On January 4, 2022 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported a $20 million equity investment by Hanmi Pharmaceutical along with revisions to the licensing agreements for ROLONTIS (eflapegrastim) and poziotinib (Press release, Spectrum Pharmaceuticals, JAN 4, 2022, View Source [SID1234598098]). Under the terms of the strategic investment, Hanmi entered into a $20 million equity purchase agreement that will be priced at $1.60 per share.

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"This investment represents a strengthening in the relationship that we have with Hanmi," said Tom Riga, President and CEO of Spectrum Pharmaceuticals. "We look forward to our continued partnership with Hanmi and to achieving the shared goal of gaining FDA approval for ROLONTIS and poziotinib."

"Following a recent meeting in Korea with Spectrum management, we wanted to make this investment as a symbol of our confidence in their strategic direction moving forward," said Se-Chang Kwon, Ph.D., Chief Executive Officer at Hanmi Pharmaceutical. "We view our collaboration with Spectrum as a key driver of our future growth and an integral part of bringing Hanmi’s novel molecules to the U.S. market."

Amendments to the licensing agreements for both ROLONTIS and poziotinib will result in the conversion of the upfront milestone payments for both products to deferred royalties. In addition, the royalty obligation for ROLONTIS will be changed to mid-single digits as a percent of sales for a specified period. Previously, the contract terms stipulated tiered royalties ranging from low double digits to mid-teens on Spectrum’s annual net sales of ROLONTIS. The milestone payment based on ROLONTIS approval in the U.S. will be eliminated in return for an additional royalty, that will continue until the milestone is fully paid, based on the incremental royalty. Also, the amended agreement eliminates poziotinib’s approval milestone payment in return for an additional royalty that will continue until the milestone is fully paid, based on the incremental royalty. The companies also agreed to an amended supply arrangement that is expected to result in a lower cost of goods sold for Spectrum.

About ROLONTIS (eflapegrastim)

ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.

On January 4, 2022 Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), reported that Dr. Henry Ji, Chairman and CEO, will participate in the following upcoming panel at the Longwood Healthcare Leaders Winter Conference (Press release, Sorrento Therapeutics, JAN 4, 2022, View Source [SID1234598097]):

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January 6th at 11:50 am PT / 2:50 pm ET
HOW M&A SPURS INNOVATION
Mark Enyedy, CEO, ImmunoGen; Henry Ji, CEO, Sorrento Therapeutics; Rachna Khosla, SVP, BD, Amgen; Stuart Mackey, Global Head, BD, Daiichi Sankyo
Moderator: Chad Shear, Principal, Fish & Richardson
Conference information: January 6-7, 2022 Webconference | Longwood Healthcare Leaders

Longwood Healthcare Leaders meetings are invitation-only forums typically held at leading academic institutions. Biopharma CEOs, heads of R&D, academic researchers, and healthcare investors join off-the-record discussions that generate new company ideas and approaches for Longwood Fund and members of our biopharma ecosystem, creating strategic business opportunities to advance the industry and bring important medicines to patients

On January 4, 2022 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that dusquetide is effective at reducing tumor size in nonclinical xenograft models. Recent studies, recapitulating results from previously published studies, have confirmed the efficacy of dusquetide as a stand-alone and combination anti-tumor therapy, with radiation, chemotherapy and targeted therapy, in the context of the MCF-7 breast cancer cell line (Press release, Soligenix, JAN 4, 2022, View Source [SID1234598096]). Dusquetide previously demonstrated benefits in reducing the duration of severe oral mucositis (SOM) in a Phase 2 clinical trial and reduction in SOM rates in the per protocol population in a Phase 3 study. In addition to the reduction of severe oral mucositis, an acceleration in the clearance of tumor response and an increase in overall survival were also observed in the Phase 2 clinical study as an ancillary benefit to treating oral mucositis in patients receiving chemo-radiation for their head and neck cancer (HNC).

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Based on the biological proof of principle shown both nonclinically and clinically with dusquetide, a novel synthetic peptide that modulates the body’s innate immune system, Soligenix continues to explore product opportunities, both in the reduction of oral mucositis in HNC and as a potential anti-cancer treatment. Dusquetide binds to p62 or SQSTM-1, a scaffold protein implicated in a number of intracellular signaling networks implicated in tumor cell survival, including autophagy. The role of p62 is best characterized in multiple myeloma and breast cancer. All variants of breast cancer, including metastatic breast cancer, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 high expressing (HER2+) and triple negative expressing cell lines, have demonstrated a significant role for p62 in tumorigenesis.

The MCF-7 cell line tested in the xenograft studies with dusquetide is both ER+ and responsive to anti-HER2 treatment. Treatment with dusquetide was effective not only as a stand-alone treatment (p<0.01 for tumor size), but also in conjunction with radiation (p<0.05 vs radiation only for survival), chemotherapy (paclitaxel) and targeted treatment (trastuzumab; p<0.001 vs. placebo only for tumor size), reducing tumor size and enhancing overall survival. Other tumor types also have been shown to be dependent on p62 expression, including multiple myeloma, liver cancer (hepatocellular carcinoma), lung cancer (non-small cell lung cancer, EGFR-TKI-resistant lung cancer), intestinal cancer (small intestinal adenocarcinoma and gastric cancer), and colorectal cancer and ovarian cancer (multi-drug resistant).

"Soligenix continues to pursue potential product opportunities with our new chemical entity dusquetide, including in oncology," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the supportive data from the Phase 2 and 3 oral mucositis trials, and the nonclinical anti-tumor efficacy demonstrated, we continue to pursue potential partnership for this novel molecule."

About Dusquetide

Dusquetide (the active ingredient in SGX942) is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body’s reaction to both injury and infection towards an anti-inflammatory, anti-infective and tissue healing response. IDRs have no direct antibiotic activity but, by modulating the host’s innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, including melioidosis. Potential anti-tumor activity has been demonstrated in in vitro and in vivo xenograft studies.

SGX942 has demonstrated safety and tolerability in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study (Study IDR-OM-01) in 111 patients with oral mucositis due to CRT for HNC, including potential long term ancillary benefits. The Phase 3 multinational, placebo-controlled, randomized study evaluated the impact of dusquetide on the duration of SOM in 268 subjects with squamous cell carcinoma of the oral cavity and oropharynx, scheduled to receive a minimum total cumulative radiation dose of 55 Gy with concomitant cisplatin chemotherapy. A clinically meaningful reduction in the duration of SOM was observed in the ITT population and a clinically and statistically significant reduction was observed in the per protocol population.

SGX942 has received Fast Track Designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, as well as Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare products Regulatory Agency for the treatment of severe oral mucositis in HNC patients receiving CRT. In addition, products containing the same active ingredient, dusquetide, have been granted Fast Track Designation as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis and Orphan Drug Designations in the treatment of MAS and the treatment of acute radiation syndrome.

Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has received partial funding from NIH for its oral mucositis clinical studies. The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study being supported by a Phase II SBIR grant (#R44DE024032) award.

In addition, a high level review of the IDR technology platform is available here.

On January 4, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that it will webcast its presentation at the 40th Annual J.P. Morgan Healthcare Conference at 10:30 a.m. PT on Tuesday, January 11, 2022 (Press release, Sana Biotechnology, JAN 4, 2022, View Source [SID1234598095]). The presentation will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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The webcast will be accessible on the Investor Relations page of Sana’s website at View Source A replay of the presentation will be available at the same location for 30 days following the conference.

On January 4, 2022 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported that Philip Astley-Sparke, Chief Executive Officer of Replimune, will present at the 40th Annual J.P. Morgan Healthcare Conference being held virtually on Monday, January 10, 2022 at 7:30 AM ET (Press release, Replimune, JAN 4, 2022, View Source [SID1234598094]).

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A simultaneous webcast will be available in the Investors section of Replimune’s website at www.replimune.com. A replay will be available for 30 days following the conference.