On May 18, 2021 Innovent Biologics, Inc. (HKEX: 01801) and Eli Lilly and Company (NYSE: LLY) reported that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC) (Press release, Innovent Biologics, MAY 18, 2021, View Source [SID1234580231]). This is the first U.S. regulatory submission of sintilimab, a PD-1 inhibitor being developed and commercialized under a global collaboration agreement between Innovent and Lilly.

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"The acceptance of this application – the first for sintilimab in the U.S. and outside of China – is an important milestone in Innovent’s global commercialization strategy and in our collaboration with Lilly," said Dr. Yongjun Liu, president of Innovent. "We look forward to working closely with the FDA to potentially bring this sintilimab-pemetrexed-platinum chemotherapy combination as a treatment option in the U.S., following the regimen’s regulatory approval in China earlier this year."

Sintilimab is currently being evaluated in a wide variety of cancer types under a broad clinical development program. To date, sintilimab has two indications approved in China, three regulatory submissions under review in China, and this regulatory application under review in U.S.. This regulatory application was submitted to the FDA in March 2021, primarily based on the results of the Phase 3 ORIENT-11 trial. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA to make a decision on the sintilimab application is in March 2022. The FDA stated that it did not identify any potential review issues in its acceptance letter. It is currently planning to hold an Advisory Committee meeting to discuss this application.

"We are pleased the sintilimab submission is progressing. Our pursuit of this proposed indication in the U.S. reinforces Lilly’s and Innovent’s joint commitment to offer additional therapeutic options for people living with lung cancer and the healthcare providers who treat them," said Anne White, president, Lilly Oncology. "This is an encouraging start for our collaborative efforts to make sintilimab available in countries beyond China, as we continue to pursue opportunities globally for this immuno-oncology medicine across various tumor types."

About the ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial assessing the efficacy and safety of sintilimab in combination with pemetrexed and platinum chemotherapy compared to placebo in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC), with no sensitizing EGFR mutations or ALK rearrangements. The primary endpoint is progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1., and secondary endpoints include overall survival (OS) and safety profile.

A total of 397 patients were enrolled and randomized 2:1 to receive either sintilimab 200mg or placebo in combination with pemetrexed and platinum chemotherapy every three weeks for up to four cycles, followed by either sintilimab or placebo plus pemetrexed maintenance therapy. Patients received treatment until radiographic disease progression, unacceptable toxicity or any other conditions that required treatment discontinuation. Conditional crossover was permitted. The results of the ORIENT-11 study were published in 2020.1

About Lung Cancer

Globally, lung cancer is the leading cause of cancer death, killing nearly 1.8 million people worldwide each year. In the U.S., lung cancer is the second most common cancer (not counting skin cancer) and the leading cause of cancer death, responsible for nearly 25 percent of all cancer deaths – more than those from colorectal, breast and prostate cancers combined. Non-small cell lung cancer (NSCLC) accounts for approximately 85 percent of all lung cancers, and about 70 percent of those with NSCLC have the nonsquamous subtype. Fifty percent of NSCLC patients present with advanced or metastatic disease at diagnosis.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Lilly. Sintilimab 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 of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
Additionally, Innovent currently has regulatory submissions under review in China for sintilimab:

In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
In combination with BYVASDA (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma
The second-line treatment of squamous non-small cell lung cancer
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

Sintilimab was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

On May 18, 2021 Outpace reported that the company is taking cell and gene control technology originally in-licensed by Lyell out of that company’s toolbox and into a broad partnering model it thinks could transform the field (Press release, Outpace Bio, MAY 18, 2021, View Source [SID1234637772]).

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Outpace Bio Inc. launched in March with a $30 million series A round led by Artis Ventures and Lyell Immunopharma Inc., with participation by Abstract Ventures, Civilization Ventures, Mubadala Capital, Playground Global, Sahsen Ventures and WRF Capital.

The company’s leadership and scientific teams include inventors of de novo protein design technology developed at University of Washington’s Institute for Protein Design (IPD), many of whom joined Lyell when their inventions were brought under the well-funded cancer cell therapy company’s roof. That IP is now assigned to Outpace.

"The reason we’re spinning out from Lyell is that even massively capitalized companies can’t chew on all the hypotheses we want to address while moving at full speed on internal clinical development," said Outpace co-founder and CEO Marc Lajoie. "We have a lot to offer the field, and Lyell will benefit from that."

Outpace is developing "a whole platform of control modalities" to program cell and gene therapies for greater potency and safety, said Lajoie.

That includes synthetic biology strategies using "AND" or "NOT" Boolean logic gates to recruit or exclude signaling molecules to specific subcellular locations, control protein turnover, or require a specific combination of signals to unlock a desired function.

By designing fit-for-purpose proteins that don’t exist in nature, the company can go beyond standard strategies that manipulate expression of individual genes.

"First-generation approaches have been mainly focused on over-expressing this gene, or knocking out that gene," which can face limitations when a gene is integral to cell function in one setting but hampers it in another, said Lajoie. In contrast, he said, working at the protein level gives Outpace the ability to introduce desired changes in more context-specific ways.

Rather than develop its own pipeline, which would require investing in clinical development, the company is partnering with others to develop products via milestone- and royalty-driven deals. "The opportunity here is to create a step change in the field, and to be able to do that, we needed to focus our efforts on early development," Lajoie said.

In some cases, Outpace and the partner company will jointly design the program from the bottom-up, while in others, the partner will come to Outpace and use the company’s existing technology to solve a specific problem in an ongoing program, said co-founder and CSO Scott Boyken.

While the products developed through collaborations will belong to the partner companies, the underlying control technologies developed through the process belong to Outpace. "We can leverage our progress on the products we’re working on to increase our efficiency for other projects in the future," Lajoie said.

Outpace’s most advanced program is a collaboration with Lyell to develop cell therapies with controlled expression of an undisclosed cytokine. Other programs in development include a CAR cell therapy resistant to exhaustion, and a strategy for drug-induced gene regulation; the partnering status of these programs is undisclosed.

Lajoie said that while Outpace’s technology can be applied to any cell or gene therapy, the company’s "sweet spot" is T cell therapies for cancer.

Lajoie and Boyken co-authored a 2020 Science study with Fred Hutchinson Cancer Research Center professor Stanley Riddell showing the Co-LOCKR (Colocalization-dependent Latching Orthogonal Cage/Key pRoteins) technology they developed, part of Outpace’s IP portfolio, directed T cells to kill target cells expressing precise combinations of cell surface antigens, opening the door to more selective tumor targeting.

"There’s no single antigen that really distinguishes cancer cells from healthy cells, but there are aberrant combinations of antigens. That’s the unique handle we really wanted to pursue in that collaboration," said Lajoie.

He believes the series A round will give the company approximately three years of runway.

At least two other companies have been founded to develop synthetic biology control mechanisms for partners’ cell therapies.

Cell Design Labs Inc. was acquired by Gilead Sciences Inc. (NASDAQ:GILD) for $175 million up front and $322 million in total milestones after Gilead’s 2017 acquisition of Cell Design Labs’ partner, Kite Pharma Inc. The University of California San Francisco spinout, which raised $34.4 million in venture funds, developed technology to control CAR T cell function; its UCSF founders published two Science Translational Medicine studies on the technology last month.

Senti Biosciences Inc., which raised a $105 million series B round in January and a $53 million A round in 2018, has both a pipeline strategy and a partnering model.

On May 18, 2021 Calliditas Therapeutics reported that Summary of Q1 2021 January 1 – March 31, 2021 (Press release, Calliditas Therapeutics, MAY 18, 2021, View Source [SID1234580180])

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No net sales for the three months ended March 31, 2021 were recognized. For the three months ended March 31, 2020 net sales amounted to SEK 0.5 million.
Operating loss amounted to SEK 150.8 million and SEK 72.3 million for the three months ended March 31, 2021 and 2020, respectively.
Loss before income tax amounted to SEK 136.2 million and SEK 63.7 million for the three months ended March 31, 2021 and 2020, respectively.
Loss per share before and after dilution amounted to SEK 2.51 and SEK 1.65, for the three months ended March 31, 2021 and 2020, respectively.
Cash amounted to SEK 867.3 million and SEK 728.6 million as of March 31, 2021 and 2020, respectively.
Significant events during Q1 2021, in summary
In January 2021, Calliditas announced a positive readout of the Phase 1 study with setanaxib, which enables clinical trials with higher dosing levels.
In January 2021, Calliditas shared the clinical development plan for setanaxib, including planned trials in Primary biliary cholangitis (PBC) and head and neck cancer, and additional data from Part A of NeflgArd study at its R&D Day.
In March 2021, Calliditas announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nefecon in patients with primary IgA Nephropathy (IgAN).
Significant events after the end of reporting period, in summary
In April 2021, Calliditas was granted accelerated assessment procedure by the European Medicine Agency’s (EMA) Committee for Human Medicinal Products (CHMP) reducing the maximum timeframe for review of the application for marketing authorization. If approved, Nefecon could be available to patients in Europe in first half of 2022.
In April 2021, Calliditas announced that the FDA accepted the submission and granted Priority Review for the NDA for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. Subject to approval, this would enable commercialization of Nefecon in the US in Q4, 2021.
Investor presentation May 18, 14:30 CET
Audio cast with teleconference, Q1 2021, May 18, 2021, 14:30 (Europe/Stockholm)

Webcast: View Source

Teleconference: SE: +46850558366 UK: + 443333009271 US: 18335268381

Financial calendar
Interim Report for the period January 1 – June 30, 2021 August 19, 2021

Interim Report for the period January 1 – September 30, 2021 November 18, 2021

Year-end Report for the period January 1 – December 31, 2021 February 24, 2022

On May 18, 2021 Iktos, a company specializing in Artificial Intelligence for new drug design, reported that it has entered into a Research Collaboration Agreement with Kadmon, a clinical-stage biopharmaceutical company based in New York, USA, pursuant to which, Iktos’s generative modelling artificial intelligence (AI) technology will be used to enable the rapid and cost-effective design of novel drug candidates for an undisclosed Kadmon drug discovery program (Press release, Kadmon, MAY 18, 2021, View Source [SID1234580216]). Under the agreement, Iktos will use its de novo structure-based generative modelling technology to identify novel compounds that match a pre-defined target product profile, with the aim of expediting Kadmon’s early phase discovery efforts.

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Kadmon discovers, develops and delivers small molecules and biologics to treat human diseases. Kadmon is expanding and integrating novel drug discovery platforms, with the aim of identifying and developing new product candidates for significant unmet medical needs. "Our collaboration with Iktos provides an exciting opportunity for Kadmon to combine Iktos’ innovative artificial intelligence (AI)-driven technology with Kadmon’s expertise in medicinal chemistry and structure-based drug design (SBDD) to accelerate novel target validation and to facilitate drug discovery", said Jean (Ji-In) Kim, Senior Vice President, Head of Chemistry at Kadmon.

Iktos’ AI technology, based on deep generative models, helps bring speed and efficiency to the drug discovery process. Iktos’ technology automatically designs virtual novel molecules that have all of the characteristics of a successful drug molecule. This approach, now validated through Iktos’ other collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules which simultaneously satisfy multiple critical drug criteria, such as potency, selectivity, safety, and project-specific properties. In early-stage discovery projects, Iktos’ technology allows the design of novel hits with optimal protein-ligand interactions, as predicted by molecular modelling technology. This approach enables the exploration of chemical space in a unique way and produces innovative molecule designs with greater Freedom to Operate. Furthermore, it drastically shortens the hit finding and hit-to-lead optimization phases by enabling multi-parametric in silico optimization from the start of a project.

"We are thrilled that Kadmon is engaging with Iktos to try expedite the discovery of a drug candidate on a promising target," commented Yann Gaston-Mathé, President and CEO of Iktos. "We are proud to have earned the trust of our collaborators and are confident that Iktos’ software will improve Kadmon’s medicinal chemists’ ability to identify promising novel chemical matter and solve complex multi parametric optimization problems. The feedback from Kadmon’s research team will be highly valuable as we work to improve our product offering. Our strategy has always been to tackle challenging problems alongside our collaborators where we can demonstrate value generation for new and on-going drug discovery projects."

On May 18, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY, the "Company") reported that it has fully placed the new shares from the capital increase resolved on April 27, 2021 (Press release, Epigenomics, MAY 18, 2021, View Source [SID1234580181]). The offer was oversubscribed multiple times. Accordingly, the Company’s share capital will be increased from currently EUR 9,852,690.00 by EUR 1,970,537.00 to EUR 11,823,227.00 by 1,970,537 new registered shares of the Company against cash contributions.

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The gross proceeds from the capital increase amount to approximately EUR 2.2 million.

The capital increase needs to be registered in the commercial register, which the Executive Board will apply for shortly. The inclusion of the new shares under the Company’s existing listing (ISIN DE000A3H2184) of the remaining shares is currently expected to take place at or around May 26, 2021.