On September 25, 2019 Tacalyx, a biotech company focused on the discovery and development of novel anti-TACA (Tumor Associated Carbohydrate Antigens) cancer therapies, reported that it has successfully secured €7 million in seed funding (Press release, Tacalyx, SEP 25, 2019, View Source [SID1234539794]). The funding round involves a syndicate of leading European life science and technology investors co-led by Boehringer Ingelheim Venture Fund and Kurma Partners and joined by Idinvest Partners, High-Tech Gründerfonds (HTGF), coparion, and Creathor Ventures.

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Tacalyx, a spin-out of the Max Planck Institute (MPI) of Colloids and Interfaces, will use the proceeds to advance its discovery platform, progress obtained leads towards candidate selection and start its pre-clinical development.

As tumor markers, TACAs are considered highly innovative targets for anticancer therapies due to their specific expression on a wider variety of tumor cells. At the same time TACAs drive tumor virulence and therefore their masking and/or down-regulation would compromise the vital functions of the tumor cell. However, because of TACAs’ low immunogenicity, the generation of antibodies against them is a challenging task and requires innovative tools as well as extensive knowledge of the employed technology.

Tacalyx’s discovery platform will allow the identification and validation of TACAs followed by the generation of leads against these difficult targets, for the implementation of novel immunotherapies that trigger an anti-cancer response more efficiently. The company combines the unique ability to synthesize sufficient amounts of ultra-pure and highly complex TACA structures with its analysis and screening capabilities and its experience in successful generation of mAb leads against non-peptidic targets.

Tacalyx secured access to licenses and the know-how from Max-Planck-Innovation GmbH to the underlying technology and related discoveries made by its scientific co-founders, Prof. Dr. Peter H. Seeberger, Director at the MPI for Colloids and Interfaces, and world leading expert in glycosciences, and Dr. Oren Moscovitz, Group leader at the MPI for Colloids and Interfaces and an expert in glyco-biology and glyco-oncology. Seeberger’s and Moscovitz’s scientific discoveries in the fields of tumor glycoscience and glycan targeting antibody generation gave rise to Tacalyx’s proprietary platform with supplementary financial support from technology transfer funds of Max-Planck-Society.

Dr. Peter Sondermann, CEO of Tacalyx, said: "This financing, by highly experienced life sciences and technology investors, represents an important validation of our platform and development strategy and will help to position us at the forefront of this breakthrough approach. Besides establishing the company and our discovery platform for lead generation, we will use these funds to explore relevant TACA biology in detail. We will also further assess and characterize our first lead antibodies and their functional role in treating cancer. Following which in vivo pharmacology studies evaluating the safety and efficacy of our lead antibodies will provide additional functional validation to progress at least one lead molecule to clinical development."

Dr. Detlev Mennerich, Investment Director at Boehringer Ingelheim Venture Fund, said: "We are pleased to have built this syndicate of leading investors to advance our mission of investing in ground-breaking therapeutics-focused biotechnology companies that drive innovation in biomedical research. Anti-TACA antibody generation requires sophisticated knowledge to produce specific high-affinity binders to TACAs. Tacalyx’s synthetic TACA chemistry, its understanding of TACA biology and ability to generate and characterize anti-TACA antibodies against these low immunogenic targets will enable the Company to realize their significant potential as treatments for multiple cancers."

In conjunction with the financing, Dr. Lena Krzyzak (High-Tech Gründerfonds), Ulrich Mahr (Max Planck Innovation), Dr. Detlev Mennerich (Boehringer Ingelheim Venture Fund), Dr. Peter Neubeck (Kurma Partners, Idinvest Partners), Dr. Sebastian Pünzeler (coparion) and Karlheinz Schmelig (Creathor) will join Tacalyx’s board of directors alongside Prof. Dr. Peter H. Seeberger (MPI for Colloids and Interfaces).

On September 25, 2019 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, reported that the Company’s management will present a Company overview and update, as well as host investor meetings, at the 2019 Cantor Global Healthcare conference (Press release, Supernus, SEP 25, 2019, View Source [SID1234539776]):

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Date: Thursday, October 3, 2019
Time: 5:20 p.m. ET
Place: InterContinental New York Barclay, New York City

Investors interested in arranging a meeting with the Company’s management during this conference should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting ‘Events & Presentations’ in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website after the conference.

On September 25, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained the approval of expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for anti-tumor agent/PARP inhibitor Lynparza (generic name: olaparib) for the maintenance treatment after 1st line chemotherapy in patients with BRCA-mutated advanced ovarian cancer from the Ministry of Health, Labour and Welfare (MHLW) (Press release, Chugai, SEP 25, 2019, View Source [SID1234539760]). With this approval, Foundation One CDx Cancer Genomic Profile will be available in Japan as a companion diagnostic for 15 therapies.

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The approval allows physicians to identify patients with BRCA-mutated advanced ovarian cancer who could benefit from Lynparza as a maintenance treatment after 1st line chemotherapy by detecting BRCA1/2 gene mutations. In Japan, AstraZeneca (LSE/STO/NYSE: AZN) has obtained approval for an additional indication of maintenance treatment after 1st line chemotherapy in patients with BRCA-mutated ovarian cancer for Lynparza from the MHLW on June 19, 2019.1) Under the global strategic oncology collaboration between AstraZeneca and MSD (NYSE: MRK), the two company has jointly commercialized Lynparza in Japan.

"We are pleased that FoundationOne CDx Cancer Genomic Profile has been approved as a companion diagnostic for Lynparza in certain patients with advanced ovarian cancer," said Dr. Minoru Watanabe, Chugai’s Vice President, Head of Foundation Medicine Unit. "The program is the first MHLW-approved companion diagnostic which can detect BRCA alterations including both germline and somatic mutations in Japan.* We are committed to improve patient access for optimal treatment through the program."

"The approval of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for Lynparza (olaparib) in women with ovarian cancer represents significant progress in delivering precision medicine to more Japanese patients via our strong collaboration with Foundation Medicine Inc. and Chugai Foundation Medicine Unit.," said Ruth March, Ph.D., Senior Vice President and Head of Precision Medicine, Oncology R&D, AstraZeneca.

Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for molecular-targeted drugs approved in Japan.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

* FoundationOne CDx Cancer Genome Profile detects BRCA mutation including both germline (inherited) and somatic (acquired) mutations, but its report does not provide information on the origin of mutation.

Approval information The underlined part has been newly added.
[Intended uses or indications]

The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
EGFR exon 19 deletions and EGFR exon 21 L858R alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
NTRK1/2/3 fusion gene Solid tumors entrectinib
BRCA1/2 alterations Ovarian cancer olaparib
Trademarks used or mentioned in this release are protected by laws.

[Reference]

Lynparza approved in Japan for 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer. Press release issued by AstraZeneca on June 19, 2019. View Source (Accessed on September, 2019)

On September 25, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported it has enrolled 158 patients in its Phase 2 trial of AG013 for the treatment of severe oral mucositis (Press release, Oragenics, SEP 25, 2019, View Source [SID1234539778]).

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In addition, the Data and Safety Monitoring Board (DSMB) for the trial, recently met and reviewed safety data to date and has determined that the trial may continue with no adjustments or further review. The company is currently enrolling approximately 200 patients in 59 study sites in the United States and Europe.

"Having reached more than three quarters enrollment is an important milestone for this trial, and we remain on track to complete enrollment by the end of the fourth quarter of 2019. In the meantime, we are grateful to our DSMB for their continued support in reviewing our incremental safety data and clearing the trial to continue uninterrupted. Finally, we look forward to providing additional updates on the progress and data from the trial as it becomes available," stated Alan Joslyn, CEO of Oragenics, Inc.

AG013, which has been granted Fast Track designation with the U.S. Food and Drug Administration and orphan drug status in Europe, is an ActoBiotics therapeutic candidate formulated to deliver the therapeutic molecule Trefoil Factor 1 to the mucosal tissues in the oral cavity in a convenient oral rinsing solution. Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and play an important role in subsequent repair. The compound was designed by the company’s strategic partner, ActoBio Therapeutics, Inc., a wholly-owned subsidiary of Intrexon Corporation (NYSE: XON).

On September 25, 2019 Innate Pharma SA (the "Company" or "Innate" – Euronext Paris: FR0010331421 – IPH), reported that AstraZeneca (LSE/STO/NYSE: AZN) will advance monalizumab into a Phase III randomized clinical trial evaluating monalizumab in combination with cetuximab in patients suffering from recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), and the companies will co-fund the trial (Press release, Innate Pharma, SEP 25, 2019, View Source [SID1234539800]). The trial initiation is expected in 2020, subject to regulatory and compliance approvals.

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"This is an important scientific milestone as we continue to invest in innovation and advance our late-stage clinical development pipeline," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Together with AstraZeneca, we are working diligently to progress this potential novel treatment for head and neck cancer patients, a population with a high unmet medical need."

About the Innate-AstraZeneca monalizumab agreement:

On April 24 2015, the Company signed a co‑development and commercialization agreement with AstraZeneca to accelerate and broaden the development of monalizumab.

The financial terms of the agreement include potential cash payments of up to $1.275 billion to Innate Pharma. The Company has already received $350 million, and the next payment due by AstraZeneca is $100 million upon dosing of the first patient in a first Phase III clinical trial. AstraZeneca will book all sales and will pay Innate low double-digit to mid-teen percentage royalties on net sales worldwide except in Europe where Innate Pharma will receive 50% share of the profits and losses in the territory. Innate will co-fund 30% of the costs of the Phase III development program of monalizumab with a pre-agreed limitation of Innate’s financial commitment.

About Monalizumab:

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Hence, monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells. Monalizumab may also enhance the cytotoxic potential of other therapeutic antibodies.

AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing Phase II development for monalizumab is focused on investigating monalizumab in combination strategies.

About Cetuximab:

Cetuximab is an anti-EGFR monoclonal antibody. NK cells mediate cetuximab-induced antibody dependent cellular cytotoxicity (ADCC) against SCCHN, and genetic and preclinical experiments suggest that ADCC can be enhanced by NK-stimulators.

The activity of cetuximab as a single agent in recurrent and/or metastatic SCCHN is limited, with a 12.6% overall response rate, a median time to progression of 2.3 months and a median overall survival of 5.8 months (Vermorken et al, JCO 2007).