On September 25, 2021 Boan Biotech, a subsidiary of Luye Pharma Group, reported that it will orally present the pre-clinical data of its proprietary CD3+ T-cell engager platform and CEA/CD3 bispecific antibody at World Bispecific Summit 2021 (Press release, Boan Biotech, SEP 25, 2021, View Source [SID1234590276]).

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 annual World Bispecific Summit aiming to promote the development of bispecific antibody therapies will take place for the 12th time this year. It has become a prestigious platform in the industry for academic exchanges. The upcoming event will take place online from September 29 to October 1, 2021 Eastern Standard Time.

Details of the oral presentation by Boan Biotech are as follows:

Title: Optimization of CD3+ T-cell Engager to Improve Safety Profile
Session: T-cell Based Approaches for Oncology Therapeutics
Time: October 1, 2021

Background

CD3+ T-cell engagers are a group of the most promising bispecific antibodies for the treatment of cancers. But they face major challenges including the dose-limiting, life threatening cytokine release syndrome (CRS) toxicity, suboptimal potency, and the on-target off-tumor toxicity. To overcome those challenges, Boan Biotech developed an optimized platform for CD3+ bispecific T-cell engagers with a unique combination of high potency, reduced cytokine release and tumor-targeting selectivity.

The CEA/ CD3 bispecific antibody BA1202 is the first clinical candidate developed on the leading bispecific T-cell Engager platform. The pre-clinical research data of BA1202 showed a high potency in killing cancer cells, significantly reduced cytokine release, and superior efficacy.

In addition to BA1202, multiple bispecific antibody candidates with similar optimized format and the reduced CD3 affinity have been validated both in vitro and in vivo to have a similar advantage against different solid tumor targets. Boan Biotech plans to speed up the effort to take these bispecific T-cell engagers as investigational drugs to clinical trials, to address the huge unmet needs in treating patients with late-stage cancers.

On September 24, 2021 Chime Biologics, a leading CDMO that enables biologics therapeutic development, reported a strategic cooperation agreement with Hangzhou Sumgen Biotechnology Co., Ltd, an innovation-driven biopharmaceutical company dedicated to the development and commercialization of antibodies for cancer and other life-threatening malignancies major diseases, regarding its Bispecific Antibody Project (SG12473) (Press release, Sumgen Biotech, SEP 24, 2021, View Source [SID1234656282]).

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!

According to the agreement, Chime Biologics will provide technology transfer and scale-up manufacturing, process characterization, process validation and BLA for Sumgen Biotech’s first bispecific antibody project (SG12473). Sumgen Biotech will make the most of Chime’s expertise in manufacturing commercial batches of cGMP 2000L drug substances, late-stage CMC development and BLA to accelerate the development of SG12473.

Dr. Miao Shiwei, Co-Founder and Senior Vice President of Sumgen Biotech, Dr. Zeng Xianfang, CEO of Chime Biologics, and other representatives of both parties attended the signing ceremony.

Dr. Miao Shiwei from Sumgen Biotech, stated that "As SG12473 is the first bispecific antibody of Sumgen Biotech in the clinical stage, we are very excited to make a strategic partnership with Chime Biologics on such an important project. The philosophy of Chime Biologics that to make biologics meeting international standards accessible to all patients worldwide through technological and manufacturing innovation coincides with that of Sumgen Biotech. That’s why we are sure that the professional technology transfer and BLA experience of Chime Biologics will fuel the smooth marketing of the drug in an efficient and accelerated manner."

Dr. Zeng Xianfang from Chime Biologics said, "We are very happy to enter into such an important collaboration with Sumgen Biotech, a highly innovative company. To date, we have completed over 30 CDMO projects with zero failure and have supplied drug substances and clinical trial samples to over 20 countries. With a proven track record in terms of quality management, GMP compliance, bioprocess expertise and cost-effectiveness, we will make every effort to support Sumgen Biotech to promote this project. And we wish this important product an earlier marketing."

On September 24, 2021 Secura Bio reported that The FDA initially targeted immunotherapies in its industry-wide review of accelerated drug approvals in oncology that failed to deliver in confirmatory trials. But the agency isn’t stopping there (Press release, Secura Bio, SEP 24, 2021, View Source [SID1234590541]).

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!

Highly Potent API Drug Product Development and Manufacturing Using Micronization Technology
Tuesday, October 12 | 11am ET / 8am PT
Development of HPAPIs presents unique challenges for product containment and requires special consideration in equipment selection, operating procedures, and safety processes. This webinar will discuss how to classify HPAPIs in early development and share recommendations for safe product handling, from clinical manufacturing to commercialization. The speakers will also share the key advantages of using micronization technology for the development and manufacturing of HPAPIs.
LEARN MORE
The FDA is gathering an oncologic drugs advisory committee meeting on Dec. 2 to review whether two drugs should keep their conditional approvals, the agency said (PDF) Friday. The products are Secura Bio’s Farydak for previously treated multiple myeloma, and Aurobindo Pharma’s Marqibo indication for Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) following two or more lines of treatments.

In the spring, the FDA’s Oncology Center of Excellence launched an industry-wide review of accelerated approvals that haven’t shown clinical benefits in confirmatory trials. The campaign cost PD-1/L1 inhibitors from Merck, Bristol Myers Squibb, Roche and AstraZeneca several U.S. indications, including small cell lung cancer, stomach cancer, bladder cancer, liver cancer and triple-negative breast cancer.

RELATED: Subcutaneous Velcade more tolerable in multiple myeloma trial

Now Secura and Farydak will have to prepare for the same scrutiny. Secura bought worldwide rights to Farydak from Novartis in 2019. The drug’s original FDA nod in 2015 was a hard-fought one, given that the FDA’s external experts voted against its approval due to concerns about side effects. Farydak is indicated for use with Takeda’s Velcade and the steroid dexamethasone.

The latest data on Fradyak, released earlier this year, came from a phase 2 trial dubbed Panorama 3. The trial tested Fradyak with a subcutaneous version of Velcade, rather than its original intravenous formulation. It showed that Fradyak, at its approved dosing strength, produced a similar response rate with the new regimen as that shown in the original Panorama 1 trial, but that it had a longer duration of response. Patients taking the combination with subcutaneous Velcade reported fewer side effects, such as severe diarrhea, than what was observed in the earlier trial."

In a statement to Fierce Pharma, Secura chief medical officer David Cohan, M.D., said the company remains "committed to working with the FDA on fulfilling all post-marketing requirements for Farydak in a timely manner."

As for Marqibo, that drug got its FDA go-ahead in 2012 and has since changed hands twice, first from Talon Therapeutics to Spectrum Pharmaceuticals in 2013 and then to Aurobindo in 2019. The drug earned its third-line ALL approval after a single-arm phase 2 study recorded a 15.4% complete response rate.

The phase 3 Hallmarq trial in patients over 60 with newly diagnosed ALL was supposed to serve as Marqibo’s confirmatory trial. The plan was to enroll 348 patients and compare Marqibo, a targeted version of chemotherapy vincristine, with standard vincristine. But Spectrum terminated the study in 2015, after recruiting just 26 participants over three years, according to clinicaltrials.gov.

RELATED: Bristol Myers pulls an Istodax lymphoma use 10 years after FDA accelerated approval

The upcoming advisory committee meeting "will have a general discussion focused on next steps for each product including whether the indications should remain on the market while additional trial(s) are conducted," the FDA said in a notice Friday.

Some pharma companies seem to be realizing that the FDA is moving its house-cleaning beyond immuno-oncology agents. And they’re getting ahead of any negative decisions. Bristol Myers in August said it’s withdrawing Istodax’s indication as a monotherapy for previously treated peripheral T-cell lymphoma after a recent confirmatory phase 3 trial flop in newly diagnosed patients.

On September 24, 2021 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will announce its fourth quarter and fiscal year end 2021 operating results on Wednesday, September 29, 2021, before the open of the U.S. financial markets (Press release, Palatin Technologies, SEP 24, 2021, View Source [SID1234590262]).

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!

Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on September 29, 2021, at 11:00 a.m. ET. The conference call will include a review of the company’s operating results and an update on programs under development.

Schedule for the Operating Results Press Release, Conference Call / Audio Webcast

Audio Webcast Live and Replay Access

View Source

The audio webcast and replay can be accessed by logging on to the "Investors-Webcasts" section of Palatin’s website at View Source.

On September 24, 2021 A group of long-time stockholders (the "Nominating Stockholders" or the "Group") of CytoDyn Inc. ("CYDY or the "Company") (OTC: CYDY) reported that has nominated five highly experienced director candidates to serve on the Company’s Board of Directors reported its comprehensive strategic plan to obtain cancer therapy approval for Leronlimab (Press release, CytoDyn, SEP 24, 2021, View Source [SID1234590261]). If implemented, the Group believes this plan would begin to generate much-needed revenue for CYDY and position the Company to earn FDA approval for the drug, while enhancing the value of all stockholders’ shares.

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 Group’s strategy is designed to overcome current CYDY management’s failures to implement a coherent, effective plan to generate revenue and obtain FDA approval for Leronlimab. While the Group has tried to discuss the enormous potential of its oncological strategy to reinvigorate CYDY with the Board and management team, they have refused to meaningfully engage every step of the way. Instead, incumbent Company leadership has decided to focus on entrenching themselves and clinging to their outsized compensation packages at the expense of shareholders.

The Group’s approach to cancer therapy will be scientifically valid and extremely efficient and will be critical to unleashing the potential value of Leronlimab and the investments of all stockholders. The full plan can be found here, and highlights are as follows:

Utilize real data based on precision medicine determination of Leronlimab binding cancers;
Apply both combination therapy with complementary immune-oncology blockbuster drugs and adjuvant monotherapy in CCR5+ tumors;
Prioritize cancer targets based on CCR5 expression; and
Partner with leading oncology companies that lack a CCR5 asset like Leronlimab.
Dr. Bruce Patterson, one of the Group’s five nominees and a renowned virologist, pathologist, and cancer technology pioneer, stated: "We are excited to present our plan on how to maximize the value of Leronlimab and save the lives of countless cancer patients. We believe we have put in place a strategy that is not only executable but also best positions CYDY for future success and will repair the Company’s standing among the medical, regulatory, and investment communities. In order to protect the value of your investment in CYDY, we strongly you recommend you for our highly qualified director nominees on the WHITE proxy card today."

Dr. Patterson added, "Immuno-oncology (IO) has revolutionized oncological therapy for many cancers and makes up one of the largest cancer drug market segments. However, CYDY’s Board and management have utterly failed to capitalize on this tremendous opportunity and have not publicly presented any strategic plan on how they might make Leronlimab a reality. On the other hand, our cancer program will combine the value that Leronlimab has as a potential adjuvant therapy following treatment with the urgent opportunities that exist in IO and in doing so, will create enormous value for CYDY and its stockholders. This carefully designed plan is critical to the Company’s success, and we are excited by the prospect of finally being able to implement it."

The full text of the Group’s cancer therapy approval plan can be accessed at: www.advancingll.com/cancerplan

All CYDY shareholders are reminded that your vote is essential to charting a course towards lasting value creation and holding the current Board and management team accountable for the immense value destruction they have overseen throughout their tenure. Help us enable CYDY to achieve its incredible potential by voting the WHITE proxy card to elect the Group’s five independent director nominees today.

Important Information

Paul Rosenbaum, Jeffrey Beaty, Arthur Wilmes, Thomas Errico, M.D., Bruce Patterson, M.D., Peter Staats, M.D., Melissa Yeager and CCTV Proxy Group, LLC (collectively the "Participants") have filed a definitive proxy statement and accompanying WHITE proxy card with the Securities and Exchange Commission (the "SEC") to be used in connection with the solicitation of proxies from the stockholders of CytoDyn Inc. (the "Company"). All stockholders are advised to read the definitive proxy statement and other documents related to the solicitation of proxies. The definitive proxy statement and an accompanying proxy card is available at no charge on the SEC’s website at View Source In addition, the Participants will provide copies of the proxy statement, without charge, upon request. Requests for copies should be directed to the Participants’ Proxy Solicitor, Okapi Partners LLC, by calling (844) 202-7428.