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]).

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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.
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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.
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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.

On October 11, 2018 Johnson & Johnson Janssen pharmaceutical companies reported that it will present updates of their entire oncology portfolio at the 2018 annual congress of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), which will be held from 19 to 23 October in Munich, Germany (Press release, Johnson & Johnson, OCT 11, 2018, View Source [SID1234529866]).

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On October 11, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will be presenting at the BIO Investor Forum on Wednesday, October 17, 2018, at 11:15 a.m. PT (2:15 p.m. ET) in San Francisco, CA (Press release, Infinity Pharmaceuticals, OCT 11, 2018, View Source [SID1234529881]). A live webcast of the presentation will be available on the Investors/Media section of Infinity’s website at www.infi.com, and will be available for 30 days following the event.

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On October 11, 2018 Iovance Biotherapeutics, Inc. (Nasdaq:IOVA) ("Iovance" or "Company"), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering (Press release, Iovance Biotherapeutics, OCT 11, 2018, View Source [SID1234530235]). All of the shares in the offering are to be sold by Iovance. Iovance intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the shares of common stock at the public offering price, less the underwriting discounts and commissions.

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Iovance intends to use the proceeds from this offering to fund the expansion of its organization to support the potential commercial launch of lifileucel, to fund its commercial manufacturing capabilities and facilities, to fund its ongoing clinical trials for its current product candidates, including its on-going Phase 2 clinical trials of LN-144, TIL for the treatment of metastatic melanoma, and LN-145, TIL for the treatment of cervical and head and neck cancers, to fund its planned clinical trials for its current product candidates, including its ongoing Phase 2 clinical trial of LN-145 for the treatment of non-small cell lung cancer, or NSCLC, in collaboration with MedImmune, and its ongoing Phase 2 clinical trials of LN-145 as an early-line therapy alone or in combination with pembrolizumab in melanoma, head and neck cancer, and NSCLC, and for other general corporate purposes. Additional indications may be explored with the use of proceeds.

Jefferies LLC is acting as sole book-running manager for the offering.

The shares of common stock described above are being offered by Iovance pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). The offering may be made only by means of a prospectus supplement and accompanying prospectus, copies of which may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor New York, New York, 10022, by telephone at (877) 821-7388, or by email at [email protected].

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 11, 2018 Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company, reported that the company will present at the 2018 BIO Investor Forum being held in San Francisco, CA on October 17-18 (Press release, Immunomics, OCT 11, 2018, View Source [SID1234529867]). William Hearl, Ph.D., Immunomic’s Founder and Chief Executive Officer (CEO), will present a company overview and will discuss Immunomic’s recently expanded investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM). Immunomic’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

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A live webcast of the presentation will be available on the company’s website, www.immunomix.com, and through the link below:

http://www.veracast.com/webcasts/bio/investorforum2018/46203468489.cfm.

An archive of the presentation will be available approximately one hour after conclusion of the live event.

Who: William Hearl, Ph.D., Founder and CEO of Immunomic Therapeutics, Inc.

What: Immunomic Therapeutics Takes Aim at Cancer at the BIO Investor Forum

When: Thursday, October 18 at 9:45 a.m. PDT

Where: Westin St. Francis Hotel, Room Elizabethan D, 335 Powell Street, San Francisco, CA 94102

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.