On September 1, 2021 Immedica Pharma AB reported that the United Arab Emirates Ministry of Health and Prevention has approved ZepzelcaTM (lurbinectedin) – for the treatment of metastatic Small Cell Lung Cancer (SCLC) (Press release, Immedica Pharma, SEP 1, 2021, View Source [SID1234587088]).

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"Small cell lung cancer is a disease with limited treatment options. The approval of Zepzelca in United Arab Emirates represents an important treatment option for patients whose metastatic SCLC has progressed after traditional chemotherapy such as platinum-based therapy," said Anders Edvell, CEO at Immedica Pharma.

Immedica has a strategic alliance/partnership with Pharma Mar, the biopharma company which has successfully developed lurbinectedin. Both companies are committed to bringing innovative therapies to patients worldwide.

Ashraf Attia, Regional Director in the Middle East at Immedica said: "Today’s announcement marks a significant milestone for Immedica’ s ambition to expand our presence in oncology in the Middle East region."

The approval of Zepzelca by United Arab Emirates Ministry of Health and Prevention is based on results from an open label, multi-center, single-arm clinical trial in 105 adults with relapsed SCLC1. The data, which appeared in The Lancet Oncology, in the May 2020 issue, showed that in relapsed SCLC, monotherapy with lurbinectedin had an overall response rate of 35% and a median duration of response of 5.3 months according to investigator assessments. The FDA approval is based on the same data.

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On September 1, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to potentially create new treatments that make a meaningful difference in patients’ lives, reported the pricing of its underwritten public offering of 2,500,000 American Depositary Shares ("ADSs"), each of which represents one ordinary share of Ascendis, at a price to the public of $160.00 per ADS (Press release, Ascendis Pharma, SEP 1, 2021, View Source [SID1234587107]). All of the ADSs are being offered by Ascendis. The offering is expected to close on or about September 7, 2021 subject to customary closing conditions. In addition, Ascendis has granted the underwriters a 30-day option to purchase up to an additional 375,000 ADSs at the public offering price, less the underwriting commissions.

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Ascendis estimates the net proceeds from the offering will be approximately $379.3 million (assuming no exercise of the underwriters’ option to purchase additional ADSs), after deducting the underwriting commissions and estimated offering expenses. Ascendis intends to use the net proceeds of the offering to support the commercial preparations, launch and commercial activities, clinical development and regulatory approval for lonapegsomatropin-tcgd, to fund clinical development of its other endocrinology rare disease programs, including palopegteriparatide and TransCon CNP, to identify and progress development of new product candidates, including in the therapeutic area of oncology, and for working capital and other general corporate purposes.

J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Evercore Group L.L.C. and SVB Leerink LLC are acting as joint book-running managers for the offering. Credit Suisse Securities (USA) LLC and Wells Fargo Securities, LLC are acting as co-lead managers for the offering and Cantor Fitzgerald & Co., Canaccord Genuity LLC, Wedbush Securities Inc. and Kempen & Co. USA, Inc. are acting as co-managers for the offering.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") on May 27, 2021, and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 1, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and GenFleet Therapeutics (Shanghai) Inc. ("GenFleet"), a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, reported that they have entered into an exclusive license agreement for the development and commercialization of GenFleet’s lead KRAS G12C candidate, GFH925 in China, including mainland China, Hong Kong, Macau and Taiwan with additional option-in rights for global development and commercialization (Press release, Innovent Biologics, SEP 1, 2021, View Source [SID1234587125]).

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GFH925, GenFleet’s lead KRAS G12C candidate, has recently received Investigational New Drug (IND) approval from National Medical Products Administration (NMPA) in China. Preclinical data showed that GFH925 has potential best-in-class activity that can effectively inhibit the growth of a variety of tumor cell lines carrying the KRAS G12C mutation, which may be helpful in accelerating the clinical validation of GFH925. In addition, other preclinical data have also demonstrated the potent potential for GFH925 in combination therapies.

According to the agreement, Innovent will be responsible for clinical development and commercialization of GFH925 in China, while retaining option-in right for development and commercialization outside of China as well. Following approval of a New Drug Application (NDA), Innovent will leverage its broad commercialization capability that includes an experienced commercialization team with extensive nationwide coverage to roll out GFH925, with the goal to benefit cancer patients in China. GenFleet will continue to be responsible for supplying GFH925 for both development and commercial purposes in China.

GenFleet will receive an upfront payment of US$22 million at signing. If Innovent exercises the option-in rights, GenFleet will receive up to US$50 million of global development support from Innovent. Upon achieving certain pre-specified milestones in development, registration, and annual sales performance of GFH925 globally, GenFleet is eligible to receive up to US$240 million in milestone payments in addition to tiered royalties based on annual net sales of GFH925 both in China and global markets.

Dr. Yongjun Liu, President of Innovent said, stated, "GenFleet has rich experience in research and development and has built up a proprietary pipeline of large and small molecule assets. We are delighted to form this strategic collaboration with GenFleet. Innovent is deeply engaged in the oncology area having built up a robust oncology pipeline of 20 clinical stage assets, an industry-leading medical operations and regulatory affairs team, a broad commercial channel and a professional commercial team of over 2000 people. KRAS G12C is an important mutation in multiple tumor types such lung cancer and solid tumors. Innovent has established a wide coverage on major tumor types including lung cancer. The collaboration on GFH925 will explore its potentials in clinical trials for both mono therapy and combination therapy such as combination with PD-1 which can further enhance our coverage in oncology area. By leveraging our synergy in clinical development and commercialization, we hope to expedite the development and launch of GFH925. Meanwhile, KRAS inhibitor has a promising global market potential. With the option-in rights for global development and commercialization, we look forward to bringing GFH925 as a new and more effective treatment option to patients both in China and globally.

Dr. Jiong Lan, CEO of GenFleet Therapeutics, stated, "We are pleased to announce our first major out-license collaboration with Innovent, an industry leading biopharmaceutical company which has demonstrated many successful track records of developing and commercializing novel anti-cancer therapies. RAS used to be an undruggable target and there was no KRAS G12C inhibitor moving into the clinics when GenFleet started the program, which highlights our "globally new" pipeline strategy that focuses on novel mechanisms of action. The partnership is not only a recognition of GFH925, a KRAS/G12C inhibitor with potential best-in-class differentiation, but also GenFleet’s internal discovery and development capability as well. The global scope of this collaboration will benefit not only patients in China, but also those throughout the world. In addition, we share the same vision of swiftly tackling unmet medical needs and the same culture of agile R&D in a biotech setting.

Professor Yilong Wu, Director of Guangdong Lung Cancer Institute, stated, "KRAS mutation is widespread among patients of non-small cell lung cancer, pancreatic cancer, colorectal cancer, etc. Preclinical data has shown that GFH925 is differentiated from other KRAS G12C inhibiting products, and we look forward to positive results of GFH925’s safety/tolerability and efficacy. Moreover, we will optimize our precision treatment plans and pave the way for the potential of combination therapies for patients with KRAS G12C gene mutation."

About GFH925 (KRAS G12C Inhibitor)

Being developed by GenFleet Therapeutics, GFH925 is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards G12C. Subsequently, GFH925 effectively inhibits the downstream signal pathway to induce tumor cells’ apoptosis and cell cycle arrest.

On September 1, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported that company management will participate in three virtual investor conferences in September 2021 (Press release, Shattuck Labs, SEP 1, 2021, View Source [SID1234591768]).

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Presentation Details

Conference: Citi 16th Annual BioPharma Virtual Conference
Format: Panel Discussion, "Framing the Tip of the Spear for Novel Antibodies and Protein Therapeutics"
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: September 9, 2021
Time: 1:25 p.m. EST

Conference: H.C. Wainwright 23rd Annual Global Investment Conference
Format: Corporate Presentation
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: September 13, 2021
Time: 7:00 a.m. EST

Conference: Morgan Stanley 19th Annual Global Healthcare Conference
Format: Fireside Chat
Presenters: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer and Andrew Neill, M.B.A., Shattuck’s Chief Financial Officer
Date: September 15, 2021
Time: 11:45 a.m. EST

A live webcast of the panel discussion, corporate presentation, and fireside chat will be available on the Events & Presentations section of the Company’s website. A replay of the webcasts will be archived for up to 90 days following the presentation date.

On September 1, 2021 Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported the closing of an oversubscribed Series B financing, which raised $108 million (Press release, Asher Biotherapeutics, SEP 1, 2021, View Source [SID1234587090]). The financing was led by Wellington Management Company LLP, and included new investors RA Capital Management, Janus Henderson Investors, Logos Capital, Marshall Wace and Alexandria Venture Investments, and, along with existing investors Third Rock Ventures, Invus, Boxer Capital of Tavistock Group, Mission BioCapital, and other undisclosed institutional investors.

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"We are pleased to announce this Series B financing and we are tremendously grateful to our new and existing investors for their support and commitment to our goal of delivering a new class of biotherapeutics, with superior selectivity and broad applicability across multiple tumor types, as well as infectious and autoimmune diseases," said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. "Since our founding, we have made significant progress validating the modularity and broad applicability of our cis-targeting platform, achieving preclinical proof-of-concept for our first three pipeline programs and building our team into a sustainable organization, with the depth and capabilities to exploit the full potential of our novel immunotherapies. This funding will enable us to accelerate the development of AB248, while continuing to drive our additional programs forward with urgency, as we aim to restore hope, health and happiness in the lives of patients."

Asher Bio aims to advance a portfolio of cis-targeted therapies derived from diverse cytokines and cell-types, each designed to address the challenge of pleiotropy that limits the efficacy and tolerability of many immunotherapies. By engaging two receptors on the same cell for activation, an immunomodulatory receptor for therapeutic action and a specific target receptor for directing the therapy to the desired cell type, Asher Bio’s cis-targeted immunotherapies seek to offer a new level of selectivity, with the potential to deliver superior clinical outcomes and an improved safety profile.

"We are encouraged by Asher Bio’s tremendous progress since launch, including the generation of new preclinical data that further validates the company’s unique cis-targeting approach," said Jeffrey Tong, Ph.D., Partner at Third Rock Ventures. "We believe cis-targeted immunotherapies may be able to overcome the selectivity challenges that prohibited first-generation cytokine immunotherapies from achieving their full therapeutic potential, ultimately providing better outcomes to patients by offering improvements in both efficacy and safety. We are pleased to continue supporting the Asher team as it applies its platform to address some of the most significant unmet needs in oncology, infectious and autoimmune diseases."

Proceeds from this financing will enable Asher Bio to fund its lead cis-targeted immunotherapy, AB248, through clinical proof-of-concept, while advancing a second program through investigational new drug (IND)-enabling studies and continuing to invest in its cis-targeting platform. Asher Bio expects to file an IND application for AB248 with the U.S. Food and Drug Administration in the third quarter of 2022. AB248 is an engineered interleukin-2 (IL-2) immunotherapy designed to specifically target CD8+ effector T cells. In preclinical and IND-enabling studies, AB248 has evidenced a highly differentiated profile, selectively expanding CD8+ T-cells, while avoiding immune cell subtypes associated with toxicities and immunosuppressive effects, resulting in enhanced anti-tumor efficacy and improved tolerability. The Series B funding will also support Asher Bio’s development of additional targeted immunotherapies, including a CD8+ T‑cell cis-targeted STAT3 cytokine and a CAR-T cis-targeted IL-2, both of which have demonstrated preclinical proof-of-concept.

"We designed our cis-targeting platform to leverage a systematic, modular process, which can be applied across an array of immunomodulatory molecules and cell types," said Ivana Djuretic, Ph.D., Co-Founder and Chief Scientific Officer of Asher Bio. "This enables us to continuously apply learnings from our research and development efforts across our earlier-stage portfolio, rapidly creating and de-risking additional programs. With this financing, we will be able to invest more aggressively in our next wave of novel therapeutic candidates, accelerating not only the development of AB248, but the advancement of our second program through IND-enabling studies."