Geron to Announce Third Quarter Financial Results on November 5, 2020

On October 29, 2020 Geron Corporation (Nasdaq: GERN) reported that it will release its third quarter 2020 financial results after the market closes on Thursday, November 5, 2020 via press release, which will be available on the Company’s website at www.geron.com/investors (Press release, Geron, OCT 29, 2020, View Source [SID1234569806]). Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

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A live, listen-only webcast will be available on the Company’s website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company’s website for 30 days.

Participants may access the conference call live via telephone by pre-registering online using the following link, View Source Upon registration, a phone number, Direct Event Passcode and unique Registrant ID will be sent via email. This information will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.

Immutep to Collaborate with LabCorp to Develop Oncology Services and Products

On October 29, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, reported that it has entered into a Licence and Collaboration Agreement with Laboratory Corporation of America Holdings, known as LabCorp (NYSE: LH) that will support the development of immuno-oncology products or services (Press release, Immutep, OCT 29, 2020, View Source [SID1234569750]).

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"Over the years, Immutep has generated a significant amount of know-how in immuno-oncology, specifically in terms of LAG-3", said Marc Voigt, CEO of Immutep.

Under the terms of the Agreement, Immutep is eligible to receive an upfront fee of US$125,000 and potential further commercial milestones and service payments. The milestone payments, which consist of up to three payments, are tied to the commercialisation of new drugs or new indications of existing drugs that requires use of an immuno-oncology diagnostic being developed by LabCorp.

The Agreement will continue until such time as the licensed technology and associated intellectual property have been exhausted and are in the public domain, or until terminated by either party.

The collaboration with LabCorp is unrelated to any of Immutep’s own in-house pharmaceutical development programs in cancer or autoimmune disease. Significantly, it enables Immutep to enter the immuno-oncology diagnostics field.

Bellicum Announces $25.0 Million Underwritten Offering Priced At-The-Market

On October 29, 2020 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported the pricing of an underwritten offering priced at-the-market under Nasdaq rules of 4,149,378 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and accompanying warrants to purchase up to 4,149,378 shares of common stock (Press release, Bellicum Pharmaceuticals, OCT 29, 2020, View Source [SID1234569654]). Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with one warrant to purchase one share of common stock at a combined effective price of $6.025. The offering is expected to involve a limited number of healthcare-dedicated institutional investors, including significant participation from two of Bellicum’s existing healthcare-dedicated institutional investors.

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

The gross proceeds to Bellicum from the offering are expected to be approximately $25.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Bellicum, excluding any proceeds that may be received upon exercise of the common warrants. Bellicum anticipates using the net proceeds from the offering, together with its existing capital resources, to fund ongoing and planned BPX-601 and BPX-603 clinical trials, and for general corporate purposes, including research and development and to fund working capital.

The common warrants will be immediately exercisable at an exercise price of $6.50 per share of common stock and will expire five years from the date of issuance. The shares of common stock or the pre-funded warrants, and the accompanying common warrants, can only be purchased together in the offering but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about November 3, 2020, subject to satisfaction of customary closing conditions.

The securities described above are being sold by Bellicum pursuant to a shelf registration statement filed by Bellicum with the Securities and Exchange Commission (SEC), which was declared effective on July 30, 2019. The securities will be sold only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained, when available, by contacting H.C. Wainwright & Co., LLC, by emailing [email protected] or by calling 646-975-6996, or by visiting the SEC’s website at View Source

This press release shall not constitute an offer to sell or the 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.

Zai Lab Announces First Patient Dosed in China in a Potentially Registrational Study of Retifanlimab in Patients with Endometrial Cancer

On October 29, 2020 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial stage biopharmaceutical company, reported dosing of the first patient in China in the global POD1UM-101 study evaluating retifanlimab in patients with previously treated, microsatellite instability-high endometrial cancer (Press release, Zai Laboratory, OCT 29, 2020, View Source [SID1234569580]).

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"Endometrial cancer is one of the most common gynecological cancers in China and represents a significant unmet need," said Dr. Beihua Kong, Professor of Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University. "More specifically, high levels of microsatellite instability (MSI-H) have been reported in up to 30% of all endometrial cancers in the recurrent setting. PD-1 inhibition with a therapeutic such as retifanlimab represents a promising clinical approach for these patients."

This is a potentially registrational, Phase 1b, open-label study evaluating retifanlimab as monotherapy in patients with previously treated, MSI-H endometrial cancer. The study is expected to enroll approximately 100 patients in the US and China. The primary endpoint of the study is overall response rate (ORR). Key secondary endpoints include duration of response (DOR), progression free survival (PFS), overall survival (OS), safety and pharmacokinetics.

About Endometrial Cancer

Endometrial cancer is one of the most common gynecological cancers in China, and its incidence is increasing. Surgery is the main treatment for most women with this cancer, with 5-year overall survival (OS) rate of 81.2%. However, the 5-year OS rate is only 17.3% for patients with metastasis or recurrence, and effective treatment options are limited.

About Retifanlimab

Retifanlimab (formerly INCMGA0012), an investigational anti-PD1 antibody, is currently under evaluation in registration-directed studies as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.

In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and exclusive commercialization of retifanlimab in China, Hong Kong, Macau and Taiwan.

Sanofi to evaluate the safety and efficacy of novel investigational candidate THOR-707 and KEYTRUDA® (pembrolizumab) in pursuit of establishing a new treatment option in oncology

On October 29, 2020 Sanofi reported that it has entered into an agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the U.S. and Canada) to conduct a Phase 2 clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of THOR-707, a highly differentiated non-alpha IL-2 candidate with a best-in-class profile, combined with or in sequenced administration with MSD’s KEYTRUDA (pembrolizumab) in patients with various cancers (Press release, Sanofi, OCT 29, 2020, View Source [SID1234569579]).

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Under the agreement, Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA.

"We believe that THOR-707 has the potential to become a foundation of the next generation of immuno-oncology therapies," said Peter Adamson, Global Head, Oncology Development and Pediatric Innovation, Sanofi. "This collaboration with MSD will enable us to explore whether THOR-707 can increase and expand the effectiveness of KEYTRUDA and improve the outcomes for patients with cancer."

THOR-707 is currently being evaluated by Sanofi in an ongoing Phase 1 open-label, multi-center, dose escalation and expansion trial. This study is designed to evaluate the safety and tolerability of THOR-707, and to determine its recommended Phase 2 dose alone and in combination with anti-PD-1 and anti-EGFR antibodies.

In addition to testing THOR-707 in combination with KEYTRUDA, Sanofi is separately evaluating the activity of this novel biologic in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors.

THOR-707 demonstrated in preclinical studies the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as single agent as well as in combination with an anti-PD1 mAb.

It is the first molecule from the Synthorin platform, Sanofi’s unique expanded genetic alphabet platform, which has the potential to create a new generation of precision medicines for oncology and autoimmune disease.

About THOR-707

THOR-707 has the potential to be a best-in-class IL-2 therapeutic for the treatment of many types of malignancies and may demonstrate improved pharmacology allowing for less frequent dosing. In pre-clinical experiments, THOR-707 shows striking synergy with anti-PD-1 therapeutics.

It is a precisely PEGylated engineered version of interleukin-2 (IL-2), where the PEG chain is attached at a location on IL-2 that prevents it from binding to immune receptors that cause drug toxicities (IL-2R-alpha, CD25) while preserving binding to immune receptors that selectively expand tumor-killing T effector and Natural Killer (NK) cells without the immunosuppressive effects of regulatory T cells or vascular leak syndrome (VLS) inducing eosinophils.