On September 15, 2020 Exelixis, Inc. (Nasdaq: EXEL) and Iconic Therapeutics reported new preclinical data that support the continued development of ICON-2, an ADC comprised of an anti-Tissue Factor (TF) antibody and Zymeworks’ proprietary linker-payload, for the treatment of diverse solid tumors (Press release, Exelixis, SEP 15, 2020, View Source [SID1234565175]). Exelixis has an exclusive option and license agreement for ICON-2 in oncology indications under its May 2019 agreement with Iconic Therapeutics, which discovered and is developing this novel ADC. The new data, which demonstrate the superior tolerability and exposure of ICON-2 compared with an MMAE anti-TF ADC, are being presented this week in a poster at the World ADC Digital Conference, which is being held online September 15-18.

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"These data provide additional preclinical validation both of our platform of proprietary anti-TF molecules designed to efficiently but safely bind TF, which is overexpressed in a variety of solid tumors, and specifically for Iconic Therapeutics’ strategy to advance its next generation ADC targeting TF," said William L. Greene, M.D., Chief Executive Officer of Iconic Therapeutics. "Other anti-TF ADCs that use MMAE as a linker-payload have been associated with side effects that can reduce tolerability, including bleeding, neutropenia and skin toxicities. The data presented today demonstrate ICON-2 effectively kills solid tumor cells in a variety of preclinical studies with an improved tolerability profile, and support continued development of ICON-2 as a treatment for solid tumors. We are currently conducting additional preclinical and nonclinical studies in support of initiating human clinical trials of this potentially best-in-class anti-TF ADC."

TF plays a critical role in the coagulation cascade and its expression is generally restricted in normal tissue. However, solid tumors, including gastrointestinal, head and neck, cervical, ovarian and bladder tumors, frequently express TF at high levels, which is associated with poor prognosis. Although TF is an attractive target for ADC therapy, previous approaches have demonstrated the potential to interfere with the coagulation cascade and may have additional toxicities that could negatively impact their risk-benefit profile.

The data presented today include results from several preclinical studies of ICON-2. Key findings from these studies are:

ICON-2 binds to TF on human and non-human primate (NHP) cells with high affinity but does not affect coagulation as measured by FXa conversion and thrombin generation assays.
ICON-2 does not induce neutropenia in NHPs.
ICON-2 is more potent than an ADC containing MMAE conjugated to the same anti-TF antibody in mouse xenograft model of human pancreatic tumor cells.
ICON-2 is highly active in patient-derived xenograft models derived from multiple tumor types.
ICON-2 exhibits superior tolerability and exposure when compared directly with an MMAE ADC using the same anti-TF antibody in a NHP study.
"We entered into our exclusive option and license agreement with Iconic Therapeutics because its expertise in TF biology and access to proprietary ADC technology provide a robust foundation for developing potentially best-in-class therapies for solid tumor indications with significant unmet clinical need," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. "The data presented today continue to support that potential and differentiate ICON-2 from other anti-TF ADCs. These promising results also underscore Exelixis’ ability to identify promising licensing opportunities as part of our ongoing pipeline expansion strategy, which includes both internally developed and in-licensed programs."

Under the terms of the May 2019 agreement, Exelixis has an exclusive option to license ICON-2 in exchange for an upfront option payment to Iconic of $7.5 million and a commitment of preclinical development funding. Exelixis can exercise its option at any time up to a potential IND application, and upon doing so would make an option exercise payment to Iconic and assume responsibilities for all subsequent clinical development and commercialization activities. Should Exelixis elect to exercise its option, Iconic will become eligible for future development, regulatory and commercialization milestone payments, as well as royalties on potential sales.

On September 15, 2020 Idera Pharmaceuticals, Inc. ("Idera") (Nasdaq: IDRA) reported that final data from the ILLUMINATE-204 trial investigating intratumoral tilsotolimod, Idera’s investigational Toll-like receptor 9 (TLR9) agonist, will be presented in a Mini Oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, to be held September 19-21, 2020 (Press release, Idera Pharmaceuticals, SEP 15, 2020, View Source [SID1234565174]). In addition, final results from ILLUMINATE-101 will be shared in a poster presentation.

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ILLUMINATE-204 is a multi-center, two-arm phase 1/2 trial in patients with anti-PD-1 refractory advanced melanoma. The phase 1 portion of the trial tested the safety and efficacy of increasing doses of tilsotolimod in combination with either Yervoy* (ipilimumab) or Keytruda† (pembrolizumab). The phase 2 expansion of the trial enrolled additional patients at the recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in combination with Yervoy, which is the treatment regimen being evaluated for the same indication in the Company’s registrational trial, ILLUMINATE-301. Adi Diab, M.D., of The University of Texas MD Anderson Cancer Center, will be delivering the Mini-Oral presentation as part of the Mini Oral Session on Melanoma and Other Skin Tumors.

ILLUMINATE-101 is a phase 1b trial evaluating intratumoral tilsotolimod monotherapy in patients with refractory solid tumors, which was completed in December 2019. Final results for ILLUMINATE-101 will be presented by Hani M. Babiker, M.D., of the University of Arizona Cancer Center.

In addition to presentations on these Idera-sponsored trials, AbbVie will be presenting a trial-in-progress poster on their phase 1b study to determine the safety, tolerability, pharmacokinetics, and preliminary efficacy of combinations of ABBV-368 plus tilsotolimod in subjects with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This trial is being conducted as part of an immuno-oncology clinical research collaboration between Idera and AbbVie.

The presentation titles are as follows:

1083MO: Final Results from ILLUMINATE-204, a Phase 1/2 Trial of Intratumoral Tilsotolimod in Combination with Ipilimumab in PD-1 Inhibitor Refractory Advanced Melanoma
1031P: Tilsotolimod Engages the TLR9 Pathway to Promote Antigen Presentation and Type I IFN Signaling in Solid Tumors
975TiP: Phase 1b Trial of ABBV-368 + Tilsotolimod in Combination With Nab-Paclitaxel and/or Budigalimab (ABBV-181) in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
The on-demand poster and oral presentations will be available beginning on Thursday, September 17 and Friday, September 18, respectively.

"We are very pleased that Dr. Diab will present final data from our phase 2 trial exploring tilsotolimod plus ipilimumab in advanced melanoma patients," stated Elizabeth Tarka, M.D., Idera’s Chief Medical Officer. "We are looking forward to completing our registrational trial for this indication, ILLUMINATE-301, where a comparator arm is included, and moving this potential therapy one step closer to those patients in need."

Idera also announced that the company will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 1:30 pm EDT. A live audio webcast of Idera’s presentation will be accessible in the Investor Relations section of Idera’s website at www.iderapharma.com.

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate and adaptive immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint and costimulation therapies. For more information on tilsotolimod trials, please visit ClinicalTrials.gov.

On September 15, 2020 Bayer reported that it has entered into an exclusive global license agreement with Systems Oncology for ERSO, a compound in pre-clinical development for metastatic Estrogen Receptor (ER) positive, breast cancer (Press release, Bayer, SEP 15, 2020, View Source [SID1234565173]). ERSO is a small molecule activator of the Unfolded Protein Response (UPR) in ER-positive breast cancer cells. ERSO’s mechanism of action is a therapeutic approach being investigated in women with metastatic ER-positive breast cancer, an area where new therapies are urgently required.

"Despite the overall progress we see in the treatment of breast cancer, there are limited treatment options for patients whose disease progressed, in particular in the metastatic setting," said Robert LaCaze, Member of the Executive Committee of the Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. "In line with our Oncology strategy to focus on areas with a high medical need and innovative approaches with the potential to make a meaningful impact, we are excited to partner with Systems Oncology in developing ERSO. ERSO is being investigated as an alternative for women with ER-positive breast cancer and enhances our portfolio, enabling us to deliver new treatment options for patients who are waiting for them."

With over 2 million new cases worldwide in 2018, breast cancer is the most common tumor type in women and the second leading tumor type overall. The prognosis as well as available treatment options depend highly on the subtype and stage of breast cancer. Around 70% of all women with breast cancer have ER-positive disease, with the survival rate for metastatic ER-positive breast cancer being only 20%. Thus, the need for additional treatment options beyond established anti-hormonal treatment approaches remains high. In preclinical studies, ERSO showed activity in ER-positive breast cancer cells as well as activity on ER mutations warranting further investigation. In addition, ERSO is also being studied in other tumor types based on its mechanism.

"Given ERSO’s potential in cancer care, it was important for us to align with a sophisticated group that understands innovation. Bayer is a proven innovator who shares our vision for ERSO, and they have the clinical, scientific, and business leadership to succeed," said Dr. Spyro Mousses, CEO and Co-Founder of Systems Oncology.

"With the experienced team at Bayer leading the development effort, I fully expect that this exciting compound has the potential to create a real paradigm-shift for breast cancer care," said Dr. Joyce O’Shaughnessy, Baylor University Medical Center, Texas Oncology, US Oncology.

"The collaboration with Systems Oncology combines their deep experience in identifying alternative treatment pathways with our global footprint and established profile in order to develop new treatment options that can improve patient outcomes," said Marianne De Backer, PhD, MBA, Member of the Executive Committee and EVP, Head Strategy and Business Development & Licensing, Pharmaceuticals Division of Bayer AG. "It underlines our commitment to explore partnerships on innovative treatment approaches at all levels."

Under the terms of the agreement, Bayer will be responsible for developing and commercializing ERSO globally. Systems Oncology will receive an upfront payment of 25 million US dollars and is eligible to receive payments from Bayer upon achievement of certain development, and commercialization milestones totaling 345 million US dollars, as well as royalties on future global net sales.

The Pharmaceuticals Business Development & Licensing team of Bayer facilitated this collaboration.

About ERSO

Scientists at Systems Oncology entered into a strategic research collaboration with two professors at the University of Illinois, Dr. David Shapiro and Dr. Paul Hergenrother, who respectively conducted pioneering research into the biology and chemistry of anticipatory activation of UPR in breast cancer. The research led to intellectual property (IP) that covered small molecule agents that can activate the UPR. Inspired with a multi-scalar systems understanding of this mechanism, Systems Oncology acquired a license to the IP from the University and invested to drive pre-clinical studies and manufacturing development, eventually establishing the ERSO program as a promising investigational compound.

On September 15, 2020 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported that Bonnie H. Anderson, chairman and chief executive officer, is scheduled to participate in two virtual investor conferences this week (Press release, Veracyte, SEP 15, 2020, View Source [SID1234565171]):

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2020 Cantor Virtual Global Healthcare Conference
Presentation on Wednesday, September 16, 2020, at 1:20 p.m. ET
Lake Street’s Virtual 4th Annual (BIG4) Conference
1×1 meetings throughout the day on Thursday, September 17, 2020
A live audio webcast of the company’s presentation, where applicable, will be available by visiting Veracyte’s website at View Source Replays of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On September 15, 2020 Enzon Pharmaceuticals, Inc. (the "Company" or "Enzon") (OTC:ENZN) reported the record date and expected subscription period for its previously-announced rights offering to raise proceeds of approximately $43 million (Press release, Enzon, SEP 15, 2020, View Source [SID1234565170]). The proceeds from the rights offering will be utilized to position the Company as a public company acquisition vehicle, where it can become an acquisition platform and more fully utilize its net operating loss tax carryforwards and enhance stockholder value.

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The Company filed Amendment Number 1 to its Registration Statement on Form S-1 providing 5:00 p.m., New York City time, on September 23, 2020 as the record date. Subject to the Registration Statement becoming effective on or about September 18, 2020, the Company intends to commence the rights offering on September 23, 2020.

Under the rights offering, holders of Enzon’s common stock will receive one transferable subscription right for each share of common stock owned. For every 1,105 subscription rights held, stockholders will be entitled to purchase one unit at the subscription price of $1,090 per unit. Each unit consists of one share of newly designated Series C preferred stock and 750 shares of Enzon’s common stock, all as described in the Registration Statement.

Although the subscription rights are transferable there can be no guarantee that a market will develop during the subscription period or that stockholders will be able to buy or sell additional subscription rights. Accordingly, unless a stockholder is able to acquire additional subscription rights during the subscription period, a stockholder must own shares of common stock as of the record date, or acquire shares of common stock prior to the record date, in multiples of 1,105 in order to receive subscription rights enabling it to purchase units, as no fractional units, preferred stock or common stock will be issued. In connection with the rights offering, Icahn Capital LP has agreed to purchase all units that remain unsubscribed for at the end of the subscription period.

Upon the sale of all 40,000 units available for purchase in the rights offering, the Company will have 40,000 shares of Series C preferred stock outstanding and an aggregate of 74,214,603 shares of common stock outstanding following the rights offering.

The expected calendar for the rights offering, unless extended or modified by Enzon, is as follows:

•September 23, 2020 at 5:00 PM, New York City Time: Record Date

•September 24, 2020: Estimated Distribution Date; Subscription Period Estimated to Begin

•October 9, 2020 at 5:00 PM, New York City Time: Subscription Period Ends

•October 16, 2020: Estimated Date of Distribution of Preferred and Common Stock

Important Information

For additional information on the Rights Offering, please see the prospectus included in Enzon’s registration statement on Form S-1 and related amendments, which has not yet become effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.