On July 28, 2021 Complix, a biopharmaceutical company developing a pipeline of transformative Alphabody therapeutics, reported that it has signed a global collaboration and license agreement with Jiangsu Nhwa Pharmaceutical Co., one of China’s leading CNS companies, to develop Cell Penetrating Alphabodies (CPABs) able to cross the blood brain barrier, for the improved treatment of diseases of the central nervous system (CNS) (Press release, Complix, JUL 28, 2021, View Source;utm_medium=rss&utm_campaign=complix-signs-global-drug-discovery-and-development-agreement-with-jiangsu-nhwa-pharmaceutical-co-to-develop-novel-alphabody-therapeutics-for-treatment-of-cns-diseases [SID1234585443]). This agreement is an important corporate milestone for Complix, as it seeks to apply its industry leading CPAB platform in yet another major disease area, beyond oncology, autoimmunity, and viral diseases.

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Jiangsu Nhwa Pharmaceutical Co. (Nhwa) is a leading CNS company in China, which has developed an innovative and differentiated pipeline in the areas of anesthesia, analgesia, psychiatry, and neurology via both its own in-house R&D and global partnerships. Nhwa has more than 4000 employees, with capabilities in research, clinical development, manufacturing, and commercialization of CNS drugs.

Complix and Nhwa will collaborate to develop novel biotherapeutics against two selected CNS targets. Complix will apply its proprietary CPAB technology, that enables biologics to traverse membrane systems and act with high affinity and precision on disease targets that are considered intractable by current drug formats. The novel compounds to be developed under this collaboration, will be designed to cross the blood brain barrier to address important disease targets in the central nervous system.

Under the terms of the agreement, Complix has granted an exclusive license to Nhwa to develop, manufacture and commercialize the CPABs resulting from this collaboration in Greater China. Both companies retain joint development and commercialization rights for these CPABs in the rest of the world.

Complix is entitled to upfront license payments and further milestone payments subject to the progress of clinical development and regulatory approval. Complix is also eligible for royalty payments based on the future commercial sales of the CPABs in China.

Mark Vaeck, CEO of Complix, said:
"We are thrilled to announce this exciting collaboration with Nhwa. We are confident that the unique targeting capabilities of our CPABs will allow us to jointly develop novel biotherapeutics that will deliver improved treatment outcomes for patients suffering from severe neurological diseases. We believe that partnering with an innovative company like Nhwa, specialized in the area of CNS diseases, is substantially value creating, as it provides access to significant research and clinical development expertise in the CNS area, as well as a strong commercial platform in China. I am confident that together we can deliver on our ambitions to develop innovative and highly needed solutions for patients with severe neurological conditions".

Jiaquan Sun, CEO of Jiangsu Nhwa added:
"We are pleased to collaborate with Complix to gain access to its highly innovative CPAB platform as we look to further strengthen our position as a market leader in CNS therapies in China. We are looking forward to working with the team at Complix as we tap into their world leading intracellular targeting expertise to generate novel therapeutics that can cross the blood brain barrier to address major unmet medical needs that still exist in the CNS disease area today’’.

On July 28, 2021 Bristol-Myers Squibb reported that newly launched multiple myeloma CAR-T drug Abecma is outstripping capacity, company executives said during a conference call Wednesday (Press release, Bristol-Myers Squibb, JUL 28, 2021, View Source [SID1234585442]). Approved by the FDA in late March, Abecma generated $24 million in second-quarter sales.

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Abecma is the first BCMA-targeted cell therapy, and "the sole focus that we have there is on steadily increasing manufacturing capacity," Bristol Myers’ chief commercial officer, Chris Boerner, said on the call.

So far, the company has managed to increase the number of manufacturing slots available to patients to catch up with Abecma demand through August, Boerner said. Like other CAR-T drugs, Abecma is a personalized treatment that engineers each patient’s own T cells to fight cancer, so drugmakers need to reserve manufacturing slots to make each patient’s version.

RELATED: Bristol Myers’ Abecma launch tools? Digital CAR-T platform and provider training, for 2

Another problem causing the supply gap is a shortage of viral vectors, which are used to deliver the cell therapy, Boerner said. Limited viral vector supply has haunted other cell therapies globally, and the situation remains "fairly dynamic," he noted, adding that he wouldn’t put a specific date to when supply would improve significantly. Ensuring a more stable supply of vectors would be a key strategy for BMS next year and beyond, the exec said.

Gilead Sciences’ Kite Pharma, probably sick of the industry’s constraint in viral vector supply, in 2019 unveiled a plan to bring viral vector manufacturing in-house with a 67,000-square-foot facility at its Oceanside, California, biologics site. The plan was to have the upgraded factory begin commercial manufacturing in the second half of this year.

Gilead makes the CD19-targeted CAR-T drugs Yescarta and Tecartus. Novartis, for its part, has suffered from manufacturing out-of-spec issues that have hampered the rollout of its CD19 CAR-T therapy, Kymriah.

RELATED: Bristol Myers, flush with pair of CAR-T approvals, blueprints first cell therapy factory in Europe

BMS itself recently launched its own CD19 CAR-T, Breyanzi. The drug hauled in $17 million in second-quarter sales. The company said it has so far activated more than 65 sites to administer the drug.

Beyond the newly-found, bittersweet CAR-T problem, BMS in the second quarter successfully overcame another headache: PD-1 inhibitor Opdivo has returned to growth.

After a 3% sales decline in 2020 and another drop in the first quarter, Opdivo ginned up 16% year-over-year growth in Q2 with sales of $1.91 billion.

RELATED: Bristol Myers, bluebird bio have their BCMA CAR-T nod, but latecomer J&J could have an advantage: analysts

New patient claims, while still lagging behind pre-COVID levels, are recovering quarter over quarter, Boerner said. Opdivo, used in tandem with chemotherapy, in April became the first immuno-oncology therapy approved for newly diagnosed metastatic stomach cancer. The new use is driving up Opdivo new patient share among checkpoint inhibitors, he said.

But the company on Wednesday said the same CheckMate-649 trial that supported the FDA nod for Opdivo and chemo in first-line stomach cancer found the dual immunotherapy combination of Opdivo and Yervoy failed to outdo chemo at extending the lives of patients whose tumors express PD-L1 at a combined positive score of at least 5.

All told, BMS recorded second-quarter revenues of $11.7 billion, representing year-over-year growth of 16%.

On July 28, 2021 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that the Rick Pauls, President and Chief Executive Officer, will be available for one-on-one meetings and will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Monday, August 9, 2021 at 10:00 am ET (Press release, DiaMedica, JUL 28, 2021, View Source [SID1234585421]). Mr. Pauls looks forward to meeting investors to discuss DiaMedica’s clinical development programs and business strategy.

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If you are interested in arranging a one-on-one meeting or listening to the live event, please contact your BTIG conference representative.

On July 28, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that it will report second quarter financial results following the close of U.S. financial markets on August 9 (Press release, Turning Point Therapeutics, JUL 28, 2021, View Source [SID1234585420]). The company will host a conference call at 1:30 p.m. PT/4:30 p.m. ET to discuss the results and provide operational updates. President and CEO Athena Countouriotis, M.D., will host the call, which will include a question and answer session.

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The update will be accessible via audio webcast through the "Investors" section of www.tptherapeutics.com or by dialing (877) 388-2118 (in the United States) or (470) 495-9489 (outside the U.S.) using conference ID 4029189. A replay will be available through the "Investors" section of www.tptherapeutics.com.

On July 28, 2021 Nuvalent, Inc., a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the pricing of its initial public offering of 9,750,000 shares of common stock, consisting of 9,150,000 shares of Class A common stock and 600,000 shares of Class B common stock, each at a price to the public of $17.00 per share (Press release, Nuvalent, JUL 28, 2021, https://www.nuvalent.com/nuvalent-announces-pricing-of-initial-public-offering/ [SID1234585351]). All shares are being offered by Nuvalent. The gross proceeds to Nuvalent from the offering, before deducting underwriting discounts, commissions and other offering expenses, are expected to be approximately $165.75 million. The Class A common stock is expected to begin trading on The Nasdaq Global Select Market under the ticker symbol "NUVL" on July 29, 2021. The offering is expected to close on August 2, 2021, subject to the satisfaction of customary closing conditions. In addition, the underwriters have a 30-day option to purchase up to an additional 1,462,500 shares of Class A common stock at the initial public offering price less underwriting discounts and commissions.

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J.P. Morgan, Cowen and Piper Sandler are acting as joint book-running managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on July 28, 2021. The offering is being made only by means of a written prospectus. Copies of the final prospectus relating to the initial public offering can be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone (866) 803-9204 or by email at [email protected]; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; and Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, 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 offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.