On July 10, 2023 Iovance Biotherapeutics, Inc. (Nasdaq: IOVA) ("Iovance" or "Company"), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte ("TIL") therapies for patients with cancer, reported the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $7.50 per share (Press release, Iovance Biotherapeutics, JUL 11, 2023, View Source [SID1234633136]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are expected to be approximately $150 million. In addition, Iovance has granted the underwriters a 30-day option to purchase up to 3,000,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about July 13, 2023, subject to customary closing conditions.

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Iovance intends to use the proceeds from this offering to fund preparations for the commercial launch of lifileucel (if approved), including continuing to prepare the Iovance Cell Therapy Center, the Company’s manufacturing facility in Philadelphia, to support ongoing clinical programs including its NSCLC registration-directed study and its frontline advanced melanoma Phase 3 confirmatory trial, to expand the combination of TIL and immune checkpoint inhibitors ("ICIs") in ICI naïve patient cohorts, to support the continued development of our pipeline candidates, to support Proleukin integration activities and for other general corporate purposes.

Goldman Sachs & Co. LLC and Jefferies LLC are acting as joint lead book-running managers 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 that became automatically effective upon filing with the Securities and Exchange Commission on June 16, 2023. The offering may be made only by means of a prospectus supplement and accompanying prospectus, copies of which may be obtained by contacting Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected] or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York, 10022, by telephone at (877) 547-6340, 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 July 10, 2023 Elsie Biotechnologies, Inc., a biopharmaceutical company unlocking the full potential of oligonucleotide therapeutics, reported a research collaboration agreement with GSK plc (LSE/NYSE: GSK) to advance the discovery and development of Elsie’s innovative oligonucleotide discovery platform with the aim of finding novel oligonucleotides optimized for safety, efficacy, and delivery (Press release, Elsie Biotechnologies, JUL 10, 2023, View Source [SID1234644227]). The collaboration combines GSK’s extensive expertise in DNA encoded library technologies with Elsie’s drug discovery platform. The companies will begin an initial research period where GSK and Elsie will explore the platform capabilities. Throughout the research term, GSK may exercise an option to a non-exclusive license from Elsie for the discovery platform and P(V) chemistry technologies to employ in GSK’s own oligonucleotide drug discovery research.

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Kevin Green, Chief Operating Officer, Elsie Biotechnologies, said: "Our next generation oligonucleotide therapeutics, which include RNA medicines, enable new opportunities to treat intractable human diseases, including those with no current or limited therapeutic options. This collaboration combines GSK’s expertise as leaders in the field of DNA encoded library technologies with the unique capabilities of Elsie’s scientists and discovery platform with P(V) chemistry with the goal to discover new RNA medicines."

Elsie’s discovery platform is an unparalleled ultra-high throughput proprietary process that allows for the complete evaluation of oligonucleotide chemical space. By applying proprietary encoding technology to oligonucleotide therapeutic candidates, all possible sequences or chemical modification patterns can be evaluated to increase activity, reduce toxicity, and improve delivery. Elsie also applies proprietary P(V) chemistry technologies, encompassing a suite of novel reagents and processes, to synthesize diverse oligonucleotide therapeutics with complete synthetic control.

Phil Baran, Ph.D., Cofounder, Elsie Biotechnologies, said, "By leveraging all the tools across Elsie’s platform, we can explore the entire chemical oligonucleotide space and uniquely define inter-nucleotide linkages and stereo chemistry to tune safety, activity, and delivery of oligonucleotide therapeutics." Phil Dawson, Ph.D., Cofounder, Elsie Biotechnologies, concluded, "We believe this approach will overcome the historical drug development limitations of this space and expand the use case for oligonucleotide medicines to previously intractable diseases."

Under the terms of the agreement, Elsie will receive an upfront collaboration payment from GSK to conduct initial research activities. Upon exercising the option during the research term, GSK would be obligated to make further payments including licensing fees, development, and commercial milestones.

On July 10, 2023 Pyrotech Biotechnology, a company dedicated to developing revolutionary innovative drugs for the treatment of inflammation and cancer, reported that it has recently raised a RMB700 million ($97 million) Series A financing round (Press release, Pyrotech, JUL 10, 2023, View Source [SID1234643785]). The company has raised more than RMB1 billion since it was founded in 2020.

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This round of financing was led by SDIC Venture Capital and China Venture Capital Innovation Investment Fund, with participation from Taiping Innovation Capital, China Life Investment, Lotus Lake Capital, and follow-on investments from seed round investors such as MSA Capital, LAV, FreeS Fund, LSV Capital, BioTrack Capital, Greenwaters Fund and CTID. Pyrotech Therapeutics’ research and development pipeline consists of multiple projects focusing on the fields of innate immune and pyroptosis, addressing indications including various inflammatory diseases and oncology. The funds raised in this round will be used to advance the clinical-stage pipeline, accelerate preclinical research for multiple projects, further expand the research and development pipeline, and enhance the already talented team.

Pyrotech Therapeutics was co-founded by Dr. Feng Shao and Dr. Tianjing Deng in October 2020, with the mission to become a leading global Chinese biopharmaceutical company driven by original innovations based on the scientific discoveries of Chinese scientists. The scientific foundation of Pyrotech Therapeutics is built upon Dr. Shao Feng’s globally leading biological discoveries in the fields of innate immune and pyroptosis. The company has chosen unaddressed medical key issues in inflammation and oncology for its primary research focus, establishing the "Molecular Switches of Pyroptosis and Innate Immune Regulation" technology platform. Through independent research and collaboration with leading medical translational institutions both domestically and internationally, the company is dedicated to developing revolutionary innovative drugs for the treatment of inflammation and tumors, aiming to benefit global patients suffering from these conditions based on innovations that originated in China.

Pyrotech Therapeutics has established research centers in Beijing, Shanghai, and the United States, and has built a top-notch international drug development team of over 100 employees. The company is engaged in multiple small molecule and gene regulation global first-in-class new drug development projects. Several projects have achieved breakthrough progress, including the development of pyroptosis inhibitors and innate immune modulators. Among them, the innate immune agonist is expected to begin a clinical study in early 2024, and the pyroptosis inhibitor is on track to select a drug candidate and enter clinical evaluation later in 2024.

On July 10, 2023 Biogen Inc. (Nasdaq:BIIB) reported that it will present second quarter 2023 financial results Tuesday, July 25, 2023, before the financial markets open (Press release, Biogen, JUL 10, 2023, View Source [SID1234633178]).

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Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available for at least 90 days following the presentation.

On July 10, 2023 Starton Therapeutics Inc. ("Starton" or "the Company"), a clinical-stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, reported to have entered into a definitive agreement to conduct its Phase 1b trial in multiple myeloma with a global Clinical Research Organization (CRO) (Press release, Starton Therapeutics, JUL 10, 2023, View Source [SID1234633150]).

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This pilot, open-label study will evaluate patients treated with continuously delivered lenalidomide for safety and tolerability, immune biomarkers, and signals of efficacy. Transplant-ineligible multiple myeloma patients who are to receive lenalidomide/dexamethasone/bortezomib in their second- or greater-line of therapy, meet all other eligibility criteria and provide informed consent are eligible for the study. The study is expected to accrue patients in the United States in two centers over a period of 10 months and will provide readouts in the tolerability of the regimen, as well as the impact of continuous delivery on immune function by measuring biomarkers of T-cell, NK-cell, and B-cell upregulation, along with cytokine profiles induced by lenalidomide. It is also expected to provide signals of efficacy in assessing response rates, duration of response, progression-free survival, and changes in minimal residual disease.

"With our recently announced FDA authorization to proceed with the Phase 1b clinical trial of STAR-LLD in multiple myeloma, we are pleased to announce a CRO partner as we actively prepare to initiate this study," said Pedro Lichtinger, chairman and CEO of Starton Therapeutics. "STAR-LLD has the potential to bring much-needed innovation to the treatment of multiple myeloma, which under current therapeutic options presents deteriorating quality of life for patients. We are eager to evaluate the potential of STAR-LLD in this trial as a critical step towards delivering on our pipeline of transformative therapies using our continuous delivery technology."

Starton has signed an agreement for a business combination with Healthwell Acquisition Corp. I (Nasdaq: HWEL) ("Healthwell"). Please see "Additional Information and Where to Find It" below for additional information related to the proposed business combination.

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide in development to expand and replace the standard of care for the most common blood cancers, multiple myeloma and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide and shrank by 80% with STAR-LLD. The study also showed 100% efficacy (overall response rate ORR) at 144 mcg/day continuous LLD and 20% of animals in this cohort were tumor free after 100 days vs. 0% ORR with active control with daily pulsatile once daily dosing. In addition, a Phase 1 bioavailability study in healthy men comparing STAR-LLD to Revlimid demonstrated the drug is well tolerated and is >91% bioavailable by the subcutaneous route. It was also observed that the Cmax is <90% lower than oral Revlimid. These data support the safety of the planned Phase 1 dose of 400 mcg/hr (9.6 mg a day) versus a standard 25 mg a day dose of Revlimid.