, 2020, View Source [SID1234563115]). INmune Bio will hold a conference call today at 4:30 PM Eastern Time. To participate in the call, please dial 415-226-5355 five minutes before the scheduled time.

"In the second quarter, and year to date, INmune Bio continued to progress forward with both of our clinical platforms," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "We announced interim Phase Ib data demonstrating that our Alzheimer’s Disease candidate, XPro1595, can reduce neuroinflammation. Our progress with XPro1595 supports our overall strategy to create platforms of therapeutics, based on reducing inflammation by targeting the innate immune system to fight disease. We are planning a number of programs employing this approach in NASH, MUC4 expressing HER2+ cancer, ALS and complications of cytokine storm caused by COVID-19. With the Natural Killer Priming platform, we anticipate INKmune Phase I in high-risk MDS to start the second half of this year."

Q2 2020 and Recent Corporate Highlights

DN-TNF Platform Highlights:

●Announced interim Phase Ib data demonstrating that XPro1595 decreases neuroinflammation in patients with Alzheimer’s Disease – XPro1595 reduced neuroinflammation by 40.6% in a white matter tract important for learning and memory.
●Announced combination therapy of Lapatinib with INB03 may be used to overcome resistance to trastuzumab in women with MUC4+/HER2+ breast cancer. This work was presented at the AACR (Free AACR Whitepaper) 2020 by Dr. Roxana Schillaci and may form the basis for a Phase II program in patients with MUC4 expressing HER2+ cancer.

●Initiated a clinical program to test targeting soluble TNF (Quellor), one of the key components of the cytokine storm, using our TNF Inhibitor (DN-TNF) Platform to prevent complications of COVID-19 infection.
●Frontiers in Oncology published an invited entitled Tumor Necrosis Factor α Blockade: an Opportunity to Tackle Breast Cancer by Prof. Roxana Schillaci, a leader in the field of TNF in cancer.

NK Priming Platform Highlights:

●Received regulatory clearance from UK MHRA to initiate a Phase I Trial of INKmune in patients with high-risk MDS – study will be the first-in man trial for INKmune – a novel therapy to prime the patient’s own NK cells to attack their cancer.

●Announced allowance of U.S. Patent covering method for treating cancer by in-vivo priming of natural killer cells.
●Received notice of allowance in counterpart patent in Australia covering method for treating cancer by in-vivo priming of natural killer cells.
●Announced publication of a review article: Killers at the crossroads: The use of innate immune cells in adoptive cellular therapy of cancer in the journal Stem Cells Translational Medicine by Prof. Mark Lowdell, Co-Founder and CSO of INmune Bio, Inc. The article reviews the potential of harnessing cells of the innate immune system to treat cancer.

Financial Highlights:

●Closed a $25 million gross proceeds public offering of common stock, including full exercise of Underwriters’ Over-Allotment Option resulting in net proceeds of approximately $23.1 million after deducting underwriting discounts and commissions and other offering expenses payable by the Company.

Upcoming Milestones:

●Report additional data on Phase 1b XPro1595 in Alzheimer’s Disease in 2H 2020.
●Enroll first patient in Phase II Quellor program, targeting COVID-19 patients with immune mediated complications from COVID-19.

●Enroll first patient in Phase I INKmune in High Risk MDS cancer, expected 2H20.
●Enroll first patient in Phase I INKmune in Ovarian cancer, expected mid-2021.

Financial Results for the Second Quarter Ended June 30, 2020:

Net loss attributable to common stockholders for the second quarter ended June 30, 2020 was $2.1 million, compared to $0.4 million for the quarter ended June 30, 2019.

Research and development expense totaled approximately $0.9 million for the second quarter ended June 30, 2020, compared to approximately $0.6 million during the second quarter ended June 30, 2019.

General and administrative expense was approximately $1.2 million for the quarter ended June 30, 2020, compared to approximately $1.3 million during the second quarter ended June 30, 2019.

As of June 30, 2020, the Company had cash and cash equivalents of approximately $4.8 million with no debt. Subsequent to the quarter end, INmune Bio closed a $25 million gross proceeds public offering of common stock resulting in net proceeds of approximately $23.1 million after deducting underwriting discounts and commissions and other offering expenses payable by the Company.

As of August 5, 2020, the Company had approximately 13.4 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call

ARC Therapeutics Launches to Develop Novel CDK Inhibitors for the Treatment of Advanced and Resistant Cancers

On August 5, 2020 ARC Therapeutics, a development-stage pharmaceutical company developing small molecule inhibitors of cyclin-dependent kinases (CDKs) for the treatment of advanced and resistant cancers,reported that launched with a $6 million financing led by founding investor Eshelman Ventures LLC (Press release, ARC Therapeutics, AUG 5, 2020, View Source [SID1234562961]). With this financing, ARC Therapeutics has executed an exclusive license agreement with G1 Therapeutics for its preclinical CDK2 inhibitor program and will utilize remaining proceeds to advance this program into the clinic.

Uncontrolled cellular proliferation is a hallmark of cancer and is commonly driven by dysregulated kinase activity of specific CDK family members. Recent advances in cancer treatment using CDK inhibition have focused on targeting CDK4/6, key mediators of cell cycle progression. While this therapeutic approach has provided significant clinical benefit to patients with ER+/HER2- metastatic breast cancer, many tumors activate other CDK family members to drive uncontrolled proliferation. As a result, primary resistance has limited the broad clinical utility of CDK4/6 inhibitors. Those that do respond inevitably develop acquired resistance, resulting in tumor progression and limiting the drug’s effectiveness.

"The clinical success of CDK4/6 inhibitors demonstrates the practice-changing outcomes that can be achieved by therapeutically targeting specific CDK family members," said Patrick Roberts, Ph.D., Pharm.D., Chief Executive Officer and Co-Founder of ARC Therapeutics. "CDK2 is a known driver of abnormal cancer cell proliferation and is an important therapeutic target of unmet need. Our team is excited to apply its knowledge and expertise in developing potent and selective CDK inhibitors toward the development of a CDK2 inhibitor that has significant promise to advance the current standard of care for people living with cancer."

Scientific Approach

With an initial focus on developing a novel, potent, and selective inhibitor of CDK2 to treat patients whose tumors are insensitive to CDK4/6 inhibition, the founding scientific team at ARC Therapeutic is applying rational design and stringent screening criteria to select a candidate CDK2 inhibitor.

"Historical efforts to target CDK2 have been unsuccessful due to an inability to design or identify potent and selective CDK2 inhibitors," said Jay Strum, Ph.D., Chief Scientific Officer and Co-Founder of ARC Therapeutics. "The rational design approach we used to develop inhibitors selective for CDK4/6 versus CDK2 at G1 Therapeutics led to a keen understanding of key structural features within the CDK2 binding pocket that can be exploited to develop a potent and selective CDK2 inhibitor. At ARC Therapeutics, we now have an incredible opportunity to effectively treat patients with advanced and resistant cancers."

ARC Therapeutics entered into an exclusive license for the IP covering G1 Therapeutics’ preclinical CDK2 inhibitor program. Under the terms of the agreement, G1 Therapeutics received an upfront payment and equity in ARC Therapeutics.

Founding Team

ARC Therapeutics was founded by a group of experts with robust drug design, discovery, and development experience. As senior members of the scientific team that successfully identified and advanced three oncology compounds into the clinic at G1 Therapeutics, including a first-in-class myelopreservation therapy, a potential best-in-class differentiated oral CDK4/6 inhibitor and an oral selective estrogen receptor degrader (SERD), the team will apply its unique, multidisciplinary expertise and knowledge to pursue novel cancer treatments and drive programs in an expeditious manner.

"This team has an ideal combination of complementary experience and expertise to select the best compounds and bring them to the clinic," said Fred Eshelman, Pharm.D., co-founder and chairman of ARC Therapeutics and founder of Eshelman Ventures LLC. "I am confident in this team’s ability to successfully discover and develop inhibitors of CDK proteins and realize the company’s mission of improving the lives of patients with advanced and resistant cancers."

The China Center for Drug Evaluation, National Medical Products Administration Has Recommended Breakthrough Therapy Designation for ciltacabtagene autoleucel (cilta-cel, LCAR-B38M CAR-T Cells), an Investigational BCMA CAR-T Cell Therapy

On August 5, 2020 Legend Biotech Corporation (NASDAQ:LEGN) reported that the China Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) has recommended Breakthrough Therapy Designation (BTD) for ciltacabtagene autoleucel (cilta-cel; LCAR-B38M CAR-T cells), an investigational B-cell maturation antigen (BCMA) targeted chimeric antigen receptor (CAR) T-cell therapy being studied for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) (Press release, Legend Biotech, AUG 5, 2020, View Source [SID1234562960]).

The BTD for cilta-cel (LCAR-B38M CAR-T cells) is based on the ongoing Phase 2 CARTIFAN-1 study being conducted in China (MMY2002, NCT03758417, CTR20181007), the ongoing Phase 1b/2 CARTITUDE-1 study of cilta-cel (JNJ-4528) being conducted in the US (MMY2001, NCT03548207) and Japan and the Phase 1, first-in-human LEGEND-2 study conducted in China (NCT03090659). Ciltacabtagene autoleucel (cilta-cel) refers to both LCAR-B38M CAR-T cells and JNJ-4528. LCAR-B38M CAR-T cell identifies the investigational product being studied in China and JNJ-4528 identifies the investigational product being studied outside of China, both of which are representative of the same CAR-T cell therapy.

The BTD procedure is part of the recently revised Drug Registration Regulation which went into effect on July 1, 2020. The BTD process is designed to expedite the development and review of therapies that are intended for treatment of serious diseases for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over available treatment options.1 Cilta-cel is the first product that has been recommended for BTD in China.2 As per the working procedure for BTD (2020 No.82) issued by NMPA on July 8, 2020, CDE had completed the review and recommended to grant the BTD on August 4th, and BTD will be granted after 5 working days of publicity period (August 5 to 12) on the CDE website.

In December 2017, Legend Biotech entered into a worldwide collaboration and license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to jointly develop and commercialize cilta-cel in patients with multiple myeloma. Cilta-cel is a structurally differentiated CAR-T cell therapy containing a 4-1BB co-stimulatory domain and two BCMA-targeting single domain antibodies designed to confer avidity.

"Breakthrough designation recommendation by the China CDE of NMPA represents an important regulatory milestone in the continued development of cilta-cel in multiple myeloma patients in China," said Frank Zhang, PhD, CEO of Legend Biotech. "Legend, in collaboration with Janssen, will continue to advance this investigational therapy in China and globally."

Previously, the following regulatory designations have been granted to Janssen for cilta-cel:

In July 2020, the Korea Ministry of Food and Drug Safety granted orphan drug designation.3
In June 2020, the Japan Ministry of Health, Labor and Welfare granted orphan drug designation.4
In February 2020, the European Commission granted orphan designation.5
In December 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation.6
In April 2019, the European Medicines Agency granted Janssen a PRIME (PRIority MEdicines) designation.7
In February 2019, the FDA granted Janssen orphan drug designation for the treatment of multiple myeloma.8
About the Clinical Development Program

CARTIFAN-1
The Phase 2 CARTIFAN-1 confirmatory trial (MMY2002, NCT03758417, CTR20181007) is being conducted in China to further evaluate cilta-cel (LCAR-B38M CAR-T cells) in patients with RRMM who have received at least 3 prior lines of therapy and have received a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD); and documented disease progression within 12 months of starting the most recent therapy. 9

CARTITUDE-1
Cilta-cel (JNJ-4528) is currently being investigated in the Phase 1b/2 CARTITUDE-1 (MMY2001, NCT03548207) pivotal study conducted in US and Japan for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a PI and IMiD; received a PI, an IMiD and anti-CD38 antibody; and documented disease progression within 12 months of starting the most recent therapy. 10

CARTITUDE-2
The global, multi-cohort Phase 2 CARTITUDE-2 (MMY2003, NCT04133636) study, cilta-cel (JNJ-4528) is actively recruiting patients with multiple myeloma in various clinical settings. This study is being conducted to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-4528 to further explore efficacy and safety in earlier patient populations.11

CARTITUDE-4
The global, Phase 3 CARTITUDE-4 (MMY3002, NCT04181827) study, cilta-cel (JNJ-4528) is actively recruiting patients with multiple myeloma who have received 1-3 prior lines of therapy including a PI and IMiD and are refractory to lenalidomide. The study is being conducted to evaluate the efficacy of JNJ-4528 compared to standard therapies7 including daratumumab, pomalidomide and low-dose dexamethasone (DPd) or pomalidomide, bortezomib and low-dose dexamethasone (PVd).12

LEGEND-2
LEGEND-2 (NCT03090659) is an ongoing, Phase 1, single-arm, open-label, first-in-human, study of 74 patients being conducted at four participating hospitals in China evaluating the efficacy and safety of LCAR-B38M CAR-T cells for the treatment of patients with relapsed or refractory multiple myeloma.13

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.14

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.15 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.16,17 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.18 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.19 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.20

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Month: August 2020

10-Q – Quarterly report [Sections 13 or 15(d)]

10-Q – Quarterly report [Sections 13 or 15(d)]

INmune Bio, Inc. Announces Second Quarter 2020 Results and Provides Business Update

ARC Therapeutics Launches to Develop Novel CDK Inhibitors for the Treatment of Advanced and Resistant Cancers

The China Center for Drug Evaluation, National Medical Products Administration Has Recommended Breakthrough Therapy Designation for ciltacabtagene autoleucel (cilta-cel, LCAR-B38M CAR-T Cells), an Investigational BCMA CAR-T Cell Therapy