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Lantern Pharma Establishes Manufacturing Network in Preparation for Its Phase 2 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer and a Phase 1 Clinical Trial for Solid Tumors and Glioblastoma

On July 20, 2020 Lantern Pharma (NASDAQ: LTRN), a clinical stage biotechnology company focused on leveraging artificial intelligence ("A.I."), machine learning and genomic data to streamline the drug development process and to identify the patients that will benefit from its targeted oncology therapies, reported that entering into agreements with leading contract manufacturing companies for process development and manufacturing for two of Lantern’s oncology drug candidates, LP-300 and LP184 (Press release, Lantern Pharma, JUL 20, 2020, View Source [SID1234562120]). Lantern Pharma filed an 8-K on Thursday, July 16 describing a recent agreement for GMP manufacturing.

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Lantern’s LP-300 is a small molecule drug candidate currently in preparation to enter phase 2 clinical trials in a growing, but unaddressed, type of non-small cell lung cancer (NSCLC) among never-smokers. Lantern is focused on developing LP-300 as a potential first-in-class combination therapy for never smoking (or non-smoking) NSCLC patients with histologically defined adenocarcinoma. NSCLC among never and non-smokers has a distinct molecular profile and according to the American Cancer Society, as many as 20% of people who die from lung cancer in the United States every year have never smoked or used any other form of tobacco. Leading researchers have started to classify lung cancer in never and non-smokers as having unique and distinct clinical, biological and pathological characteristics that have the potential to be impacted by new therapeutic options. According to market research, and data analytics firm, GlobalData, approximately $10 billion USD will be spent annually on NSCLC therapies in 2020 in the leading eight markets (by annual drug sales), with approximately $4 billion in the US.

Lantern’s LP-184 is a small molecule drug candidate currently in preclinical development for certain genomically defined solid tumors that overexpress certain RNA, as well as for glioblastoma multiforme (GBM). Lantern is currently planning to enter a Phase 1 clinical trial with this drug candidate in late 2021 or early 2022, after finalizing further biomarker studies with leading researchers, and after completing IND-enabling studies. Lantern estimates that, by 2025, potential annual sales for therapies in the genomically defined solid tumors targeted by LP-184 will be over $2.5 billion USD globally, and that potential annual sales for therapies to treat GBM will be nearly $1 billion globally. Both molecules have been advanced using Lantern’s proprietary RADR A.I. platform. With nearly 500 million data points, the RADR A.I. platform uses machine learning techniques, genomics, and computational biology methods to accelerate drug development by accelerating the discovery of potential mechanisms of action and developing genomic and biomarker signatures that correlate to drug UNDER EMBARGO UNTIL 8:00 AM EASTERN MONDAY, 07/20/20 response in cancer patients.

Both molecules, LP-300 and LP-184, are being developed with the vision of pairing them with companion diagnostics generated, in-part by RADR, to enable precision medicine trials and selection of patients with the highest probability of benefiting from the drug and offering the potential for best-in-class outcomes.

Panna Sharma, CEO and President of Lantern Pharma, stated, "the launch of manufacturing activities with our partners represents key steps in establishing a specialized global manufacturing network that can provide Lantern with critical scalability, flexibility and innovation to help maximize the impact of our capital resources and efficiently prepare our drug supply for our clinical trials and studies." Sharma continued, "These key capabilities are especially important now as we advance LP-300 and LP-184 towards commencement of clinical trials that can likely shape the timing and terms of potential future partnering discussions."

Dr. Reddy’s to release Q1 FY 21 results on July 29th, 2020 Earnings call slated for July 29th @ 5:30 PM IST / 8:00 AM EDT

On July 20, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it will announce results for the first quarter ended June 30, 2020 on Wednesday, July 29th, 2020 after the Board Meeting (Press release, Dr Reddy’s, JUL 20, 2020, View Source [SID1234562117]).

Summary of Events

Event Date and Time Medium
Release of financial results July 29th, after the Board Meeting Stock Exchange, Media, Company website, Business wire, Email

Press meet presentation Will be available on the Company’s website Company’s website www.drreddys.com

Earnings Call July 29th, 5:30 PM IST / 8:00 AM EDT
Hosted by the Company

(Details below)

Playback of Earnings Call After the earnings call till August 6th, 2020 Details below

Transcript of the Earnings call Will be available on the Company’s website URL available on Company’s website, www.drreddys.com

Earnings Call

Following the release, the management of the Company will host an earnings call to discuss the Company’s financial performance. (Dial In and other details given below)

Play Back

The play back will be available after the earnings call, till August 6th, 2020. For play back dial in phone No: +91 22 7194 5757 | +91 22 6663 5757, and Playback Code is 58336.

IPA Announces Repayment of Remaining 2018 Debentures and $3,811,205 in Warrant Exercises

On July 20, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTCQB: IPATF) (FSE: TQB2), a leader in full-service, therapeutic antibody discovery and development, reported that it has repaid the remaining 12.5% debentures issued in April 2018 (Press release, ImmunoPrecise Antibodies, JUL 20, 2020, View Source [SID1234562116]). In addition, IPA has received CAD$3,811,205 in connection with the exercise of previously issued warrants.

"Over the last two months we have strengthened our balance sheet with the oversubscribed convertible debenture financing and the receipt of approximately $3.8 million from warrant exercises," states Jennifer Bath, Chief Executive Officer of ImmunoPrecise. "The early repayment of the 2018 debentures removed a significant short-term debt obligation."

Of the CAD$3.8 million in warrants exercised, warrant holders exercised 875,000 warrants at CAD$1.00; 1,357,971 warrants at CAD$0.70 per share and 1,588,500 warrants were exercised at CAD$1.25 per share.

Pfenex to Announce Second Quarter Financial Results on August 6

On July 20, 2020 Pfenex Inc. (NYSE American: PFNX) reported that it will report its financial results for the first quarter ended June 30, 2020, after the market close on Thursday, August 6, 2020 (Press release, Pfenex, JUL 20, 2020, View Source [SID1234562115]). Pfenex will host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 PM Pacific Time (4:30 PM Eastern Time).

Conference Call & Webcast
Thursday, August 6th @ 1:30 PM Pacific Time (4:30 PM Eastern Time)
Domestic: 877-705-6003 (Domestic)
International: 201-493-6725
Conference ID: 13705182

The call will also be webcast and can be accessed from the Investors section of the Company’s website at www.pfenex.com or View Source

A replay of the call will also be available through August 13th. Participants may access the replay from the Investors section of the Company’s website at www.pfenex.com or View Source

China NMPA Accepts NDA Submission of Ripretinib for Advanced Gastrointestinal Stromal Tumor

On July 20, 2020 Zai Lab Limited (NASDAQ: ZLAB) and Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for ripretinib for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib (Press release, Zai Laboratory, JUL 20, 2020, View Source [SID1234562114]). Ripretinib was recently granted full approval by the U.S. Food and Drug Administration (FDA) for the treatment of fourth-line GIST. Ripretinib is also approved by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and by the Australian Therapeutic Goods Administration for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

"There is a significant unmet medical need for patients with GIST in China, especially for those who are refractory to prior therapies. Based on the recent full U.S. FDA approval and compelling clinical data from the INVICTUS trial1, we believe ripretinib has the potential to alter the treatment landscape for GIST patients in China," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "We look forward to working closely with the NMPA to make a profound impact on the way GIST is treated in China."

"The earlier than expected acceptance of the ripretinib NDA in China underscores its potential and follows the recent FDA approval in the U.S.," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "The magnitude of the unmet need for GIST patients in China is striking, with over 30,000 Chinese patients reportedly diagnosed each year. We look forward to our continued collaboration with Zai as we work to bring ripretinib to patients who are waiting for an additional treatment option."

INVICTUS is a Phase 3 randomized, double-blind, placebo-controlled, international, multicenter clinical study designed to evaluate the safety, tolerability, and efficacy of ripretinib compared to placebo in 129 patients with advanced GIST whose previous therapies have included imatinib, sunitinib, and regorafenib. Patients were randomized 2:1 to either 150 mg of ripretinib or placebo once daily. The primary efficacy endpoint was progression-free survival (PFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). As previously reported, the median PFS in the study was 6.3 months compared to 1.0 month in the placebo arm, with significantly reduced the risk of disease progression or death of 85% (hazard ratio of 0.15, p<0.0001). Secondary endpoints as

determined by independent radiologic review using modified RECIST included Objective Response Rate (ORR) and Overall Survival (OS). Ripretinib demonstrated an ORR of 9.4% compared with 0% for placebo (p=0.0504). Ripretinib also demonstrated a median OS of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36).

The most common adverse reactions (≥20%) were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia syndrome, and vomiting. Adverse reactions resulting in permanent discontinuation occurred in 8% of patients, dosage interruptions due to an adverse reaction occurred in 24% of patients and dose reductions due to an adverse reaction occurred in 7% of patients who received ripretinib.

Note: (1) NDA submission is supported by strong results from the INVICTUS pivotal Phase 3 study showing clinically meaningful improvement in both progression-free survival and overall survival.

About Ripretinib

Ripretinib is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases by using a unique dual mechanism of action that regulates the kinase switch pocket and activation loop. Ripretinib inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST, as well as the primary exon 17 D816V mutation involved in systemic mastocytosis, or SM. Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.

Ripretinib is approved by the U.S. FDA under the brand name QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Ripretinib is also approved by Health Canada under the brand name QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and by the Australian Therapeutic Goods Administration under the brand name QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Deciphera Pharmaceuticals is developing ripretinib for the treatment of KIT and/or PDGFRα-driven cancers, including GIST, SM, and other cancers.

Zai Lab has an exclusive license agreement with Deciphera for the development and commercialization of ripretinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan.