Immutep Announces Data from Ongoing TACTI-mel Phase I Clinical Trial in Unresectable or Metastatic Melanoma

On March 6, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) (Immutep or the Company), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported positive, more mature data from its ongoing TACTI-mel phase I clinical study of the Company’s lead product candidate, eftilagimod alpha ("efti" or "IMP321") (Press release, Immutep, MAR 6, 2019, View Source [SID1234534115]). The data will be presented at the World Immunotherapy Congress 2019 in San Diego USA, by Dr. Frédéric Triebel, Immutep’s Chief Scientific Officer and Chief Medical Officer at 3:00 PM Pacific Standard Time on 5th March 2019.

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The TACTI-mel study is evaluating the combination of efti with anti-PD-1 therapy KEYTRUDA (pembrolizumab) in 24 patients with unresectable or metastatic melanoma. It is a multi-center, open-label clinical trial that involves four cohorts of six patients, each cohort testing different dosages of efti, including 1 milligram (mg), 6 mg and 30 mg, in combination with pembrolizumab.

Part A of the study is starting the combination therapy at cycle 5 of the pembrolizumab treatment in three cohorts with a treatment duration of 6 months. Part B of the study includes a cohort of 6 patients at 30 mg of efti in combination with pembrolizumab, starting at cycle 1, day 1 and with a treatment duration of 12 months.

*Exploratory ORR when tumour size is measured according to irRC from day 1 of cycle 1 of pembrolizumab and following combination therapy (which starts at cycle 5 of prembrolizumab treatment).

Safety results (total n=24):

Efti has very favorable safety profile in doses up to 30 mg administered s.c. every 2 weeks;

Combination with PD-1 antagonists is feasible without dose limiting toxicity (DLTs) or reaching MTD; and

No DLT or new safety signal have been observed in either part of the study.

Notes to the results

Part B

All patients high risk with 100% M1c status, 83% elevated LDH and 50% ECOG 1;

Very deep responses with 1 patient having complete disappearance of target lesions at 3 months already; and

Treatment is ongoing (6+ months) in 4 patients.

Part A

Late stage (78 % M1C stage, 38 % elevated LDH) patients sub-optimally responding to pembrolizumab monotherapy;

Long lasting and durable responses (up to 30 months) continue to be observed in a subset of patients, 4 patients still in PFS follow-up; and

Tumor shrinkage in 56% of patients incl. 2 patients with complete disappearance of all target lesions.

The full presentation slides from this event can be accessed via Immutep’s website.

Immutep CSO and CMO, Frédéric Triebel, CEO, Marc Voigt and Director of Clinical Development, Christian Mueller will discuss the data, along with the clinical development program for IMP321, including other trials, on a global webcast in the coming weeks. Details of the webcast will be announced separately.

About the TACTI-mel clinical trial

The ongoing TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial is a multi-center, open-label study evaluating the combination of eftilagimod alpha ("efti") with pembrolizumab, in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy (clinicaltrials.gov identifier NCT 02676869).

Infinity Pharmaceuticals Announces Royalty Monetization of COPIKTRA™ for $30 Million Gross Proceeds

On March 6, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported a royalty monetization with HealthCare Royalty Partners (HCR) for the right to receive certain royalty payments based on worldwide annual net sales of COPIKTRA (duvelisib), payable by Verastem (Press release, Infinity Pharmaceuticals, MAR 6, 2019, View Source [SID1234534015]). Under the agreement, HCR has agreed to pay Infinity a $30 million upfront payment and up to $20 million in potential milestone payments. The transaction is expected to close by March 11, 2019.

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"This non-dilutive financing provides Infinity with immediate and substantial capital to support our expansion of the breadth and depth of IPI-549 development," said Adelene Perkins, Chief Executive Officer of Infinity. "We continue to be focused on creating value for patients and shareholders as we continue to progress the development of IPI-549 into additional combinations, indications, lines of therapy and later-stage trials."

The right to receive royalty payments will revert to Infinity if HCR receives a multiple of its total investment amount and certain reasonably incurred expenses paid by HCR, up to a prespecified cap amount which increases over time. If the cap amount is met, Infinity will continue to receive COPIKTRA royalty revenue until the revenue stream ends and if the cap amount is not met prior to June 30, 2025, the COPIKTRA royalty revenue will not revert to Infinity and will instead be paid to HCR until the revenue stream ends.

In connection with Infinity’s monetization of its interest in the royalty stream, Infinity has granted to HCR Collateral Management, LLC a security interest in all of the Company’s interest in the royalty stream and other specified collateral, including certain patents owned by Infinity underlying duvelisib and other related rights. HCR Collateral Management may exercise its rights with respect to the collateral under specified limited circumstances.

Under Infinity’s license agreement with Intellikine, LLC, a subsidiary of Takeda Pharmaceuticals Company Limited, Infinity and Takeda would share equally in the royalties due from Verastem. In connection with the royalty monetization, Infinity entered into an amendment of its license agreement with Takeda pursuant to which Takeda has instead agreed to receive a

portion of the total investment amount and Infinity will continue to pay Takeda a percentage of the royalties that would have been payable to Infinity but for the consummation of the transaction. If the right to receive royalty payments from Verastem reverts to Infinity, Infinity will thereafter go back to the original terms of its license agreement.

Verastem will continue to pay directly to Infinity royalties that Infinity is obligated to pay to Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Limited and Infinity will retain in full its obligations to make the royalty payments to those entities pursuant to its separate agreements with those entities.

For a further description of the foregoing transactions, please refer to Infinity’s Current Report on Form 8-K which was filed with the Securities and Exchange Commission on March 6, 2019.

Morgan Stanley & Co. LLC acted as sole structuring agent on the monetization.

About COPIKTRA (duvelisib) Royalties

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Infinity licensed worldwide development and commercialization rights to COPIKTRA to Verastem, Inc. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.

About Healthcare Royalty Partners HealthCare Royalty Partners ("HCR") is a private investment firm that purchases royalties and uses debt-like structures to invest in commercial or near-commercial stage life science assets. HCR has $4.4 billion in cumulative capital commitments with offices in Stamford (CT), San Francisco, Boston and London. For more information, visit www.healthcareroyalty.com.

IMV Inc. Closes Previously Announced Public Offering

On March 6, 2019 IMV Inc. ("IMV" or the "Corporation") (NASDAQ: IMV; TSX: IMV), a clinical-stage immuno-oncology corporation, reported the closing of its previously-announced underwritten public offering (the "Offering") of 4,900,000 common shares at a price to the public of C$5.45 per common share, for aggregate gross proceeds to the Corporation of approximately C$26.7 million, before deducting the underwriting commissions and estimated Offering expenses (Press release, IMV, MAR 6, 2019, View Source [SID1234534034]). In addition, the Corporation has granted the underwriters of the Offering a 30-day option to purchase up to an additional 735,000 common shares on the same terms and conditions.

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The Corporation intends to use the net proceeds of the Offering to accelerate the development of DPX-Survivac in combination with Keytruda as part of the basket trial select advanced or recurrent solid tumours in bladder, liver (hepatocellular carcinoma), ovarian or non-small-cell lung cancers, as well as tumours shown to be positive for the microsatellite instability high biomarker and for general corporate purposes.

Wells Fargo Securities and Raymond James acted as joint book-running managers for the Offering. B. Riley FBR acted as co-manager.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the "SEC") on June 6, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Prospectus") dated June 5, 2018. A preliminary prospectus supplement relating to the Offering was filed on February 28, 2019 with the securities commissions in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, Nova Scotia and Newfoundland and Labrador in Canada, and with the SEC in the United States, and a final prospectus supplement relating to the Offering (the "Supplement") was filed on March 1, 2019 with the securities commissions in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, Nova Scotia and Newfoundland and Labrador in Canada, and with the SEC in the United States. The Supplement and the accompanying Base Prospectus contain important detailed information about the Offering. The Supplement and the accompanying Base Prospectus can be found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained from Wells Fargo Securities, Attn: Equity Syndicate, 375 Park Avenue, New York, NY 10152, by telephone at (800) 326-5897, or by email at [email protected] or from Raymond James, Attn: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or e-mail at [email protected].

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

Acorda to Present at Oppenheimer’s 29th Annual Healthcare Conference

On March 6, 2019 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that Andrew Hindman, Acorda’s Chief Business Officer, will present at the Oppenheimer & Co. Annual Healthcare Conference on Tuesday, March 19 at 1:35 p.m. EST (Press release, Acorda Therapeutics, MAR 6, 2019, View Source [SID1234534058]). A live audio webcast of the presentation can be accessed under "Investor Events" in the Investor section of the Acorda website at www.acorda.com, or you may use the link:

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https://www.veracast.com/webcasts/opco/healthcare2019/84112556645.cfm

Sangamo Therapeutics Announces Participation At Upcoming Investor Conferences

On March 6, 2019 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that management will participate in the following healthcare investor conferences in March (Press release, Sangamo Therapeutics, MAR 6, 2019, View Source [SID1234534074]):

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Cowen 39th Annual Health Care Conference
Presentation Date: Tuesday, March 12th at 8:40 a.m. Eastern Time
Location: Boston, MA
Barclays 2019 Global Healthcare Conference
Presentation Date: Thursday, March 14th at 8:00 a.m. Eastern Time
Location: Miami, FL
ARM 7th Annual Cell & Gene Investor Day
Presentation Date: Thursday, March 21st at 2:45 p.m. Eastern Time
Location: New York, NY

The presentations will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentations will be archived on the Sangamo website for two weeks after the events.