On September 28, 2020 CureVac reported that Its focus is squarely on getting an mRNA vaccine against COVID-19 onto the market, but has bigger ambitions from its deep pipeline (Press release, CureVac, SEP 28, 2020, View Source [SID1234567807])

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CEO: Franz-Werner Haas
Based: Tübingen, Germany
Founded: 2000
Clinical focus: Prophylactic vaccines, cancer immunotherapies and protein therapies

The scoop: CureVac, alongside BioNTech and Moderna, is one of the biotechs that put mRNA on the map. It suffered the field’s first big clinical setback when prostate cancer vaccine CV9104 flunked a phase 2b in 2017, only to bounce back through the progression of other programs and a significant infectious disease pact with Eli Lilly.

Then COVID-19 happened. As the coronavirus spread, CureVac received €300 million ($356 million) from the German government, struck a broad, big-ticket deal with GlaxoSmithKline, completed a Nasdaq IPO and briefly became a mainstream news story when President Donald Trump reportedly tried to buy it.

What makes CureVac Fierce: The biotech that emerged from the early months of the pandemic has a new CEO, Franz-Werner Haas, a new near-term focus, COVID-19, and, by extension, a radically revised outlook and strategy for the next year or two.

"[COVID-19] is really transforming the company," Haas said.

CureVac went into 2020 thinking it was still years away from bringing a product to market, meaning its focus was on running clinical trials and manufacturing materials for use in them. Now, CureVac is planning to bring a COVID-19 vaccine to market next year and lining up a contract to sell up to 405 million doses to the European Union.

The rapid acceleration of CureVac’s time to market has changed the focus of the leadership team. Today, Haas is occupied with questions about how to establish the expertise and scale CureVac will need to succeed as a commercial company. In January, those questions were distant concerns.

CureVac has a little more time to address the questions than some other developers of COVID-19 vaccine. While its peers were racing into the clinic, CureVac spent more time in preclinical doing the optimization work that it thinks will enable its vaccine to trigger balanced immune responses and be readily manufactured at scale. CureVac took a different approach to other mRNA vaccine developers.

"These other candidates, they’re building upon chemical modification of the RNA, which we don’t do. We are optimizing the RNA on the RNA level, so using the potency of the untranslated regions. That’s a differentiating factor," Haas said. One consequence of CureVac’s approach is the maximum dose in its first clinical trial is 8 µg. Moderna is testing a 100-µg dose in its phase 3.

The relatively small amount of mRNA used in its vaccine should enable CureVac to get more doses out of the manufacturing capacity it is adding. Infrastructure set up to support the COVID-19 vaccine could prove valuable as other assets get to market. CureVac’s rabies vaccine could come to market within the next five years. Perhaps more significantly, CureVac is retaining the commercialization rights in three European countries to the five candidates covered by its deal with GSK.

"These are big products, which need huge capacity in terms of manufacturing. And so there will be a kind of decision point: Where are these five projects? How can we bring these into the market? This is a transforming platform deal for us," Haas said.

Haas sees vaccines as the "sweet spot" for CureVac’s technology today as they are given at low doses in two-shot prime-boost regimens, rather than the repeated administration needed to treat disease. That is reflected in CureVac’s pipeline, which is led by vaccines against COVID-19 and rabies, but the biotech’s ambitions, like those of its mRNA rivals, extend well beyond prophylactics.

CureVac is testing its tumor microenvironment modulator CV8102 in cancer patients in combination with anti-PD-1 antibodies, and the Boehringer Ingelheim-partnered self-adjuvanting mRNA vaccine CV9202 is in early-phase development in non-small cell lung cancer. A third wing of the biotech is working on protein-based therapies, including in programs that pair its technology with the potentially complementary capabilities of CRISPR Therapeutics and Genmab.

Investors: Dievini Hopp BioTech holding, Kreditanstalt für Wiederaufbau and GlaxoSmithKline

On September 28, 2020 Medigene AG (FSE: MDG1, Prime Standard) reported its participation at the following upcoming scientific and investor conferences (Press release, MediGene, SEP 28, 2020, View Source [SID1234567736]). Please note that all mentioned conferences will be conducted virtually due to COVID-19.

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Cell Therapy Manufacturing & Gene Therapy Congress
Date: 19 – 22 October
Website: https://informaconnect.com/celltherapy/

TCR Therapies Summit
Date: 26 – 29 October
Website: https://tcr-therapies-summit.com/

BIO-Europe Digital
Date: 26 – 29 October
Website: https://informaconnect.com/bioeurope/?gclid=EAIaIQobChMIn-75yv7b6wIVFed3Ch27uAezEAAYASAAEgLuufD_BwE

Neoantigen Based Therapies Summit
Date: 3 – 5 November
Website: View Source

35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020)
Date: 9 – 14 November
Website: View Source;Home=%2Fevents%2Fevent-description

62nd ASH (Free ASH Whitepaper) Annual Meeting and Exposition
Date: 5 – 8 December
Website: View Source

On September 28, 2020 xCures, a clinical study platform provider, reported the US Food and Drug Administration (FDA) granted their IND for an intermediate Expanded Access Program (EAP) for the ERK inhibitor ulixertinib (BVD-523) (Press release, xCures, SEP 28, 2020, View Source [SID1234567705]).

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Ulixertinib is being developed by BioMed Valley Discoveries (BVD), a clinical stage biotechnology company, as a treatment for patients with MAPK pathway aberrant cancer, including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK, mutations.

The EAP is open across the United States to adolescent and adult cancer patients who cannot access an open clinical trial for the investigation of ulixertinib (BVD-523).

"xCures prospective real-world evidence generation capability transforms managed access programs such as the ulixertinib expanded access program by making them an efficient way for physicians and patients to gain access to promising therapies when clinical trials are not an option," says Mika Newton, CEO of xCures, Inc. "xCures’ programs uniquely capture high-value evidence related to the safety and efficacy from this expanded set of patients."

This intermediate-sized expanded access program (NCT04566393) is currently open and available for physicians interested in treating their patients. Physicians can reach out to [email protected] for more information. Patients can register and find more information at enroll.xcures.com/uli-eap or receive additional information via xCures patient advocacy partner Cancer Commons (www.cancercommons.org).

About ulixertinib (BVD-523):
Ulixertinib is a first-in-class and best-in-class small-molecule inhibitor of extracellular signal-regulated kinase (ERK) family kinases (ERK1 and ERK2) that is being developed as a novel anti-cancer drug. ERK kinases are downstream components of the mitogen-activated protein kinase (MAPK) signaling cascade (RAS-RAF-MEK-ERK). Ulixertinib has demonstrated promising early efficacy for patients with tumors harboring alterations in the MAPK pathway, including atypical (non-V600) BRAF alterations, for which there are currently no approved targeted agents.

About Expanded Access:
Expanded access, which is often called "compassionate use," is the use of an unapproved drug for treatment of patients with serious or life-threatening illnesses outside of a clinical trial. Expanded access is subject to oversight from the US FDA in accordance with the regulations outlined in 21 CFR 312.305.

About the Program:
This Expanded Access program provides ulixertinib for compassionate use in advanced cancer patients with a MAPK pathway-altered solid tumor(s) who have exhausted available therapies. The protocol aims to collect sufficient information about the patient’s treatment to provide a complete and accurate case report to health authorities using real-world data collection to assess response to treatment, safety, tolerability, and quality-of-life.

On September 28, 2020 Sosei Group Corporation ("the Company") (TSE: 4565) reported that it has been notified by Pfizer that the first subject in a clinical trial has been dosed with a new drug candidate nominated from the multi-target drug discovery collaboration between the two companies (Press release, Sosei Heptares, SEP 28, 2020, View Source [SID1234567704]). Achievement of this milestone triggers a payment of $5 million to Sosei Heptares. This candidate was nominated for advancement by Pfizer in June 2019 generating a $3 million milestone payment at that time.

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Pfizer nominated three distinct clinical candidates from the collaboration with Sosei Heptares during 2019, two of which have now subsequently entered clinical trials. The collaboration has leveraged Sosei Heptares’ unique StaR technology and Structure-based Drug Design (SBDD) capabilities to design oral small molecules that modulate different G protein-coupled receptor (GPCR) targets across multiple disease areas of interest to Pfizer.

This candidate is the eighth GPCR-targeted drug candidate to enter clinical trials originating from Sosei Heptares’ StaR technology and structure-based drug design (SBDD) platform.

Dr. Rob Cooke, Chief Technology Officer of Sosei Heptares, said: "The start of this new clinical trial is another great example of the productivity of our StaR technology and structure-based drug design approach. It also highlights our ability to work collaboratively and successfully with leading pharma companies, applying cutting-edge complementary capabilities to discover and develop completely new drug candidates with potential to treat major diseases. We are extremely pleased with the progress being made in our long-term partnership with Pfizer."

About the Agreement with Pfizer

Sosei Heptares and Pfizer entered a multi-target drug discovery collaboration in November 2015 to research and develop potential new medicines directed at up to ten GPCR targets across multiple therapeutic areas. Many of these targets have clinical or biological validation as key points for therapeutic intervention potentially targeting a range of diseases but have proven difficult to address with conventional discovery approaches because of inherent technical challenges.

To address these challenges, Sosei Heptares and Pfizer scientists worked closely together to leverage their respective complementary expertise in enabling GPCR-focused structure-based drug design (SBDD) and development initially directed to the GPCR targets selected by Pfizer. Pfizer is responsible for developing and commercializing any potential therapeutic agents (small molecules or biologics) for each target and will have exclusive global rights to any potential resulting agents.

Sosei Heptares has delivered multiple stabilized receptors (StaR proteins), X-ray structures and biophysical data on certain programs, triggering multiple significant milestone payments from Pfizer resulting from the nomination of new clinical candidates and entry into clinical trials. Further possible milestones payments are contemplated under the agreement, with potential for royalties also payable provided the criteria under the agreement are satisfied.

Pfizer also made a $33 million equity investment in Sosei Heptares in 2015. In the future, Pfizer and Sosei Heptares anticipate publication of select research findings from their collaboration.

On September 28, 2020 Imvax Inc., an emerging oncology leader that is revolutionizing immunotherapy for patients with glioblastoma multiforme (GBM) and other solid tumors with significant unmet medical needs, reported that it has been named by Fierce Biotech as one of 2020’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Imvax, SEP 28, 2020, View Source [SID1234567702]).

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"It is an honor to be named to the 2020 Fierce 15 list, especially among this class of promising biotech companies," said John Furey, Imvax Chief Executive Officer. "2020 has been a year of rapid growth and momentum for Imvax and this award reaffirms our efforts towards improving outcomes for people living with devastating and intractable solid tumor cancer."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is Fierce Biotech’s 18th annual Fierce 15 selection.

The 2020 Fierce 15 comes at a time when the world is focused on a pandemic, but even as coronavirus remains a threat, patients with cancer, rare diseases and other disorders still need treatment, Fierce Biotech Senior Editor Ben Adams said. "This year, we’ve chosen from a diverse range of those fighting COVID, as well as those fighting longer term plagues against our biology," Adams said.

In July, Imvax announced the completion of a $112 million Series C financing. This financing has enabled Imvax to continue clinical development of lead product candidate IGV-001 for treatment of newly diagnosed GBM through Phase 2. IGV-001 is an autologous tumor vaccine made from patients’ tumor cells combined with an antisense molecule to affect a personalized immune response. The financing will also enable Imvax to broaden the development portfolio into additional oncology therapeutic indications. The team is continuing its pre-clinical work, targeting to start additional solid tumor Phase 1 trials during 2021.