On April 23, 2020 Tocagen Inc. (Nasdaq: TOCA), historically a clinical-stage, cancer-selective gene therapy company, reported financial results for the first quarter ended March 31, 2020 (Press release, Tocagen, APR 23, 2020, View Source [SID1234556540]).

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On February 19, 2020, Tocagen announced it had entered into a definitive agreement in which a wholly-owned subsidiary of Tocagen will merge, in an all-stock transaction, with Forte Biosciences Inc., a privately held clinical-stage biopharmaceutical company developing a live biotherapeutic for the treatment of inflammatory skin diseases. Upon stockholder approval, the combined company is expected to operate under the name Forte Biosciences Inc. and trade on the Nasdaq Capital Market under the ticker symbol FBRX. The transaction has been unanimously approved by the Board of Directors of both companies and is expected to close in the second quarter of 2020, subject to customary conditions, including approval by Tocagen and Forte stockholders.

First Quarter 2020 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $3.1 million for the quarter ended March 31, 2020, compared to $12.4 million for the quarter ended March 31, 2019. The decrease of $9.3 million was primarily due to decreases in clinical trial related costs due to wind down activities and a reduction in our workforce.

General and Administrative (G&A) Expenses: G&A expenses were $5.6 million for the quarter ended March 31, 2020, compared to $4.4 million for the quarter ended March 31, 2019. The increase of $1.1 million was primarily due to increased personnel costs, including non-cash stock-based compensation and severance costs in connection with wind down activities and a reduction in our workforce.

Net Loss: Net loss was $10.3 million, or $0.43 per common share (basic and diluted), for the quarter ended March 31, 2020, compared to a net loss of $17.1 million, or $0.74 per common share (basic and diluted), for the quarter ended March 31, 2019. The calculation is based on 23.9 million average common shares outstanding for the first quarter of 2020, compared to 23.0 million average common shares outstanding for the first quarter of 2019.

Cash Position

Cash, cash equivalents and marketable securities were $14.2 million at March 31, 2020 compared to $21.8 million at December 31, 2019.

On April 23, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for Tyvyt (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (nsqNSCLC) (Press release, Innovent Biologics, APR 23, 2020, View Source [SID1234556556]). Tyvyt was officially approved by the NMPA in December 2018 for the treatment of relapsed or refractory classical Hodgkin’s lymphoma after at least two lines of systemic chemotherapy, and has been the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List (NRDL) since November 2019.

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The NDA was based on the pre-specified interim analysis of a randomized, double-blind, Phase 3 clinical trial (ORIENT-11)—Tyvyt (sintilimab injection) or placebo in combination with ALIMTA and platinum as first-line therapy for advanced or recurrent nsqNSCLC without sensitizing EGFR mutation or ALK rearrangement. Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), Tyvyt in combination with ALIMTA and platinum demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo in combination with ALIMTA and platinum, which met the pre-defined efficacy criteria. After a median follow up of 8.9 months, the median PFS of the experimental group and the control group assessed by Independent Radiographic Review Committee was 8.9 months and 5.0 months respectively, HR (95%CI) = 0.482 (0.362,0.643), P < 0.00001. The safety profile is consistent with previously reported sintilimab studies, and no new safety signals were identified. Detailed data will be released in an upcoming international academic conference and journal.

Professor Li ZHANG, Head of Department of Internal Medicine, Sun Yat-sen University Cancer Center, the primary investigator of ORIENT-11 study, stated: "Nearly half of Chinese nsqNSCLC patients lack sensitizing EGFR mutation or ALK rearrangement, which makes them do not respond to targeted therapy. ORIENT-11 study has demonstrated a significant delay of disease progression brought by sintilimab in combination with chemotherapy in this patient population."

Dr. Hui ZHOU, Vice President of Medical Science and Strategy Oncology of Innovent, stated: "The morbidity and mortality of lung cancer both rank first among all types of cancers in China. Despite treatment advances, there remains significant unmet needs for additional effective treatment options for lung cancer patients. The acceptance of NDA by the NMPA represents an important progress in demonstrating the potential value of Tyvyt in lung cancer. We will actively cooperate with the regulatory authority to bring the high quality therapy to more patients with advanced non-squamous NSCLC as soon as possible."

"The intention of Lilly’s strategic cooperation with Innovent is to bring new anti-tumor treatments, developed with global standards, to patients in China. As the success of this partnership, Tyvyt is the only anti-PD-1 monoclonal antibody included in the NRDL for relapsed or refractory classical Hodgkin’s lymphoma," said Dr. Li WANG, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. "With the encouraging result of ORIENT-11, Tyvyt may soon expand its indication to lung cancer. In the future, we will strengthen cooperation with Innovent to further explore Tyvyt’s potential in the field of immuno-oncology therapy and how Tyvyt may bring benefits to more patients."

About ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial to evaluate the efficacy and safety of Tyvyt (sintilimab injection) or placebo in combination with ALIMTA (pemetrexed) and platinum as first-line therapy for advanced or recurrent nsqNSCLC without sensitizing EGFR mutation or ALK rearrangement (ClinicalTrials.gov, NCT03607539). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee based on RECIST v1.1. The key secondary endpoints include overall survival (OS) and safety profile.

A total of 397 subjects have been enrolled in ORIENT-11 trial and randomized in a 2:1 ratio to receive either sintilimab 200mg or placebo in combination with ALIMTA (pemetrexed) and platinum every 3 weeks for up to 4 cycles, followed by either sintilimab or placebo plus ALIMTA maintenance therapy. The subjects will receive treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.

About nsqNSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 percent to 85 percent of lung cancer. Approximately 70 percent of NSCLC are locally advanced or metastatic at initial diagnosis, rendering the patients with no chance of radical resection. Meanwhile, even after radical surgery patients still have a high chance of recurrence and eventually die from disease progression. About 70 percent of NSCLC in China are non-squamous subtype and 50 percent of nsqNSCLC are without sensitizing EGFR mutation or ALK rearrangement. These patients do not respond well to targeted therapy and there are limited treatment options available to them.

About Tyvyt (Sintilimab Injection)

Tyvyt (sintilimab injection), an innovative drug developed with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after at least two lines of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. Tyvyt is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019.

Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.

On April 23, 2020 Dana-Farber Cancer Institute reported that its first clinical trial in patients with a hard-to-treat form of uterine cancer, a targeted drug that subjects tumor cells to staggering levels of DNA damage caused tumors to shrink in nearly one-third of patients.

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The preliminary results, to be presented online at Thursday’s virtual session of the Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, demonstrated strong activity of WEE1-directed therapy in uterine serous carcinoma (USC), which accounts for about 10% of uterine cancers but up to 40% of deaths from the disease, trial leaders say.

The drug tested in the study – adavosertib – takes advantage of an inherent weakness in the relentless growth of some cancer cells. Their non-stop proliferation creates a condition known as replication stress, where their ability to duplicate their DNA effectively is significantly impaired. The cell cycle – the carefully choreographed process by which cells grow, copy their DNA, and divide into two daughter cells – includes several checkpoints that halt the cycle so DNA can be inspected and repaired, if necessary. In some cancers, a checkpoint fails to function due to a genetic mutation or other problem, allowing the cycle to proceed even as DNA damage accumulates.

USC is one such cancer. More than 90% of cases are marked by a mutation or other abnormality in the TP53 gene, which plays a critical role in the checkpoint between the first phase of cell growth and the DNA-duplication phase. Without a working TP53 gene, cells can barrel into the DNA-duplication phase with extensive DNA damage on board.

The absence of functional TP53 places enormous strain on a checkpoint further on in the cell cycle called G2/M. Providing a final quality check, G2/M, guards the entry to mitosis, the act of dividing into two daughter cells. Hobbling G2/M by blocking one of the proteins involved in it could burden tumor cells with so much DNA damage that they cannot survive.

That is the strategy behind adavosertib, which targets a protein called WEE1 that helps regulate the G2/M checkpoint. The new trial marked the first time the drug, which has been tested in patients with other cancers, including breast and ovarian cancer, was tested in patients with USC.

The trial involved 35 patients, all of whom had previously been treated with platinum-based chemotherapy. They took adavosertib orally on a set schedule. At a median follow-up of 3.8 months, 10 of 34 patients who could be evaluated, had shrinkage of their tumors – a response rate of almost 30%. In some cases, the responses were exceptionally durable, with some patients still responding more than a year after undergoing treatment, study leaders say.

The most common adverse side effects of the treatment were anemia, diarrhea, nausea, and fatigue.

"Adavosertib demonstrated remarkable activity as a single agent in this group of patients," says the study’s lead author, Joyce Liu, MD, MPH, of Dana-Farber. "It’s especially encouraging in a disease such as USC, for which current treatments are of limited effectiveness."

On April 22, 2020 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales for the first quarter of 2020 (Press release, Ipsen, APR 22, 2020, View Source [SID1234556488]).

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Aymeric Le Chatelier, Chief Executive Officer and Chief Financial Officer of Ipsen stated: "Thanks to the resilient Specialty Care product portfolio, the Group delivered solid sales growth in the first quarter with limited impact from COVID-19. Our priorities in these unprecedented times are to ensure the safety of our employees as well as driving business continuity so patients can maintain access to important medicines. Our 2020 guidance remains suspended until we have more visibility.

"During the first quarter, we received authorization to re-initiate dosing of palovarotene in patients with FOP and are now focused on working with the FDA and other agencies on defining a regulatory path forward with the objective of bringing palovarotene to FOP patients as quickly as possible.

"Thanks to the continued commitment and dedication of our people around the world, we are mobilized to face the COVID-19 pandemic. Together, we will continue to advance and strengthen our pipeline and drive growth and sustainability to fulfill our mission of improving patients’ lives."

First quarter sales

Continuing its growth trajectory, Ipsen achieved solid Group sales growth of 9.6% as reported, or 8.7%1 at constant exchange rates in the first quarter of 2020.

Specialty Care sales growth of 12.5%1, reflecting continued strong double-digit growth of Somatuline (lanreotide) and the continued growth of Cabometyx (cabozantinib) and Decapeptyl (triptorelin).
Consumer Healthcare sales down by 21.9%, mainly related to China with the negative impact of the implementation of hospital central procurement and COVID-19.

COVID-19 update

In the first quarter of 2020, the business remained strong with COVID-19 having a limited impact on sales due to increased stocking in the Oncology portfolio in some European countries toward the end of first quarter. This offsets a lower demand in China in February and March which had a significant impact on the Consumer Healthcare portfolio.

Ipsen continues to operate all of its manufacturing sites and is closely monitoring the situation. There is an adequate level of inventory with no supply chain issues anticipated to continue providing medicines to patients. There is also limited impact to date on clinical trials, with minimal disruption to investigational drug supply for ongoing patients, despite a general slowdown in the recruitment of new patients as well as new site activations in ongoing trials across Europe and the U.S.

Ipsen remains focused on ensuring that patients continue to have access to their treatments and on addressing the impact of this pandemic in their communities. Most Ipsen employees around the world, excluding mainly those at the manufacturing and distribution sites, are working from home today, and the commercial organization continues to support healthcare providers virtually.

In the second quarter of 2020, the situation in China should improve as business begins to resume. However, despite Ipsen’s sustainable and resilient Oncology portfolio comprised mostly of highly-differentiated long-acting treatments for critical conditions, there is expected to be some impact from delayed diagnoses and lower new patient gains. It is also anticipated that there will be more of a negative impact on Dysport sales and revenues in both the therapeutics and aesthetics markets with delayed injections.

2020 Guidance

As announced in March 25th, the 2020 guidance remains suspended due to the lack of visibility on all the consequences of the global COVID-19 pandemic despite a resilient Oncology portfolio. It is not possible at this stage to quantify the impact on the Group’s financial statements. Further updates will be provided as the situation evolves.

Palovarotene update

In the last few months, Ipsen made significant progress on advancing palovarotene, a top priority for the company. On 26 March 2020, clearance was received from the U.S. Food and Drug Administration (FDA) and other regulatory authorities to re-initiate palovarotene dosing in patients 14 years of age and older in the fibrodysplasia ossificans progressiva (FOP) clinical program. It was also decided to terminate the Phase 2 MO-Ped trial in patients with multiple osteochondromas (MO) in order to analyze the accumulated data and to better inform on the efficacy, safety and future of palovarotene in MO. A Complete Response was recently submitted to address the FDA’s questions related to the partial clinical hold on patients under 14 years of age in palovarotene trials.

Positive topline results from pivotal Phase 3 CheckMate -9ER trial

CheckMate -9ER, a pivotal Phase 3 trial evaluating Cabometyx in combination with Opdivo (nivolumab) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC), met its primary endpoint of progression-free survival (PFS) at final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR).

The safety profiles of Cabometyx and Opdivo observed in the trial reflect the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in first-line RCC.

Detailed results of CheckMate -9ER will be submitted for presentation at an upcoming medical conference.

2020 Near-term priorities

Ipsen remains focused on the following near-term priorities:

COVID-19: Ipsen will effectively manage the developing situation of COVID-19 by ensuring the safety of all employees and business continuity for patients as well as preparing for business recovery including protecting profitability and cash flow generation.
CEO search: The board of directors is progressing with its search for a new CEO with no delay expected due to COVID-19.
Palovarotene program: Ipsen intends to engage with the FDA and other regulatory authorities on the appropriate patient population eligible for treatment and a potential regulatory path forward for palovarotene in FOP.

2020 Annual Shareholders’ Meeting and proposed distribution of €1.00 per share confirmed

The Annual Shareholders’ Meeting will be held on 29 May 2020 behind closed doors, without the physical attendance of shareholders. It will be broadcast via a link provided on Ipsen’s website. Ipsen will request its shareholders to cast their votes remotely and submit their questions in advance.

Furthermore, the company confirms the proposed distribution of €1.00 per share for the 2019 financial year to be paid on 5 June 2020. The ex-dividend date is set for 3 June 2020.

Conference call details

Ipsen will hold a conference call on Wednesday, 22 April 2020 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately 15 minutes prior to its start. Participants can register for the call on the link below:

View Source

A recording will be available for seven days on Ipsen’s website.

[1] At constant exchange rates. Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.

On April 22, 2020 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on May 7, 2020, at 4:30 p.m. EDT to discuss its financial results for the fiscal second quarter ended March 31, 2020 (Press release, Arrowhead Pharmaceuticals, APR 22, 2020, View Source [SID1234556506]).

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 7566917.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 7566917.