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Forbius Nominated for “Best New Drug Developer” Award at the 2018 World ADC Awards

On October 11, 2018 Forbius (Formation Biologics) reported that it was nominated in the "Best New Drug Developer" category at the 5thAnnual World ADC Awards (Press release, Forbius, OCT 11, 2018, View Source [SID1234531671]). This competitive nomination process involved over 2,545 casted votes to recognize leaders and innovators in the antibody-drug conjugate (ADC) research field.

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Forbius’ lead program, AVID100, is an ADC targeting EGFR. AVID100 is undergoing Phase 2 clinical trials in patients with confirmed EGFR overexpression in squamous cell carcinoma of the head and neck, squamous non-small cell lung cancer, and triple negative breast cancer. Phase 2a development of AVID100 is supported by the recently announced $18.75M peer-reviewed grant from the Cancer Prevention Research Institute of Texas (CPRIT).

Oncolytics Biotech® Announces Publication of Positive Clinical Results for
Pelareorep in Abstract for ESMO 2018 Congress

On October 11, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported publication of an abstract on pelareorep (formerly known as REOLYSIN) for the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place October 19-23 in Munich (Press release, Oncolytics Biotech, OCT 11, 2018, View Source [SID1234530639]).

The abstract, authored by Sanjay Goel, Department of Medical Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, et al., "Dose finding and safety study of Reovirus (Reo) with irinotecan/ fluorouracil/ leucovorin/ bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic colorectal cancer (mCRC): Final results", outlines positive clinical trial results for pelareorep in the treatment of patients with KRAS mutant metastatic colorectal cancer. Thirty-six patients received treatment with FOLFIRI/B and pelareorep, and the results demonstrated that the combination is not only safe and well tolerated, but that progression free survival (PFS) and overall survival (OS) are significantly superior to historical data.

The patients receiving the recommended phase 2 dose had a 50 percent response rate (3 of 6 patients) and the median PFS and OS were 65.6 weeks and greater than 98.3 weeks (as of May 9, 2018), respectively.

"The noted improvement in both PFS and OS compared to historical results are meaningful for Oncolytics and for the patients," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "The favorable results reported from this clinical trial demonstrate the potential of pelareorep to be a compelling treatment choice for a patient population that otherwise has limited therapeutic options after they have progressed on current standard-of-care chemotherapy."

The complete Abstract can be found online at View Source Full details from the poster presentation will be announced after it is presented.

Presentation Number:
565P
Date:
October 21, 2018
Lecture Time:
1:05 pm CEST
Location:
Hall A3 – Poster Area Networking Hub, ICM München, Munich, Germany
Speakers:
Sanjay Goel
Session Name:
Basic science, Endocrine tumours, Gastrointestinal tumours – colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The

compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

Iovance Biotherapeutics Reports Results from FDA End of Phase 2 meeting and Provides Updates About the Company’s Clinical Program

On October 11, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported results from an FDA End of Phase 2 meeting and provided a corporate update (Press release, Iovance Biotherapeutics, OCT 11, 2018, View Source;p=RssLanding&cat=news&id=2371343 [SID1234530323]).

The company reported that an End of Phase 2 meeting with the FDA was held. FDA has acknowledged the potential acceptability of a single-arm cohort for registration. FDA has further acknowledged that conduct of a randomized Phase 3 trial may not be feasible in its intended population of advanced melanoma patients who have been treated with at least one systemic therapy including a PD-1 blocking antibody and if BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor and is not required for initial registration of lifileucel. A new cohort of 80-100 patients in C-144-01 will be enrolled with a prospective definition of the primary endpoint of ORR to be read out by a Blinded Independent Review Committee (BIRC) to support registration of lifileucel. This new cohort, which the company refers to as Cohort 4, will be initiated in early 2019 and is expected to be fully enrolled by late 2019/early 2020. BLA submission to FDA is expected in the second half of 2020.

The company also reported that Iovance was granted a Regenerative Medicine Advanced Therapy (RMAT) designation for lifileucel in advanced melanoma based on data provided to the U.S. Food and Drug Administration (FDA) from the company’s C-144-01 study. RMAT designation is granted for regenerative medicine drugs and allows for increased access to FDA during development. Under this designation, surrogate endpoints can be used to receive approval for a product, accelerated approval may be granted, and a rolling review of a Biologics License Application (BLA) may be possible for the Center for Biologics Evaluation and Research (CBER).

"We are very excited with the progress made at Iovance during 2018. Specifically, we are pleased to have alignment with FDA regarding acceptability of a single-arm cohort to support registration of our lead product. In addition, we have greatly optimized our manufacturing process with Gen 2, leading to a scalable, commercial manufacturing process. We now have a global footprint with our clinical sites resulting in increased clinical enrollment and have produced sufficient data to discuss our registration path with FDA. As part of the recent interactions, we have also received an RMAT designation allowing for more frequent interactions with the FDA, benefiting from the agency’s guidance during development of lifileucel," said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics.

Corporate Update

Regulatory

Iovance held an End of Phase 2 meeting with FDA during which the agency acknowledged that a single-arm cohort as part of C-144-01 could be supportive of initial registration and conduct of a randomized Phase 3 trial in the patient population being enrolled may not be feasible.
Iovance was granted an RMAT designation for advanced melanoma.
Iovance intends to continue consultation with FDA under the RMAT designation and enroll a new cohort of patients to support registration of lifileucel. The new cohort will have a prospective definition of the primary endpoint of ORR by BIRC and release criteria for lifileucel.
Clinical

The Company also reported that data from 46 patients of Cohort 2 of trial C-144-01 will be provided at SITC (Free SITC Whitepaper) 2018. For these 46 patients, an objective response rate (ORR) of 37% has been observed in the cohort, with duration of response (DOR) ranging from 1.3+ to 14+ months depending on time of enrollment. The ORR includes one (1) complete response and 16 partial responses, six (6) of which are unconfirmed and pending patient’s upcoming second assessments.
Enrollment in the global Phase 2 metastatic melanoma study, C-144-01, has reached the predefined sample size. Enrollment into the existing Cohort 2 will be closed and a new Cohort 4 will be initiated in early 2019. The company plans on initiating enrollment into Cohort 4 in early 2019 and expects to fully enroll the necessary patients into Cohort 4 by late 2019/early 2020.
BLA submission is expected in the second half of 2020.
Enrollment continues in other Iovance studies. Patient dosing in EU was initiated in the C-145-04 study of cervical carcinoma. The study design is based on Simon’s two-stage design. Stage one has now been completed and enrollment in the study continues. To date, preliminary data for 15 patients yields an ORR of 27% with an early look at the DOR ranging from 2.4 to 2.5+ months. In the C-145-03 study of head and neck cancer, to date, preliminary data for 13 patients yields an ORR of 31% with a DOR ranging from 2.8 to 7.6 months. The safety findings from these studies remain consistent with previous reports.
Data referenced above is from a data cut as of October 4, 2018.
Manufacturing

In support of the ongoing studies in EU, in addition to Lonza, Netherlands, a second European manufacturing collaboration was initiated.
IP

Two U.S. patent applications covering therapeutic methods based upon Generation 2 manufacturing, developed at Iovance, have been recently allowed.

Karyopharm Therapeutics Announces Pricing of $150 Million of Convertible Senior Notes

On October 11, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported the pricing of $150 million aggregate principal amount of its 3.00% convertible senior notes due 2025 (the "Notes") (Press release, Karyopharm, OCT 11, 2018, View Source [SID1234530278]). The Notes will be sold in a private offering to qualified institutional buyers in reliance on Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). Karyopharm also granted to the initial purchasers of the Notes a 13-day option to purchase up to an additional $22.5 million aggregate principal amount of the Notes. The offering is expected to close on or about October 16, 2018, subject to satisfaction of customary closing conditions.

The Notes will be unsecured, senior obligations of Karyopharm, and will bear interest at a rate of 3.00% per annum, payable semi-annually in arrears on April 15 and October 15 of each year, beginning on April 15, 2019. The Notes will mature on October 15, 2025, unless earlier repurchased, redeemed or converted in accordance with their terms. Subject to certain conditions, on or after October 15, 2022, Karyopharm may redeem for cash all or a portion of the Notes at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date. The Notes will be convertible at the option of holders of the Notes, upon satisfaction of certain conditions and during certain periods, into cash, shares of Karyopharm’s common stock, or a combination of cash and shares of Karyopharm’s common stock, at Karyopharm’s option. The conversion rate for the Notes will initially be 63.0731 shares of Karyopharm’s common stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $15.85 per share. This represents a premium of approximately 27.5% over the last reported sale price of $12.435 per share of Karyopharm’s common stock on The Nasdaq Global Select Market on October 10, 2018. The conversion rate will be subject to adjustment upon the occurrence of certain events.

Karyopharm estimates that the net proceeds from the sale of the Notes will be approximately $145.1 million (or approximately $167.0 million if the initial purchasers exercise their option to purchase additional Notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Karyopharm. Karyopharm intends to use the net proceeds from the sale of the Notes: to continue establishing the infrastructure to support the potential commercial launch of selinexor; to support continued clinical development of selinexor in hematologic malignancies and solid tumors; to conduct ongoing activities to support regulatory submissions for oral selinexor as a new treatment for patients with penta-refractory multiple myeloma and, if the results of Karyopharm’s SADAL trial are positive, as a new treatment for patients with relapsed/refractory diffuse large B-cell lymphoma; for clinical trials of two of Karyopharm’s pipeline drug candidates in oncology, eltanexor and KPT-9274; and for working capital and other general corporate purposes.

The Notes will be offered and sold to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the Notes and the shares of common stock issuable upon conversion of the Notes, if any, have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction, and the Notes and any such shares may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. Any offer of the Notes will be made only by means of a private offering memorandum.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the Notes or any other securities, nor shall there be any offer, solicitation or sale of the Notes or any other securities (including the shares of Karyopharm’s common stock issuable upon conversion of the Notes, if any) in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful

Immune Design Announces Program Updates & Portfolio Prioritization for G100 and CMB305

On October 11, 2018 Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported program updates for its G100 intratumoral TLR4 agonist and CMB305 cancer vaccine programs in development for the treatment of cancer (Press release, Immune Design, OCT 11, 2018, View Source [SID1234530255]).

The company has completed a portfolio review and determined that, given advances in G100 and its broad potential, new CMB305 data, and existing capital, it should focus on accelerating and expanding the development of G100.

G100 has a unique mechanism of action that differs from current therapies in lymphoma. It triggers an immune-mediated anti-tumor effect with a favorable safety profile that could position G100 as a pillar of chemo-free regimens for the treatment of lymphomas and beyond.
◦
Immune Design’s first goal is to develop G100 in combination with pembrolizumab in follicular lymphoma patients who have received three prior lines of systemic therapy. These patients may represent an unmet medical need, which may allow for an accelerated approval path in this indication.

The company will evaluate the clinical activity based on Objective Response Rate (ORR) in an open label setting.

To accelerate enrollment, Immune Design plans to use both an open IND and submit a new IND for this specific unmet medical need population, as requested by the FDA.

The data from both INDs would be combined in a potential BLA filing.

Based on existing ORR data, approximately 100 patients may be required. The final sample size will be adapted depending on the ORR observed in the initial patients.
◦
Given its broad potential reach, Immune Design’s second goal is to evaluate G100 beyond late-stage follicular lymphoma.

Immune Design intends to evaluate G100 in earlier-stage follicular lymphoma patients in combination with rituximab, the backbone treatment for lymphomas in multiple lines of therapy.

The company also plans to explore G100 in combination with other agents in both indolent and aggressive lymphomas that are known to express TLR4.

Finally, the company plans to evaluate the safety and efficacy of G100 in solid tumors, initially through supporting investigator-sponsored studies.

Based on a recent review of the CMB305 program, including an early analysis of the ongoing Phase 2 study that showed the combination of CMB305 and Tecentriq (atezolizumab) is not likely to show a survival benefit in relapsed synovial sarcoma patients, the company has decided to discontinue the SYNOVATE trial. Immune Design will seek external collaborations to explore the continued development of CMB305 in sarcoma.

This portfolio prioritization and an associated company re-structuring extends Immune Design’s cash runway into 2021, which enables significant potential value creation from the focus on, and expanded development of, G100.

Conference Call Information

Immune Design will host a conference call and live audio webcast this afternoon at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss these program updates.

The live call may be accessed by dialing (844) 266-9538 for domestic callers and (216) 562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the Immune Design website at View Source and will be archived there for 30 days. A telephone replay of the call will be available for five days by dialing (855) 859-2056 for domestic callers or (404) 537-3406 for international callers and entering the conference code 7095731.

An archived copy of the webcast will be available on Immune Design’s website beginning approximately two hours after the conference call. Immune Design will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.