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 OCTIMET Oncology NV, the Belgian life science company with a focus on accelerated development of highly selective differentiated MET kinase inhibitors is reported the recruitment of the first patient into the second module of its phase I/II clinical study in patients with advanced solid malignancies (Press release, Octimet Oncology, SEP 25, 2019, View Source [SID1234539793]).

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The Study (NCT03138083) is currently evaluating OMO-1 in a monotherapy setting as well as in combination with small molecule EGFR tyrosine kinase inhibitors (TKIs). OMO-1 is an oral, highly selective small molecule MET kinase inhibitor that has demonstrated potent single agent and combination activity in a range of preclinical models. OCTIMET obtained a worldwide exclusive license to OMO-1 from Janssen Pharmaceuticals which had previously carried out a healthy volunteer trial where predicted efficacious exposures were reached without any significant adverse events.

The primary objective of Module 2 of this Phase I/II study is to demonstrate that OMO-1, in combination with EGFR TKIs, has an acceptable safety and tolerability profile in patients with advanced MET amplified cancer types, whose tumours are progressing during treatment with an EGFR-TKI; secondary objectives include determination of pharmacokinetic (PK) characteristics, and indication of clinical efficacy at doses and schedules at or below the monotherapy recommended phase 2 dose (RP2D). Preliminary top-line results of the combination of OMO-1 with EGFR TKIs are expected in 2020.

This adaptive study, with an innovative modular design, is being conducted in different countries across Europe and the USA.

Glen Clack, CMO of OCTIMET: "MET amplification is known to be a key driver of resistance to EGFR TKIs. This study module will explore the combination of OMO-1, a differentiated selective MET kinase inhibitor, with EGFR TKIs, and provide clear clinical proof of concept data for this combination."

Shelley Margetson, CEO, of OCTIMET added: "This adaptive clinical trial with patient cohorts enriched for validated and highly relevant biomarkers is the hallmark of OCTIMET’s accelerated development approach and illustrates how we are striving to get effective drugs to the right patients as fast as possible."

About the Study, NCT03138083

The study is a modular, multi-arm, multi-part, open label, first in human study to evaluate the safety and tolerability of OMO-1, alone and in combination with anti-cancer treatments, in patients with locally advanced, unresectable or metastatic solid malignancies.

The study will consist of a number of study modules – the first of which is Module 1, a monotherapy module to be followed by further modules studying OMO-1 in combinations with other oncology drugs to address developing resistance to or progression on current treatment as well as possible synergistic effects.

In Module 1 of the first-in-patient study, OMO-1 monotherapy has shown a favourable safety profile at a recommended phase 2 dose (RP2D) of 250mg BD and a first expansion cohort for MET exon 14 mutated NSCLC patients is currently enrolling at that dose (DOI: 10.1200/JCO.2019.37.15_suppl.3062, Lolkema et al. Journal of Clinical Oncology 37, no. 15_suppl [May 20 2019] 3062-3062).

About EGFR Tyrosine Kinase Inhibitors

Lung cancer is the leading cause of cancer-related mortality worldwide. Of all lung cancer cases, 80–85% are non-small-cell lung cancers (NSCLC), and the majority of these cases are in advanced or metastatic stage (III or IV) at the time of diagnosis. Among these patients with NSCLC, a substantial number are harboring activating EGFR mutations, ranging from 10% in Europe to 38.4% in Asia. During the past years, EGFR tyrosine kinase inhibitors (TKIs) have been developed and have become standard first-line treatment for patients with EGFR mutation-positive NSCLC. Various trials showed higher response rates and improved progression-free survival (PFS) for first-line treatment with the EGFR TKIs afatinib, erlotinib, and gefitinib compared to platinum-based doublet therapy in patients with activating EGFR-mutated (exon 19 deletion or exon 21 L858R mutation) NSCLC. Recently, in head-to-head trials, the newer EGFR TKIs, dacomitinib and osimertinib, showed a significantly longer PFS compared to standard EGFR-TKIs, while dacomitinib, a second-generation EGFR-TKI, had a better efficacy compared to gefitinib, and osimertinib showed a more favorable PFS compared to standard EGFR-TKI (gefitinib or erlotinib). MET amplification is known to be a common driver of resistance to EGFR TKIs.

On September 25, 2019 Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, reported the pricing of an underwritten offering of 7,821,230 shares of its common stock (Common Stock) (or Common Stock equivalent) and common warrants to purchase up to an aggregate of 7,821,230 shares of Common Stock (the Offering), priced at-the-market (Press release, Citius Pharmaceuticals, SEP 25, 2019, View Source [SID1234539792]). Each share of Common Stock (or Common Stock equivalent) is being sold together with a common warrant to purchase one share of Common Stock at a combined effective price of $0.8951 per share and accompanying common warrant. The Company has granted the underwriter a 30-day option to purchase up to an additional 1,173,184 shares of Common Stock and/or common warrants to purchase up to 1,173,184 shares of Common Stock.

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H.C. Wainwright & Co., LLC is acting as the sole book-running manager for the Offering.

The common warrants will be exercisable immediately at an exercise price of $0.77 per share and will expire five years from the date of issuance. The shares of Common Stock (or Common Stock equivalent) and the accompanying common warrants can only be purchased together in the Offering but will be issued separately. The Offering is expected to close on or about September 27, 2019, subject to customary closing conditions.

The gross proceeds of the Offering are expected to be approximately $7.0 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. Citius intends to use the net proceeds from the Offering for general corporate purposes, including its Phase 3 clinical Mino-Lok trial for the treatment of catheter related bloodstream infections, the investigational new drug (IND) regulatory pathway for Mino-Wrap and its Phase 2b clinical trial of Hydro-Lido cream for the treatment of hemorrhoids, and working capital and capital expenditures.

A registration statement on Form S-1 (File No. 333-233759) relating to the securities was declared effective by the U.S. Securities and Exchange Commission (SEC) on September 24, 2019. The Offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to and describing the terms of the Offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, copies of the final prospectus relating to the Offering may be obtained for free by visiting the SEC’s website at www.sec.gov or from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at [email protected] or by telephone at 646-975-6996.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 25, 2019 OncoQuest Inc., a privately held, cancer immunotherapy company reported that a Notice of Allowance was received from the U.S. Patent and Trademark Office (USPTO) for patent protection of the schedule of administration of our monoclonal anti-CA-125 antibody, mAb-B43.13, now known as oregovomab, in a specific schedule in combination with carboplatin and paclitaxel in Stage III-IV ovarian cancer patients (Press release, OncoQuest, SEP 25, 2019, View Source [SID1234539791]).

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A Notice of Allowance signifies that the applicant is entitled to receive patent protection of 20 years under the law. The patent claim lays out a specific schedule of administration of oregovomab in combination with carboplatin and paclitaxel, and as a standalone injection 10 to 14 weeks after the third oregovomab administration. This administration protocol generated a statistically significant Progression Free and Overall Survival advantage over chemotherapy alone in a 97-patient randomized controlled Phase 2 study in newly diagnosed Stage III-IV ovarian cancer patients which was completed in 2017 [NCT01616303].

The Company is currently planning to launch a Phase 3 trial in Q1 2020. The planned Phase 3 study is expected to enroll over 500 patients with newly diagnosed, advanced ovarian cancer globally. The primary endpoint will be to evaluate progression-free survival of patients treated with oregovomab plus a standard-of-care chemotherapy combination, carboplatin and paclitaxel, compared to the chemotherapy alone.

"We are very pleased that this additional patent was allowed as it is a significant addition to our oregovomab patent portfolio, providing extended exclusivity protection, in addition to what we are already expecting from the Biologics Price Competition and Innovation Act (BPCIA)," said Dr. Madiyalakan, CEO of OncoQuest. "This marks an important step in our ongoing efforts to optimize the value of our oregovomab product as we embark on our initiation of the Phase III registration study and towards commercialization of oregovomab."

On September 25, 2019 Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, reported that the company will deliver a corporate presentation at the 2019 Cantor Global Healthcare Conference, being held October 2-4, 2019 in New York, NY (Press release, Viking Global Investors, SEP 25, 2019, View Source [SID1234539790]).

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Details for this presentation are as follows:

2019 Cantor Global Healthcare Conference – webcast available
Time/Date: 4:45 p.m. Eastern on Wednesday, October 2, 2019
Location: InterContinental New York Barclay Hotel
Room: Grand Ballroom 2
To access the live webcast of Viking’s presentation, please visit "Webcasts & Presentations" within the News & Events section of Viking’s Investors page at www.vikingtherapeutics.com. Additionally, a replay of the webcast will be available on the Viking website following the conference.