On March 22, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that the Investigational New Drug (IND) application for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) submitted to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) by the Company’s partner in China, Qilu Pharmaceutical, was approved ahead of the original timeline of April 2021 (Press release, Sesen Bio, MAR 22, 2021, View Source [SID1234576965]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With approval of the IND, Qilu Pharmaceutical is authorized to conduct the proposed clinical trial to assess the efficacy and safety of Vicineum in patients with BCG-unresponsive NMIBC in China, at the sole cost of Qilu Pharmaceutical. Assuming a successful trial, Qilu Pharmaceutical anticipates submission of the product market application for Vicineum in 2022 with potential approval in China expected in 2023.

"The approval of the IND for Vicineum in China represents a significant milestone in realizing our mission to save and improve the lives of patients globally," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Due to more limited use of BCG in China compared to the US, there is an opportunity to transform the treatment paradigm of NMIBC in China. The approval of the IND ahead of the original timeline underscores the strong collaboration between Sesen Bio and our partner, Qilu Pharmaceutical. Given the highly experienced clinical oncology team at Qilu Pharmaceutical, and the Phase 3 trial results achieved in the US, we are optimistic on the prospects for a successful trial and expeditious submission. We look forward to continuing to work with Qilu Pharmaceutical and the NMPA to bring this potentially best-in-class treatment to patients in China."

Sesen Bio is entitled to receive a $3M milestone payment from Qilu Pharmaceutical, the first of $23M in potential milestone payments. China represents a large potential market for Vicineum, with peak year sales estimated at $155-$418M. Additionally, the Company anticipates Qilu Pharmaceutical will become a key strategic partner for global supply of Vicineum and the manufacturing technology transfer to Qilu Pharmaceutical is on track to be completed in mid-2021. The completion of the manufacturing technology transfer triggers an additional $2M milestone payment.

About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On March 22, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it will release its financial results for fiscal year 2020 and business update on Tuesday, March 30, 2021 (Press release, Protalix, MAR 22, 2021, View Source [SID1234576983]). The Company’s management will host a conference call to discuss the financial results and provide a business update on recent corporate and clinical developments at 8:30 a.m. Eastern Daylight Time (EDT).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On March 22, 2021 Amgen reported that The National Institute for Health and Care Excellence (NICE) has recommended a triple combination therapy comprised of Kyprolis, lenalidomide and dexamethasone for the treatment of previously-treated multiple myeloma patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In final guidance, NICE backed the use of Kyprolis (carfilzomib) plus lenalidomide and dexamethasone for people with multiple myeloma, who have had at least one previous therapy – including targeted therapy bortezomib (Janssen’s Velcade).

In clinical trials of the triple combination, Kyprolis with lenalidomide and dexamethasone was found to extend periods of remission and help people to live longer, compared to the current second-line treatment for multiple myeloma patients – lenalidomide and dexamethasone alone.

In a statement, NICE said that its independent appraisal committee saw evidence that shows the benefit of the triple therapy appears to continue for up to six years.

Following its review, the committee said the most-likely cost-effectiveness estimates for Kyprolis plus lenalidomide and dexamethasone are within what NICE considers a cost-effective use of NHS resources.

"The recommendation of our committee will be welcomed by people with multiple myeloma who have told us of the need of a new second line treatment option that gives longer periods of remission and improves survival," said Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Assessment at NICE.

"The clinical data shows that the benefits of this triple therapy continue after treatment has stopped. A positive decision has been made possible after the company and NHS England came to a commercial arrangement which allows carfilzomib to be used on the NHS with a confidential discount," he added.

On March 22, 2021 ProMIS Neurosciences Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported that the completion of an US$7M (CDN$8.75M) private placement of convertible unsecured debentures (the "Debentures") (Press release, ProMIS Neurosciences, MAR 22, 2021, View Source [SID1234576949]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The investors include Mike Gordon of Fenway Sports Group, the Kraft Group, Henry McCance, co-founder of the Cure Alzheimer’s Fund, and Jeremy Sclar of WS Development Group. "After conducting diligence with a number of experts in the field, we are impressed with the tremendous potential of ProMIS Neurosciences and its unique platform of drug candidates to have a profound impact in the fight against Alzheimer’s and other neurodegenerative diseases. Our group is pleased to provide funding for the next phase of the company’s exciting future", stated Mike Gordon of Fenway Sports Group.

"We are honored to have the support of such a distinguished group of investors, all of whom are accomplished leaders in the business and life sciences arenas" said Gene Williams, ProMIS Executive Chairman.

Debenture Terms

The Debentures are convertible into ProMIS common shares at the option of the holder at a conversion price of US$0.10 per share and accrue interest at 1% per annum, which is payable annually. At the company’s election, accrued interest may be paid in cash or common shares (such number of shares determined by dividing the interest due by the 5-day volume-weighted average trading price or "VWAP" of the common shares).

The Debenture mature on March 22, 2026. Prior to the maturity date, the Company may force conversion of the Debentures at the conversion price upon raising US$50M in equity and/or debt cumulatively. On the maturity date, the Company may redeem the outstanding principal amount of the Debentures in either cash or common shares (at the then 5-day VWAP less a 10% discount) or a combination thereof at its election. Amounts redeemed in common shares on the Maturity Date will be subject to TSX acceptance.

The investors were granted a right to participate, on a pro rata basis, in subsequent company offerings of equity securities for cash consideration pursuant to a public offering or a private placement.

The Debentures and any common shares issued on conversion are subject to a four-month hold period that expires on July 22, 2021. Net proceeds will be used for working capital and general corporate purposes.

ProMIS plans to accelerate progress toward a number of top priorities, including:

Advancing the PMN310 monoclonal antibody, our potential "best in class" next generation Alzheimer’s treatment, into clinical testing;
Enhancing our partnering prospects for programs under active discussion by allowing us to invest in additional validation data;
Expanding our portfolio of products and intellectual property into new target areas, using our proprietary discovery platform;
Advancing our partnered diagnostic programs;
Achieving NASDAQ listing;
Expanding our Board of Directors; and
Expanding our management team, capitalizing on the talent pool in Boston, to support a growing and ambitious scope of activity.
Retirement of our CEO

Finally, a note of great appreciation for our CEO, Dr. Elliot Goldstein. Elliot, who just turned 70, has announced his intention to retire from a full time role by the end of 2021. Even though Elliot is irreplaceable, ProMIS has initiated a search for a new CEO to help us achieve our potential. "Elliot has been a close friend and valued business partner for decades," said Gene Williams, "without his significant contributions, we would not have been able to take ProMIS from just a great science idea to a company with a growing portfolio of therapies that have the potential to be life-altering for patients. On behalf of the entire ProMIS community, and patients who in the future may benefit from our therapies, I offer Elliot our sincere thanks and gratitude".

"ProMIS Neurosciences was launched six years ago based on a world class scientific platform from our CSO and scientific founder, Dr. Neil Cashman. Playing a key role in this endeavor has been one of the most challenging yet rewarding experiences of my 40 odd years in pharmaceutical drug development. I am delighted for this exciting new phase of the Company", stated Dr. Elliot Goldstein, ProMIS CEO.

On March 22, 2021 4D pharma plc (Nasdaq: LBPS; AIM: DDDD) ("4D pharma" or the "Company"), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) – a novel class of drug derived from the microbiome – reported completion of its merger ("the Merger") with Longevity Acquisition Corporation ("Longevity")(Nasdaq: LOAC) (Press release, 4d Pharma, MAR 22, 2021, View Source [SID1234576966]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

4D pharma American Depositary Shares ("ADSs") are expected to begin trading today on the Nasdaq Global Market under the ticker symbol ‘LBPS.’

Warrants of Longevity assumed by 4D pharma in the Merger are currently expected to begin trading on Nasdaq under the ticker symbol ‘LBPSW’ tomorrow, Tuesday, March 23, 2021. Longevity units are expected to be separated and holders thereof are expected receive 4D pharma ADSs and warrants in exchange at the same time as the warrants begin trading.

As a result of the Merger, Longevity shares, warrants, rights and units ceased trading on Nasdaq on Friday, March 19, 2021.

4D pharma ordinary shares continue to be admitted to trading on the London Stock Exchange’s AIM market under the ticker symbol ‘DDDD.’